In an action that’s been called a “public health power move” and a “step in the right direction,” the federal agency responsible for regulating food safety and drugs is taking on smoking addiction.

Scott Gottlieb, commissioner of the Food and Drug Administration, announced the agency’s comprehensive plan to reduce nicotine in cigarettes to non-addictive levels. Citing smoking’s yearly death toll of 480,000, Gottlieb, appointed by President Donald Trump, said the FDA is “ready to do its share” in preventing smoking addiction in future generations.

“Unless we change course, 5.6 million children alive today will die prematurely later in life from tobacco use,” Gottlieb said in his July 28 remarks. “A renewed focus on nicotine can help us to achieve a world where cigarettes no longer addict future generations of our kids.”

This is the widest use of the FDA’s tobacco regulation power as granted by the Family Smoking Prevention and Tobacco Control Act. The act, passed in 2009 under President Barack Obama, gave the FDA regulatory power over tobacco–until now that power has not been used.

The FDA’s announcement comes as more state governments are hopping on the bandwagon to combat teen smoking addiction. New Jersey recently joined Hawaii and California in raising the legal smoking age to 21.

Though the opioid addiction crisis has been a major priority for the government in recent years, Gottlieb said he views the FDA’s opportunity to confront nicotine addiction with the same obligation.

“I’ve pledged a deep commitment to taking aggressive steps to address the epidemic of addiction to opioids,” Gottlieb said. “I’ll pursue efforts to reduce addiction to nicotine with the same vigor.”

We commend @SGottliebFDA & @US_FDA for adopting a common sense, balanced approach to tobacco & nicotine regulation. https://t.co/hOWUntQLhA pic.twitter.com/adf3MabZJx

— Tom Price, M.D. (@SecPriceMD) July 31, 2017

The agency’s next steps include seeking the public’s input on several tobacco and e-cigarette related topics, such as the prevalence of kid-friendly flavors in vaping products.

“Public input on these complex issues will help ensure the agency has the proper science-based policies in place to meaningfully reduce the harms caused by tobacco use,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.

The nicotine-reduction plan overshadowed the FDA’s announcement of several compromises on e-cigarette regulations, including the decision to postpone the deadline for companies to submit applications for new products by five years, to 2022.

These revised timelines will give the agency time to evaluate how new products and a changing tobacco market best fit into the agency’s wider goal of fighting smoking addiction, according to an FDA release.

“This action will afford the agency time to explore clear and meaningful measures to make tobacco products less toxic, appealing and addictive,” the release reads.

Anti-smoking advocates have criticized this move, saying Gottlieb’s nicotine-reduction plan was announced to detract from the potential consequences of postponing regulations on products that children and teenagers are using more.

In a statement, Matthew Myers, president of the Campaign for Tobacco-Free Kids, called the delay a “serious error.”

“This long delay will allow egregious, kid-friendly e-cigarettes and cigars, in flavors like gummy bear, cherry crush and banana smash, to stay on the market with little public health oversight,” Myers said. “There is no reason to allow these products to stay on the market while developing and implementing the comprehensive strategy Dr. Gottlieb outlined today.”

The Los Angeles Times Editorial Board published a response to Gottlieb’s announcement, calling it “troubling,” and questioning the commissioner’s intentions.

“We want to believe Gottlieb is sincere about regulation limiting nicotine,” the piece reads. “It would be one of the most important accomplishments of the Trump administration, though it would take years to implement. The damage caused by delaying the regulations on other tobacco products, however, will be immediate.”

Avery Anapol

Avery Anapol is a blogger and freelancer for Law Street Media. She holds a BA in journalism and mass communication from the George Washington University. When she’s not writing, Avery enjoys traveling, reading fiction, cooking, and waking up early. Contact Avery at Staff@LawStreetMedia.com.

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When Upton Sinclair wrote “The Jungle,” he intended to show the harsh conditions of poor immigrants working in the meat packing factories of Chicago. Published in 1906, his book ended up being one of the earliest catalysts for American food regulation. People were revolted by the unregulated food industry and the awful truth behind where their meat came from.  Sinclair’s book led to a public outcry, and many called for more regulations for the food industry. And for good reason–throughout American history up until that point there had never been any serious attempts to regulate the food industry. 

We now live in an age of big farms and monoculture. It used to be that most of the food you ate was grown or raised fairly close to where you lived. As technology and jobs changed, and the demand for meat grew, food began to be produced on a larger scale. Read on to learn more about the changing food culture and the concept of “food sovereignty.” 

Eating Local?

During President Theodore Roosevelt’s tenure, the U.S. began regulating food and drugs produced in the country with the Pure Food and Drugs Act of 1906. This act prohibited “misbranded and adulterated foods, drinks, and drugs in interstate commerce.” This was regulated by the Bureau of Chemistry in the Department of Agriculture, which eventually became the Food and Drug Administration (FDA) in 1930.

Today, food laws are still imperfect. But the American public is increasingly conscious of where and how food is produced. Debates regarding food production are happening all over the country. Most Americans eat three times a day. A 2011 study found that the average American eats roughly 1,996 pounds of food each year. With that much food at stake, it makes sense that people are concerned.

Recently in America there has been a push toward “eating local.” Many people want to go to farmers markets and buy their tomatoes and cabbage from the farmer who grew it. They want to buy their eggs from chickens that were raised in hen houses that they could visit, rather than from a place straight out of “Food Inc.” 

In short, people are more aware of where their food is coming from. And that is where “food sovereignty” comes in. It’s an issue that is starting to gain traction in the U.S. Those who advocate for food sovereignty feel that farming has become over regulated. The movement is global, and many farmers around the world are standing up for themselves and for food production as a whole.

What is Food Sovereignty?

La Vía Campesina, an international “peasant” movement, coined the term “food sovereignty” at the 1996 World Food Summit. The group defines it as such:

Food sovereignty is the right of peoples to healthy and culturally appropriate food produced through sustainable methods and their right to define their own food and agriculture systems.

With the increased demand for locally-grown produce in America, it’s becoming more popular for farmers to want to sell their produce to their local communities. But it’s also important to note that outside of the U.S., food sovereignty takes on a much more important role. Hannah Wittman, Annette Desmarais, and Nettie Wiebe, authors of “Food Sovereignty: Reconnecting Food, Nature and Community,” wrote: 

The stunted growth and high mortality rates of hungry children and the ill health and lost potential of malnourished adults are clear and tragic results of the chronic food shortages suffered by an increasing number of people. A growing number of households and communities fear for tomorrow’s meals, even though there may be enough food for today.

Shifting more power to local farmers would increase the availability of food. And food would not have to travel as much, making it less costly and more likely to be fresh.

In the U.S., Maine Leads the Way

The U.S. has very structured regulations for farmers. One state is breaking away from this model. On June 16, Maine Governor Paul LePage signed LD 725, or An Act to Recognize Local Control Regarding Food Systems. This act is the first of its kind in the United States. It shifts power from the state to local municipalities. The Bangor Daily News described the rationale behind the law:

Supporters of food sovereignty want local food producers to be exempt from state licensing and inspections governing the selling of food as long as the transactions are between the producers and the customers for home consumption or when the food is sold and consumed at community events such as church suppers.

There were already about 20 municipalities in Maine that had their own food sovereignty laws. Now with this statewide law, municipalities that apply for food sovereignty will be granted more control. 

The law allows small farmers to sell food within their communities with fewer government regulations. Maine Rep. Craig Hickman enthusiastically embraced the passage of the law. In an interview with the Bangor Daily News, he said, “Food sovereignty means the improved health and well-being of the people of Maine by reducing hunger and increasing food self-sufficiency through improved access to wholesome, nutritious, and locally produced foods.”

According to a 2012 USDA census, Maine has some of the youngest farmers in the country. And the field is drawing in more and more young farmers, partially due to the growing demand for local produce. As more farmers embraced this lifestyle, and consumers demanded local produce, Maine decided to change the regulations a bit to accommodate them.

In 2013, many municipalities in Maine fought for food sovereignty. One of their complaints was about a new law that allowed small farms that sold less than $1,000 worth of chicken a year to slaughter chickens on their own farms rather than go to a slaughter house. The regulations it sought to change would require those farms to spend as much as $40,000 to be able to properly slaughter their chickens.

The Advantages of Food Sovereignty

Less regulations may give pause to the more cautious eater or the revolted reader who cannot get the images of “The Jungle” out of his or her head. But many local Maine representatives feel that this new act is a good thing for Maine. So what regulations are being repealed exactly? While the law states that food produced locally must still adhere to federal standards, these local farms do not require state licensing, nor do they have to go through state inspections of food produced, sold, and consumed locally.

The new law does not apply to every food producer and seller, however. Chain grocery stores and establishments selling large quantities of food must still adhere to the old laws. The new act is specifically designed for small farmers selling within their communities.

Betsy Garrold, the acting executive director of Food for Maine’s Future, felt that this will encourage many young and burgeoning farmers to enter the trade. She told the Bangor Daily News, “This means face-to-face transactions are legal if your town has passed a food sovereignty ordinance [and] you can sell food without excessive government regulations,” she said. “If we can feed ourselves, no one can push us around.”

Garrold felt that with the amount of farms in Maine, large and small, it is hard to make one law that regulates everyone equally. “Now if a small vegetable farmer wants to diversify their holdings and run a few meat birds, they can,” she said.

But Not Everyone is Onboard

Maine might be alone in its quest to deregulate farmers for a while. As of right now, no other states are moving to enact food sovereignty laws.

There are national food sovereignty groups, like the U.S. Food Sovereignty Alliance (USFSA). However, the group is more engaged in activism than writing laws. USFSA “works to end poverty, rebuild local food economies, and assert democratic control over the food system,” according to its website.

And while other states do not seem to be following Maine any time soon, not even all Maine farmers are pleased with the new act. When Maine began allowing certain municipalities more sovereignty back in 2013, Kevin Poland, a local Maine farmer, was less than pleased.

“It has nothing to do with encouraging local farming,” Poland said in an interview with NPR back in 2013. “There’s plenty of that here. What there should be more encouragement of is food safety. The state of Maine has laws that work,” he added.

Perhaps this is why other states have not joined Maine in passing their own food sovereignty laws. With all of the criticism that the food industry faces, it could seem counterintuitive to try to ease regulations on those who provide us with our food.

Global Impact

While Maine may be the first state in the U.S. to enact a food sovereignty law, other global initiatives have been on the forefront of this movement for decades. La Vía Campesina (The Peasants’ Way) started in 1993 as a way to support small farmers. The group is now a huge global initiative that has been one of the largest advocates of food sovereignty. 

La Vía Campesina says on its website that it represents, “164 local and national organizations in 73 countries from Africa, Asia, Europe and the Americas. Altogether, it represents about 200 million farmers.”

Most recently, the group supported a rally in Morogoro, Tanzania on June 23. The protesters felt that the government was not acting in the best interest of the Tanzanian people. In a statement on its website, La Vía Campesina said, “We know that our African elites in the public and private sectors have been for many years colluding in corruption with the evil transnational corporations which today represent the new face of imperialist neo-colonialism.”

Conclusion

Food sovereignty is a topic that is gaining traction around the world. Those fighting for it do so because they cannot comply with the regulations imposed by the government that are intended for larger farms. For small farmers selling food within their community, these regulations can be damaging. In America, it is less dire that we change our food sovereignty laws, but in other countries, the consequences are higher. Food shortages and government corruption are why farmers around the world want to take their food back into their own hands. 

Anne Grae Martin

Anne Grae Martin is a member of the class of 2017 University of Delaware. She is majoring in English Professional Writing and minoring in French and Spanish. When she’s not writing for Law Street, Anne Grae loves doing yoga, cooking, and correcting her friends’ grammar mistakes. Contact Anne Grae at staff@LawStreetMedia.com.

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While the federal government has often struggled to control drug usage, including drugs ingested via snorting like cocaine, it’s not often that officials have to make a call on snorting chocolate powder. But since Legal Lean, an Orlando-based business, recently created a product called Coco Loko, that’s exactly what the Food and Drug Administration (FDA) may need to do.

The name Coco Loko is actually a play on Four Loko, an energy drink and alcohol mix that was banned in 2010 and deemed a public health concern. Coco Loko shares plenty of similarities with its namesake, including the energy drink aspect. The fine, brown cacao powder contains taurine and guarana, which were both identified as dangerous substances in Four Loko. The energy-boosting benefits are another commonality between the two products, Legal Lean founder Nick Anderson said.

Anderson said that snorting the powder creates “almost like an energy-drink feeling, like you’re euphoric but also motivated to get things done.” The effects normally last between 30 minutes and one hour, Anderson told the Washington Post. The product, which hit shelves in June, is being marketed as a drug-free, non-addictive way to get a buzz and an energy boost.

An important distinction for the curious is that cacao powder is the purest, least processed form of chocolate while cocoa powder is the refined powder commonly found in American stores, according to One Green Planet.

Legal Lean and Anderson first became interested in developing the product after learning of the trend that was beginning in Europe. The mixture was popular in European nightclubs, culinary institutions, and even among cyclists, according to Daily Mail. Anderson said that while he was skeptical at first, he tried snorting powder and thought “this is the future right here.”

Soon after, Anderson invested $10,000 to create his own version and spent the next 10 months searching and testing for the right recipe. By June, Anderson had the right mixture and Coco Loko was on the shelves even without approval from the FDA up to this point. One tin of powder, which contains 10 servings, sells for $24.99, according to the Washington Post.

One issue that the FDA faces is that this is uncharted territory; no one really knows the risks of snorting cacao powder, Dr. Andrew Lane, director of the Johns Hopkins Sinus Center told the Washington Post. Lane expanded:

There are a few obvious concerns. First, it’s not clear how much of each ingredient would be absorbed into the nasal mucus membranes. And, well, putting solid material into your nose — you could imagine it getting stuck in there, or the chocolate mixing with your mucus to create a paste that could block your sinuses.

A spokesman for the FDA said the agency would need to “evaluate the product labeling, marketing information, and/or any other information pertaining to the product’s intended use” before making a decision. So, for now, the product can be sold even without FDA approval.

Concerns also circulated that snorting the powder could lead customers to try other drugs, but Lane said he isn’t particularly worried about that. The FDA has not decided if, or how, it will regulate consumption. Since the product is comprised of mostly chocolate, obviously a legal food, the powder may be challenging to federally regulate, according to U.S. News and World Report. 

Sales have increased in recent months according to Alex P. of Exclusive Distributors, which helps spread the product nationwide. “It’s not flying off the shelves or anything, but people are definitely curious,” Alex, who did not release his last name, told the Washington Post. Anderson’s brother, a rapper who goes by Bezz Believe, claims to have helped popularize the product by his own usage and its appearance in his music videos.

For now, snorting the cacao powder is more of a silly niche than the fad that swept Europe over the past year. Its popularity remains minimal, but interest has grown in Houston and Atlanta, according to the New York Post. Now that an American-based product has been introduced into the market, popularity could increase. As popularity increases, more attention will be paid to how (and if) the FDA opts to regulate the product.

Josh Schmidt

Josh Schmidt is an editorial intern and is a native of the Washington D.C Metropolitan area. He is working towards a degree in multi-platform journalism with a minor in history at nearby University of Maryland. Contact Josh at staff@LawStreetMedia.com.

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We have all been subjected to the cruel injustice of opening up a new bag of chips only to find that it’s not even half-empty (or full, I guess). On Monday night, as Reuters first reported, two consumers of Wise potato chips said enough is enough, and filed a class action lawsuit in a Manhattan federal court seeking damages for consumers in New York and Washington DC who are being misled by Wise Foods and its bags of air, which contain some potato chips.

Sameline Alce and Desiré Nugent, who are from New York City and DC, respectively, cite in their complaint that Wise Foods leaves its bags 58 percent to 75 percent empty, which is far from the 30 percent that would justify the price consumers pay for the bag.

The 30 percent benchmark that the plaintiffs are referring to comes from the food industry standard known as functional slack-fill. The U.S. Food and Drug Administration defines nonfunctional slack-fill as the empty space in a package that is filled to less than its capacity for reasons besides things like protection from damages during shipping and handling, or the need for the package to perform a specific function. Certain states like California have certain protections for consumers regarding slack-fill, according to The National Law Review.

Over the years, there has been a growing trend of nonfunctional slack-fill cases. In 2015, according to The National Law Review, a class action lawsuit was filed against GNC Holdings Inc. by two consumers who claimed that GNC’s whey protein products were under-filled. In 2016, Herr Foods had a class action lawsuit filed against it for under-filling its potato chips bags.

And if you don’t believe that these slack-fill lawsuits are truly a growing trend, just go on truthinadvertising.org–the website for a non-profit that works to protect consumers from deceptive marketing–search “slack-fill,” and look at how many class action lawsuits have been filed citing this claim against food companies like Mars, Inc. and Kellogg.

So good on Alce and Nugent for fighting the good fight against big food companies constantly deceiving us. It’s only a matter of time before a lawsuit is filed to fight back against other food company outrages like how grape-flavored candies never actually taste like grapes and white chocolate isn’t actually chocolate.

Austin Elias-De Jesus

Austin is an editorial intern at Law Street Media. He is a junior at The George Washington University majoring in Political Communication. You can usually find him reading somewhere. If you can’t find him reading, he’s probably taking a walk. Contact Austin at Staff@Lawstreetmedia.com.

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Medical information is usually viewed as a private affair. But due to the proliferation of technologically advanced devices–heart monitors, X-ray devices, and even fitness trackers–the ability to gain access to a person’s sensitive health information may be easier than most realize. Unsecured devices could lead to disastrous consequences, as any alteration to a patient’s device could be a life or death situation. Medical device hacking may be the largest cybersecurity threat faced by Americans in the coming years. This gigantic security concern is quietly lurking in citizens’ insulin pumps and pacemakers.

Despite having federal and state guidelines to protect and secure individually identifiable health information, accessing a person’s most detailed medical information may be as simple as pressing a few buttons. New Food and Drug Administration (FDA) guidelines issued at the end of 2016 may be able to combat easy access to medical devices, but only with cooperation from device manufacturers. There are also no current plans for enforcement of these guidelines by the FDA, as they are non-binding recommendations. Read on to learn about the security concerns presented by medical devices.

What is a Medical Device?

A medical device, as defined by the FDA, is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory” that is used “in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.” Such devices are regulated by the FDA and may be utilized for animals as well as humans. Tongue depressors, bedpans, x-ray machines, and complex programmable pacemakers with microchip technology all fall under the broad definition of a medical device. Moreover, surgical lasers, wheelchairs, and even sutures and orthopedic pins are classified as medical devices. If the primary intended use of a product is achieved via a chemical reaction or metabolized by the body, then it will usually fall under the definition of a “drug.” The U.S. is the global leader in the medical device market, with a total market size of roughly $148 billion in 2016. The Department of Commerce determined that U.S. exports of medical devices in specific categories exceeded $44 billion in 2015. Research and development in this sector are also more than twice the average for all U.S. manufacturers.

Medical Privacy Laws

A person’s medical history is a deeply personal collection of information. Highly sensitive material ranging from mental health treatment and sexual history to genetic disorders and diseases can be contained in an individual’s medical file. Numerous laws have been passed in the U.S. on federal and state levels to ensure that Americans’ health information remains confidential and secure. The most comprehensive law ever passed in the field of medical privacy is the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The act required the Secretary of the Department of Health and Human Services to develop regulations to protect the privacy and security of certain medical information. Under HIPAA, the government established national standards to protect individuals’ medical records and give patients control over who can access personal health information. Essentially, without direct patient authorization, specific entities are limited on the uses and disclosures of individuals’ medical records.

“Paper files of medical records” Courtesy of Newtown grafitti : License: (CC BY 2.0)

In 2000, the Standards for Privacy of Individually Identifiable Health Information (the Privacy Rule) came into effect; the guidance comprehensively explains answers to questions about the privacy requirements of HIPAA. Generally, the Privacy Rule permits that incidental uses and disclosures are permissible only if they are a by-product of a reasonable or permissible disclosure. The rule requires covered entities to take reasonable steps to limit the use or disclosure of protected health information. It applies to health plans, health care clearing houses, and any health care provider who transmits health information in electronic form. Individually identifiable health information is information that relates to: an individual’s past, present, or future physical or mental health or condition, the provision of health care to the individual, or the past, present, or future payment for health care for the individual.

The Security Standards for the Protection of Electronic Protected Health Information (the Security Rule) also established national security standards for certain health information held or transferred in electronic form. The Security Rule particularly addressed technical and non-technical safeguards that covered entities must utilize to protect individuals’ electronic protected health information (e-PHI). Entities covered by the Security Rule must ensure the confidentiality and integrity of all e-PHI being received or transmitted, as well as protect against any reasonably anticipated threats to the security or integrity of such information. Under the intricacies of HIPAA’s Privacy Rule and Security Rule, the U.S. government has clearly gone to great lengths to protect citizens’ medical records from improper use or disclosure by entities without direct patient authorization. Certain medical devices utilized today may contain information regarding a person’s medical condition that is as detailed as their medical records–what ailments a person is being treated for, or what dosage of medicine a person takes daily. Therefore, protecting these devices from unwanted intrusion and hacking should be of the utmost importance to ensure patient health and privacy.

Medical Device Security and Privacy Concerns

The FDA has been warning hospitals and health providers for years that medical devices and hospitals are vulnerable to hackers. In early 2016, the Hollywood Presbyterian Medical Center in California fell victim to a ransomware attack, which infects a computer and then encrypts files until someone pays to have it unlocked. The attackers in California held patients’ medical data hostage until the ransom was paid, roughly $17,000 in bitcoin. Ransomware also hit other hospitals around the country.

One of the largest consumer concerns regarding medical devices is that individuals can do little to protect their devices themselves. It’s up to the manufacturers of a device’s hardware and software to employ proper security measures. Another issue plaguing medical devices is that most of the laws protecting medical privacy fall under the Health and Human Services’ umbrella; however, regulating medical devices falls in part under FDA jurisdiction. The disconnect explains how the interactions between medical device regulations and privacy laws lead to administrative issues. In a cybersecurity briefing, the U.S. government warned that pacemakers were easy targets for hackers.

Furthermore, in October 2016, Johnson & Johnson notified 114,000 diabetic patients that a hacker could potentially exploit one of its insulin pumps. The pump could be attacked by either disabling the device or altering the dosage of insulin. Some medical infusion pumps in hospitals are even connected wirelessly because it makes monitoring dosages easier. Patients in the hospital could potentially have their pumps controlled remotely by a hacker, which is relatively simple to do.

While the threat to medical devices has been common knowledge for the past few years, few people have attempted to rectify the glaring holes in the current system. Security researchers have managed to remotely control medical devices including pacemakers, insulin pumps, and defibrillators. Thus, it is quite possible that hackers may start setting their sights on specific medical devices, not just entire hospital systems. U.S. officials began investigating flaws in pacemakers in August 2016, when a batch ran out of battery three months earlier than anticipated. While that particular batch simply had a rare defect that caused them to fail, the months of investigation culminated in the FDA releasing 30 pages of guidance regarding medical devices’ security flaws.

New FDA Guidelines

The FDA first issued a guidance in October 2014 that contained recommendations for manufacturers to build medical devices with cybersecurity protections. These guidelines were expanded in December 2016; however, the recommendations to manufacturers were non-binding, making the document not legally enforceable and not a particularly strong stance on securing future medical devices. As part of the new recommendations issued, the FDA encourages manufacturers to swap information with each other and consistently deploy software patches and updates to fix any security vulnerabilities. Moreover, the agency has asked manufacturers to adhere to a checklist created by the National Institute of Standards and Technology. Early product development that focuses on protecting medical devices from hackers is of the utmost importance. The FDA also suggested that manufacturers join the Information Sharing and Analysis Organization to share details about detected security risks and attacks when necessary.

Conclusion

Researchers saw a rise in the occurrences of cyberattacks on a global scale in 2016. Technological advances in medical devices certainly encourage more effective health treatment, but the increasing reliance on vulnerable software potentially puts the health of citizens at risk. Thus, implementing a structured and comprehensive plan to manage cybersecurity risks is critical. While the new FDA guidelines are a respectable start to ensuring medical devices are free from cybersecurity threats, making the recommendations mandatory as opposed to voluntary may be the only way to keep individuals’ medical information safe from prying eyes. Many contend that while the recommendations could be more stringent, this is just the first step in a long road to addressing cybersecurity in the medical field. For now, the onus remains on the manufacturers to patch detected vulnerabilities in their devices and software and develop devices safe for consumers.

Nicole Zub

Nicole is a third-year law student at the University of Kentucky College of Law. She graduated in 2011 from Northeastern University with Bachelor’s in Environmental Science. When she isn’t imbibing copious amounts of caffeine, you can find her with her nose in a book or experimenting in the kitchen. Contact Nicole at Staff@LawStreetMedia.com.

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For the roughly quarter of the population that is lactose-intolerant, as well as the vegan population and those who choose to forgo dairy products for whatever reason, milk substitutes like almond milk, coconut milk, and soy milk are a total cash cow, pun intended. But dairy producers aren’t particularly happy that these things can call themselves “milk.” And they’re ready to fight back against these so-called imposters.

Congressmen from states that are home to a number of milk producers are joining together to try to get the FDA to crack down on these non-milk milk producers. In a bipartisan effort, Representative Peter Welch (D-VT) and Representative Mike Simpson (R-ID) were recently joined by 23 of their colleagues, who all signed on to a letter to the FDA. That letter asks the FDA to enforce the definition of “milk”–essentially that it has to come from a cow (or presumably, another animal that produces milk, like a goat.)

The dairy producers argue that these other kinds of milk mislead consumers into thinking that they provide the same health benefits and nutrients as cow milk. But, that’s apparently not true. According to NPR, “Some milk-like drinks contain very little protein or calcium.”

The letter to the FDA reads:

While consumers are entitled to choose imitation products, it is misleading and illegal for manufacturers of these items to profit from the ‘milk’ name. These products should be allowed on the market only when accurately labeled. We urge FDA to enforce this matter by requiring plant-based products to adopt a more appropriate name that does not include the word ‘milk.’

But the producers of these other kinds of milks have their own points to make, namely that people aren’t confused by the use of the word milk–in fact, consumers buy milk alternatives specifically because they can’t or don’t want to eat dairy.

This isn’t the first time that cow milk producers have tried to get the FDA to crack down on the other uses of the word milk; similar efforts were launched in 2001 and 2010 to no avail. It’s still unclear what the FDA plans on doing this time, although the agency has said it will respond to the congressmen who sent the letter.

Anneliese Mahoney

Anneliese Mahoney is Managing Editor at Law Street and a Connecticut transplant to Washington D.C. She has a Bachelor’s degree in International Affairs from the George Washington University, and a passion for law, politics, and social issues. Contact Anneliese at amahoney@LawStreetMedia.com.

The post What Can Legally Be Called Milk? Congress Gets Involved in the Fight appeared first on Law Street.

The federal government is cracking down on the labeling of homeopathic remedies. The Federal Trade Commission (FTC) is going to require that producers of homeopathic remedies either present science to show that their products work, or label them in a way that makes it clear that there’s “no scientific evidence that the product works.”

The homeopathic market in the United States is near $3 billion annually, but there’s no actual evidence that most of these kinds of treatments work–it’s a sort of pseudoscience. Homeopathy is based on the concept that “like cures like”–essentially if you’re sick you should take or use something that mirrors your symptoms and your body will cure itself. So, if you’re itchy, you might take some version of poison ivy. And while this new regulation won’t mean that homeopathic remedies like the St. Ignatius bean (used for anxiety) and St. John’s wort (used for pain) will disappear from shelves, the hope is that it will become clearer to the people who turn to them that they’re not actually really doing much.

According to the FTC:

Homeopathy, which dates back to the late-eighteenth century, is based on the view that disease symptoms can be treated by minute doses of substances that produce similar symptoms when provided in larger doses to healthy people.

Many homeopathic products are diluted to such an extent that they no longer contain detectable levels of the initial substance. In general, homeopathic product claims are not based on modern scientific methods and are not accepted by modern medical experts, but homeopathy nevertheless has many adherents.

To be fair, these new warnings may not change much. People who use homeopathy usually do so based on a true belief that the science is correct, regardless of the evidence. But for those who walk into a drug store, see homeopathic remedies, and assume that they’re effective because they’re sold alongside real medicine, these labels could make a difference.

Anneliese Mahoney

Anneliese Mahoney is Managing Editor at Law Street and a Connecticut transplant to Washington D.C. She has a Bachelor’s degree in International Affairs from the George Washington University, and a passion for law, politics, and social issues. Contact Anneliese at amahoney@LawStreetMedia.com.

The post Homeopathic Treatments Will Now Need to Disclose if They’re BS appeared first on Law Street.

For decades, Americans have been grappling with what it means to eat a healthy, well-balanced diet as more information regarding our industrial food system comes to light. Now, it seems the Food and Drug Administration (FDA) has jumped on the bandwagon, revisiting food labels and the definition of “healthy” in an effort to redefine an outdated version.

Public health concerns over misleading food labels and nutrient content claims have increased rapidly, particularly because of the growing obesity epidemic in America. While it is sure to be a lengthy and laborious process, the FDA is seeking public comments to help shape the new definition of “healthy.” The original definition of “healthy” was created decades ago in the mid-1990’s. As nutrition science has evolved, food labels and FDA-regulated definitions of nutrient content claims have been exceedingly slow to catch up. 

Food Labels and Nutrient Content Claims

The FDA is responsible for ensuring that all food sold in the U.S. is safe and properly labeled, whether food is produced domestically or in foreign countries. The federal laws governing food products are primarily the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act. The FD&C Act is a set of laws passed by Congress in 1938 to give the FDA oversight in ensuring the safety of food, drugs, and cosmetics. These laws regulate many aspects of the food industry, including food additives, food coloring, and even bottled water.

The Fair Packaging and Labeling Act applies to labels on most consumer products. Passed under President Lyndon B. Johnson in 1966, it requires a label to state: (1) the identity of the product; (2) name and place of business of the manufacturer, packer, or distributor; and (3) the net quantity of contents. The Act applies to products considered “consumer commodities” to prevent unfair or deceptive packaging and labeling.

The Nutrition Labeling and Education Act (NLEA), however, amended the FD&C Act and gave the FDA explicit authority to require food labeling on most food packages and nutrients listed on the nutrition label. The NLEA was passed in 1990 by President George H. W. Bush. Moreover, the NLEA requires that all nutrient content claims, like “low fat” or “high fiber,” comply with the FDA’s regulations. The NLEA does not apply to food served or sold in restaurants, nor does it apply to meat or poultry products, which are regulated by the United States Department of Agriculture. The FDA  proposed a variety of new amendments and regulations, with a few goals in mind: clearing up any sort of confusion surrounding nutrition and food labels, assisting consumers in choosing healthier products, and finally, giving food companies an incentive to improve nutritional qualities of their products.

Nutrient content claims can be found plastered all over food products and packages. Under the NLEA, the FDA regulates the definitions of  “free,” “low,” “light,” “reduced,” “less,” “high,” and many more. In developing the criteria for each of the claims, the FDA looked to dietary recommendations for each nutrient, analytical methods, distribution and abundance of particular nutrients in the food supply, and other considerations.

“Healthy” Food

The push to change the FDA’s definition of “healthy” came originally from the makers of Kind bars, which are granola bars containing many fruits and nuts. The product is currently marketed as “healthy and tasty.” The problem, however, is that the amount of fat contained in the bars is far too high to comply with the FDA’s low-fat restrictions on healthy food. In May of 2016, the company challenged the status quo when the FDA complained that the label “healthy” on Kind bars was improper based on the current definition.

“Kind Snack Bars” Image Courtesy of Mike Mozart : License (CC BY 2.0)

Currently, if a food product is to be labeled “healthy,” the product must be very low in fat according to the regulations. Essentially, it is a nutrient content claim, meaning the term can only be used on a product if it has certain nutritional qualities based on attributes like levels of fat and sodium. While the rules themselves are highly complex, it boils down to the fact that a snack food, for example, can have no more than three grams of fat per serving to be considered “healthy.” It also must contain at least ten percent of the recommended daily value for vitamin A, vitamin C, calcium, iron, protein, or fiber per RACC (Reference Amounts Customarily Consumed). The definition differs for individual foods, seafood/game meat, and a meal or main dish.

Thus, under the current definition, nuts–which have long been known to be a high-fat food–cannot qualify as “healthy” under the current FDA regulations. While nuts are high-calorie, they are full of healthy fats that are known to be good for preventing cardiovascular disease, maintaining mental health, and are now seen as an ideal source of protein.

The term “healthy” was originally defined in 1994, at the height of the fat-free craze. Americans started replacing high-fat foods with more processed foods that were full of refined sugar, but still touted as healthy because they were “low-fat.” It was difficult to navigate a grocery store aisle without seeing “low-fat” labels plastered proudly on a variety of products, even ones that a consumer would not even think to have a high-fat content. We now know that consuming massive quantities of other food products with additives, like sugar, has far more negative consequences than eating plant-based food sources teeming with healthy fats.

The Future of “Healthy

Critics of the current definition of “healthy” have valid points. Under the current regulations, Frosted Flakes may be labeled “healthy” as the product is low-fat and fortified with vitamins, which is counterintuitive to what Americans know to be healthy food choices. While the FDA is determining how best to redefine “healthy,” it has stated it will exercise discretion in how it enforces the current rules. Thus, the agency will not be taking action against food manufacturers, like Kind, who produce foods that don’t meet the exact definition, but are still low in total fat and contain at least ten percent of the recommended vitamin D and potassium. The FDA issued guidance in September to reflect its newfound discretion, as prior public participation was not deemed feasible or appropriate.

Dietary guidelines have been more quickly catching up to changing nutritional science. Earlier this year, the dietary guidelines for 2015-2020 and the Nutrition Facts label were updated to recommend that people eat food rich in healthful fats. Over the next few years, nutrition labels will be updated to more accurately and clearly reflect a serving size, as well as how much added sugar is in a particular product. After decades of nutrition labels remaining mostly the same, this is a significant step in addressing the obesity epidemic in the U.S., particularly since many citizens rely on nutrition labels to provide them with reliable information. A governmental study showed that 77 percent of American adults say they read labels on food packaging when they shop.

When imagining how the new definition of “healthy” could unfold, it is likely there will be a focus on sugar. Current evidence demonstrates a link between excessive sugar consumption and obesity. Additionally, the new definition will likely redefine fat intake, particularly encouraging responsible consumption of healthy fats from plants and omega-3 sources, like fish.

Conclusion

These proposed changes clearly show the FDA is finally attempting to follow significant nutrition science breakthroughs. Ideally, people would not need food labels to tell them how to eat more healthfully and would simply make smarter food choices, like limiting processed foods and eating loads of fruits and vegetables. Famed nutrition scientist Marion Nestle argues against food labels, stating that companies utilize them to make misleading claims about their products.

Currently, many Americans still rely heavily on food labels to provide them with information about how to eat more healthfully. For now, nutrition labels and dietary guidelines are here to stay, particularly as this country attempts to combat a widespread obesity epidemic. Moreover, “healthy” isn’t the only label that may receive a significant overhaul; the FDA is currently reviewing giving “natural“a legal definition after receiving roughly 7,600 comments on the term.

The public has the ability to comment on the FDA’s website right now to help shape the new definition of “healthy” for the future. The changes may not be implemented for some time, but having a concrete voice in the FDA’s future rules and definitions is an important thing to consider. The comment period started on September 28, and will remain open for the time being. You may submit electronic comments and information to the Regulations.gov website or mail in written comments to the address listed on the FDA’s website.

Resources

Primary

FDA: Food Labeling Guide

FDA: Nutritional Labeling and Education Act (NLEA) Requirements (8/94 – 2/95)

FDA: “Healthy” on Food Labeling

FDA: Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products

NIH: History of Nutrition Labeling

NIH: FDA Regulatory Requirements for Nutrient Content Claims

Additional

NPR: Why The FDA is Re-Evaluating the Nutty Definition of ‘Healthy’ Food

Wall Street Journal: FDA Takes Step Toward New ‘Healthy’ Labeling

CNN: Your Food Labels are Getting a Makeover, FDA Announces

NPR: FDA Is Redefining the Term ‘Healthy’ on Food Labels

Nicole Zub

Nicole is a third-year law student at the University of Kentucky College of Law. She graduated in 2011 from Northeastern University with Bachelor’s in Environmental Science. When she isn’t imbibing copious amounts of caffeine, you can find her with her nose in a book or experimenting in the kitchen. Contact Nicole at Staff@LawStreetMedia.com.

The post “Healthy” Food: FDA to Redefine the Term on Food Labels appeared first on Law Street.

When introducing a new drug into the consumer marketplace, companies must undergo a rigorous testing and approval process from the Food and Drug Administration (FDA). After a company obtains promising lab results, applications are then submitted to the FDA to implement clinical trials. Clinical trials can last for years before a new drug application (NDA) is submitted to the FDA for approval. To speed up this lengthy process, an initiative was passed in 2007 by Congress under the Food and Drug Administration Amendments Act (FDAA) that contained a special section for priority review vouchers. Drugs for specific tropical diseases and rare pediatric disorders are eligible for such a voucher.

Priority review vouchers allow a company to fast-track government review for a particular drug. These “golden tickets” can be extremely valuable for drug companies, since the difference in drug approval can be as long as seven months. Companies also have the option to sell the vouchers to the highest bidder; since vouchers do not expire, they can then be sold an unlimited amount of times. While this valuable program may incentivize the creation of drugs for problematic diseases and disorders, it has also been met with its critics who state the program is ineffective and simplifies complex issues.

Evolution of Priority Review Vouchers

The development of a new drug is an extremely long and cost intensive process. Drugs tend to be in the preclinical and discovery state for one to six years, and then enter the clinical phase for about six to eleven years before finally reaching the FDA for review. Normally, FDA drug review takes ten or more months, but can be upwards of two years before a drug is approved for the market.

The priority review voucher program was first introduced in a paper in March 2006, published in the Health Affairs journal, from a team of researchers at Duke University. In “Developing Drugs for Developing Countries,” the authors advocated for a priority review system, as there were no sufficient incentives for companies to produce drugs for neglected tropical diseases. The “prize” could either be redeemed by the recipient or sold to another company for use. The voucher does not guarantee approval by the FDA, but it does guarantee that a drug will be reviewed and have a decision rendered within six months in conjunction with the NDA.

In 2007,  the priority review voucher system became a reality when Congress passed the FDAA, which contained the provision “Priority Review to Encourage Treatments for Tropical Diseases” in Section 1102. Any drug intended to treat a number of diseases including: malaria, cholera, tuberculosis, and leprosy, among many others, was eligible to receive a priority voucher. These diseases were chosen because they tend to occur in poorer and developing countries that lack adequate market incentives to invest and develop treatments for “neglected tropical diseases” (NTD). As of April 19, 2016, Zika was also added to the list of tropical disease eligible to receive a priority review voucher.

Expansion of the Program

In 2012, the the priority review voucher program was expanded to include rare pediatric diseases. Under the Food and Drug Administration Safety and Innovation Act (FDASIA), Congress approved the voucher for additional therapies for rare pediatric subsets of other diseases. Section 908 of FDASIA has defined a “rare pediatric disease” as one which “primarily affects individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents.” It is also a rare disease according to federal statute, meaning it affects 200,000 persons in the U.S. or fewer.

The expansion of the voucher system to rare pediatric diseases included some key differences. While modeled after the tropical diseases voucher, the rare pediatric voucher was much easier to use. For a tropical voucher, the FDA had to be notified 365 days prior to its use, while the rare pediatric voucher had a 90-day time frame. Moreover, the rare pediatric voucher was eligible to be sold an unlimited amount of times, while the tropical disease voucher could be sold only once.

In December of 2014, the stark differences were eliminated between the two vouchers under the law Adding Ebola to the FDA Priority Review Voucher Program Act. Now tropical vouchers may be sold an unlimited number of times and may be redeemed in just 90 days. Currently, the cost of the voucher fee for 2016 is $2.7 million, in addition to the NDA feed of $2.4 million.

Vouchers Awarded and Used

To win a voucher, a company requests a priority review designation from the FDA, which determines if the drug is significant enough to treat a particular condition. Once the FDA awards a company priority review designation, it will take another six months to determine if the drug should be awarded a priority review voucher. If a company receives or purchases a priority review voucher, it is then able to inform the FDA of its intent to use the voucher on an upcoming submission. The FDA will have the option to accept the voucher and agree to review the drug and come to a decision within six months.

Currently, the FDA has awarded nine vouchers–six for rare pediatric diseases and three for tropical diseases. Drugs for the NTDs malaria, tuberculosis, and leishmaniasis were awarded vouchers, as well as the drugs for the following pediatric diseases: Morquio A syndrome, high-risk neuroblastoma, rare bile acid synthesis disorders, hereditary orotic aciduria, hypophosphatasia, and lysosomal acid lipase deficiency.

Interestingly enough, five of the vouchers awarded have remained unused. Five of them were either transferred or sold, and to date, only four vouchers have been used. In total, two of the vouchers used have resulted in FDA approval, one has been rejected, and one is still in review.

The money these vouchers have been able to generate in the market has been staggering. BioMarin’s voucher from 2014, the first ever to be sold, was purchased for $67 million. Subsequent vouchers sold fetched even higher prices, with the most recent voucher sold in August 2015 by AbbVie, who paired $350 million for a voucher original awarded to United Therapeutics.

Efficacy of Priority Review Vouchers

Recently, priority review vouchers have come under fire for not necessarily incentivizing development in the areas the program was designed to assist, namely NTDs.  A few articles have emerged lambasting the use of priority review vouchers, denying that they are stimulating any sort of drug innovation and development.

For example,  the first priority review voucher was awarded to Novartis’ anti-malarial drug Coartem; however, the drug was widely used around the globe for almost a decade before the FDA approval. Thus, awarding a priority review voucher for this drug does not necessarily create an incentive for new drug innovation. Instead, it is merely a large sum of money that does not encourage new research and development. Moreover, Impavido, a treatment for leishmaniasis created by Knight Therapeutics, was largely developed by the World Health Organization and other partners back in the 1990s and approved in 14 countries before 2010.

This seems to be indicative of a loophole for pharmaceutical companies, one in which older drugs are are registered in order to obtain a highly valuable voucher. At least for NTDs, exploitive practices by companies appear to be the norm, most recently illustrated by KaloBios’ attempt to obtain a voucher for a widely used drug to treat Chagas’ disease after acquiring the rights to the drug from another company.

As for rare pediatric diseases, the U.S. Government Accountability Office has recently stated that it is still too early to determine whether the voucher program is working. The six drugs awarded vouchers were already in development before the program’s expansion in 2012. It is quite possible that drugs would have been approved without a voucher in the first place, and they were not developed with the incentive of a priority review voucher as the ultimate goal.

Other Concerns

Recent papers published earlier this year in an issue of Health Affairs note even more concerns with the priority review vouchers, as well as ways to strengthen the program. The availability and affordability of the drugs in the program are also a concern; after garnering a priority review voucher, there is no requirement that the drug be affordable or accessible. Global health advocates even requested that Sirturo, a tuberculosis drug awarded a voucher, be made more affordable for lower income families in areas where the disease exists the most.

The FDA has qualms that the voucher program is diverting resources away from other drugs still in review. The timelines between standard drugs and priority review voucher drugs differ substantially. By compressing the time frame significantly in which a drug must be reviewed, the FDA experiences more strain in trying to find qualified staff. Additionally, the drugs reviewed may be highly complex, which does raise some safety concerns.

Another significant concern is that the priority review voucher ignores a new drug’s actual utility, focusing only on a new drug’s ingredients. An effective drug that needs to be taken multiple times a day, something highly resource-intensive in developing countries, would be given priority over a following drug that was more sustainable from a cost and resource standpoint. Furthermore, drugs with little or no urgency may be able to have an accelerated review and approval, while drugs desperately needed on a much smaller timeline may have to wait years.

Conclusion

The lucrative nature of priority review vouchers is undeniable. The prize of a voucher means a swift path to a final FDA decision, which can put a company far ahead of the competition. Since the vouchers can then be sold an unlimited amount of times, the amount of money generated for already well-endowed pharmaceutical companies indicates that the program may need substantial review and an intensive overhaul. It may be critical to strengthen the qualifying criteria for obtaining a priority review vouchers to encourage new drug development or perhaps fixing the quantity of vouchers that can be available or redeemable at any given time.

The purpose of such a program is noble; for long-forgotten corners of the world, incentivizing the creation of drugs to combat and manage devastating diseases can be the difference between life and death. However, ensuring the drugs are not only new, but also accessible and affordable to those affected by severe diseases is of the utmost importance.

Resources

Primary

FDA: Development & Approval Process (Drugs)

U.S. Government Accountability Office: Rare Diseases: Too Early to Gauge Effectiveness of FDA’s Pediatric Voucher Program

Congress.gov: S.2512 – Adding Zika Virus to the FDA Priority Review Voucher Program Act

Additional

NPR: Are Golden Tickets That Speed Drugs Through FDA Worthwhile?

PriorityReviewVoucher.org

Regulatory Affairs Professeionals Society: Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

Health Affairs Blog: Are Priority Review Vouchers The Answer To Incentivize Drug Development? Not So Fast.

Health Affairs: Prescription Drugs, Global Health & More

OxFam International: Robbing the Poor to Pay the Rich–Novartis’ Christmas Gift to Itself!

MarketWatch: KaloBios Approved for Chagas Disease Drug Deal

Aids-Free World: Open Letter: Reducing the Price of Bedaquiline

Nicole Zub

Nicole is a third-year law student at the University of Kentucky College of Law. She graduated in 2011 from Northeastern University with Bachelor’s in Environmental Science. When she isn’t imbibing copious amounts of caffeine, you can find her with her nose in a book or experimenting in the kitchen. Contact Nicole at Staff@LawStreetMedia.com.

The post FDA Priority Review Vouchers: Golden Tickets or Inefficient Incentives? appeared first on Law Street.

Every day, millions of Americans use antibacterial hand soaps and body washes. Fears of disease and infection have caused the ubiquitous use of these products in the home, at work, and at school. In 2009, the H1N1 virus caused Americans to buy antibacterial soaps in record numbers; it’s now difficult to even find a single soap on the market not dubbed as “antibacterial.” On September 2, 2016, the Federal Food and Drug Administration (FDA) rattled common conceptions about these antibacterial products in a final order issued by the administration.

According to the FDA, over-the-counter (OTC) antiseptic wash products with one or more of a specific list of 19 active ingredients can no longer be marketed to consumers. With the rising threat of antibiotic resistance, noted by the Center for Disease Control (CDC) in a report issued in 2013, this shows a dramatic shift toward limiting the daily use of antibacterial products by consumers. According to the CDC, washing with plain soap and water continues to be the most effective method for avoidance of illnesses and preventing the spread of germs. Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, stated that data now suggests long-term use of antibacterial ingredients may be doing more harm than good.  Keep reading to learn more about the history of antibacterial soaps and the potential hazards they possess. 

HISTORY AND EVOLUTION OF ANTIBACTERIAL SOAPS AND WASHES

Chemically, soap is a salt of a fatty acid that transforms insoluble particles to soluble ones in water, allowing them to be rinsed off. Oil particles, for example, become soluble in water with the addition of a few soap drops. Soap has been around for centuries, with the earliest record of its use found around 2800 B.C. in ancient Babylon. A formula for soap consisting of water, alkali, and cassia oil was even found on a Babylonian clay tablet dating back to that time period. The Latin word for soap, sapo, first appears in Pliny the Elder’s encyclopedia “Historia Naturalis,” which discusses the manufacture of it from tallow and ashes. 

In the past, bathing with soap was for social or ritualistic reasons rather than for cleanliness. Industrialized nations began using soaps more commonly due to an increased understanding of the role hygiene plays in reducing the size of microorganisms. Amidst the 16th century, more luxurious soaps started being produced in Europe using vegetable oils. The late 18th century gave rise to the first industrially manufactured bar soaps. Liquid soap was not invented until the 1800’s, and in 1865, William Sheppard patented a liquid version of soap.  

According to official records, antibacterial soap was invented in 1984 by David Poshi and Peter Divone, who filed for a patent in December of that same year. Poshi and Divone added triclosan to the formulation, an antibacterial and antifungal agent that breaks down bacterial cell walls to kill them. Triclosan had previously only been used in the 1970’s as a hospital scrub. Now, it can be found not just in soap, but shampoos, deodorants, mouthwashes, and toothpastes.  

Dial soap, however, was technically the world’s first antibacterial soap on the market. In 1948, chemists from Armour and Company, a meat-packing company, developed the soap and introduced it to the Chicago market. The antibacterial properties were from the chemical hexachlorophene, referred to as AT-7, and it promised “round-the-clock” protection. The company first advertised the product on the pages of the Chicago Tribune with scented ink, and it became the leading deodorant soap manufacturer in the U.S. By the 1970’s, however, hexachlorophene was removed from the market and restricted only to the hospital setting due to reports of the chemical causing infant neurological damage. Armour then replaced the ingredient with triclocarban. Currently, the United States spends about 1 billion dollars annually on products containing triclosan and triclocarban, and about 80 percent of all antimicrobial bar soap contains triclocarban.

GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE 

In 1938, Congress passed a set of laws known as the Federal Food, Drug, and Cosmetic Act to oversee and ensure the safety of food, drug, and cosmetic products in the United States. The Act defines “new drugs” as ones that have a “composition which has not been generally regarded as safe and effective by qualified experts.” The designation of generally recognized as safe and effective (GRASE) applies to particular old drugs that do not require prior approval of the FDA in order to stay or enter the marketplace because they have been recognized as generally safe and effective by medical professionals.

Essentially, a drug is not considered a new drug when it fits under the designation of GRASE. The FDA has three criteria for establishing a drug as GRASE:

1. The particular drug must have been the subject of adequate and well-controlled clinical investigations.
2. The investigations must be published in scientific literature available to qualified experts.
3. Experts must generally agree based on the published studies that the product is safe and effective for intended uses.

After reviewing available literature and research, along with hosting public meetings, the FDA has now determined that 19 chemicals used in antibacterial soaps and washes are no longer generally recognized as safe and effective.

POTENTIAL HAZARDS FROM DAILY USE

In 2013, the FDA proposed a rule after data suggested that long-term exposure to certain active ingredients in hand and body washes could pose serious health risks, such as bacterial resistance or hormonal effects. Manufacturers were then required to provide additional data to the agency regarding the general safety and effectiveness of particular ingredients in order to continue marketing these products.  This included a demonstration that the products were superior to non-antibacterial ones. Since then, manufacturers of antibacterial hand soaps and body washes containing these ingredients have not provided the necessary data to satisfy a designation of “safe and effective.”

Two of the most commonly used ingredients, triclosan and triclocarban, are two of the 19 chemicals included in the list. As indicated by the FDA, almost all soaps labeled as “antibacterial” or “antimicrobial” contain at least one of the 19 ingredients. Triclocarban has a hazard quotient of greater than one, which indicates adverse effects on organisms due to toxicity. It is found in extremely high concentrations in aquatic environments and may be disruptive to hormones critical for developmental and endocrine processes in wildlife. In tests conducted all over the globe, including the United States, scientists have detected triclosan in water supplies. Both triclosan and triclocarban have also been shown to be 100-1,000 times more effective in inhibiting and killing algae, crustaceans, and fish than they are at killing microbes. The Environmental Protection Agency currently regulates the use of triclosan as a pesticide.

“Antibacterial Soap Triclosan” Courtesy of [Mike Mozart via Flickr]

The high potential for triclosan-caused endocrine disruption in humans is also a significant hazard. While the rate of absorption in the skin is low and minimal interaction with the chemical may not have adverse effects, repeated low-dose exposure to triclosan could cause endocrine disruptions over time. Although there is not yet definitive proof that demonstrates triclosan is dangerous to humans, the information uncovered through years of animal studies suggests otherwise.

Moreover, research now demonstrates that it is critical to maintain exposure to bacteria to maintain a healthy human microbiology. A study published this month in Environmental Science and Technology noted a positive association between the concentration of antimicrobials and the abundance of antibiotic resistant genes. The team of scientists from the University of Oregon, Harvard School of Public Health, and Arizona State University found that particular dust samples collected with high levels of triclosan had higher levels of genes linked to antibiotic resistance. Even back in 2001, a team of scientists found that 76 percent of liquid soaps on that market contained antibacterial agents. They also found that no scientific evidence had ever been published to note that the use of such chemicals did anything to prevent infection.

CONCLUSION

Public health concerns over antibiotic resistance and deadly outbreaks from superbugs prompted this deeper inspection into antibacterial products and their efficacy. This final rule by the FDA impacts the soap industry on a massive scale, and some advocates are pushing back. A spokesperson for the American Cleaning Institute stated that “washing the hands with an antiseptic soap can help reduce the risk of infection beyond that provided by washing with non-antibacterial soap and water.”  

Manufacturers have only one year to comply with the final ruling by either reformulating the ingredients in their products or removing them from the marketplace altogether. Many companies have already started to phase these 19 chemicals out of their products after the 2013 FDA proposed rule, in an effort to stay ahead of the curve. Triclosan has now been replaced in products with one of three other chemicals: benzalkonium chloride, benzethonium chloride, or chloroxylenol. Companies have another year to provide data demonstrating their safety and effectiveness.

An important point to note is that this final rule does not apply to consumer hand sanitizers and wipes, or antibacterial products used in healthcare settings. For sanitizers, the FDA has requested additional information to support the safety and efficacy of those ingredients used in OTC topical consumers antiseptic products. Additionally, products such as toothpaste are not affected by this change, including all of the clothing, kitchenware, furniture, and toys that are formulated with triclosan to prevent bacterial contamination. Even with drastic industry changes ahead, it seems much research is still needed regarding antibacterial product use.

RESOURCES

Primary

U.S. Food & Drug Administration: FDA Issues Final Rule on Safety and Effectiveness of Antibacterial Soaps

U.S. Food & Drug Administration: GRASE

U.S Food & Drug Administration: Antibacterial Soap? You Can Skip It — Use Plain Soap and Water

U.S. Food & Drug Administration: FDA Requests Additional Information to Address Data Gaps for Consumer Hand Sanitizers

EPA.gov: Triclosan

American Cleaning Institute: Soaps & Detergents

Environmental Science & Technology: Antimicrobial Chemicals Are Associated with Elevated Antibiotic Resistant Genes in the Indoor Dust Microbiome

Additional

NPR: FDA Bans 19 Chemicals Used in Antibacterial Soaps

Funding Universe: The Dial Corp. History

Forbes: FDA Saves Us From Ourselves, Halts Overexcessive Use of Antibacterial Soaps

Nicole Zub

Nicole is a third-year law student at the University of Kentucky College of Law. She graduated in 2011 from Northeastern University with Bachelor’s in Environmental Science. When she isn’t imbibing copious amounts of caffeine, you can find her with her nose in a book or experimenting in the kitchen. Contact Nicole at Staff@LawStreetMedia.com.

The post 24-Hour Protection?: FDA Bans Common Chemicals in Antibacterial Washes appeared first on Law Street.

There is a divide in America between how the federal government classifies marijuana and how some individual states do. And that divide probably won’t be bridged any time soon. On Wednesday, the chief of the Drug Enforcement Administration (DEA) wrote a letter to a trifecta of petitioners who sought to prod the institution into liberalizing its restrictions on the drug. Chuck Rosenberg, the chief of the DEA, wrote: “[Marijuana] does not have a currently accepted medical use in treatment in the United States, there is a lack of accepted safety for its use under medical supervision, and it has a high potential for abuse.” Marijuana is a Schedule I substance, which limits researchers’ abilities to study its medical properties, and of course, renders it illegal.

Governor Gina Raimondo (D-RI), Governor Jay Inslee (D-WA), and a nurse from New Mexico, Bryan Krumm filed the petition with the DEA, and were the fourth straight petitioners to be rejected for similar requests. In his letter, Rosenberg painted his decision as hardly a decision at all, but as a responsibility bound by science and the FDA’s conclusions regarding the lack of evidence in regards to any positive medical properties of the drug.

“This decision isn’t based on danger. This decision is based on whether marijuana, as determined by the FDA, is a safe and effective medicine,” Rosenberg wrote, “and it’s not.”

Keeping marijuana in the same category as heroin is absurd. The time is long overdue for us to remove the federal prohibition on marijuana.

— Bernie Sanders (@BernieSanders) August 11, 2016

Marijuana’s classification as a Schedule I drug is a nearly 50 year-old demarcation defined under the Controlled Substances Act of 1970. The characteristics of a Schedule I drug, according to the CSA, include “a high potential for abuse,” “no currently accepted medical treatment use in the U.S.,” and “a lack of accepted safety for use of the drug or substance under medical supervision.” Rosenberg said the FDA upholds those standards in regards to marijuana, and the classification at this point in time remains the same.

“If the scientific understanding about marijuana changes,” he added, “the decision could change.” Heroin, LSD and bath salts are some of the other drugs classified as Schedule I. Cannabis is treated differently at the state-level, however. At the moment, 25 states and the District of Columbia have legalized medical marijuana.

The War on Marijuana by the DEA continues…

— Tommy Chong (@tommychong) August 11, 2016

And though there is no direct causal evidence that marijuana can treat specific diseases or disorders, doctors often prescribe patients the drug for pain relief. The American Academy of Pediatrics, while it opposes legalizing marijuana for recreational use, supports re-classifying the drug in order to allow for unhindered research. “The Academy supports further study of cannabinoids, which limited research to date shows can help specific conditions in adults,” the group wrote last year.

Rosenberg acknowledged the difficulty scientists face in researching marijuana, but said the DEA has “never denied” requests to study legally produced pot. At the moment, the University of Missouri has the only lab that can legally grow the plant for research purposes. Some analysts see the FDA and DEA as being in an intractable loop: the FDA can’t conduct research on marijuana because of how the DEA classifies it, and the DEA classifies it as such because of the lack of scientific literature proving it as safe and beneficial.

At this point, it might be Congress is the only means forward for loosening the restraints on marijuana research. It’s a largely bipartisan priority, and with five states voting this November to legalize recreational marijuana, the issue won’t be disappearing any time soon.

Alec Siegel

Alec Siegel is a staff writer at Law Street Media. When he’s not working at Law Street he’s either cooking a mediocre tofu dish or enjoying a run in the woods. His passions include: gooey chocolate chips, black coffee, mountains, the Animal Kingdom in general, and John Lennon. Baklava is his achilles heel. Contact Alec at ASiegel@LawStreetMedia.com.

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It’s a question that lays bare the ambiguity of semantics, a deceivingly tricky question with wide-ranging consequences, a question that has stumped consumers and companies for years: When should packaged food products be labeled “natural”?

In a response to petitions and lawsuits from consumer advocacy groups and consumers themselves, the Food and Drug Administration (FDA) reached out to the public in 2014 to help them define once and for all what “natural” constitutes when it’s slapped on food products. The public comment period closed on May 10 and it could take months for the FDA to pour over the nearly 7,600 statements, which came from consumers, companies, food experts and health and legal authorities.

Here is a sampling of public comments written between November 2015 (when the comment period opened) to May 10, 2016 (when it closed):

• “I believe natural foods should be defined as a product that has went through little processing as possible. Although it goes through little to no processing, it is still completely healthy to consume or use.”
• “Natural means in it’s original state and how nature intended it to be, not fattened, chemically altered or any other practice that uses synthetic or unnatural anything.”
• “Please stop poisoning us. Ban all chemicals, artificial colors, preservatives from our food. Life is not all about profits and money. Companies add all this unhealthy stuff to our food to maximize profits.”

Certain things are more obviously unnatural than others. There are some products labeled “all natural” that contain artificial preservatives, coloring, and other chemical additives. But then there is the slippery world of genetically modified organisms, or GMOs. According to the Non GMO Project, GMOs are “living organisms whose genetic material has been artificially manipulated in a laboratory through genetic engineering.”

But humans have been modifying crops and animals for millennia to select for advantageous features–pest resistance, size, nutritional value, yield–so the question of whether GMOs are natural or unnatural is murky. A study published by the National Academies of Sciences, Engineering and Medicine on Tuesday found GMOs to be no less healthy than untouched varieties, though they do produce pesticide resistant pests, which could lead to a cycle of increased spraying and even more resistance.

An example of how the line between “natural” and GMO isn’t quite clear cut:

In January 2014, a consumer by the name of Elizabeth Cox brought a deceptive marketing lawsuit against Gruma Corp, the maker of Mission tortilla chips–whose packaging contained in big white font: “All Natural!” Cox was angered over the label because the corn used in the chips came from the GMO variety. Gruma deferred to the FDA, arguing that as it pertained to their definition of “natural,” GMOs fit the bill. There have been more than 50 similar cases brought against producers by consumers.

It will likely take months before the FDA lands on a definition for what “natural” means, so for now it’s up to you to decide what’s best for your body.

Alec Siegel

Alec Siegel is a staff writer at Law Street Media. When he’s not working at Law Street he’s either cooking a mediocre tofu dish or enjoying a run in the woods. His passions include: gooey chocolate chips, black coffee, mountains, the Animal Kingdom in general, and John Lennon. Baklava is his achilles heel. Contact Alec at ASiegel@LawStreetMedia.com.

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The Food and Drug Administration (FDA) is making a big push to regulate e-cigarettes, cigars, and other non-cigarette smoking devices for the first time. The FDA has been working on these rules for a while, but finalized them on Wednesday. Most of the regulations pertain to smoking via means that aren’t traditional cigarettes, cigarette-related products, or smokeless tobacco–such as hookah, e-cigarettes, and cigars.

One of the most noteworthy new policies is that the FDA will ban the sale of e-cigarettes to individuals under the age of 18. Additionally, the way that e-cigarette manufacturers are allowed to market the e-cigarettes already on sale will require federal permission. The other regulations that will be placed on e-cigarettes include:

A prohibition on distribution of free samples; a ban on selling e-cigarettes in vending machines unless they are in secure places that never admit young people; and a requirement that e-cigarettes carry warnings that they contain nicotine, which is addictive.

Additionally, the regulations will ban the sale of cigars, pipe tobacco, and hookah tobacco to minors under 18.

The FDA put out a statement about its new regulations, stating:

This action is a milestone in consumer protection — going forward, the FDA will be able to review new tobacco products not yet on the market, help prevent misleading claims by tobacco product manufacturers, evaluate the ingredients of tobacco products and how they are made, and communicate the potential risks of tobacco products.

The FDA has been attempting to regulate e-cigarettes for some time. In 2009, the FDA tried to regulate e-cigarettes as drug-delivery products, but a court ruling struck those provisions down in 2010. The newly announced regulations have been two years in the making, as the FDA has sought to deal with the new influx of e-cigarettes on the market and in popular culture.

The federal government isn’t the only one cracking down on e-cigarettes (or vaping–the act of using e-cigarettes or other electronic smoking devices). California’s governor Jerry Brown just signed a law that, in addition to changing the legal smoking age to 21, will restrict the use of e-cigarettes in some public places. According to the Los Angeles Times:

Electronic cigarettes are considered to be tobacco products and cannot be used in restaurants, theaters, bars and other places where smoking has long been banned. They also cannot be marketed to minors.

E-cigarettes are certainly more popular than ever, but as various federal and state regulations crack down, that popularity may not be permanent.

Anneliese Mahoney

Anneliese Mahoney is Managing Editor at Law Street and a Connecticut transplant to Washington D.C. She has a Bachelor’s degree in International Affairs from the George Washington University, and a passion for law, politics, and social issues. Contact Anneliese at amahoney@LawStreetMedia.com.

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Sleepless nights; nights full of tossing and turning. It happens to all of us–but for some it’s more frequent than others. In fact, an estimated 50 to 70 million American adults suffer from sleep disorders like insomnia or obstructive sleep apnea. Many turn to prescription sleep medications for relief– but women are more likely to take sleep drugs than men. About 3.1 percent of American men and 5 percent of American women report having used a prescription sleep medication within the last 30 days.

What does this use of sleep aids mean for women? Read on to learn more about sex differences in sleep and sleep drugs.

Sex Differences and Sleep

There are distinct biological and physiological differences between women’s and men’s sleep. According to the Society for Women’s Health Research (SWHR®), sex chromosomes, as well as gonadal hormones play a role in how individuals of each sex sleep, the sleep disorders they experience, and their responses to sleep medications. Examples of sleep differences between the sexes include women being more likely to experience disorders such as insomnia and restless leg syndrome (RLS); depression, pain, and stress are more likely to cause sleep disturbances in women than in men; and women being susceptible to changes in sleep throughout their lives, particularly at points when they experience hormonal and physical changes like puberty, pregnancy, and menopause.

Sex Differences and Sleep Drugs

Similar to how sex differences can impact sleep and sleep disorders, the way that these disorders are treated can also be affected by sex differences.

Case Study: Zolpidem

In 2013, the Food and Drug Administration (FDA) took a huge step by recommending sex-specific regulations for the prescription of sleep drugs that include zolpidem. This was groundbreaking in that it was the first time that the FDA had ever specifically recommended a sex-specific dosage for a particular medication. Zolpidem, which is used to treat insomnia, is found in Ambien, Edluar, and Zolpimist–all commonly prescribed sleep drugs. Zolpidem, a sedative-hypnotic, slows down activity in the brain.

The FDA reduced the recommended Zolpidem dosage for women to half of what was being prescribed. According to the SWHR:

This change in dosage was based on the discovery that women were metabolizing the same dose of drug 50 percent slower than men, which resulted in higher amounts of Ambien in women’s bloodstream leading to more excessive sleepiness in women compared to men.

Currently, the FDA is reviewing other popular sleep medications to determine if similar sex-specific recommendations should be issued for those as well.

Sleep Drugs and Contraceptives

We’ve all seen commercials for prescription drugs that recommend “talking to your doctor” before taking the advertised product, especially if currently using other medications. There’s a reason for that: drugs can interact and make other drugs less effective, causing unexpected side effects, or increasing the action of a particular drug. For women, it’s especially important to be aware of the interactions between hormonal contraception and sleep drugs.

Case Study: Modafinil

Combined hormonal contraceptives include the birth control pill, patches, injections, and vaginal rings like the NuvaRing. In the U.S., roughly 22 percent of women between the ages of 15 and 44 use contraceptives that fall into this category. Modafinil, which is a drug prescribed for certain sleep disorders like narcolepsy, sleep apnea, and excessive sleepiness, can lower the effectiveness of combined hormonal contraceptives. According to SWHR:

A specific enzyme in the liver breaks down modafinil to its composing molecules, which are then eliminated in the urine. The same enzyme that is responsible for clearing the body of modafinil also breaks down contraceptives. Studies have shown that, when taken together with modafinil, the overall blood levels of contraceptives decrease by 18 percent, resulting in potentially significantly lower effectiveness of the contraceptives.

Modafinil could also lower the effectiveness of other types of contraceptives, like emergency contraceptives such as the morning-after pill.

These interactions are also particularly concerning for women who become pregnant while still taking modafinil. Because modafinil lowers the effectiveness of contraceptives, this interaction is extremely unsafe for pregnant women and could potentially cause harm to a fetus.

Can contraceptives affect sleep?

Some evidence suggests contraceptives can cause changes in sleep for women. According to a 2001 study published in the European Journal of Physiology, oral contraceptives can affect sleep cycles and raise the body temperature of young women–another factor that plays a role in how well an individual sleeps. A woman’s menstruation cycle can also affect her body temperature, and therefore, how well she sleeps.

Sleep Drugs and Older Women

Women aged 55 and older are more likely to report sleepiness than men, and on average report 20 minutes fewer sleep per night than men. Post-menopausal women also report more fragmented sleep–they have a harder time staying asleep for long periods of time without waking up. According to the UCLA Sleep Disorders Center, physical factors can also disturb a post-menopausal woman’s sleep, such as arthritis and other pain-related conditions, chronic lung disease, heartburn, and a need to urinate more frequently.

But women aren’t alone in experiencing differences in sleep as they age–men do as well. As a result, both older men and women use sleep aids, which are often over-the-counter products. According to SWHR:

A recent health and wellness survey shows that 35 percent of people 60 years or older take OTC sleep medications at least 20 days a month. And 70 percent of them take OTC pain and sleep combination products, increasing the amount of the active ingredient in their system. This growing practice of self-medicating with OTC sleep products in an off-label way is alarming.

While those concerns are certainly valid–the mixing of medications, including over the counter drugs, can often cause problems; it’s still undetermined if there are any sex-specific effects of sleep medications on older women. Moreover, limited information is available as few sex-specific studies have been completed on how sleep medications and medications often taken by older women interact–a worrisome problem as older women continue to use these medications.

What’s Next?

The FDA is continuing to recognize that sex-differences are important when it comes to not only the differences in how American women and men sleep, but also how sleep medications can affect each sex. Additionally, nonprofits have been pioneering work studying and raising public awareness of these issues. Take, for example, the SWHR Interdisciplinary Network on Sleep. Launched in 2014, the network identifies areas in sleep health in which more work needs to be done specifically regarding women. According to SWHR:

The Society for Women’s Health Research is proud to bring together this interdisciplinary group to look at the critical issue of sleep in women’s health. We need greater focus on sex differences in sleep research to improve the diagnosis, treatment, and prevention of sleep disorders for both women and men. There continues to be knowledge gaps in the medical community regarding women and sleep. This SWHR Network is helping to address those gaps and highlight the importance of healthy sleep for everyone.

Sleep is important to all of us–woman or man, young or old. But recognizing the way different hormonal and physiological factors affect how we sleep, creating guidelines for medications based on those factors, and raising public awareness of risks associated certain sleep drugs and other medications are all steps in the right direction and will help us all sleep a little easier.

Resources

CDC: Prescription Sleep Aid Use Among Adults: United States, 2005-2010

Journal of Women’s Health: Exploring Sex and Gender Differences in Sleep Health: A Society for Women’s Health Research Report 

Huffington Post: Why We Need to Pay More Attention to Women’s Sleep

NIH/Medline Plus: Zolpidem

NIH/Medline Plus: Modafinil

FDA: Questions and Answers: Risk of Next-Morning Impairment After Use of Insomnia Drugs; FDA Requires Lower Recommended Doses for Certain Drugs Containing Zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist)

Huffington Post: Are Your Sleep Drugs Hurting Your Contraceptives?

Guttmacher Institute: Contraceptive Use in the United States 

RareConnect: Oral Contraception / Birth Control and Modafinil

European Journal of Physiology: Oral Contraceptives Alter Sleep and Raise Body Temperature in Young Women

UCLA Sleep Disorders Center: Sleep and Women

Huffington Post: Beware Risky Sleep Drug Usage in Older Americans, All for a Good Night’s Sleep

Sleep Review: Society for Women’s Health Research to Study Sleep Differences

Society for Women’s Health Research: Interdisciplinary Network on Sleep 

Society for Women’s Health Research

The Society for Women’s Health Research (SWHR®), is a national non-profit based in Washington D.C. that is widely recognized as the thought-leader in promoting research on biological differences in disease. SWHR is dedicated to transforming women’s health through science, advocacy, and education. Founded in 1990 by a group of physicians, medical researchers and health advocates, SWHR aims to bring attention to the variety of diseases and conditions that disproportionately or predominately affect women. For more information, please visit www.swhr.org. Follow us on Twitter at @SWHR. SWHR is a partner of Law Street Creative. The opinions expressed in this author’s articles do not necessarily reflect the views of Law Street.

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In light of the prescription drug abuse epidemic, the Food and Drug Administration (FDA) is cracking down on the labeling of opioid painkillers. According to the FDA, immediate-release opioid painkillers will now carry what is called a “black box” warning, which will warn about the “risk of abuse, addiction, overdose and death.”

The new labeling will also state that prescribing immediate-release opioid painkillers “should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options are inadequate or not tolerated.” There will also be clearer instructions for dosage and dosage changes throughout treatment.

Immediate-release opioid painkillers include almost 175 different brands and generics, including Vicodin and Percocet. According to the Chicago Tribune:

Those medications, which often combine oxycodone with lower-grade medications, are among the most commonly used drugs in the U.S. and account for 90 percent of all opioid painkillers prescribed.

The extensions of these warnings apply particularly to the immediate-release painkillers; the FDA already upped labeling restrictions for extended-release painkillers in 2013. Extended-release painkillers were thought to be a bigger risk for addiction, but after the labeling changes in 2013, increased cases of overdoses, addiction, and death continued. In 2014, there was a high of 19,000 deaths related to the misuse of opioid painkillers, according to the CDC.

There’s also a worrisome connection between opioid painkillers and heroin use–given that some individuals who have become addicted to painkillers eventually turn to heroin once they are no longer able to access painkillers, or because heroin is often cheaper. If you combine deaths from opioid painkillers and heroin, the number of fatalities in 2014 jumps to almost 29,000.

Despite the fact that this labeling comes with a very good intention–cutting down on the abuse of opioids and resulting tragic deaths. However, some experts say that the FDA isn’t going quite far enough. Dr. Andrew Kolodny, the executive director of Physicians for Responsible Opioid Prescribing, pointed out that the new labeling still does not recommend maximum amounts. According to the New York Times Dr. Kolodny stated:

Without an upper dose or maximum duration of use on the label, I don’t think the change will have much of an impact.

As heroin and prescription drug abuse remain huge issues in the U.S., it’s laudable that the FDA is trying common-sense approaches to address them. The Obama administration is pushing for action by federal agencies and governors, so we should probably expect to see more efforts to combat drug addiction in the coming months.

Anneliese Mahoney

Anneliese Mahoney is Managing Editor at Law Street and a Connecticut transplant to Washington D.C. She has a Bachelor’s degree in International Affairs from the George Washington University, and a passion for law, politics, and social issues. Contact Anneliese at amahoney@LawStreetMedia.com.

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Everyone uses cosmetics, lotions, soaps, and other personal care items as a part of daily life, and we trust that those products are safe. But who actually determines whether or not a personal care product is safe? The Food and Drug Administration (FDA) has jurisdiction over the regulation of personal care products, however, the Agency continues to follow outdated guidelines that don’t reflect recent scientific breakthroughs. In an attempt to change this outdated system, Senators Dianne Feinstein (D-California) and Susan Collins (R-Maine) introduced the Personal Care Products Safety Act (S. 1014) to the Senate in April. The proposed bill is a bipartisan initiative and has the backing of many cosmetic and personal care product companies and the support of advocacy groups such as the Society for Women’s Health Research (SWHR ®). Read on to learn about current personal care products regulation, attempts for reform, and the status of the Personal Care Products Safety Act.

Personal Care Products Regulation in the U.S.

Personal care products were first brought under the umbrella of the FDA with the passage of the 1938 Food, Drug, and Cosmetic Act, which provided for federal authority over such products. However, which products are defined as personal care products and which are defined as drugs is a nuanced question. According to the FDA, there’s no clear distinction under the law, but there are generalities that the agency uses to designate the category various products fall into. According to the FDA:

Under the law, some of the products commonly referred to as “personal care products” are cosmetics. These include, for example, skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants. Some, however, are regulated as drugs. Among these are skin protectants (such as lip balms and diaper ointments), mouthwashes marketed with therapeutic claims, antiperspirants, and treatments for dandruff or acne.

Some personal care products can meet the definitions of both cosmetics and drugs when that product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug, as it is intended to cleanse the hair and treat dandruff.

Regulations on drugs are obviously stricter than those on personal care products–understandably so– but there are some concerns over the ways that those personal care products are regulated.

What’s lacking from the FDA regulation of personal care products?

Guidelines that govern the FDA’s policies on personal care products haven’t been updated since the 1938 law that gave the Agency the authority to regulate these products. Yet, the science behind these products has evolved rapidly over the same time period. We now know more information about chemicals that could potentially be harmful. Additionally, many products contain new man-made chemicals, and the Agency should have policies in place that reflect the current state of the science governing these products.

Currently, the FDA cannot issue recalls of personal care products that it deems to be harmful. It can only recommend voluntary recalls, which critics are concerned aren’t strong enough to adequately remove dangerous products off the shelves in a timely fashion.

The lack of testing guidelines for personal care products are another area of concern for health advocates. Currently, the FDA doesn’t have the authority to mandate testing of ingredients before they go on the market, with one exception: color additives and no health studies or pre-market testing are required. Instead, the cosmetic industry is largely self-regulated through an organization known as the Cosmetics Ingredient Review (CIR). However, many advocacy organizations also question the efficacy of that group, particularly when it comes to CIR’s banning of substances. In the 36 years since its inception, the regulatory group has only 11 chemicals for use in personal care products, a stark contrast to the hundreds banned by European Union regulators.

Advocacy groups are also concerned over the labeling laws currently in place for personal care products. Currently, full ingredient disclosure isn’t required, which many criticize as a major loophole with regards to transparency and patient safety. There’s also no requirement for contact information, so people who may suffer from adverse reactions to products can’t always figure out how to get in touch with the manufacturer to report the problem.

Overall, the process for FDA approval of personal care products is significantly less strict than the process the Agency uses to approve drugs and medications.

What is the Personal Care Products Safety Act?

The Personal Care Products Safety Act would help remedy many of the regulatory loopholes cited above. and would give the FDA the regulatory authority it needs to issue recalls, improve testing guidelines, and require more stringent labeling.

Further, this legislation would mandate that the FDA take a proactive approach to ensuring that chemicals used in personal care products are safe by requiring that the FDA test and review at least five chemicals each year. The bill also lays out the first group of chemicals that would be reviewed, all of which have been subject to recent controversy. According to Senator Feinstein’s release on the act, that first group consists of:

Diazolidinyl urea, which is used as a preservative in a wide range of products including deodorant, shampoo, conditioner, bubble bath and lotions;

Lead acetate, which is used as a color additive in hair dyes;

Methylene glycol/formaldehyde, which is used in hair treatments;

Propyl paraben, which is used as a preservative in a wide range of products including shampoo, conditioner and lotion; and

Quaternium-15, which is used as a preservative in a wide range of products including shampoo, shaving cream, skin creams and cleansers

Additionally, the Personal Care Products Safety Act would require manufacturers of personal care products to register with the FDA. It would remove the protected status of “coal tar,” a carcinogen found in some hair dyes that currently is permitted as long as there are proper warning labels. It would also direct the FDA to come up with a list of “Good Manufacturing Practices” to guide producers.

The new programs and regulations instated by the bill would be funded by collecting user fees from personal care product manufacturers–this is a similar process FDA uses for the review and approval of prescription drugs.

Why is the Personal Care Products Safety Act particularly important for women?

While Americans use an average of roughly 10 personal care products each day, that number isn’t split up by sex. Women in particular use an average of 12 products, exposing themselves to 168 unique chemical ingredients each day. This puts women at a higher risk when it comes to being harmed by untested or unsafe chemicals. SWHR recognizes the impact that the Personal Care Product Safety Act, if it passes, will have on women’s lives and health. SWHR stated in support:

Women use these products daily, and safer, better-regulated personal care items means healthier women and families. SWHR commends this step towards advancing women’s health and the health of all Americans who use these products.

Where is the Personal Care Products Safety Act in the Legislative Process?

As of right now, the legislation has only been introduced into the Senate–it has a long way to go before it becomes a law. But there is some good news: the bill has bipartisan support, which in today’s political climate is certainly rare. Senators Feinstein and Collins are the original sponsors, but they’ve since been joined by four additional co-sponsors: Senator Barbara Boxer (D-California), Senator Amy Klobuchar (D-Minnesota), Senator Mark Kirk (R-Illinois), and Senator Mazie Hirono (D-Hawaii).

In addition to the SWHR, many other advocacy groups support the Personal Care Products Safety Act, including the Endocrine Society, the Environmental Working Group, and HealthyWomen.

Who Doesn’t Support the Personal Care Products Safety Act?

There are some who don’t agree with the tenants laid out in the Personal Care Products Safety Act. For example, People for the Ethical Treatment of Animals (PETA) has brought forth concerns that a greater concentration on testing means that there will be more testing on animals.

Others that disagree with the push for new regulations include members of the personal care products industry, including the Independent Cosmetic Manufacturers and Distributors (ICMAD) which says that it “places too large a burden on small business, stifles innovation in the cosmetics and personal care industry, and does not provide appropriate and significant national uniformity.”

Conclusion

The Personal Care Products Safety Act has a very long way to go before it could be enacted. But it reflects common sense approaches to regulating the personal care industry that haven’t been updated in almost 75 years. In order to ensure the health of all, particularly those who use these products on a regular basis, we need to make sure that there’s accountability and transparency in what goes into our personal care products.

If you would like to support the legislation, click below.

Resources

Primary

Society for Women’s Health Research: SWHR Proudly Supports Personal Care Products Safety Act

U.S. Senate: Personal Care Products Safety Act

GovTrack: S. 1014: Personal Care Products Safety Act

FDA: The 1938 Food, Drug, and Cosmetic Act

FDA: Are All “Personal Care Products” Regulated as Cosmetics?

Dianne Feinstein: Senators Introduce Bill to Strengthen Personal Care Product Oversight

Additional 

Harvard School of Public Health: Harmful, Untested Chemicals Rife in Personal Care Products

Environmental Working Group: Why This Matters–Cosmetics and Your Health

FDA Law Blog: Proposed Personal Care Products Safety Act Would Significantly Expand FDA Authority over Cosmetics

Washington Monthly: Beauty Tips for the FDA 

Women’s Voices for the Earth: Will the New Personal Care Products Safety Act Make Cosmetic Ingredients Safe?

The Huffington Post: New Bill Would Require FDA To Regulate Ingredients In Cosmetics & Personal-Care Products

PETA: Proposed Law Likely to Mean Tests on Animals for Cosmetics Ingredients in U.S.!

Society for Women’s Health Research

The Society for Women’s Health Research (SWHR®), is a national non-profit based in Washington D.C. that is widely recognized as the thought-leader in promoting research on biological differences in disease. SWHR is dedicated to transforming women’s health through science, advocacy, and education. Founded in 1990 by a group of physicians, medical researchers and health advocates, SWHR aims to bring attention to the variety of diseases and conditions that disproportionately or predominately affect women. For more information, please visit www.swhr.org. Follow us on Twitter at @SWHR. SWHR is a partner of Law Street Creative. The opinions expressed in this author’s articles do not necessarily reflect the views of Law Street.

The post The Personal Care Products Safety Act: Modernizing Outdated Regulations appeared first on Law Street.

Are you a big fan of powdered caffeine? If so, you might want to watch out. There are some serious health concerns that accompany getting your fix that way. In fact, the Food and Drug Administration (FDA) has just sent warnings to five producers of powdered caffeine.

The five companies that the FDA sent warning letters to were SPN, LLC (Smartpowders), Purebulk, Inc., Kreativ Health Inc. (Natural Food Supplements), Hard Eight Nutrition, LLC and Bridge City Bulk. They all produce powdered versions of caffeine that seriously concentrate the drug–one teaspoon of powdered caffeine is equal to roughly 28 cups of coffee. According to the FDA, two teaspoons would kill most adults. What’s most worrisome about powdered caffeine is that it’s very difficult to tell the difference between a “safe” and “unsafe” amount. Given the potency of the product, the line between the two is very narrow.

However, consumers are attracted to the product because it gives an energy boost without the calories or additives inherent in other caffeinated products such as coffee, tea, or soda. It’s often sold in just a plastic bag, without a child lock or warning label. While it’s rare to find powdered caffeine in stores, it’s pretty easy to order online.

Deaths have occurred from the use of powdered caffeine. Two young men died in 2014 after consuming it. One, an 18-year-old teenager from LaGrange, Ohio, suffered cardiac arrhythmia, as well as a seizure, and was found to have a fatal amount of caffeine in his system during his autopsy. His death was noted as one of the catalysts for the FDA investigation.

In addition to the potential dangers of consuming powdered caffeine, the FDA is concerned about the fact that many don’t know how to recognize the symptoms of dangerous levels of caffeine. Given that many Americans indulge in a serving or few a day safely, the symptoms aren’t easily recognizable. In the letter to the five companies from the FDA, the agency stated:

While consumers of caffeinated products such as coffee, tea, and soda may be aware of caffeine’s less serious effects – such as nervousness and tremors – they may not be aware that these pure powdered caffeine products are much more potent and can cause serious health effects, including rapid or dangerously erratic heartbeat, seizures and death. Vomiting, diarrhea, stupor and disorientation are also symptoms of caffeine toxicity.

The FDA also warned of action it might be taking moving forward, explaining to the companies that it will be carefully monitoring the market, and if it needs to, seizing products or obtaining court injunctions to stop the sales. The warning letter doesn’t necessarily tell the companies to stop producing or selling powdered caffeine–although some may as a result. Others may take stronger precautions, such as using warning labels or including measuring devices. But it’s clear the FDA is no longer messing around when it comes to powdered caffeine.

Anneliese Mahoney

Anneliese Mahoney is Managing Editor at Law Street and a Connecticut transplant to Washington D.C. She has a Bachelor’s degree in International Affairs from the George Washington University, and a passion for law, politics, and social issues. Contact Anneliese at amahoney@LawStreetMedia.com.

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Should women be allowed to take a drug that could potentially increase their sexual desire?

After two previous rejections, the Food and Drug Administration yesterday decided yes, opting to approve Sprout Pharmaceuticals’ female libido enhancing drug Flibanserin, soon to be sold under the brand name Addyi. But before we rejoice the FDA’s approval, lets take a closer look at the little pink pill that people are calling the “female Viagra” to see if the drug’s benefits even outweigh its potential side effects.

First lets talk about sex–or rather sexual desire.

Sexual desire varies from person to person, but it’s been popularly decided that when it comes to male and female libidos men are always ready to hump like rabbits, while women require a bit more finesse and can look forward to eventually losing interest altogether. But that’s not really the truth. Sex drive can vary depending on a number of factors, including age, diet, and stress levels, therefore causing some men and women to have much higher sex drives than others. So if you’re a woman, (despite what you’ve been told) there’s no magical quantity of oysters and chocolate covered strawberries that will drastically enhance yours. That’s where this pill comes in.

Unlike Viagra, which combats erectile dysfunction by increasing blood flow to the genitals, Flibanserin targets the components in the brain that contribute to someone’s sex drive. According to NPR, it “shifts the balance of three key brain chemicals by increasing ‘excitatory factors for sex’—dopamine and norepinephrine—and decreases serotonin, which can dampen the sex drive.” But it’s not without side effects.

About women who took Flibanserin were found to experience dizziness, sleepiness, low blood pressure, and increased fainting. Since it must be taken orally every day like birth control pills in order to be effective, any combination of these side effects could have dangerous results for women doing basic daily activities such as driving. The drug also should not be taken with any alcohol or any other central nervous system depressants.

But is the drug even effective?

Well according to the ,

In one clinical trial, women taking Flibanserin reported having an average of 4.4 ‘satisfying sexual experiences’ a month, compared to 3.7 for women getting a placebo and 2.7 before the study began.

Despite these seemingly lackluster results, the FDA’s decision to move forward with the drug may have been motivated by other reasons. Supporters of the pill previously accused the agency of being biased, which it denied, for approving Viagra and other drugs to help men have sex, and not Flibanserin for women. But for those out there saying it wouldn’t be fair for women not to have a pill for sexual desire when men already do, it’s more complicated than that. Viagra doesn’t increase the male sex drive, but rather fixes the “performance issues” preventing said sexual desires from being actualized.

Even though this drug isn’t exactly a Viagra substitute, it does have the possibility to help the number of women out there suffering from loss of sexual arousal. However, the longevity of the drug’s popularity remains to be seen. By granting approval for the drug, the FDA has essentially determined that the drug’s benefits outweigh its potential harm, but Sprout Pharmaceuticals will still have to prove to women that the newly named Addyi is both safe and effective.

Alexis Evans

Alexis Evans is an Assistant Editor at Law Street and a Buckeye State native. She has a Bachelor’s Degree in Journalism and a minor in Business from Ohio University. Contact Alexis at aevans@LawStreetMedia.com.

The post The Little Pink Pill: Sexually Freeing or Potentially Harmful? appeared first on Law Street.

Even though the world very well may be reaching its breaking point with how much Kardashian news coverage it can take, recent legal trouble between the family’s top breadwinner Kim Kardashian West and the Food and Drug Administration has warranted keeping the reality stars in the spotlight.

Last week Kardashian West posted a selfie on Instagram of herself holding a prescription bottle of Diclegis, made by the pharmaceutical company Duchesnay USA. The pregnant celeb credited the drug with helping her manage her bouts of morning sickness with baby number two.

FDA tells @KimKardashian she’s doing it wrong http://t.co/DVHXBLes08 pic.twitter.com/wQWZKkOLlW

— Halle Tecco (@halletecco) August 12, 2015

The post, which has since been deleted, read:

I tried changing things about my lifestyle, like my diet, but nothing helped, so I talked to my doctor. He prescribed me #Diclegis, and I felt a lot better and most importantly, it’s been studied and there was no increased risk to the baby.

Kim is no stranger to social media product promotions; she’s utilized her personal accounts to sell everything from teeth whiteners to tennis shoes to her 42 million followers on Instagram and 25 million on Facebook. But, the so-called “selfie queen” failed to cover her bases with her latest venture.

Although the post linked to the drug’s website and its safety information, FDA Division Director for the Office of Prescription Drug Promotion Robert Dean says it wasn’t enough. In his warning letter dated August 7, Dean writes, “the social media post is false or misleading in that it presents efficacy claims for DICLEGIS, but fails to communicate any risk information associated with its use and it omits material facts.” He also points out that the post neglected to mention that the drug has not been studied in women with hyperemesis gravidarum, a complication of pregnancy characterized by uncontrollable nausea, vomiting, and dehydration.

The confusion over the side effect omission boils down to the drug’s classification. Diclegis, is labeled under the pregnancy category A, which means it has failed to demonstrate a risk to the fetus in the first trimester of pregnancy. Despite this, disclosing risks of the drug during pregnancy are still required in labeling and promotions.

Forbes explains further writing,

Incidentally, such pregnancy classifications were eliminated by FDA last month and companies are now required to give prescribers more precise safety details on a drug’s fetal and maternal risk profile because the old classification was “often misinterpreted and misused in that prescribing decisions were being made based on the pregnancy category, rather than an understanding of the underlying information that informed the assignment of the pregnancy category.

According to the drug’s website, Diclegis’ most common side effect is drowsiness and therefore should not be combined with alcohol, certain depressants and pain medications, and sleeping aides. Women are also encouraged not to drive, use heavy machinery, or “engage in other activities that need your full attention” while taking the drug.

In response to the letter, Duchesnay spokeswoman Laney Landsman said the company is working very hard to take quick action and is working out a plan to submit to the FDA. The letter warned that “failure to correct the violations discussed may result in FDA regulatory action, including seizure or injunction, without further notice.” It’s unclear if Kim will have to forfeit her compensation for the ad since it has been deleted, but it’s safe to say the reality star will likely be “keeping up with” the FDA’s requirements.

Alexis Evans

Alexis Evans is an Assistant Editor at Law Street and a Buckeye State native. She has a Bachelor’s Degree in Journalism and a minor in Business from Ohio University. Contact Alexis at aevans@LawStreetMedia.com.

The post Kim Kardashian’s Selfie Comes With an FDA Warning appeared first on Law Street.

What’s for dinner tonight? Perhaps steamed corn, infused with some delicious dichlorophenoxyacetic acid. Or maybe, if you’re feeling bold, you’ll eat some tofu bites containing glyphosate, which the International Agency for Research on Cancer classified in March as “probably carcinogenic in humans.” Corn, soy, sugar, papayas, milk, zucchini—the list goes on; the number of genetically modified organisms, or GMOs, is multiplying. The U.S. House of Representative’s decision on Thursday to pass a law that would block states from mandating GMO labels only contributes to the danger that these GMO or genetically engineered (GE) foods inflict on farmers, on the environment, and on consumers.

So what are GMOs exactly, and why are they causing such a scene on Capitol Hill? Genetically modified organisms are plants or animals that are genetically altered to exhibit traits that are not natural, primarily a resistance to pesticides and herbicides. It may sound brilliant to have developed crops that can withstand the chemicals necessary to cultivate large amounts, but GMOs are often untested, require dangerous chemicals in their farming, and may be a threat to organic foods and to the environment. In the United States, GMO foods require no pre-market testing. Unlike with drug production, where there is mandatory testing on animals, mandatory human clinical trials, mandatory tests of carcinogenicity, fetal impact, neurological impact, and at least some limited allergy testing, none of those steps are required for these crops.

The American Medical Association has stated that mandatory testing should be required before GE foods and ingredients are introduced on the market, but lawmakers continue to ignore medical research centers, farmers, and constituents who oppose or at least want labels on GMOs. Maine, Connecticut, and Vermont have all passed laws mandating the labeling of genetically modified foods for consumers but unfortunately these three states are the exception, not the rule. Last week, a majority of Representatives voted in favor of a law that prevents states from mandating GMO labels, stating that labeling GMO foods is “misleading.” Supporters of the bill said that labeling foods that contain GMOs sends a message to consumers that the products are risky, and that according to the Food and Drug Administration (FDA), GMOs are not dangerous. However, that information is based on testing by scientists who are funded and influenced by the companies who own GMOs. Opponents of the bill called banning the labeling of GMOs “an infringement of the public’s right to know what’s in their food.”

Currently, 64 countries worldwide require the labeling of GMOs, including all 28 nations of the European Union, Russia, and China. Our lack of GMO labels is not only causing us to fall behind most other developed countries, but is also failing the satisfy a vast majority of Americans who support GMO labeling. A total of 92 percent of Americans want GMO foods to be labeled and in the past two years, more than 70 labeling bills or ballot initiatives were introduced across 30 states.

In 2012, some of America’s most profitable chemical companies teamed up with large food companies to defeat California’s Proposition 37, an initiative that would have required labeling of genetically engineered foods. Monsanto, PepsiCo, CocaCola, Nestle, and several other companies spent over 45 million dollars to block the legislation. Why? Because keeping consumers in the dark about the dangers of GMOs can be profitable, and requiring labels would allow consumers to question what they’re consuming before they buy. The companies that own GMO seeds, which are patented, sell their seeds to farmers who then buy herbicides from the same companies who also own the chemicals. This brilliant business model is racking up millions for these corporations, but is causing people to consume more and more dangerous herbicides.

Another concerning symptom is that weeds are becoming resistant to the hazardous chemicals. Genetically engineered crops are designed to survive weed killers. Corporations like Monsanto that create these herbicides and pesticides claim that herbicide use has decreased since the introduction of GE crops; however, before GE crops were cultivated, weeds resistant to Roundup did not exist. There are now 14 known species of Roundup-resistant weeds in the U.S. alone, known as “super weeds.” Super weeds have been reported on half of all U.S. farms and cost farmers millions of dollars a year to control. With more weeds becoming resistant to Roundup, farmers now have to spray larger quantities of even more toxic herbicides on their crops to kill weeds, like 2,4-dichlorophenoxyacetic acid (2,4-d), a component of the poisonous Agent Orange used during the Vietnam War. GMOs intensify the problem of herbicide use and create more super weeds that are immune to harsh chemicals, disrupt the environment, and contaminate water systems.

In 2010 the President’s Cancer Panel reported that 41 percent of Americans will be diagnosed with cancer in their lifetime. The panel pointed to chemicals, primarily herbicides in our air, water, soil, and food as the primary cause of this increased cancer rate. Later that same summer, the journal Pediatrics reported in a peer-reviewed study that there is a direct correlation between pesticide exposure and increased ADHD diagnoses. In 2011 a study revealed that the insecticide in GMO corn was detected in the umbilical cord blood of pregnant women. With 90 percent of soy and 85 percent of corn now genetically engineered, and super weeds on the rise leading to harsher chemicals being used on our food, GMO consumers are being exposed to more and more dangerous chemicals. And without GMO labels, shoppers have no idea if the foods they are eating are a part of that group.

Congress’s decision last week to block any mandatory labeling of foods made with genetically engineered crops proves that corporate influence in Washington is taking away our right to choose what we consume. Genetically modified foods can and should be labeled, and Congress has an obligation to listen to the 92 percent of Americans who support the right to know what they are consuming via GMO labels. The FDA’s Federal Food Drug and Cosmetic Act states that the consumer has a right to know when something is added to food that changes it in ways a consumer would likely not recognize, and that indicates labeling should be required. Just like juice from concentrate, wild versus farmed, country of origin, and many other mandatory labels we see on our foods, GMOs should also be visible, since the chemicals that come with them are not. We have a right to know and a right to choose. It’s time to question whether the FDA and Congress are here to protect us, the people, or to protect a handful of chemical companies that want to keep us in the dark.

Emily Dalgo

Emily Dalgo is a member of the American University Class of 2017 and a Law Street Media Fellow during the Summer of 2015. Contact Emily at staff@LawStreetMedia.com.

The post GMO Labeling: The American People Have A Right To Know appeared first on Law Street.

You just sunk every penny you have into opening a restaurant. After spending years perfecting every detail from menus to music, you forgot one major element: an advertising budget. How will you make sure people experience your culinary genius? Fueled by passion, you do something you know you probably shouldn’t. You write a glowing review of your restaurant on Yelp.

Is the review a lie just because it came from the owner? Not necessarily. Just because a biased party tells you something is good doesn’t necessarily mean it’s not; their recommendation just holds less value than one from a disinterested party.

But, bias fueled by passion and economic interest happens in medical research all the time. Like you and your restaurant review, medical study funders often promote the information best for their cause. They finesse study designs and findings to make results seem more favorable for their product or service. A manufacturer of a new blood pressure drug might play up one specific benefit of their product in a way that makes you believe the drug beats others overall. It’s not fraud or misconduct, it’s just spinning results in a positive way–something any human with a vested interest in an outcome tends to do. Furthermore, data from a study means nothing by itself to most people, so invested parties can play with it as much as they want to tell a good story.

In discussing the interpretation of statistics in Made to Stick, authors Chip and Dan Heath put it this way:

Ethically challenged people with lots of analytical smarts can, with enough contortions, make almost any case from a given set of statistics.

Keep reading for more on funding bias and what you can do about it.

How is scientific research funded?

When you read a juicy new bit of research about something that might kill you or change the world as we know it, the study’s funding probably escapes your interest. But any study you read, whether it’s about drugs, medical treatments, nutrition, or even sleep, costs money. Where does the money come from? It can come from government grants, nonprofits, independent companies, and even you. When you buy dish soap, some of that profit might go to funding a Procter & Gamble study on a new cleaning chemical. Some portion of your taxes might trickle down to a government grant and end up in a laboratory. And of course, if you donate to a charity, that money might fund studies supporting that cause.

Money Talks

Since money fuels science, science itself can be shackled by economic interests, and interests of any kind can lead to bias. Even without fabricating results, funders have tools they can use to sway study results.

In a paper titled “Tobacco industry manipulation of research,” Dr. Lisa A. Bero calls out some reasons why research findings might not be as concrete as they seem:

• Any study has a context that can be skewed by framing the study, defining the problem, and sculpting that language of study questions and results.
• Data doesn’t present itself. It’s up to the funders and researchers to deliver it to the world, and this delivery can be nuanced to serve a given purpose.

That covers underlying reasons why bias happens, but how does it happen? The World Health Organization analyzed thousands of books, articles, and other materials to see how bias can occur in drug studies and promotions. Its paper, “Drug Promotion – What We Know, What We Have Yet to Learn,” outlined several ways researchers can skew results:

• Publishing results in multiple journals and with multiple authors. Different researchers can write papers on the same exact study. The multiplication of evidence revealing the same findings makes the results look more credible and can lead to a general overestimation of the studied drug’s treatment power.
• Leaving out unfavorable conclusions. Industry-funded studies left out negative results more often than their nonprofit counterparts.
• Using retrospective design, which looks backward to prove a determined outcome. With a known outcome, it’s easier to manipulate study designs to show X might cause Y.
• Putting focus on some features and leaving out others. Industry-funded studies tend to focus on acute benefits of drugs and stray away from ranking the drug’s benefits overall.
• Publishing only favorable results. If a study doesn’t achieve the desired outcomes, the industry funder can simply choose not to publish it, like a lie of omission.

Now let’s look at some real-world examples. In practice, a common method of skewing public scientific opinion involves funding counter blows to combat damaging research.

Bias in Practice

So we know bias happens, we know how it happens in theory, and in the real world the skewing attempts get even scrappier. In these examples, the industries used their funding prowess to spin the science of others.

Sugar

This NPR article relays the story of Dr. Christin Kearns, a dentist who was shocked when a handout of government advice about diabetes didn’t mention sugar. Detecting the scent of industry involvement, she began digging for evidence of similar foul play in the dental community.

After months of research and scouring through internal beet and cane sugar documents dating back to the 1950s, Kearns found that the industry does in fact push policy, especially when it concerns potentially damaging research. When the sugar industry caught wind of dental professionals’ intentions to tackle sugar consumption, they launched a counterattack to help people combat tooth decay while eating as much sugar as they wanted. They looked into enzymes that busted up plaque and other ways to fight tooth decay.

Tobacco

No surprise here: the tobacco industry’s efforts to combat damaging research have been fodder for many public health case studies. Tobacco companies specialized in contending with the findings of detrimental studies. Their philosophy read something like this: The longer you argue, the longer it takes to make decisions. And the longer it takes to make decisions, the more time we have to continue business as usual before we’re hampered with new policies. The tobacco industry used this philosophy to fight regulations for decades.

The 1950s and 60s saw tobacco companies fighting claims that smoking was bad for you. After that, they gracefully transitioned to denying the harms of secondhand smoke.

Here’s a commercial for Camel cigarettes showing doctors smoking and enjoying cigarettes and even recommending the Camel brand. Their decision to use a doctor as the main character sends a strong message to the public: If smoking was so bad, would a doctor do it?

In the 1990s, tobacco companies moved to using PR campaigns focusing on “junk science” to criticize reports on the risks of tobacco smoke, even from the government.

In 1998, big tobacco and the United States reached an agreement about how tobacco could be marketed and advertised. This Master Settlement Agreement surfaced documents outlining tobacco’s science-fighting strategy that confirmed what many had already suspected. When it came to steering science dialogue, tobacco’s policy was to:

• Pay for, publish, and promote research supporting their goals; and ,
• Suppress and criticize research going against their goals.

Tobacco’s efforts mark some of the first concerted and funded campaigns against science in history. Their efforts demonstrate the power of manipulating public opinion. Luckily, physician opinion is much harder to shape.

Does funding bias influence practice?

Good news: doctors know how to evaluate medical studies.

In a randomized study of physicians’ interpretations of funding disclosures published in the New England Journal of Medicine, researchers found a majority of physicians were fully capable of evaluating research based on academic rigor and were not fooled by common manipulations. In fact, the knowledge that a study was funded by industry caused their evaluation of the study’s rigor and likelihood of prescribing the studied drug to decrease.

What You Can Do

We can’t ignore oodles of research just because it might be biased. Luckily, there are safeguards in place. Title VIII of the Food and Drug Administration (FDA) Amendments Act of 2007 (FDAAA) made researchers start registering and submitting results to clinicaltrials.gov where you can check them out at any time. Individual journals also have publishing regulations protecting us from misleading science. For example, the New England Journal of Medicine publishes information on funding, protocols, and the funding organization’s involvement in the study with all of their articles.

But if you’re feeling less than trusting, you can develop your own methods of evaluating the research you read. When you see something new, check for other studies on the same subject to see if they coincide and take an extra careful look at the study’s design.

This graphic from Compound Interest ranks study methods on a descending scale. Keep this in mind when you’re evaluating research.

Even if it’s just something you see in a magazine, you can look up the original study to investigate the design for yourself and form your own opinion. We have access to more science than ever before. With that comes great power, but also great responsibility. Science can be biased but it’s still up to you whether or not to buy into the bias.

Resources

Primary

World Health Organization: Drug Promotion: What We Know, What We Have Yet to Learn

Additional

Washington Post: As Drug Industry’s Influence Over Research Grows, So Does the Potential For Bias

NPR: Documents Detail Sugar Industry Efforts to Direct Medical Research

Heath, Chip and Dan: Made to Stick

Plos Medicine: Sugar Industry Influence on the Scientific Agenda of the National Institute of Dental Research’s 1971 National Caries Program: A Historical Analysis of Internal Documents

Journal of the American Medical Association: Association of Funding and Conclusions in Randomized Drug Trials: A Reflection of Treatment Effect or Adverse Events?

University of California Museum of Paleontology: Who Pays For Science?

Public Health Chronicles: Tobacco Industry Manipulation of Research

Scientific American: Can the Source of Funding For Medical Research Affect the Results?

New England Journal of Medicine: A Randomized Study of How Physicians Interpret Research Funding Disclosures

New England Journal of Medicine: The Proposed Rule For U.S. Clinical Trial Registration and Results Submission

Ashley Bell

Ashley Bell communicates about health and wellness every day as a non-profit Program Manager. She has a Bachelor’s degree in Business and Economics from the College of William and Mary, and loves to investigate what changes in healthy policy and research might mean for the future. Contact Ashley at staff@LawStreetMedia.com.

The post Trusting Scientific Research: Who Funds Our Opinions? appeared first on Law Street.

3D printers have revolutionized a multitude of industries. Although they have been around for the last 30 years, people know very little about them. The first few rounds of 3D printers have been crazy expensive, isolating them from the general consumer market. Although there have been buzz-worthy exceptions, the printers have traditionally been out of reach for the general public. But for those with access, like those in the military and medical fields, 3D printing is allowing wonders. As of last year, a new wave of 3D printing seems to have taken off. Less technically advanced versions have hit the everyday market. You can now find them in your average hardware store. The future of this innovation seems limitless. 3D printers could be a household item in the not-too-distant future. With that in mind, institutions like the Food and Drug Administration (FDA) are already discussing regulations. Read on to learn more about 3D printing and what’s in store for the innovative technology.

 What is 3D Printing?

A 3D printer creates compact, three-dimensional products compared to the average printer that produces an image on paper with ink. The materials used for 3D printing are endless, but include plastic, wax, resin, paper, gold, and titanium. The printer jets are directed by computer-assisted design software to “create an object by spraying or squeezing one thin layer of material at a time onto the platform, then melding them into place with a precisely directed laser.” The culmination of layers eventually form the desired object.

First you must create a virtual design of the intended object. This is done in a Computer Aided Design File using a 3D modeling program. You can also use a 3D scanner in order to make a 3D digital copy of an already existing object before entering it into a 3D modeling program. The software then cuts the final model from the digital file into “hundreds or thousands of horizontal layers” and prints the object “layer by layer,” to ultimately produce a three-dimensional object.

Unlike typical manufacturing processes, 3D printing is an additive process, not a subtractive one. Typically, material is cut away from a larger whole to produce a desired object. The layer-by-layer process of 3D printing is “highly efficient because there is virtually no wastage.” As a bonus, the resulting product can be more minutely detailed and up to 60 percent lighter in weight than a traditionally manufactured product.

Common 3D Printing Methods

Selective Laser Sintering (SLS)

In this method, the 3D printer lays “high power particles of plastic, metal, ceramic or glass powders” into a specific 3D form. The chosen materials placed in the printer are fused layer by layer on top of a powder bed. After the creation of each layer, “the powder bed is lowered one layer thickness.” The process repeats for each new layer until the desired object is created. The unused powder base remains as a support structure and extra can be used for another printing project.

Fused Deposition Modeling (FDM)

Any home 3D printer would most likely use FDM. In this process, the printer, “extrude[s] a stream of heated or melted thermoplastic material” in the additive layer-by-layer process. Thermoplastic material becomes pliable or moldable at a specific temperature and solidifies again once cooled. As the material leaves the printer through an extrusion nozzle, the material should immediately harden and take the desired shape.

Practical Application

The U.S. Army and 3D-Printed Food

To create 3D-printed food, ingredients are placed in the printer’s cartridge and dispensed in the additive layer-by-layer process to create specific foods. The U.S. Army is looking to develop 3D technology that ultimately creates food that can sustain a warfare environment.

Supplying durable and nutritious food for soldiers in combat is difficult, especially long term. 3D printers offer a possible ingenious solution–3D technology can print food specific to a soldier’s dietary needs. First, a solider would undergo an initial scan that sends nutritional information back to the computer software. If a solider is experiencing a certain vitamin deficiency, for example, a 3D printer can then dispense food that nourishes that individual’s needs.

According to Lauren Oleksyk, a leading food technologist at the Natick Soldier Research, Development and Engineering Center, “some companies are actually considering 3D printing meat or meat alternatives based on plant products that contain the protein found in meat.” As of today, 3D-printed food is only created in powder or liquid forms. Further research will determine if the creation of printed solid food is possible. Military experts and 3D scientists predict soldiers will be eating printed food by 2025.

Medical 3D Developments: Prosthetic Hands

State-of-the-art prosthetic devices are extremely expensive, costing thousands of dollars. 3D printing offers a cheaper alternative. One in one thousand babies are born each year with missing fingers and others lose them due to injuries. Many parents find investing in a costly prosthetic replacement for a growing child impractical as it will need to be soon replaced with another. With 3D technology, the materials used for a prosthetic hand, for example, can cost as little as $20-$50. There are also various volunteer organizations available that share machines and software plans with others in need.

3D prosthetic hands are often made to look fun and colorful for children. They can be made with fluorescent or glow-in-the-dark colors. The Cyborg Beast model “looks like a limb from a Transformer,” while the Raptor Hand and Talon Hand models, “hint at comic-book superpowers.”

The above video shows a 3D-printed prosthetic hand that can open and close by flexing the wrist. This pulls on cables called tendons. Each piece is printed individually and assembled afterward. The printing process is about 20 hours, while assembly takes about two or three hours. Ivan Owen, one of the 3D-printed hands inventors, claimed “it is not much harder than putting together a complex Lego kit.”

The easy accessibility due to volunteers and openly shared machines and software and low cost make 3D prosthetic replacements a true medical wonder. Prosthetic hands are just one of the ways in which 3D technology is changing the face of prosthetics.

Regulations

Regulations must be put into effect for safety, especially as 3D technology enters the medical arena. The FDA states that it regulates 3D devices in essentially the same way it regulates non-3D devices, although there are added questions in the review process. Medical manufacturing companies can conventionally distribute medical devices in a few sizes. With 3D printing, these same products can be inexpensively tailored to the individual. Oxford Performance Materials, a Connecticut-based biomedical firm, printed a cranial prosthetic that replaced 75 percent of a man’s skull. All this innovation, however, must be checked. FDA medical engineer James Coburn explains, “We typically ask manufacturers to put safeguards on their products so you can’t go beyond the design space, so that when you’re patient-matching a device to someone, it will tell you when you have exceeded that limit and won’t let you push beyond it.” This also protects individuals with 3D printers from printing a dangerous device.

3D-printed products in the aviation field are also monitored. They must be fire-resistant and reliable. The Federal Aviation Association (FAA) looks for 3D products that meet or exceed the characteristics of their non-3D counterparts. For example, Custom Control Concepts, a company that “builds tailored interiors for high-end luxury jets,” finds it difficult to win FAA approval. The company uses Ultam (one of the only FAA-approved 3D plastics) and uses an FAA approved on-site testing laboratory. As another example, GE Aviation “uses in-process monitoring” to make sure that the pieces match standards and “puts every third part through a scanner and X-ray it.”

This GE Aviation video demonstrates the making of a 3D jet engine and shows a safety test in progress.

There is also the fear that 3D printing can be used to create weapons. On May 5, 2013 the first 3D gun, called the Liberator, was printed by Defense Distributed, an American organization lead by a “25-year-old Texas law student and committed libertarian named Cody Wilson.” In 2014, Congressman Steve Israel (R-NY) introduced legislation that would fully ban 3D guns. Although it was not successful, he plans to reintroduce legislation that would once again ban 3D guns and all completely plastic firearms. Israel argued:

My legislation is about making sure that we have laws in place to ensure that criminals and terrorists can’t produce guns that can easily be made undetectable. Security checkpoints will do little good if criminals can produce plastic firearms and bring those firearms through metal detectors into secure areas like airports or courthouses.

It is yet to be seen whether this legislation will make it through.

 Conclusion

We have only just seen the beginning of 3D printing. It could enter our everyday lives in force within the next couple of years. Regulations and perfecting various products have slowed the general trend, but the kinks and safety approvals will eventually work themselves out. Researchers and scientists are dedicated to perfecting this new art. The benefits seem utterly limitless. It seems right to invest time, money, and effort into any machine that can give patients new limbs or keep U.S. soldiers healthy, but it’s important to make sure that it’s all done as safely as possible.

Resources

3D Printing: What is 3D Printing?

National Geographic: What, Exactly, is a 3D Printer?

3D Printing for Beginners: A Comprehensive Introduction to 3D Printing Technology

Fed Scoop: How the FDA Regulates 3D devices

Financial Times: Regulatory Concerns Hold Back 3D Printing on Safety

Forbes: US Army Looks to 3D Print Food For Soldiers

Live Science: What is Stereolithography?

The New York Times: Hand of a Superhero

NPR: Army Eyes 3D Printed Food For Soldiers

Popular Mechanics: Should We Be Afraid of the 3D Printed Gun?

Wired: Bill to Ban Undetectable 3D Printed Guns is Coming Back

Jessica McLaughlin

Jessica McLaughlin is a graduate of the University of Maryland with a degree in English Literature and Spanish. She works in the publishing industry and recently moved back to the DC area after living in NYC. Contact Jessica at staff@LawStreetMedia.com.

The post Regulating the Innovative World of 3D Printing appeared first on Law Street.

Counterfeit drugs pose both domestic and global threats, presenting serious health risks worldwide. Although the issue is most prevalent outside the United States, Americans aren’t immune to the illegal market’s reach, as there have been far-reaching counterfeit drug cases in the U.S. As a result, there’s been a large effort to combat the problem in America. Read on to learn more about the proliferation of counterfeit drugs, and what’s being done to stop them.

What are counterfeit drugs?

According to the World Health Organization (WHO):

Counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.

The issue was first addressed in the 1995 WHO Conference of Experts on Rational Drug Use in Nairobi, Kenya. Since then, the market has expanded, but preventive measures have also multiplied. Most counterfeited drugs consist of antibiotics, hormones, analgesics, steroids, and antihistamines. In all, counterfeit drugs are divided into six categories: products without active ingredients (32.1 percent of counterfeits), products with incorrect quantities of active ingredients (20.2 percent of counterfeits), products with wrong ingredients (21.4 percent of counterfeits), products with correct quantities of active ingredients but with fake packaging (15.6 percent of counterfeits), copies of an original product (1 percent of counterfeits), and products with high levels of impurities and contaminants (8.5 percent of counterfeits).

The FDA believes the growth in the counterfeit drug market may be due to the escalating costs of prescription drugs, advanced technologies to develop counterfeit drugs, and the anonymity and ease of the internet.

Health Risks

The severity of the risk factors for any specific counterfeit drug will vary. Generally, they can actively cause unexpected side effects, an allergic reaction, the worsening of the existing medical condition, and/or prolong treatment periods.

A counterfeit drug that substitutes an inert substance for the active ingredient will not improve a person’s medical condition. For example, the main ingredient in Lipitor (a commonly counterfeited drug in the U.S.) is atorvastatin. Its purpose is to lower high cholesterol and triglyceride levels, and therefore reduce the risk of stroke and heart attack. If a patient believes he/she is taking atorvastatin, but in fact is consuming an inert substance, the consequences could be deadly. Even worse, in some cases, not all substituted or added substances are inert, but are instead hazardous.

 U.S. and Global Statistics About Counterfeit Drugs

The international counterfeit drug market amasses $200 billion a year. Internet sales make up $75 billion of that market. Most counterfeits are made in China and India. In the United States, 80 percent of counterfeit medicine is brought into the country from outside.

The WHO estimates that up to ten percent of the drugs sold internationally are counterfeit. In some countries this number can reach up to 50 percent. Developed countries that have strict regulations and institutions like the FDC, are estimated to sell less than one percent of counterfeit drugs. However, the United States has seen its share of highly publicized cases. With a few exceptions, the United States counterfeit market is generally focused on “lifestyle” drugs like diet, erectile dysfunction, and hair growth pills.

The counterfeit market is growing in the U.S. In 2014, an estimated 60 various Pfizer products were being counterfeited compared to just 20 in 2008. One of the most popular counterfeited pharmacy items is ChapStick. China reported holding 1,300 alleged counterfeiters and confiscating $362 million worth of counterfeit product in 2013.

According to the WHO, an estimated 200,000 people die a year due to “ineffective, fake, and substandard malaria drugs” that don’t eliminate parasites from a person’s system. To make matters worse, the fake drugs often contain a smaller dosage of the active ingredient than necessary. Thus the fake drug cures symptoms without curing the disease and fuels drug-resistant strands.

Counterfeit Drugs in the U.S.

A counterfeit maker of Avastin, a cancer drug, accessed the U.S. supply chain in 2012. This was the first major exception to the notion that counterfeits in the U.S. were limited to lifestyle drugs. Undetected, doctors and purchasing managers for oncology clinics “bought and administered the counterfeit medicines to their patients.”

In May 2012, a counterfeit version of Teva Pharmaceutical’s Adderall 30 mg tablets entered the market. The FDA labeled the counterfeit “unsafe, ineffective, and potentially harmful.” The counterfeit version did not contain the active ingredients dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amephtamine sulfate. Instead, it contained ineffective ingredients tramadol and acetaminophen. The original product is orange and peach in color with markings, while the counterfeit is white and devoid of any markings. Entering the counterfeit market for Adderall was probably seen as a lucrative opportunity, as Adderall is on the FDA’s drug shortage list, which means that it is dispersed only when available.

The drug Procrit, used to treat anemic patients with “cancer and other serious diseases,” had a large counterfeit scare in 2013. FDA investigators found three fake batches bearing three different lot numbers and expiration dates. The fake medicines contained a clear liquid with no active ingredient and two life-threatening strains of bacteria. Not only was patients’ anemia going unchecked, but already-weak patients were consuming potentially deadly bacteria. The FDA dispersed a warning to the public and provided ways to check the authenticity of the product.

Precautions to Avoid Counterfeit Drugs

There are ways to help ensure that patients and customers purchase legitimate prescription drugs. Most counterfeited drugs are sold through the internet. The National Association of Boards of Pharmacy investigated 10,000 pharmaceutical sites and found that only three percent of the sites appeared “to be in compliance with pharmacy laws and practice standards.”

Internet sites to be avoided include those outside the United States; those that don’t offer a physical address; those that don’t display a license by the applicable state board of pharmacy;  those that don’t provide a licensed pharmacist to answer questions; and sites that don’t require a prescription. Consumers should also look for the Verified Internet Pharmacy Practice Sites (VIPPS) seal. There are over 30 online pharmacies that display this seal, which was created by the National Association of Boards of Pharmacy to combat sites selling counterfeit drugs.

Consumers must also be cautious when inspecting the packaging of their product by looking for altered or unsealed containers or any physical differences in the appropriate packaging or product appearance. A change in taste and side effects could signal counterfeits as well.

 Actions Against Counterfeit Drugs

In 2012, the United States and 110 other countries participated in INTERPOL’s Pangea sting operation. The operation resulted in:

11,000 illegal online pharmacies being shut down, the removal 19,000 ads for fake drugs on social media sites, the seizure of 9.4 million doses of phony medicines…Google agreed to spend $50 million annually over the next five years to crack down on advertising for illegal online pharmacies.

Pharmaceutical companies also have their own internal investigations to fight against counterfeit medicines. For example, one method is similar to fingerprinting. Pfizer designed an infrared spectrometer that analyzes a product’s chemical bonds. Every drug has unique “reflected and absorbed wavelengths.” A graph will produce peaks and valleys–like a fingerprint–depending on the ingredients and their quantities. Those in the Pfizer lab can superimpose fake “fingerprints” over the real ones on the computer and note the differences. Further testing with X-ray diffraction can show exactly what ingredients the fake is composed of.

In 2014, Eli Lilly, an Indianapolis-based pharmaceutical company, invested $110 million in creating traceable, unique stamping codes for all of its products sold globally. The stamping codes will allow the company to trace each product from manufacturing facility to patient, and combat fakes.

The Legal Side of Drug Counterfeiting

The Prescription Drug Marketing Act of 1987 (modified in 1992) effectively closed off the United States supply chain. The law directly aimed at protecting American consumers and avoiding counterfeit drugs by providing legal safeguards. It “provides that prescription drug products manufactured in the United States and exported can no longer be reimported, except by the product’s manufacturer.” It also provides uniform standards for all distribution channels including hospitals and wholesalers.

The Food and Drug Administration Safety and Innovation Act was enacted in July 2012. It granted the FDA new and enhanced powers to regulate prescription drugs and combat counterfeit drugs in the U.S. The FDA, for example, can now “administratively detain drugs believed to be adulterated or misbranded, and the authority to destroy certain adulterated, misbranded, or counterfeit drugs offered for import.”

The 2013 Drug Quality and Security Act “outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.” Pharmaceutical companies must implement a tracking system by 2015 and tag serial numbers to each singular unit sold in the U.S. by 2017.

Conclusion

The counterfeiting of medicines is not a problem secluded to developing countries. Without proactive enforcement, counterfeit drugs could erupt in the United States. It is a highly lucrative industry for the black market. Pharmaceutical companies and consumers alike need to be responsible with prescription drugs, as the potential health risks can be deadly. This is a global problem that requires global cooperation.

Resources

Primary

FDA: Counterfeit Drugs, Questions and Answers

CDC: Counterfeit Drugs

FDA: Counterfeit Drugs

Additional

Nova Next: Cracking Down on Counterfeit Drugs

CBS News: Your Anemia Drug May Be Fake

Fierce Pharma: Lilly Steps up War on Counterfeits With $110M Serialization Program

HRF: 20 Shocking Counterfeit Drug Statistics

Medscape: Counterfeit Version of Adderall Unsafe, Ineffective, FDA Warns

PhRMA: Counterfeit Drugs

National Center for Biotechnology Information: The Prescription Drug Act of 1987

Jessica McLaughlin

Jessica McLaughlin is a graduate of the University of Maryland with a degree in English Literature and Spanish. She works in the publishing industry and recently moved back to the DC area after living in NYC. Contact Jessica at staff@LawStreetMedia.com.

The post The United States Isn’t Immune to Counterfeit Drugs appeared first on Law Street.

Skin cancer is the most common type of cancer in the United States. Some forms of skin cancer cause disfigurements and some  are fatal. Either way, skin cancer is nothing to take lightly. There are a variety of factors that account for the prevalence of skin cancer. In recent years, tanning beds have especially come under attack for their part in steadily increasing skin cancer diagnoses in the United States, especially for young people. Fortunately, not all is lost. Researchers are creating innovative skin cancer trials that are seeing encouraging results, while government officials promote state and federal policies to reduce the risks of skin cancer.

What is Skin Cancer?

Skin cancer is defined as:

The uncontrolled growth of abnormal skin cells. It occurs when unrepaired DNA damage to skin triggers mutations, or genetic defects, that lead the skin cells to multiply rapidly and form malignant tumors.

What are the most common types of skin cancer?

Basal Cell Carcinoma (BCC) is the most common form of skin cancer. In the U.S., 2.8 million cases of BCCs were diagnosed in 2010 and those numbers continue to increase. BCCs are “abnormal, uncontrolled growths or lesions” that form in the skin’s basal cells. Basal cells outline the outermost layer of the skin. BCCs resemble open sores, red patches, pink growths, shiny bumps, or scars. In most cases, both long-term sun exposure and short intense sun exposure can lead to the formation of BCCs. In rare instances, other factors like contact with arsenic, radiation exposure, and burn complications can trigger BCCs as well. They are rarely life threatening, but can cause disfigurement and muscle or nerve damage.

Squamous Cell Carcinoma (SCC) is the second most commonly occurring form of skin cancer. It develops in the skin’s upper layer squamous cells. Approximately 700,000 cases of SCC are diagnosed annually in the United States. Reportedly, between 3,900 and 8,000 cases had fatal results in 2012. In the last thirty years, SCC cases have increased by 200 percent. They generally resemble “scaly red patches, open sores, elevated growths with a central depression, or warts” that may crust or bleed. SCCs are most often caused by ultra violet (UV) exposure whether through daily long-term sun exposure, short intense sun exposure, or tanning beds. With a few exceptions, SCCs occur on parts of the body most often exposed to the sun. Although previously associated with men over 50, SCCs are steadily increasing in women under 30. This phenomenon is largely attributed to tanning beds.

Melanoma is the most dangerous form of skin cancer. Melanoma tumors “originate in the pigment-producing melanocytes in the basal layer of the epidermis.” They resemble moles, and can develop from moles as well. Most often, they are black or brown. The main source of melanomas is intense, sporadic UV exposure regularly leading to sunburn. There is also a significantly higher risk for those with a genetic predisposition toward skin cancer. Melanomas account for 9,710 deaths in the U.S. annually. There are 120,000 new cases diagnosed each year. Early detection is key as the disease is harder to cure when the cancer metastasizes to other parts of the body.

Statistics

Each year there are approximately five million Americans treated for skin cancer. There are more new cases of skin cancer than incidences of breast, lung, colon, and prostate cancer combined. One in five Americans will develop skin cancer in his or her lifetime. There is a 40-50 percent chance that an American who lives to the age of 65 will either develop a BCC or SCC. Approximately 90 percent of non-melanoma skin cancers are developed from UV radiation from the sun. And surprisingly, more people develop skin cancer through tanning than lung cancer through smoking.

One person dies of melanoma every 57 minutes and one in every 50 men and women will be diagnosed with it in his or her lifetime. Melanoma is one of three cancers with an increasing mortality rate (liver cancer and esophageal cancer). It is the most frequently occurring cancer in young adults (25-29) and the second most frequently occurring cancer in young people (15-29).

 What Causes Skin Cancer?

There are a variety of contributing risk factors for skin cancer. Unprotected overexposure to UV radiation from both the sun and tanning beds is the predominant source of skin cancer. This can come from extended daily exposure over the course of a lifetime or short intense spurts that result in sunburn. It is generally the latter that causes melanoma.

As of September 2, 2014, the FDA reclassified tanning beds from low-moderate risk to moderate-high risk devices. Indoor tanning is linked to more than 419,000 skin cancer cases a year in the U.S. A one-time indoor tanning session increases a person’s risk of developing squamous cell carcinoma by 67 percent and basal cell carcinoma by 29 percent. Two to three million teens use indoor tanning beds every year and subsequently increase their risk of melanoma by 75 percent.

Other risk factors include having pale and easily sunburned skin, genetics/family history, workplace exposure to coal tar, creosote, arsenic compound or radium, moles, and previous severe sunburns.

 Skin Cancer Clinical Trials

Through the successes of clinical trials, the FDA has approved seven new treatments for advanced metastatic melanoma cancer since 2011. The new treatment options include targeted therapies and immunotherapies. Targeted therapies “disrupt specific molecules that help cancer cells survive and grow.” Researchers are particularly excited about innovative immunotherapies that restore and enhance the immune system’s ability to fight cancer

National Cancer Institute’s Howard Streicher stated the difference for patients diagnosed with advanced melanoma just 5 years ago and today “is like night and day.”

Targeted Therapies

Targeted therapies disrupt the vital communication route of the signaling pathway in tumor cells known as the MAP kinase or MAPK pathway. The pathway influences “critical functions such as cell division and cell death.” Two proteins involved in the makeup of the MAPK pathway are the BRAF and the MEK. More than half of advanced melanomas have mutations in the BRAF gene. Two of the recently approved FDA drugs specifically target BRAF proteins: vemurafenib and dabrafenib. Each drug was approved after findings from phase III trials that tested patients with tumors that had one or two specific mutations in the BRAF gene. Trial results proved a longer overall survival rate without the disease worsening compared to the drug used as the standard of care at the time.

Immunotherapies

Melanoma is particularly predisposed to inducing an immune response. Researchers realized that tumors can divert T-Cells (particular proteins on the surface of immune cells) and other immune cells from attacking them by manipulating the immune system. The tumors essentially mask themselves from the T-Cells, while “dial[ing] back the immune response.”

One of the new drugs, Ipilimumab, “targets a checkpoint protein on T cells called CTLA-4” that releases the T-cells to attack tumors. This drug came into effect after a phase III trial that tested patients with cancer no longer reacting to FDA-approved and/or common therapies.

The other newly FDA-approved drugs for both targeted and immunotherapies saw similarly encouraging results. Testing is still in a fairly new territory and final results await to be seen. Future inquiries include: what combination of drugs would be most effective and which patients necessitate which specific drugs? Researchers are also looking to further limit side effects. Although most side effects were minor, some included severe skin rashes, diarrhea, colitis, and fatal lung inflammation.

 Law and Policy Regarding Skin Cancer

For starters, the Surgeon General’s office published its most recent Call to Action in 2014 on preventing skin cancer. A Call to Action is a “science-based document to stimulate action nationwide to solve a major public health problem.” The aim of this specific document is to increase skin cancer awareness and to call on various organizations and sectors in the U.S. to become invested in skin cancer prevention. The Call to Action presents a five step plan: promote sun protection in outdoor settings, inform the public about UV exposure, promote policies that advocate skin cancer prevention, minimize side effects from indoor tanning, and “strengthen research, surveillance, monitoring, and evaluation related to skin cancer prevention.” It also emphasizes skin cancer as a major threat toward American youth. It calls for coordination and support from federal, state, and local sectors of the business, health, and educational communities.

In accordance with the Surgeon General’s emphasis on American youth skin cancer prevention, many states have banned indoor tanning for minors. Currently, these states include California, Delaware, the District of Columbia, Illinois, Louisiana, Minnesota, Nevada, Oregon, Texas and Vermont. In addition, 42 states regulate indoor tanning by minors in varying ways. For example, Alabama bans indoor tanning for minors below the age of 15. Counties and cities across the country have regulated the activity as well. Howard County, Maryland was the first county to ban indoor tanning for minors under 18.

California has some specific laws that deal with UV safety prevention. Billy’s Bill for Sun Safety requires schools to allow students to wear protective sun gear outside and wear sunscreen without a physician’s note or prescription during the school day. The California Labor Code also allows lifeguards who develop skin cancer while working with a public agency or the California Department of Parks and Recreation to be eligible for workers’ compensation. Lastly, minors under 14 are prohibited from indoor tanning and children between the ages of 14-18 must have a parent or guardian’s written permission.

In New York, aside from regulations for minors, tanners 18 and over must sign a statement acknowledging the dangers of indoor tanning before stepping into the tanning booth. Staff at tanning salons are required to wear protective gear as well. The state also requires sun-safety education and necessary equipment for state employees that spend five or more hours in the sun daily.

Altogether, it seems more and more states are getting on board regarding UV preventative regulation and informing the public.

 Conclusion

Skin cancer is definitely a major health concern in the United States. New clinical research and national legislation are at the forefront of the fight. On the public end, we need to stay informed, help educate others, and take simple preventative measures. By implementing everyday habits we can best fight skin cancer, such as regularly applying sunscreen and wearing proper attire. Moreover, as a society, we need to stop perpetuating the trend that tanned skin in more attractive. But in all, the strides fighting skin cancer look extremely promising and the efforts don’t show any signs of slowing down.

Resources

Primary

The Surgeon General: Call to Action to Prevent Skin Cancer

Additional

Skin Cancer Foundation: Skin Cancer Facts

American Cancer Society: Skin Cancer Facts

NCSL: Indoor Tanning Restrictions for Minors

NYSCOPBA: Sun Safety

Skin Cancer Foundation: Basal Cell Carcinoma

Skin Cancer Foundation: Melanoma

Skin Cancer Foundation: New York Tightens Tanning Laws for Teens

Skin Cancer Foundation: Skin Cancer Information

Skin Cancer Foundation: Squamous Cell Carcinoma

Jessica McLaughlin

Jessica McLaughlin is a graduate of the University of Maryland with a degree in English Literature and Spanish. She works in the publishing industry and recently moved back to the DC area after living in NYC. Contact Jessica at staff@LawStreetMedia.com.

The post Skin Cancer: Clinical Trials, Current Policies, and Certain Progress appeared first on Law Street.

“Natural” and “organic” labels on food have become a tremendously popular–and tremendously profitable–means of discussing, buying, and selling food.

But what do we really know about what it means when those $4.99 cherry tomatoes are labeled as “organic,” or when that chicken is marketed as “all natural”? And who are we really concerned about when we talk about food labels–only consumers, or the people who produce our food, as well?

 What’s so natural about “natural”?

The U.S. Food and Drug Administration (FDA) doesn’t seem to have a clear answer to this question. In regards to the definition of “natural” food, the FDA’s website states that it:

Has not developed a definition for use of the term natural or its derivatives. However, the agency has not objected to the use of the term if the food does not contain added color, artificial flavors, or synthetic substances.

Without any legally binding regulations to mark which foods can be sold as “natural” and which cannot, the meaning of the label is ambiguous at best. Since “natural” foods are defined inconsistently–perhaps in whatever way sells best–the label is often criticized as being both misleading and meaningless.

The definition of “natural” is, however, regulated for meat and poultry. The U.S. Department of Agriculture’s Food and Safety Inspection Service requires that, in the case of meat and poultry labeling, “natural” must mean:

A product containing no artificial ingredient or added color and is only minimally processed. Minimal processing means that the product was processed in a manner that does not fundamentally alter the product. The label must include a statement explaining the meaning of the term natural (such as ‘no artificial ingredients; minimally processed’).

This emphasis on fundamentally altering the product means that the natural label is determined not by the process of raising the animals involved, but in their preparation for being sent to grocery stores after death. This means that what is fed to animals before their death is not regulated by a “natural” label. As a Take Action petition for banning “natural” labels that confuse customers reminds us, this means that:

Meat labeled as ‘natural’ can come from animals that were raised with daily doses of antibiotics and other drugs, given artificial growth hormones, fed genetically engineered soy and corn feed and other artificial ingredients and continually confined indoors.

 How organic is “organic”?

The definitions of “organic” are more legally binding than those of “natural.” According to the U.S. Environmental Agency (EPA), there are standards of “organic farming” that determine whether or not a food item can be labeled and sold as organic. This emphasis on organic as a farming process means that organic definitions are less about ingredients and more about the process of growing and considering the treatment of the plants that were harvested for food.

However, this also means that–especially due to the many kinds of organic labels–foods marketed as “organic” can still be full of chemicals. An informal investigation of Whole Foods organic products by Duke University senior Emma Loewe revealed many additives that are permissible under organic labeling. She writes,

Over the course of my search, I came across organic trail mix that featured Silicon Dioxide, Cirtric Acids and Maltodextrin. Try saying that five times fast. The canned goods aisle brought me to organic soup made up of sodium citrate and a dash of ‘cheese flavor’ for good measure. The organic cereal I picked up was made with vegetable glycerin—a common additive in cosmetics and soaps because of its cooling effect on the skin.

These additives are permitted under “organic” labels largely because there are different kinds of organic. According to the National Science Foundation, the different means of organic phrasing–100 percent organic, organic, made with organic ingredients, and others–are held to a diversity of legal standards. In order to use the U.S. Department of Agriculture (USDA) Organic Seal, foods claiming to be 100 percent organic must be made with 100 percent organic ingredients, excluding water and salt. Foods using the label “organic” must have 95-99 percent organic ingredients. Foods can still call themselves organic by saying they are “made with organic ingredients” if between 70 and 84 percent of the ingredients are organic.

This brings us back to the question: what does it mean to be an “organic ingredient”? According to the U.S. Department of Agriculture’s Agricultural Marketing Service, the regulations for crops and animals are as follows:

Organic crops. The USDA organic seal verifies that irradiation, sewage sludge, synthetic fertilizers, prohibited pesticides, and genetically modified organisms were not used.

Organic livestock. The USDA organic seal verifies that producers met animal health and welfare standards, did not use antibiotics or growth hormones, used 100% organic feed, and provided animals with access to the outdoors.

Vague statements like “access to the outdoors” and “prohibited pesticides” raise a great number of questions and criticisms regarding loopholes in the standards of organic labeling.

 From the Farm: Labor and Labels

Discussions about food labels so often focus exclusively on the health of people consuming the food. However, these conversations generally erase a bigger conversation about health, that is, the health of the farm workers who are the human backbone of agriculture in this country.

Advocates hope that efforts like these and others, such as emphases on broader immigration reform and health care, can bring a more total picture of health into the conversation about the health issues surrounding “organic” farming and “natural” foods.

So Are “Natural” and “Organic” Foods Actually Healthier?

It is important to determine whose health we are asking about when we discuss the healthiness of “organic” and “natural” foods. Those who consider the health of farm workers that produce foods labeled “organic” and “natural,” worry that the production of these foods can generate horrible health consequences for the humans involved in the process.

As to the question of “is it healthier to consume these foods?”, the answer is perhaps not. It’s important to remember that many large corporations, such as Coca-Cola, own organic brands, which links organic brands to larger environmental devastation and labor exploitation that negatively impact global health.

Given the legal impotence and inconsistency of the label “natural” advocates against the labels argue that foods with this label have anything in common other than their respective corporations’ attempt to tap into a market that wants to eat “natural” foods. Regarding the consumption of “organic” foods, the Mayo Clinic states that while the jury is technically still out, studies conducted over the past fifty years do not make a convincing argument that there are any significant differences in nutritional content between “organic” and non-organic foods. So, next time you go to your grocery store, you may want to keep a close eye on more than just the labels on your food.

Resources

Primary

Food and Drug Administration: What is the Meaning of ‘Natural’ on the Label of Food?

U.S. Department of Agriculture: Meat and Poultry Labeling Terms

U.S. Department of Agriculture: National Organic Program

Environmental Protection Agency: Organic Farming

Additional

Farmworker Justice: Home

Agricultural Justice Project: Home

Grist: Workers on Organic Farms are Treated as Poorly as Their Conventional Counterparts

TakeAction: Stop Confusing Consumers: Ban the ‘Natural’ Label

EcoWatch: Organic Labeling: What You Need to Know

NaturallySavvy: The USDA Organic Program Faces Criticism

EarthJustice: Pesticides: The Workplace Hazard the EPA is Ignoring

Salon: California’s Rampant Farm-Labor Abuse

Jennifer Polish

Jennifer Polish is an English PhD student at the CUNY Graduate Center in NYC, where she studies non/human animals and the racialization of dis/ability in young adult literature. When she’s not yelling at the computer because Netflix is loading too slowly, she is editing her novel, doing activist-y things, running, or giving the computer a break and yelling at books instead. Contact Jennifer at staff@LawStreetMedia.com.

The post Natural or Organic: Not Just the Labels on Our Food appeared first on Law Street.

Imagine ripping into a warm baguette with your bare hands. You owe its intoxicating fluffiness and delectable chewiness to gluten. A water insoluble protein found in wheat, gluten and its compounds bring us everything we expect from bread. It helps dough rise and hold its shape while also lending elasticity, making bread deliciously chewy.

Yes, we’re talking about the same gluten that has become a modern villain, misunderstood and widely hated. Popular books like “Wheat Belly and Grain Brain: The Surprising Truth About Wheat, Carbs” and “Sugar—Your Brain’s Silent Killers” turned gluten into poison in the public eye. Testimonials extolling the virtues of a gluten-free diet crusade the internet, converting many a faithful bread eater. In short, few foods have gained as much notoriety as gluten and many people think it equals anything bad in food.

Far from evil, gluten just presents a digestive challenge. When you digest wheat, the proteins break down into peptides with compact and complicated structures that cause adverse reactions in people with conditions like Celiac Disease, wheat allergies, or IBS. Unfortunately, in the past 60 years these conditions have become more common, stumping manufacturers and regulators who struggle to satisfy growing market demand for safe, gluten-free products. Read on to find out what they’ve done about gluten, and what they still have to figure out.

The anti-gluten craze: trend or reality?

Is gluten-hatred just a viral trend that people flock to like lemmings? Or is there some truth behind the gluten hate?

Scientifically, aspects of gluten-hatred hold water. Celiac Disease has quadrupled in the last 60 years. Celiac Disease is a disorder triggered by gluten that causes intestinal problems and poor absorption of vitamins and minerals.

Unfortunately, these statistics don’t point to an explanation, leaving scientists to toss around possible theories like darts. Some point the finger at wheat-breeding practices, others insist modern processing plays a part. At this point, only more well-controlled studies on the subject will lead to a consensus.

One study ruled out the possibility that the statistical growth in Celiac Disease results from better detection and diagnosis. A researcher at the Mayo Clinic analyzed existing blood samples from Air Force recruits taken between 1948-1954. He searched for the presence of transglutaminase, an enzyme that indicates Celiac Disease, and compared the percentage he found in the retro sample to the percentage he found in a modern sample of similar subjects. The percentage in the retro sample was significantly lower than what he found in the modern sample, leading him to conclude that something has happened since the 1950s to increase the overall rate of the disease–and it has nothing to do with diagnostics and detection.

The increase in Celiac Disease, combined with the increased demand for gluten-free products, even among people without diagnosed conditions, put pressure on regulators and producers. They responded first with better labeling.

Put a Label on it

In August 2013, the Federal Drug Administration (FDA) issued a final rule on gluten-free labeling that became enforceable the following year. The rule took nine years to develop and stems from the Food Allergen Labeling and Consumer Protection Act of 2004. It set a uniform protocol for companies wishing to market their products as gluten-free that established the acceptable gluten threshold at 20 parts per million (ppm). Why not zero ppm? Some processing techniques can remove most gluten from wheat-derived ingredients. The rule ensures these ingredients can’t add up to pass the safe threshold for people with gluten sensitivity. Furthermore, any food bearing a gluten-free label that lists wheat as an ingredient must also provide an explanation of how the wheat has been processed to remove the gluten.

The rule doesn’t expressly require testing and monitoring of gluten levels in ingredients to ensure compliance, but that would certainly be a safe bet for manufacturers. With the substantial list of ingredients from different sources going into processed foods, only diligent testing and monitoring can guarantee a gluten-free product. Even foods that don’t contain gluten can be cross-contaminated at some point in the long supply chain.

Per the rule, if a food labeled gluten-free actually contains gluten, it would be deemed misbranded by the FDA and subject to regulatory action. Depending on the nature of the offense, that could mean anything from a little warning letter to criminal prosecution.

Gluten Outlaws

Gluten labeling has lead to criminal prosecution before, and it happened when no FDA rule existed to break. In 2011, several customers of the Great Specialty Bread Co. in North Carolina found their Celiac symptoms became mysteriously aggravated after eating bread labeled “gluten-free.” These angry customers took their complaints to the North Carolina Department of Agriculture and Consumer Services, which passed it on to the Wake County District Attorney.

During the trial that followed, testimonies from injured customers forged a strong case against the company. One of them was a new mother whose Celiac reaction to the mislabeled bread caused her to prematurely deliver her baby. Other complaints included severe abdominal pain and rashes.

The owner of the company was ultimately found guilty of 23 counts of fraud and sentenced to nine to 11 years in prison.

Gluten: It’s Complicated

So we have an enforceable labeling policy and some criminal precedent for labeling abuse. What we lack to advance policies is a complete understanding of why gluten sensitivity is growing in the first place and how to control it.

Negative reactivity to gluten changes depending on the specific condition a person has and the variety of wheat that they eat, making gluten sensitivity hard to study as an overall subject. Gluten-sensitive conditions like Celiac Disease, wheat allergies, and other wheat sensitivities are also irritated by different compounds in wheat. Furthermore, separate varieties of wheat contain different amounts of gluten compounds and these amounts can fluctuate among the same variety depending on growing techniques and processing methods.

Growing Techniques

Studies have shown that reactivity of a wheat variety can change based on its growing location. Some compounds in wheat even increase with fertilization and in certain weather conditions. We don’t track gluten content from farm to table, so at present it’s impossible to isolate these factors to produce less reactive products.

Processing Techniques

Processing methods influence the reactivity of wheat products and stand as the prime suspect in explaining why wheat-related sensitivity has increased over the last 60 years. Of all the factors affecting the wheat industry, processing methods have changed the most. Today we favor refined white flour, we extract wheat proteins to use as additives, and we shorten the natural fermentation process using fast-acting yeast.

All of these complex factors complicate the study of gluten sensitivity and keep us from determining why conditions are growing. Any and all of these factors could be contributing to the problem. Costs and the complexity of food processing deter researchers and producers from tackling the issue, but only further testing can provide food manufacturers with the guidance they need to improve their growing and processing methods to lessen negative reactivity among their gluten-sensitive customers. While the process would be tedious, it could indicate what wheat varieties and techniques to favor in order to cater to the growing culture of wheat sensitivity.

Gluten, Still a Hot Topic

While many people mock the anti-gluten trend, a growing segment of our population needs to avoid gluten for medical purposes. Even so, a gluten-free lifestyle remains persistently trendy outside of that population. In the National Restaurant Association’s What’s Hot in 2014 survey, gluten-free took the #5 spot.

The trend ultimately helps people with diagnosed conditions as manufacturers and restaurants race to innovate tasty new products. If demand holds steady, it won’t be long until a perfect, gluten-free iteration of an exquisite baguette is within reach.

Resources

Primary

FDA: FDA Defines “Gluten-Free” for Food Labeling

FDA: Food Allergen Labeling and Consumer Protection Act of 2004 Questions and Answers

Federal Register: Food Labeling; Gluten-Free Labeling of Foods

Additional

Food Politics: Good News: FDA Issues Rules for a Gluten-Free Claim on Food Packages

New Yorker: Against the Grain

Comprehensive Reviews: A Grounded Guide to Gluten: How Modern Genotypes and Processing Impact Wheat Sensitivity

Food Liability Law: FDA Issues Gluten Free Labeling Compliance Guide

WRAL: Durham Bread Company Owner Sentenced For Fraud

Institute of Food Technologists: Testing for Gluten in Foods

National Restaurant Association: 2014 Culinary Forecast

Ashley Bell

Ashley Bell communicates about health and wellness every day as a non-profit Program Manager. She has a Bachelor’s degree in Business and Economics from the College of William and Mary, and loves to investigate what changes in healthy policy and research might mean for the future. Contact Ashley at staff@LawStreetMedia.com.

The post How to Regulate Gluten, the Modern Food Villain appeared first on Law Street.

E-cigarettes are one of America’s latest trends. Since entering the United States over the last ten years, they have taken the smoking community by storm. To many of us however, they are still somewhat of a mystery. Generally, we have a sense that they are less harmful than cigarettes, but how much less harmful exactly? With any new product, it is hard to foresee long-term health effects. But what do we know so far? Should e-cigarettes and their advertisements be regulated similarly to conventional cigarettes? Read on for a breakdown on what e-cigarettes are, the debates over them, and what regulation is being discussed.

What are electronic cigarettes?

E-cigarettes, also known as e-cigs and vaporizer cigarettes, are used as an alternate method to smoking tobacco via cigarettes, pipes, or cigars. They are battery operated and don’t involve smoke inhalation. The idea is that they bypass tobacco smoke, which can include more than 7,000 different harmful chemicals, many of which are known to cause cancer, heart disease, and lung disease. Some of the more well-known poisonous chemicals are cyanide, methanol, and ammonia. In addition, tobacco smoke includes tar, carbon monoxide, and nitrogen oxide.

Many e-cigs are designed to look like cigarettes and create a similar experience for those who are smoking them. A Chinese pharmacist perfected them in 2003-2004 and they were quickly brought to the international market in 2005-2006. In the current, automatic versions, a user sucks on an end piece to activate a sensor that allows a heating element to vaporize a liquid solution held in the mouthpiece.

Components

E-cigarettes are generally reusable and come in three parts: the Mouthpiece, the Atomizer, and the Battery.

• Mouthpiece (Cartridge): The mouthpiece holds the liquid solution, also known as e-liquid and e-juice. This solution can contain different grades of nicotine and come in a variety of flavors. Some are meant to imitate established cigarette brands, while others are more exotic. The nicotine is most often dissolved in propylene glycol, a food additive. The FDA has labeled propylene glycol as a “Generally Recognized as Safe” (GRAS) substance.
• Atomizer: This is the heating element that allows for vaporization. It requires replacement every three to six months.
• Battery: The battery is the largest piece of the e-cigarette. It is usually lithium-ion and rechargeable. It catalyzes the heating element and often contains an LED light to showcase activation.

Nicotine 

This product eliminates the inhalation of tobacco smoke, however it is important to note that nicotine itself isn’t very healthy. Although it is not the element of cigarettes that causes cancer, the U.S. Surgeon General has linked nicotine to negative impacts on fetal and adolescent brain development, premature birth, and low birth weight. In rare cases, nicotine can even cause abnormal heart rhythm and atrial fibrillation. It is also known to cause mouth irritation, mouth and throat pain, high blood pressure, and canker sores.

In 2014, a study found that “e-cigarettes with a higher voltage level have higher amounts of formaldehyde, a carcinogen.” This is under debate however due to the methods and nature of the study.

How are conventional cigarettes regulated?

We already know that smoking tobacco is awful for your health. It is to blame for 30 percent of all cancer deaths in the U.S., and accounts for 87 percent of lung cancer deaths in men and 70 percent in women. As a result of these health concerns, cigarettes and their advertisements are heavily controlled. To ascertain whether e-cigarettes should be similarly regulated, we need to understand established cigarette regulations. Here are some recent highlights.

The Family Smoking Prevention and Tobacco Control Act

The Family Smoking Prevention and Tobacco Control Act, passed in 2009, authorized the FDC to regulate the manufacture, distribution, and marketing of tobacco products. It requires prominent warning graphic labels for cigarettes and larger text warnings on smokeless tobacco products. It regulates describing tobacco products as “light, low, or mild.” Tobacco companies must yield research on health, toxicological, behavioral, or physiologic effects of tobacco use. The FDA can conduct compliance check inspections of any establishment selling tobacco products and fine any establishments not adhering to set regulations. It also requires tobacco manufactures to receive an order or exemption from the FDA before it can introduce new tobacco products.

Other parts of the law are focused on preventing advertisements aimed at America’s youth. Cigarettes cannot be flavored. The packaging design and color must be muted. It prohibits tobacco brands from sponsoring “sporting, entertainment, or other cultural events.” It prohibits free samples of cigarettes. And lastly, it prohibits tobacco branding on non-tobacco products.

E-Cigarette Regulation

Currently, there aren’t any regulations concerning the manufacture, distribution, and marketing of e-cigarettes. The only type of e-cigarettes subject to regulation are those designed for therapeutic purposes, as the FDA has authority to oversee those.

Only three states in the U.S. ban e-cigarettes in designated 100 percent smoke-free venues: Utah, New Jersey, and North Dakota. Only 15 states restrict the use of e-cigarettes in other venues. There are 162 local laws that restrict e-cigarettes in various venues, but those appear to be few and far between.

Are e-cigarettes dangerous?

The question remains: should we be worried about e-cigarettes? That’s a debate that’s happening across the country. They do eliminate deadly smoke inhalation, the most detrimental part of smoking cigarettes. However, there are still concerning aspects of e-cigarettes that need to be taken into account.

E-Cigs as a Gateway to Smoking for Young Adults

The Journal of the American Medical Association (JAMA) published a 2014 study entitled, “Electronic Cigarettes and Conventional Cigarette Use Among US Adolescents.” The study was conducted out of a concern over the increasing use of unregulated e-cigarettes by today’s youth. The results came from a sample of U.S. middle and high school students who participated in the 2011 and 212 National Youth Tobacco Survey. It found:

Use of e-cigarettes was associated with higher odds of ever or current cigarette smoking, higher odds of established smoking, higher odds of planning to quit smoking among current smokers, and, among experimenters, lower odds of abstinence from conventional cigarettes. Use of e-cigarettes does not discourage, and may encourage, conventional cigarette use among US adolescents.

In accordance, a 2013 study published by the Centers for Disease Control and Prevention (CDC) concluded that:

Youth who had never smoked conventional cigarettes but who used e-cigarettes were almost twice as likely to have intentions to smoke conventional cigarettes as those who had never used e-cigarettes.  Among non-smoking youth who had ever used e-cigarettes, 43.9 percent said they have intentions* to smoke conventional cigarettes within the next year, compared with 21.5 percent of those who had never used e-cigarettes.

Additionally, the CDC found that more than 250,000 young adults who have never smoked a cigarette have tried an e-cigarette. That is a triple increase from 2011.

Targeting youth?

If these studies are indicative of reality, then it’s scary to think of how e-cigarette companies are targeting the youth demographic. According to a study published in Pediatrics, “electronic cigarette advertisements increased by 256 percent from 2011 to 2013 and young adult exposure to e-cigarette ads jumped 321 percent in the same time period.“ It found that 75 percent of youth exposure to e-cigarette ads happened through the medium of cable networks like AMC, Comedy Central, and VH1. E-cigarette ads appear on programs like “The Bachelor,” “Big Brother,” and “Survivor,” which were rated amid the 100 highest-rated youth programs in 2012-13.

Other tactics accused of being aimed at young adults include free giveaway samples at music and sporting events, candy flavors, and the glamorization of packaging. All of these actions have been banned for traditional cigarettes companies because of their appeal to the youth.

 Do e-cigs help people quit smoking?

It’s difficult to determine. Studies indicate that they don’t necessarily help stop smoking.

JAMA Study Findings

As previously discussed, the 2014 study published by JAMA found that e-cigarettes do not help smokers quit. Specifically with regard to quitting smoking, 88 (out of 949) smokers claimed to start using e-cigarettes at the beginning of the study. In the next year, 13.5 percent of those 88 quit smoking traditional cigarettes. Almost equal percentages of e-cigarette users and solely traditional smokers quit smoking traditional cigarettes within the year. The difference was so slight, it fell within the study’s margin of error.

There are also testimonials, easily found online, that share success stories of smokers that quit with the help of e-cigarettes. These findings and interviews are not to say that it never happens, but it does not seem to be the norm.

Discussions for Future Regulation

The FDA has the authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. The FDA proposed the “deeming rule” on April 24, 2014 to extend tobacco products to include e-cigarettes. If approved, e-cigarettes would be regulated in the same manner as traditional cigarettes. This includes federal prohibition on free sampling, federal warning label requirements, and age verification requirements for retailers. It is still uncertain when and to what extent the FDA will be empowered to regulate e-cigarettes.

Conclusion

Studies looking into e-cigarette health concerns and their position as a gateway product for America’s youth are still new. The product only reached the U.S. in the last ten years and nothing is 100 percent conclusive. On one hand, smoking an e-cigarette is less harmful to your health than smoking a traditional cigarette. If a traditional smoker quits cigarettes and manages to only smoke e-cigarettes for the rest of his or her lifetime, that is a good thing. In the same respect, if a young adult who would have developed a smoking habit only ever uses e-cigarettes because of their availability, that is also a good thing. On the other hand, e-cigarettes aren’t necessarily safe for your health just because they are safer than cigarettes. And we could eventually find that they definitively promote cigarette smoking. The government and FDA can revisit the subject when there is more conclusive information available.

Resources

Primary

JAMA Pediatrics: Electronic Cigarette and Conventional Cigarette Use Among U.S. Adolescents

FDA: Deeming Tobacco Products to Be Subject to the Food, Drug, and Cosmetic Act

FDA: E-Cigarettes

Additional

BeTobaccoFree.gov: Law/Policies

American Cancer Society: Tobacco-Related Cancers Fact Sheet

American Lung Association: General Smoking Facts

American Nonsmokers’ Rights Foundation: U.S. State and Local Laws Regulating Use of Electronic Cigarettes

E-Cigarette Research: The Deception of Measuring Formaldehyde in E-Cigarette Aerosol

American Lung Association: Statement on E-Cigarettes

Medical News Today: What Are E-cigarettes?

RTI International: E-Cigarette TV Ads Targeting Youth Increased 256 Percent in Past Two Years

Science News: E-Cigarettes Don’t Help Smokers Quit

Jessica McLaughlin

Jessica McLaughlin is a graduate of the University of Maryland with a degree in English Literature and Spanish. She works in the publishing industry and recently moved back to the DC area after living in NYC. Contact Jessica at staff@LawStreetMedia.com.

The post E-Cigarettes: Should We Treat Them Like Traditional Cigarettes? appeared first on Law Street.

Heroin addiction is a scary reality for many Americans. It’s often an ongoing roller coaster involving several rehab stints, withdrawal, and lifelong addiction struggles. And it’s unfortunately becoming a more common phenomenon. Today, the drug is no longer an outlier compared to its competitors.  It has been identified by some as the new drug of the upper-middle class. Is this a fair assessment? Here are the facts.

What is heroin?

Heroin received its name from the “hero-like,” invincible effect the drug provides its user. It is also called by other names on the street including: H, Junk, Smack, Big H, Hell Dust, and countless others. Additives can change the color from white (pure heroin) to rose gray, brown, or black. Heroin can be laced with a variety of poisons and/or other drugs. It is injected, smoked, and snorted.

What is the science behind heroin?

From a scientific perspective:

Heroin is an opiate made from the chemical morphine, which is extracted from the dried latex of the opium poppy. Morphine is extracted from the opium latex, and these chemicals are used to make opiates, such as heroin, diamorphine and methadone. Heroin is the 3,6-diacetyl derivative of morphine (hence diacetylmorphine) and is synthesised from it by acetylation.

So what does that mean? Essentially, heroin is an opiate–a drug created from opium that sedates, tranquilizes, and/or depresses the body. It’s similar to a common base in a variety of pain killers–morphine. Opium comes from the cultivation of poppy seeds.

Effects of Heroin                                                     

Heroin users report several effects that differ based on the individual. Heroin can cause a temporary state of euphoria, safety, warmth, and sexual arousal. It can also create a sense of disconnect from other people, causing a dreamlike state and/or sense of floating. It is a depressant, rather than stimulant like cocaine, and it can be used as a self-medicated pain reliever.

Adversely, users can immediately experience vomiting, coughing, constipation, hypothermia, severe itching, and inability to orgasm. Long-term effects include rotten teeth, cold sweats, weakening of the immune system, respiratory illnesses, depression, loss of appetite, insomnia, and tuberculosis. Although this is not a direct effect, the sharing of needles from intravenous injection can often lead to AIDS, Hepatitis C, and other fatal infections.

After the effects wear off, users will start to feel extreme withdrawal symptoms if another dose is not administered. The symptoms of withdrawal can include “restlessness, aches and pains in the bones, diarrhea, vomiting, and severe discomfort.”

How do Americans get heroin?

Afghanistan is the “world’s largest exporter,” producing over 80 percent of the world’s opium. According to the United Nations Office on Drugs and Crime (UNODC), the Afghan poppy cultivation and opium industry amassed $3 billion in 2013, a 50 percent increase from 2012.

Overall, Mexico is the largest drug supplier to the United States. Specifically, Mexico produces Black Tar Heroin, one of the “most dangerous and addictive forms of heroin to date.” This variety looks more similar to hash than powder and can cause sclerosis and severe bacterial infections.

Colombia is the second largest Latin American supplier to the United States. Colombian cartels historically distribute from New York City and are in “full control of the heroin market in the Eastern United States.”

The “Golden Triangle” includes the countries of Burma, Vietnam, Laos, and Thailand. Before the escalation of the Afghan opium market, these southeastern Asian countries reigned over the world’s opium production.

Is it true that middle class heroin use is on the rise?

The Journal of the American Medical Association (JAMA) published a study in 2014 about the changing demographics of heroin users in the last 50 years. Over 2,800 people entering treatment programs participated in self-surveys and extensive interviews.

The results do seem to indicate that heroin is transitioning to the middle class. It is leaving the big cities and becoming more mainstream in the suburbs. Of course, there has been heroin drug use in suburbia before; however, now there is a marked increase.

In the 1960s, the average heroin user was a young man (average age of 16.5) living in a large urban area. Eighty percent of these men’s first experiences with an opioid was heroine. Today, the average heroin user is either a male or female in their twenties (average age of 23). Now, 75.2 percent of these users live in non-urban areas and 75 percent first experienced an opioid through prescription drugs. Almost 90 percent of first-time heroin users in the last ten years were white.

In New York City, doctors and drug counselors report a significant increase in professionals and college students with heroin addictions, while emergency rooms also report an increase in opiate overdoses. In Washington D.C., there has been a 55 percent increase in overdoses since 2010.

Why Heroin?

With all this information readily available through school systems and the internet, why is the educated, middle class turning to heroin? Factors may include increases in depression, exposure to painkillers, and acceptance. The perception of the heroin junkie has changed. A user can snort heroin (bypassing the track marks from injection) and go undetected by those around. It can be a clandestine affair–an appealing notion if the user does want to keep their drug use secret.

Anxiety disorders are the largest mental illness in the United States today, affecting more than 40 million Americans. In a country that loves to self-medicate, heroin offers a false yet accessible reprieve from anxiety and depression.

Prescription drug users also move to heroin. Prescription drugs are expensive and only legally last for the prescribed amount of time. To name a few, these gateway prescriptions drugs come in the forms of hydrocodone (Vicodin), fentanyl (Duragesic), and oxycodone (OxyContin). From 1999-2008, prescription narcotic sales increased 300 percent in the United States. Unlike these expensive prescriptions, a bag with approximately a quarter-sized amount of heroin can be sold for $10 off the streets. The transition isn’t hard to imagine, especially when the desired effects are similar.

Case Study: Understanding Suburban Heroin Use

Young upper-middle class adults are generally perceived as being granted every opportunity and foundation for success. Parents can afford a comfortable lifestyle and access to decent education for their children. So the question continues: why are so many from this walk of life turning to heroin? Through the funding of the Reed Hruby Heroin Prevention Project, the Illinois Consortium on Drug Policy conducted a report Understanding Suburban Heroin Use, to “demonstrate the nuanced nature of risk and protective factors among the heroin interviewees.” A risk factor puts a person in danger of using heroin, while a protective factor reduces the chance of use.

The overriding connection among the interviewees is the “experienced degree of detachment between parent and child and the overall lack of communication.” Contrary to common stereotypes, verbal, physical, and/or earlier drug abuse wasn’t vital in providing a pathway to heroin. A large portion of the answers, proved in these case studies, seem to be the previous emotional health of the users.

Example One

Interviewee one is a 31-year-old male who transitioned from pills to heroin. He is described as athletic, articulate, and candid. He was raised in an upper-middle class Chicago suburb. Although his family was close and intact, he experienced a sense of loneliness. His parents practiced a more hands-off approach to parenting that made him feel like an adult at an early age. His parents didn’t drink or abuse drugs during his childhood. His brother was diagnosed with ADHD, while he was not, although he experienced “restlessness.”

He was caught smoking marijuana at age 14 by his father, quit for a couple months, then resumed. His parents assumed he remained clean because he received good grades and they liked his group of friends. At age 17, he chose to work rather than attend college after graduating high school a semester early. He was earning almost as much income as his father. At 17, he tried his first opioid with a friend whose medical condition allowed easy access to OxyContin. When the prescription ran dry, they turned to heroine. He rationalized the transition thinking if he could handle OxyContin, he could handle heroin. Six months later, he was using approximately $100 worth of heroin daily and eventually moved to violent and illegal actions to sustain his supply. He admitted:

Heroin gave me something. It made me feel the best I have ever felt…Maybe I think love was missing. Like, love. I think. I that, uh, because I always felt like alone. Like even though I had good family, I always felt alone. Different.

Example Two

Interviewee two is a 27-year-old female from the western suburbs of Illinois. She is described as attractive, cheerful, and helpful. She was raised in an educated, wealthy family. She was a cheerleader in high school and earned good grades. There aren’t any psychological or substance abuse problems in her family. She felt disconnected from her siblings as they were much older and felt distant from her parents, as well. Her parents often “bickered” but never had big fights. When she confided in her mother as a child that she might be depressed, her mother seemingly brushed it off.

She started smoking pot in junior high at age 15. Although social, her group of friends was not part of the most popular crowd. This was a constant concern. She maintained a B average and continued with sports, while starting to smoke marijuana every day. An after-school job paid for this habit. When her parents found drug paraphernalia in her room, they didn’t probe the situation and just sent her to her room. Searching for a personal connection, she started dating an older boy. She connected with his parents in a way she could not with her own. During senior year, they both started using cocaine, which became a daily habit. She eventually transitioned to heroin, because as she put it in an answer to one question:

Heroin made me feel real mellow like I had not a care in the world. I had a lot of “what am I doing with my life” and physical pain that I was covering up.

After losing her job, she pawned her belongings with a variety of her parents’ things, and stole from others. She refrained from turning to prostitution, although she heard of other girls going down that road. She finally sought out help after witnessing her boyfriend get pistol-whipped and robbed during a drug exchange.

What does this tell us about heroin use?

There are similarities and differences to all of the case studies in this project. In these two examples, the users come from seemingly sturdy homes and backgrounds. The stereotypes of drug users aren’t present in these cases; however, they both felt distant from the people around them at an early age in life. They also wanted to avoid internal and external pressures. This glimpse into the lives of users offers some potential answers to the question of why relatively well educated, middleclass Americans may turn to heroin.

Fighting Back

In March 2014, the United States Department of Justice and the Attorney General Eric Holder vowed to take action against the “urgent public health crisis” of heroin and prescription opiates. Holder claimed that between 2006-2010, there was a 45 percent increase in heroin overdoses. To start, Holder pushed law enforcement agencies to carry the “overdose-reversal drug” Naloxone and urged the public to watch the educational documentary “The Opiate Effect.” Holder also outlined the DEA plan as follows:

Since 2011, DEA has opened more than 4,500 investigations related to heroin. They’re on track to open many more. And as a result of these aggressive enforcement efforts, the amount of heroin seized along America’s southwest border increased by more than 320 percent between 2008 and 2013…enforcement alone won’t solve the problem. That’s why we are enlisting a variety of partners – including doctors, educators, community leaders, and police officials – to increase our support for education, prevention, and treatment.

Conclusion

Heroin has seen a migration to the middle class. But what can we do to stop it? Many of these new users are already educated on the adverse effects of heroin and know the bottom line. A fear of health concerns isn’t enough. We need to stop it at the source, whether it is gateway prescription drugs or emotional health. Substance abuse is a disease to be cured, not the label of a criminal. The Affordable Care Act and Mental Health Parity and Addiction Equity Act aim to expand behavioral health coverage for 62.5 million people by 2020. Every addict, regardless of demographics, should have the ability and necessary tools to recover.

Resources

Primary

U.S. Justice Department: Attorney General Holder, Calling Rise in Heroin Overdoses ‘Urgent Public Health Crisis,’ Vows Mix of Enforcement, Treatment

JAMA Psychiatry Releases: Demographics of Heroin Users Change in Past 50 Years

Reed Hruby Heroin Prevention Project: Understanding Suburban Heroin Use

Additional

About Health: What Heroin Effects Feel Like

Anxiety and Depression Association of America: Facts & Statistics

The New York Times: The Middle Class Rediscovers Heroin

Original Network of Resources on Heroin: Heroin By Area of Origin

RT: America’s $7.6 Billion War on Afghan Drugs Fails, Opium Production Peaks

Tech Times: Study Profiles New American Heroin Addicts

Foundation For a Drug Free World: The Truth about Heroin

WTOP: Heroin Use Rises in D.C. Among Middle, Upper Class

Jessica McLaughlin

Jessica McLaughlin is a graduate of the University of Maryland with a degree in English Literature and Spanish. She works in the publishing industry and recently moved back to the DC area after living in NYC. Contact Jessica at staff@LawStreetMedia.com.

The post Heroin: The New Drug of the Middle Class? appeared first on Law Street.

We’re all told that a daily multivitamin supplement packs the same vitamin punch as a varied cornucopia of food. No preparation. Tons of nutrients. Zero calories. No wonder these little short cuts are so popular. Supplements are hard to resist when you’re told they might be the answer to all of your problems.

But are these concoctions too good to be true?

You’ll have to decide for yourself. Here’s what you need to know about vitamin supplements and their long-term effects to get started on your decision.

What are vitamins anyway?

Vitamins aren’t capsules; they’re organic compounds that we need to survive and function. We can’t make them in our bodies; we have to get them from outside sources like food or supplements. Despite what the vitamin aisle of your grocery store might lead you to believe, only 13 recognized vitamins exist.

This infographic from Compound Interest names the 13 vitamins, reveals their alternate names, and summarizes why our bodies need them.

What do they do in our bodies?

We don’t digest vitamins like food, we have to absorb them.

Vitamins A, D, E, and K dissolve in fat, so they need fat to be absorbed. The same stomach acid released to break down fat also breaks down the vitamins so you can absorb them. If a person doesn’t have enough fat in his diet or has digestive problems, he can’t absorb fat-soluble vitamins. On the other end of the spectrum, fat cells store these vitamins long term, and excesses can build up. For example, chronic high intakes of vitamin A can lead to hypervitaminosis A, and symptoms of dizziness, nausea, headaches, and skin irritation.

All of the B vitamins as well as vitamin C dissolve in water. These vitamins are easily absorbed in the bloodstream through water-based blood plasma–no stomach acids required. Unlike fat-soluble vitamins, you can’t store water-soluble ones. Excesses of these vitamins exit the body easily with urine. Since you have no storage system for these vitamins, you have to replenish them often.

How much do we need?

The Food and Drug Administration (FDA) uses Daily Value (DV) as the ultimate guide to how much of each vitamin we need. You’ll see DV on every nutrition label. Don’t worry, they don’t just make them up. They determine DVs using experimental human studies and observational data.

Long-Term Effects of Vitamin Supplements

Studies on the long term effects of multivitamins yield conflicting results, even when the studies focus on the same vitamin. How is that possible? The answer lies in the study’s construction. Conflicting results happen because:

1. The vitamin doses tested were different. A study found vitamin D protects against fractures using a 700-800 IU (international unit) daily dose. If they used a 400 IU dose of vitamin D instead, they might not have seen the same benefits.
2. The study timeframe was different. A study spanning ten years might find benefits that a study over two years missed. Diseases, for example, take a long time to develop. Therefore any benefits a vitamin provides in its prevention would also take a long time to determine.
3. The subjects had different lifestyles. Lifestyle habits, like exercise or smoking, affect disease outcomes and vitamin interactions. If the study fails to control for differing lifestyles, results conflict.
4. The disease or condition was tested at different stages. Vitamins produce results at different times of a disease or condition. Studies show folate supplements might protect against birth defects, but only if taken in the first few weeks of a pregnancy.
5. The results were measured differently. Researchers determine what outcome they’re studying before they begin. They will only pay attention to that outcome and might miss other benefits.

Keep these factors in mind as you read the conflicting good and bad news for vitamin supplements below. Also keep in mind that more studies need to be done on the long-term effects of vitamin supplements, especially as supplement use grows. Currently about half the people in the United States take vitamin supplements; that number may continue to rise.

The Good News For Vitamin Supplements

Most of the good news for vitamin supplements involves specific populations. Here are some groups found to benefit the most from vitamin supplements.

Coronary Heart Disease Patients

Studies have shown that supplements of vitamin E decrease incidence of cardiovascular events in patients with a history of coronary heart disease.

Smokers

Male smokers given a supplement of alpha-tocopherol (a type of Vitamin E) had a 32 percent lower incidence of prostate cancer than those who took a placebo.

Older Adults

One study found supplements of vitamin D reduced bone fractures in older adults. People who took vitamin D had a 22 percent lower fracture rate in general, and a 33 percent lower fracture rate for vulnerable areas like hips, wrists, and vertebrae.

Diabetes Patients

Multivitamin use in people with diabetes might reduce the risk of minor infections. Based on the subjects’ logged reports, all people taking a multivitamin had a lower infection rate than those in the control group. The benefit increased in diabetes patients within the group. Only 17 percent of diabetes patients in the supplement group reported an infection, compared with 93 percent of diabetes patients taking placebos.

Breast Cancer Patients

Women diagnosed with breast cancer who took supplements of vitamins E and C, as well as multivitamins shortly after diagnosis had an 18 percent reduced mortality risk and 22 percent reduced recurrence risk. This study adjusted for multiple lifestyle factors to maintain consistency.

The Bad News For Vitamin Supplements

Suspicions about the long-term benefits of multivitamins have led to numerous studies over the years. Here are some highlights of the not-so-good studies on multivitamins.

Bad News for Breast Cancer

Although a study above indicates that it might be good for people who have breast cancer to take vitamins, this study suggests that multivitamin use might actually increase the risk for breast cancer in the first place. In a study of Swedish women, researchers found that multivitamin use increased the risk of breast cancer. Folic acid surfaced as a possible risk factor. Results from epidemiological studies have not confirmed this association.

Vitamin Supplements Offer No Benefits to People With Balanced Diets 

A found sparse evidence that vitamin supplements benefit people with balanced diets. A systematic evidence review for the U.S. Preventive Services Task Force also found that vitamin supplements failed to reduce cancer and cardiovascular disease risk in adults without nutritional deficiencies.

Vitamin Supplements Do Little For Memory

A long-term, randomized trial of cognitive function in men aged 65 years or older found zero differences in cognitive function between men taking a multivitamin and men taking a placebo. They used established tests to measure cognitive function and memory. Another study sought to test a connection with folic acid, B6, B12 and memory. Previous studies connected deficiencies in these vitamins with memory problems and confusion. They tested supplements on people with normal blood levels of the vitamins, and found no additional benefits after a three-year trial.

Vitamin Supplements Don’t Reduce Risk of Heart Attack

Researchers evaluated the benefits of a high dose multivitamin supplement in men and women with a history of heart attack. After nearly five years, the supplement group and the placebo group had the same number of cardiovascular events.

Why You Need to Do Your Own Research

Although vitamin supplements come in medicinal pill-like bottles, they aren’t regulated like drugs that are thought to be unsafe until proven otherwise. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), supplements are assumed safe until proven otherwise.

• Drugs: need to be proven safe. The FDA approves of any new drug entering the market. Manufacturers must show evidence of a drug’s safety and ability to treat a condition based on clinical trials. Once a drug makes it to the market, the FDA monitors it for doctor-reported side effects and possible problems.
• Supplements: need to be proven unsafe. Dietary supplements can be sold if they don’t contain any ingredients that pose a significant risk when used as directed. So if a vitamin supplement incorporates a food substance that’s generally recognized as safe, no worries. If manufacturers wanted to use a completely new substance, they do have to show that it’s safe, but they don’t have to perform any clinical trials. The FDA can’t stop a company from selling a supplement until someone proves that it causes harm. So don’t assume something is safe just because it’s on a shelf. Since supplements aren’t tracked as closely as drugs, their interactions, side effects, and other consequences aren’t as readily noticed.

Hidden Vitamins

We have a lot left to learn about vitamin supplements before we can tell if they’re the answer to all of our problems. We do know they’re not one-size fits all. People with certain deficiencies and conditions benefit more from supplements than healthy people with well-rounded diets.

We also know that taking excess vitamins could be harmful, especially if they’re the fat-soluble kind that your body stores. But controlling your added vitamin intake might not be as simple as controlling your supplements. Many foods, like breakfast cereals and snack bars, are fortified to contain vitamins and minerals. Pair those foods with a max-dose vitamin supplement and you could be on your way to getting too much of a good thing. The nonprofit Environmental Working Group reports that about half of American kids consume harmful amounts of vitamins because they’re added to foods.

So think twice before reaching for a second bowl of those addictive Cocoa Krispies, especially if you already took a vitamin supplement. Also, keep in mind that vitamins are good for you, but you still need to be careful and smart with all dietary choices.

Resources

Primary

American College of Physicians: Enough is Enough: Stop Wasting Money on Vitamin and Mineral Supplements

Additional

Harvard School of Public Health: Supplement Studies: Sorting Out Confusion

Compound Interest: The Chemical Structures of Vitamins

Men’s Health Adviser: Do You really Need Those Vitamin Supplements? 

Mind, Mood & Memory: Straight Talk About Vitamin and Mineral Supplements For Memory

Nursing Standard: Women Being Treated For Breast Cancer Benefit From Vitamins

Trial: Over the Counter and Under the Radar

Nature Reviews Endocrinology: Vitamin Pills May Raise Cancer Risks

New Scientist: Pills Are Pointless

Web MD: Vitamins and Minerals: How Much Should You Take?

Scientific American: Fact or Fiction?: Vitamin Supplements Improve Your Health

Live Strong: Digestion of Vitamins and Minerals

Original Internist: To E or Not to E, That is the Question

Clinician Reviews: Who Will Benefit Most From Vitamin Supplementation?

Medical Daily: Vitamin D Benefits Are Enhanced if Meal Contains Fat; Absorbing More From Supplements

Gallup: Half of Americans Take Vitamins Regularly

American Cancer Society: FDA Regulation of Drugs Versus Dietary Supplements

Environmental Working Group: How Much is Too Much?

Environmental Magazine; Over-Fortified Processed Foods

Ashley Bell

Ashley Bell communicates about health and wellness every day as a non-profit Program Manager. She has a Bachelor’s degree in Business and Economics from the College of William and Mary, and loves to investigate what changes in healthy policy and research might mean for the future. Contact Ashley at staff@LawStreetMedia.com.

The post Vitamin Supplements: Are They Worth It? appeared first on Law Street.

Move over marijuana, there’s a new form of contraband in town.

Milk.

Not just any milk, but raw milk, which is simply milk that hasn’t been pasteurized or heated to a temperature that kills illness-causing bacteria. It’s illegal to sell raw milk directly to consumers in about half of the United States. It’s also illegal to distribute raw milk packaged for consumption across state lines. Still, raw milk advocates stand up for their right to consume it. For example, protesters from a private buying club, Grassfed on the Hill, milked a cow on the Capitol lawn back in 2011 to protest the Food and Drug Administration’s action against a Pennsylvania farmer accused of selling raw milk across state lines.

Raw milk proponents say pasteurization kills flavor, nutritional benefits, and beneficial bacteria in addition to killing the harmful bacteria that it’s supposed to eradicate. Opponents say there’s simply no proof that raw milk has any benefits that pasteurized milk can’t confer, and that drinking it isn’t worth the health risk as it contains potentially dangerous bacteria. Both sides stand firm, creating controversy around one of America’s most wholesome and common commodities.

If you haven’t heard anything about raw milk yet, chances are you will. Warnings from regulatory and public health agencies are increasing, raw milk crusaders are banding together, and politicians are jumping on board to take a stand. As early as 2012, Ron Paul was using the topic of raw milk to rally a Wisconsin crowd, as seen in the video below.

Here’s what you need to know about the raw milk debate before it escalates to a full scale food fight.

Why do we pasteurize milk in the first place?

To understand the raw milk controversy, you need some background on pasteurization and why we do it in the first place.

Before milk makes its way to a carton, it starts in a cow’s udders, which are basically saggy mammary glands. (Yuck.) Like other bodily fluids, the milk produced in these glands contains bacteria, both good and bad. Unlike many other farm foods, milk isn’t usually cooked before consumption. Since cooking kills pathogens, many people ended up drinking a cocktail of bacterial specimens before pasteurization was invented.  In the early 1800s, illnesses like tuberculosis, scarlet fever, and typhoid fever were often transmitted through milk because of the unclean dairy practices common at the time.

Luckily for the American dairy industry, the French love their wine. They love it so much that Emperor Napoleon III gave a scientist by the name of Louis Pasteur the noble task of stopping wine spoilage. Pasteur soon became famous for nuancing a process that would keep wine from spoiling without changing its flavor. It involved heating the liquid to the right temperature for the right amount of time to destroy spoilage bacteria. He called it pasteurization.

Pasteurization was applied to dairy in the late 1800s, and incidence of disease caused by milk decreased drastically. At first it was only used for dairy farmed in unsafe conditions, but soon it was leveraged to reduce risk of illness for nearly all dairies. From there, pasteurization grew to dominate the dairy industry.

What are the laws regarding raw milk?

Although individual states have always regulated their own dairy processing, the Standard Milk Ordinance, now called the Grade A Pasteurized Milk Ordinance (PMO), was implemented in 1924 to help each state meet certain standardized quality recommendations to ensure public safety.

Raw milk didn’t become a truly legal issue until the 1980s when Public Citizen filed a petition with the Food and Drug Administration that requested a ban on raw milk and raw milk products. The FDA had been trying to require that all products labeled “milk” be pasteurized since the 1970s, but met resistance and delays from the Department of Health and Human Services and certified raw milk producers. After hearing witness accounts and testimonies, the courts concluded that raw milk posed a serious threat to public health and should be banned from interstate sale.

It has been illegal to distribute raw milk from state to state ever since.

Since each state makes its own rules about the sale of raw milk, commerce within state borders gets a bit more complicated. Some states, like Florida and Virginia, prohibit all sales of raw milk. In Kentucky, you can only purchase raw goat milk straight from the farm. In New Hampshire, you can buy raw milk at a retail outlet, but it must adhere to uniform coliform standards. Things like cow-share agreements, where customers pay a fee for a percentage of cow’s milk, make things even more complicated. Alaska is an example of one state that allows “share” operations. Check out this chart for state-by-state raw milk regulations.

What Proponents Say About Raw Milk 

The supporters of raw milk tout benefits like taste and nutrition with religious fervor. Some even claim other benefits like decreased allergies and less acne.

The Taste Argument

People who’ve tasted raw milk and liked it keep going back for more. In this study of dairy producers who drink raw milk, 72 percent cite taste as their primary motive.

Raw milk lovers say it’s richer, sweeter, and more complex. Connoisseurs credit subtle flavors to a cow’s diet of natural greens. Many raw milk producers  “pasture” their cows, allowing them to eat greens as nature intended, as opposed to feeding them popular corn- and grain-based feeds.

Beyond drinking milk, raw milk cheese has a cult following, especially in France. Many of the country’s legendary cheeses are made with raw milk, which savants say imparts enticing characteristics unmatched in pasteurized varieties. In this 1998 New York Times article on the subject, cheese maker Bernard Antony said, ”Pasteurized cheese is not cheese; it’s like plastic.”

The Health Argument

In addition to being a holy grail of nuanced flavors, many raw milk advocates flock to raw milk because of its purported health benefits. They believe pasteurization kills beneficial enzymes and good bacteria. They also say raw milk can help quell body pains, reduce allergies, cure lactose intolerance, and more as evidenced from this Realmilk.com testimonials page.

Supporting studies for the claims are patchy. This study does suggest there might be an association with consumption of farm milk and asthma and allergies, but not enough to be conclusive. A Standford University School of Medicine study found that raw milk does not reduce lactose intolerance, in direct conflict with some testimonials and surveys. Why the clash between testimony and science? More research is needed to find out.

The Liberty Argument

Back in 2011, FDA officials raided Rawesome Foods and arrested its owner, James Stewart, and other raw milk suppliers for selling raw milk directly to customers. Apparently, Stewart had failed to show up for previous court appearances to face charges of shady fundraising, among other things. Even so, the arrest struck a cord with raw milk advocates who showed up to Stewart’s hearing wearing “raw milk heals” t-shirts.

They didn’t care if Stewart’s actions were illegal, they cared that he was fighting for their rights to consume raw milk. They believe that it should be individuals, not the government, who dictate what consumers put in their bodies.

What Opponents Say About Raw Milk  

Opponents, most specifically regulatory officials, argue that consuming raw milk and dairy products pose a serious threat to health, a threat that exceeds any potential benefits. And why take an unnecessary risk?

Watch the emotional video below that plays to the fear of what can come from taking unnecessary risks.

They also say that there aren’t any benefits of raw milk that you can’t get from pasteurized milk. These quotes from the Centers for Disease Control and Prevention Raw Milk Questions and Answers page address some common raw milk proponent beliefs:

Many studies have shown that pasteurization does not significantly change the nutritional value of milk — pasteurized milk is rich in proteins, carbohydrates, and other nutrients. Heat slightly affects a few of the vitamins found in milk– thiamine, vitamin B12, and vitamin C– but milk is only a minor source of these vitamins.

While it’s true that the heating process of pasteurization does inactivate some enzymes in milk, the enzymes in raw animal milk are not thought to be important in human health.

There are no health benefits from drinking raw milk that cannot be obtained from drinking pasteurized milk that is free of disease-causing bacteria. The process of pasteurization of milk has never been found to be the cause of chronic diseases, allergies, or developmental or behavioral problems.

Why do they say raw milk is such a threat to health?

Unlike many other farm foods (e.g. milk and eggs), milk isn’t usually cooked before consumption, so there isn’t a step to kill illness-causing bacteria. Milk’s low acid content and high protein levels make it easier for pathogens to grow.

Even if milk comes out of the cow without bacteria, it can become contaminated easily during the farming process. Dairy farms breed pathogens naturally, even when they take necessary precautions. Pathogens can be transferred on multiple occasions on the farm:

• The milk might accidentally come in contact with cow feces
• The cow might have an udder infection (mastitis)
• The cow might have an undetected illness
• Bacteria on the cow’s skin might get into the milk
• Dirt from the barns and processing equipment might get on the milk
• Animal pests living in barns, like rats and insects, might contaminate the milk
• Humans with soiled hands or clothing might contaminate the milk

For these reasons and more, officials cite that pasteurization is the only way to make sure the pathogens in milk won’t pose a threat to human health. They say even farmers who follow hygienic practices and test their raw milk cannot guarantee safety.

Supporting Data

According to the CDC, outbreaks caused by raw milk  have increased from 30 in 2007-2009 to 51 in 2010-2012. The outbreaks are most commonly caused by Campylobacter, Escherichia coli, and Salmonella and include symptoms like diarrhea, vomiting, muscle aches, and fever. Relative to the amount of raw milk that is consumed, the risk of an outbreak from raw milk is 150 times greater than the risk of an outbreak from pasteurized milk.

Shouldn’t science stop this debate?

Advocates from both sides point to studies, surveys, testimonials, and data to prove their points, but still each side clings to their beliefs with evangelical conviction. In a literature review requested by the Maryland House of Delegates’ Health and Government Operations Committee, the authors point to a need for both raw milk advocates and regulatory agencies to be open to discussion and compromise. Surely both sides of this contentious debate can find some common ground in the future.

Will raw milk become a substance relegated to the black market? Will federal lawmakers cave and loosen boundaries on interstate trade? Only time will tell, but 2015 promises to be an interesting year for those on both sides of the aisle in the raw milk debate.

Resources

Primary

CDC: Raw Milk Questions and Answers

Rev Sci Tech Off Int Epiz: Milk Pasteurisation and Safety: A Brief History and Update

CDC: Increased Outbreaks Associated with Nonpasteurized Milk, United States, 2007–2012

NIH: Food Safety Hazards Associated With Consumption of Raw Milk.

NIH: A Survey of Foodborne Pathogens in Bulk Tank Milk and Raw Milk Consumption Among Farm Families in Pennsylvania.

CDC: Raw (Unpasteurized) Milk

U.S. District Court: Public Citizen v Heckler

Additional

New Yorker: Raw Deal

Chris Kresser: Raw Milk Reality: Benefits of Raw Milk

How Stuff Works: How Pasteurization Works

Raw Milk Facts: State by State Raw Milk Legislation

USDA: How Do Cows Make Milk?

The New York Times: How We Poison Our Children

NPR: Unlocking France’s Secrets to Safer Raw Milk Cheese

The New York Times: The French Resist Again: This Time, Over Cheese

Marler Clark: A Legal History of Raw Milk in the United States

Ashley Bell

Ashley Bell communicates about health and wellness every day as a non-profit Program Manager. She has a Bachelor’s degree in Business and Economics from the College of William and Mary, and loves to investigate what changes in healthy policy and research might mean for the future. Contact Ashley at staff@LawStreetMedia.com.

The post What’s the Deal With Raw Milk? appeared first on Law Street.

This summer, fellow Law Streeter Brittany Alzfan wrote about the National Gay Blood Drive, which was the second event of its kind and served as an attempt to draw awareness to the fact that gay men are prevented from donating blood by the Food and Drug Administration (FDA). The FDA recently acted to change those restrictions, but activists worry that the change doesn’t really do much to alleviate the discrimination against gay men who want to donate blood.

The new policy allows gay men to donate blood, but only if they haven’t had sex with another man in the last 12 months. So essentially, only celibate gay men are allowed to donate–for the vast majority of adults, this changes nothing. It does the exact same thing as the lifetime ban–prevents gay men from donating–but without saying so in the same words. The FDA is basically pretending to change its policy and hoping no one notices that it’s still essentially the same discriminatory policy.

There really are numerous problems with the FDA’s policy. First of all, it reflects outdated science. Donated blood is tested for HIV regardless of who donates it. That’s smart, pragmatic science, given that HIV can be transmitted through any sort of sexual activity, regardless of the participants’ genders or sexual identities. It can also be transmitted through needle-sharing, or other manners that have absolutely nothing to do with sex. As Scott Schoettes of Lambda Legal explains:

Within 45 days of exposure, currently required blood donation testing detects all known serious blood-borne pathogens, including HIV.  Therefore, a deferral of more than two months—for anyone—is not necessary and does not noticeably enhance the safety of the blood supply.

Given that HIV tests are pretty quick and reliable–some tests can detect HIV as early as nine days after infection–this 12 month timeline seems arbitrary at best.

Moreover, the ban is insulting. When donating blood, participants are required to be honest about their medical and personal issues. Questions asked at donation locations include inquiries about travel history, whether or not the donors have gotten tattoos, and about HIV, AIDS, Malaria, and a whole host of other diseases. These are questions for everyone–regardless of age, gender, ethnicity, or sexuality. So why does the FDA believe that absolutely everyone who goes in to give blood can be trusted except for gay men? There’s only one word for that: demeaning.

Finally, the FDA ban–even the new, almost equally bad ban–might be dangerous on a larger scale. By not allowing gay men to donate, the agency is turning away potentially life-saving donations. The Williams Institute at UCLA estimates that if the ban were lifted, donations would increase dramatically. As the institute put it:

If the current MSM [men who have had sex with men] ban were completely lifted, we estimate that an additional 360,600 men would likely donate 615,300 additional pints of blood each year.

Instead of a ban, activists argue that the United States should adopt a model like the one that Italy and Spain have. Those two countries screen each person as an individual based on his or her personal risk factors. Since instituting that policy change, there has been no evidence of blood supply contamination.

It does make sense that the FDA would want to keep any HIV-infected blood samples from getting into the donation supply; however, broad discrimination based on nonsensical science and old prejudices is most certainly not the way to do so.

Anneliese Mahoney

Anneliese Mahoney is Managing Editor at Law Street and a Connecticut transplant to Washington D.C. She has a Bachelor’s degree in International Affairs from the George Washington University, and a passion for law, politics, and social issues. Contact Anneliese at amahoney@LawStreetMedia.com.

The post The FDA’s New Blood Donation Policy Still Discriminates Against Gay Men appeared first on Law Street.

Petri dishes do far more than indicate if you have strep throat. They were a key prop in the theater of antibiotic discovery. A mere glance in a petri dish ushered in the antibiotic revolution.

On a bright and sunny (just a guess) day in 1928, Alexander Fleming puzzled over what he saw in a petri dish of Staphylococcus bacteria. One small, moldy area of the dish had somehow dodged the enterprising colonization of the bacteria. Fleming speculated this was not a coincidence. He wondered if the mold, Penicillium Notatum, was somehow inhibiting bacterial growth. He experimented some more and eventually published his findings in the British Journal of Experimental Pathology. Fleming’s brick wall had been isolating the penicillin from the mold to use as a drug. Luckily his research eventually ended up in the hands of two scientists at Oxford who were ready to take up the challenge.

Penicillin — the first antibiotic — was used to treat a human patient in 1941. We’ve probably all taken them, but what are they really? Antibiotics are microorganisms (and now synthesized drugs) that attack the bacteria that cause infection in your body. Just as bacteria couldn’t grow on the moldy part of Fleming’s petri dish, bacteria cannot grow in a body on antibiotics.

World War II soldiers were among the first to benefit from penicillin before it was released to the general public in the late 1940s. Newspapers hailed it as a miracle drug.

The potential downside of this miracle drug had not evaded the experts, however. Alexander Fleming himself warned of microbes developing penicillin resistance in his acceptance speech for the Nobel Prize in Physiology or Medicine in 1945.

Miracles Happen

Antibiotics thwarted some of the leading causes of death in human existence. Childbirth, ear infections, and even simple skin scrapes were often deadly before these saviors entered the fray. Many children didn’t see their first birthdays, succumbing to infections we don’t think twice about today. Having surgery in the early 1900s? Just kiss your family goodbye before you go under the knife.

Antibiotics are microorganisms ideally adapted to kill other microorganisms while causing little or no harm to the host. The word “antibiotic” actually means “against life.”

Scientists design synthetic versions of these antibiotic microorganisms so we may have a profusion of drug options. About 150 million prescriptions are written for antibiotics every year.

And that’s a problem because…?

Antibiotics may be miraculous, but bacteria are not taking the challenge lying down. They’re fighting back by developing mechanisms to resist antibiotics. Don’t take it personally, it’s what any organism would do for the sake of survival. It turns out that bacteria are marvelous adaptors. Two million people in the United States suffer from antibiotic-resistant infections every year and many die as a consequence. Additionally, the CDC estimates a cool $20 billion in resulting economic burdens.

In short, our arsenal of antibiotics is losing efficacy. If this continues unchecked, we risk being thrust back into the dark ages of medicine when common ailments put many a healthy body six feet under. Antibiotic resistance is also detrimental to treatments for more serious illnesses. Therapies for cancer and organ transplants are often complicated with infection. Doctors rely heavily on antibiotics to keep their patients’ strained bodies free of infection. If antibiotics become ineffective, these life-saving treatments might be relegated to the past. It would mark one monumental step back in health care.

If you’re not scared yet…

Everyone loves a good villain to embody their fears. Emerging “superbugs” epitomize scary. When antibiotics were new, development was explosive. New drugs essentially kept microbes on their toes and resistance was less prolific. Invention of new drugs has now stagnated enough that bacterial evolution threatens to overtake our developmental countermeasures.

Welcome to the world of superbugs, aka resistant germs. These include nightmares like:

Carbapenem‐resistant Enterobacteri‐aceae (CRE): Literally nicknamed “nightmare bacteria.” It’s resistant to nearly all antibiotics and kills about half of the people infected by it.

Staphylococcus aureus (MRSA): MRSA usually manifests as a skin infection. Because of its resistant capabilities, it can wreak havoc by spreading through medical facilities.

These monsters aren’t made up, they’re frighteningly real and we may soon lose our ability to fight them.

Let’s Get “Sciencey”

Microbes are tricky little beasts. They will always evolve to develop resistance to what threatens them. The more bacteria are exposed to antibiotics (which we just learned is quite frequently), the more chances they have to develop resistance. When bacteria are exposed to antibiotics, susceptible strains die, leaving zero competition for the resistant ones so they are free to survive and flourish. Scientists call this selective pressure.

Resistant bacteria get that way by acquiring resistance genes through genetic mutation or getting the resistance from another bacterium. They can even get multiple resistant traits and end up developing resistance to multiple families of antibiotics.

Watch the video below for a perfect explanation of how this happens.

Why is this happening?

1. They’re over-prescribed: Antibiotics are some of the most commonly prescribed drugs used in medicine. For example, the first Ebola patient in the United States was sent home on antibiotics before doctors knew what he had. Antibiotics won’t do anything for Ebola or even the sinus infection they believed he had. Most sinus infections are viral so antibiotics don’t do anything — unless it was 1 out of the 100 cases where the sinus infection is caused by bacteria.
2. They’re mis-prescribed: Physicians often have to use incomplete or imperfect information. They prescribe antibiotics as a an all-purpose band-aid.
3. They’re used heavily: The chance of bacteria developing resistance increases with antibiotic use. Unfortunately, doctors must rely heavily on antibiotics to reduce risk of infection in critically ill patients. Furthermore, close proximity among sick patients in hospitals creates an ideal environment for resistant germs to spread.
4. They’re used in agriculture: Agriculture use accounts for half of the antibiotics produced in the United States. Scientists agree that adding antibiotics to feed is a key problem in developing antibiotic resistance. Agriculturally, antibiotics are used to promote animal growth and proactively prevent infections in addition to just treating sick animals.

Who is going to save us?

The CDC released a report on the threat of antibiotic resistance in 2013. It was the first exhaustive compilation of the health threats antibiotic resistance presents. If you’re not up to reading the whole 100 pages, here is a snapshot of the strategies they recommend to save us all from antibiotic resistance:

1. Prevent infections from happening in the first place: No infection, no antibiotics, and consequently less risk that resistance develops.

2. Track antibiotic resistance: Tracking will shed light on the specific mechanisms of resistance development. With this knowledge, intervention strategies will be more informed and more effective.

3. Change the way antibiotics are used: Antibiotics are generally overused. Up to 50 percent of antibiotic prescriptions are unnecessary. Physicians can take up the mantle of antibiotic stewardship by using antibiotics only when necessary.

4. Develop drugs and diagnostic tests: Bacteria develop antibiotic resistance as they evolve — it’s a natural process resulting from biological pressure. Introduction of new drugs will slow down this natural evolution. Diagnostic tests will allow us to understand and track the evolution in a more timely way.

Hey…did we budget for all of this?

Federal spending to combat antimicrobial* resistance has been limited. In 2014, the budget was $450 million. That figure sounds grand, but it amounts to just about $1.04 per American. On the other hand, antibiotic resistance costs the United States an estimated $55-70 billion each year.

A little bit lopsided, don’t you think?

*Antimicrobial resistance includes antibiotic resistance but also refers to resistance of other microbes like parasites and viruses. Antibiotic resistance refers specifically to bacteria that cause infection. Most strategies cover the more comprehensive antimicrobial resistance.

Making plans…

The Obama Administration announced a game plan in September for facing antimicrobial resistance. Here’s the to-do list:

• Leverage findings from the President’s Council of Advisors on Science and Technology (PCAST) report on combating antimicrobial resistance. The report suggests doubling the current federal investments from $450 million to $900 million a year. It also outlines recommendations for strong federal leadership, effective surveillance, research, clinical trials, increasing economic incentives for development, increasing stewardship for current antibiotic use, limiting agricultural use of antibiotics, and increasing international coordination.

• Implement the National Strategy for Combating Antibiotic Resistant Bacteria. The PCAST report was used to create a National Strategy for Combating Antibiotic Resistant Bacteria. The strategy focuses on five major goals:

Slow the development of resistant bacteria and prevent the spread of resistant infections; strengthen national one-health surveillance efforts to combat resistance; advance development and use of rapid and innovative diagnostic tests for identification and characterization of resistant bacteria; accelerate basic and applied research and development for new antibiotics, other therapeutics, and vaccines; and improve international collaboration and capacities for antibiotic resistance prevention, surveillance, control, and antibiotic research and development.

• Form a task force that combats antibiotic resistant bacteria. Established by Executive Order, the task force is responsible for implementing the National Strategy for Combating Antibiotic Resistant Bacteria. It is working on a detailed report of specific action plans due in February 2015.

• Finance diagnostic innovation. A $20 million prize, co-sponsored by the National Institutes of Health and the Biomedical Advanced Research and Development Authority, will be granted for a point-of-care diagnostic test that identifies antibacterial-resistant infections.

A little legal setback…

The July ruling in the NRDC v. US FDA case was marked as a major setback in the fight against antimicrobial resistance. The plaintiffs (including the Natural Resources Defense Council and Center for Science in the Public Interest) were dismayed that the court ruled against compelling the FDA to ban the use of antibiotics in healthy animals used for food.

The case overturned two other district court rulings that would have required the FDA to rescind approved use of antibiotics for purposes other than to treat sick animals. Companies could have gotten around the ruling if they proved the drug in question posed little risk for contributing to the development of antimicrobial resistance in humans.

Some other hangups

There are a few other pesky issues that might hinder some of the strategies for reducing antimicrobial resistance:

• Individual privacy could potentially get in the way of optimal surveillance of antibiotic resistance. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) guarantees privacy of health information that is individually identifiable. Patient preferences could determine what information can be used to track antimicrobial resistance.

• Companies lack incentives to create new antibiotics because the traditional sales volume and price linkage is missing. Because fighting antibiotic resistance forbids overusing one particular drug, companies would probably not get a good return on investment.

• Ponderous approval processes for new drugs might also hinder the speed of new antibiotic drug development. A balance will need to be struck in ensuring speed of innovation without compromising safety.
  

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So the government has antimicrobial resistance under control?

It has a robust plan for taking action against antibiotic resistance, but being an informed patient never hurt anybody. The CDC recommends a few steps you can take, including abstaining from antibiotic use for viral infections, not saving leftover antibiotics, and not taking antibiotics prescribed for someone else.

The fight against antimicrobial resistance is really no fight at all, but a call for permanent change in our medical and agricultural systems. As long bacteria exist and want to survive, our desire to survive must be stronger.

Resources

Primary

CDC: Antibiotic Resistance Threats in the United States, 2013

President’s Council of Advisors on Science and Technology: Report to the President on Combating Antibiotic Resistance

Additional

Cochrane Summaries: Antibiotics for Acute Maxillary Sinusitis

Food Safety News: White House Calls for Action Plan to Address Antibiotic Resistance

The White House: New Executive Actions to Combat Antibiotic Resistance and Protect Public Health

CDC: Untreatable: Today’s Drug Resistant Health Threats

Explorable.com: History of Antibiotics

American Chemical Society: Discovery and Development of Penicillin

National Institute of Allergy and Infectious Diseases: Antimicrobial Drug Resistance

World Health Organzation: Antimicrobial Resistance

Huffington Post: Feds Failing to Act on Antibiotic Resistance Despite Grave Threat

Natural Resources Defense Council: Food, Farm Animals and Drugs

CDC: Legal Issues Associated with Antimicrobial Drug Resistance

CDC: White House Announces National Strategy for Combating Antibiotic Resistance

Ashley Bell

Ashley Bell communicates about health and wellness every day as a non-profit Program Manager. She has a Bachelor’s degree in Business and Economics from the College of William and Mary, and loves to investigate what changes in healthy policy and research might mean for the future. Contact Ashley at staff@LawStreetMedia.com.

The post Are We Doing Enough to Prevent Antibiotic Resistance? appeared first on Law Street.

Our adventures in genetics began with a monk named Gregor Mendel.  Mendel systematically bred pea plants to demonstrate the concepts behind genetic transmission before “gene” was even a word. He brandished a paint brush to cross breed plants that exhibited inheritance of exciting traits like wrinkly peas and inflated pods. Mendel was confined to pea plants in his search for potential traits. Today, we aren’t bound to the same species in our search for traits. We can bend the rules of nature as we know them using recombinant DNA technology. Welcome to the world of genetically modified organisms.

OMG…what are GMOs, anyway?

GMO is more than just a backwards OMG. GMO stands for genetically modified organism. Other terms used to describe them include bioengineered, transgenic, genetically engineered (GE), or just genetically modified (GM). All of these terms describe an organism created through genetic engineering. Genetic engineering allows us to transfer genes that yield desirable traits from one organism to another. Technology has granted us power to cross species barriers, so unlike Mendel, we don’t have to choose traits from just one species.

How are traits transferred?

Genetic engineering uses recombinant DNA technology to splice a piece of DNA from one species and insert it into the DNA of another species. Scientists identify the piece of DNA responsible for the desired trait, clone it, modify it to make it more compatible with the destination organism, and then insert it into the new organism. The modification occurs on a cellular level and the borrowed gene transforms to fit the destination organism’s DNA. Other methods involve repressing a gene that causes a certain characteristic, like they did to make a tomato that ripened after harvesting.

The Great Health Debate

Genetic engineering enables us to create crops with ideal characteristics, taking yields far beyond the possibilities of even the most resourceful farmers. Everyone must be thrilled! Not so much. In fact, many people are concerned about what GMOs might be doing to our health. Even with hazy understanding of GMOs, worries run rampant.

Leave it to Jimmy Kimmel to delve deep into society’s perceptions of hot-button issues.

What’s behind all of these worries?

No studies have proven that GMOs pose a significant health threat. There were some false alarms, but the studies were flagged for faulty mechanisms. In the absence of clear-cut science, why are people still worried about GMOs and their health?

Most people fear that a reason to be concerned just hasn’t been found yet, not that it doesn’t exist. Common misgivings are that gene transfer might also transfer antibiotic resistance and allergens, and that GMOs might not be as nutritious as their natural counterparts. While many of these apprehensions remain unsubstantiated, they’re still putting GMOs under scrutiny.

Are we right to worry about GMOs and our health? It turns out we may not know enough. Experts agree that the completed studies fall short in meriting total confidence. GMO testing has no minimal length requirement, even for crops cultivated on a large scale. Many point to a need for more long-term, quality, and transparent studies done on possible health effects of GMOs.

This article from University of California San Francisco quotes Patrice Sutton, a public health expert, to summarize concerns regarding GMOs and public health:

“Many people could rightly look at the existing science and see that it’s extremely weak,” Sutton said. “However, weak science does not prove safety; it just demonstrates that the public health impacts of GMOs are uncertain. It’s an overall public health principle that in the face of scientific uncertainty to expose everybody to something is a legitimate concern that should give us pause.”

Some contend that labeling food containing GMOs could fill in information gaps. After all, 97 percent of edible GMOs are cultivated in the United States and South America where no labeling requirement exists. Without labeling, long term studies and traceability are impossible. Which leads to our next point…

Should we label GMOs?

The FDA says “no” and hasn’t changed its mind since 1992. It adheres to substantial equivalence, the concept that a GMO doesn’t merit concern if it’s substantially equivalent to an existing food. This view was challenged in the court case, Alliance for Bio-Integrity v. Shalala. The court sided with the FDA, deferring to  its technological expertise in this complicated matter.

These decisions did little to quell budding concerns from the public. Today, 93 percent of Americans desire GMO labels on food, according to an ABC News poll.

The “Yes” People

The “yes” people rally behind the “right to know” battlecry, using it as the basis for GMO labeling initiatives. They believe consumers have a right to know what their products contain and make informed decisions for themselves.

At present, GMO ingredients in food are credence qualities — those that a consumer cannot evaluate let alone leverage in their purchase decisions. Labeling proponents say consumers can’t make informed decisions at the point of purchase without labels.

Doctors have also chimed in on the “right to know,” asserting that GMO labeling could affect how they study and treat their patients. It could be challenging to detect potential health impacts, including food allergies, if consumers don’t know what they’re eating.

Of course the worries mentioned above — allergies, antibiotic resistance, and nutrition — also factor into the “yes” arguments. Without labeling, it will be taxing to discern if these worries ever manifest as realistic concerns.

The “No” People

The “no” people suppose that a consumer’s “right to know” could lead to a consumer’s “right to be confused.” They think labels might give people a false reason to worry since no evidence suggests GMOs are harmful to health. A label doesn’t guarantee an informed consumer, especially when people are already confused. Furthermore, some argue that a GMO label only treats a symptom of consumers’ grander problem with industrial farming techniques.

And there’s more where that came from. The “no” people have a whole laundry list of concerns surrounding GMO labeling. Here’s a preview:

• A GMO label may inspire worry, leading to decreased demand and therefore production. Poor market acceptance could prematurely cripple a promising technology.
• A GMO labeling requirement could cause costs to skyrocket — some estimate by 10 percent of an annual grocery bill.
• A GMO label isn’t necessary. Concerned consumers can just buy certified organic foods that prohibit the use of GMOs.
• The food system infrastructure in the United States would need to be overhauled if a GMO label is required. Producers would need to implement extensive tracking and reporting systems to accommodate the new requirement, possibly with unforeseen costs and consequences.

So that covers “yes” and “no,” but the question of GMO labeling is far too complex for  monosyllabic responses. The decision packs a load of potential economic, legal, and societal implications.

From lawyers to farmers, this NPR spot explores why voters in Colorado and Oregon are answering “yes” or “no” to the deceptively simple question of GMO labeling that they’re facing on upcoming ballots:

There you have the gist of both sides. Now, what decisions have actually been made concerning GMO labeling?

Decisions…decisions…

States are buzzing with proposals to require GMO labeling. The Center for Food Safety keeps track of the status of proposed bills on this page if you’re curious. So far, GMO labeling bills have been rejected in California and Washington. Connecticut and Maine have passed laws, but they lack potency until neighboring states also pass labeling laws. Vermont stands alone as the only state to pass a GMO labeling law, no neighbors required. The labels will start popping up in 2016. Or maybe not. Food manufacturing heavyweights have filed a lawsuit against Vermont’s GMO labeling law. The groups purport that Vermont exceeded its constitutional authority by forcing costs and undermining the authority of federal agencies like the FDA. The results of the lawsuit will determine the temperature of GMO labeling measures in other states. Oregon is up to bat next as it makes a statewide ballot decision about GMO labeling on November 4, 2014.

Umm…what about the rest of the United States?

If you’re thinking state-by-state labeling laws could get complicated, you’re not alone. Two bills from the 113th Congress address GMO labeling on a nationwide scale. They’re on opposite ends of the spectrum:

1. The Safe and Accurate Food Labeling Act was introduced by Representative Mike Pompeo (R-Kan.) in April 2014. The bill would require producers to notify the Secretary of Health and Human Services of the use of a bioengineered organism intended for consumption. It would then be up to the Secretary to determine if a label should be required based on whether or not there is a material difference between the bioengineered product and the traditional food. The bill would nullify any previous state laws passed requiring mandatory labeling. Some critics have called the bill the DARK or Deny Americans the Right to Know  act because many GMOs would likely escape labeling.
2. Conversely the Genetically Engineered Food Right to Know Act introduced by Senator Barbara Boxer (D-Calif.) and Representative Peter DeFazio (D-Ore.) would require any food with one or more genetically modified ingredients to be labeled as such or be deemed misbranded.

Some companies have decided to take GMO matters into their own hands. After all, the customer is always right!

GMO Labeling Trailblazers

Private companies don’t have to wait for a state or federal government to make company-wide GMO decisions. According to the NPD Group, 11 percent of primary shoppers would pay more for non-GMO products. Some companies commit to serving this hyper-concerned segment.

• General Mills announced its original Cheerios are GMO free.
• Whole Foods plans to move to full GMO transparency by 2018.
• Ben and Jerry’s fully supports mandatory GMO labeling and wants to remove GMOs from its products. The company believes happy ingredients = happy ice cream.

Will labels determine the fate of GMO ingredients?

Consumer concerns will remain regardless of decisions on GMO labeling. With most American consumers saying they deserve the right to know, the search for information will continue whether it’s slapped on the front of a package or not.

But GMO labeling decisions and subsequent market reactions could determine if GMO technology skyrockets or stalls.

Conclusion

What will GMOs mean to future generations? A Pandora’s Box of unnatural selection? A budding innovation that ends world hunger? Right now, we really don’t know. In this circumstance, not knowing simply means we have many more exciting things to learn in the years to come.

Resources

Choices: Genetically Modified Organisms: Why All the Controversy?

UC San Francisco: Genetically Modified Food Labeling Through the Lens of Public Health

National Geographic: The GMO Labeling Battle is Heating Up–Here’s Why

International Journal of Biological Sciences: Debate on GMOs Health Risks After Statistical Findings in Regulatory Tests

WebTV: Food Fight: The Debate Over GMOs in Colorado

Slate: The Price of Your Right to Know

World Health Organization: Frequently Asked Questions on Genetically Modified Foods

Denver Post: GMO Labeling Measure in Colorado Triggers Heated Debate

NPR: Voters Will Get Their Say On GMO Labeling In Colorado And Oregon

AgBioForum: Labeling Policy For GMOs: To Each His Own?

Colorado State University: Labeling of Genetically Modified Foods

Center for Food Safety: Ben & Jerry’s, GE-Labeling Advocates Protest Anti-GE Labeling Bill

Politico: GMO Labeling Bill Would Trump States

Politico: Food Industry to Fire Preemptive GMO Strike

Los Angeles Times: General Mills Drops GMOs from Cheerios

Institute of Food Technologists: Most Consumers Won’t Pay More For Non-GMO Food

National Academies Press: Genetically Modified Organisms: An Ancient Practice on the Cusp

Science Meets Food: What You Need to Know About GMOs, GM Crops, and the Techniques of Modern Biotechnology

Ashley Bell

Ashley Bell communicates about health and wellness every day as a non-profit Program Manager. She has a Bachelor’s degree in Business and Economics from the College of William and Mary, and loves to investigate what changes in healthy policy and research might mean for the future. Contact Ashley at staff@LawStreetMedia.com.

The post Yes or No? GMO Labeling Is Not That Simple appeared first on Law Street.

If you are going to a pharmacy for a particular drug, you’re often offered a choice — do you want the name brand or the cheaper generic? Generics have long been lauded for their ability to provide the same benefits to patients while also offering a less hefty price tag; however, recently generics have been getting more expensive, and people are wondering why. Congress announced this week that it’s going to launch an investigation into why the price of generic drugs is rising.

When a drug company develops a particular drug, it gets to hold the patent for approximately twenty years (some nations or jurisdictions give protections for a bit longer). During that period, that company is the only one that can produce that particular drug. After the patent expires, however, other companies can make a “generic” version of the drug.

There are certain regulations created by the Food and Drug Administration (FDA) to make sure that the generic drugs are able to be distributed. The FDA requires that a generic drug has the same active ingredients as the one that it is imitating, but not necessarily the same inactive ingredients (such as coloring). A generic has to perform the same function as the name brand, and it must of course meet the same health and safety standards.

Generic drugs tend to be less expensive than the name brands — and given the high cost of American health care, offer great and affordable options for consumers. However, it seems like the cost of these drugs is increasing. For example, the patent for Ambien, a popular sleep aid, recently expired. Now it’s a lot easier to get a generic version of Ambien for a cheaper price, and more people are able to get the product they need.

A study completed in August discovered that some generic prices have been dropping, while others have been rising almost exponentially. According to the Wall Street Journal:

The prices paid by pharmacies more than doubled for one out of 11 generics. And in a few cases – notably, the tetracycline antibiotic and the captopril blood pressure pill – the cost increases not only exceeded 1,000%, but topped 17,000%…. Yes, 17,000%.

Doctors have reported how troubling this kind of price increase can be in certain generic drugs for the patients who rely on them. Some patients who are on fixed incomes, such as those on Medicaid, may not be able to pay for the non-covered costs of the drugs if prices skyrocket that much. They may try to skip their prescriptions in an attempt to make ends meet. Not only is this obviously problematic for the patients themselves, but it also leads to more emergency room visits and a less healthy society in general.

That brings us to the investigation that Congress is evidently undertaking to try to figure out why exactly these generic prices are climbing so sharply and how to reverse the trend. The analysis is being pushed by Senator Bernie Sanders of Vermont and Representative Elijah Cummings of Maryland. We can all say a lot about the inadequacies of Congress, but this is a good move on its part. It’s really important that we get the prices of generics under control, because price increases like this are almost always passed directly to the consumer. With as many healthcare problems as we have, this is an issue that needs to be nipped in the bud as soon as possible.

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Anneliese Mahoney (@AMahoney8672) is Lead Editor at Law Street and a Connecticut transplant to Washington D.C. She has a Bachelor’s degree in International Affairs from the George Washington University, and a passion for law, politics, and social issues. Contact Anneliese at amahoney@LawStreetMedia.com.

Featured image courtesy of [Chris Potter/Stockmonkeys.com via Flickr]

Anneliese Mahoney

Anneliese Mahoney is Managing Editor at Law Street and a Connecticut transplant to Washington D.C. She has a Bachelor’s degree in International Affairs from the George Washington University, and a passion for law, politics, and social issues. Contact Anneliese at amahoney@LawStreetMedia.com.

The post Congress to Investigate Rising Generic Drug Costs appeared first on Law Street.

On Friday, gay and bisexual men participated in the second annual National Gay Blood Drive. The drive’s goal was to call attention to the FDA’s lifetime blood donor deferral for all men who have had sex with another man, in place since 1977. Despite the national attention that it received, the first gay blood drive last summer did little to sway the FDA and the ban remained. Organizations such as the American Red Cross, America’s Blood Centers, and the American Association of Blood Banks have all spoken out in support of easing blood donor restrictions. They say that they all, “believe the current lifetime deferral for men who have had sex with other men should be modified and that donor deferral criteria should be made comparable with criteria for other behaviors that pose an increased risk for transmission of transfusion-transmitted infections.”

But let’s back up a bit here–why is there a restriction preventing gay men from donating blood in the first place? About three decades ago, when the AIDS crisis was in full swing, there was panic about how the HIV virus was transmitted. The restriction was put in place to prevent gay men from transmitting HIV through blood donations. But the times, and our scientific knowledge, have changed. We have had the ability to perform blood tests for nearly 30 years now, and it’s been nearly that long since we’ve had a single case of HIV via blood transfusion. The laws are also a relic of a time when it was thought that HIV was an exclusively homosexual disease–it’s since been proven that it can be passed on to anyone of any sexual orientation. That’s exactly why every sample is tested for many things, including HIV, after it is donated.

Ryan James Yezak, the drive’s organizer, wrote a passionate plea for lifting the ban this week on behalf of the Human Rights Campaign. He explained how three years ago, he wanted to go with his boss to give blood after a natural disaster. In his plea, he explained:

While I was healthy as could be, I could not donate due to the fact that I was gay. I had to explain the situation to everyone in my department. For the first time in my life, I felt like I was being treated differently solely on the basis of my sexual orientation – it felt alienating, it felt wrong, but above all – it felt unnecessary.

Yezak could not be more correct–it is unnecessary. A simple blood test and waiting period eliminates the need to categorize individual donors as a risk. The exclusion of gay and bisexual men from donating blood only propagates a stigma against which gay rights activists have spent the past 30 years fighting.

In fact, the only thing that this ban really does is cut down the number of potential blood donors, which is not something we should be doing. Blood shortages have been a major issue in the United States over the past several years.  According to the American Red Cross, more than 41,000 blood donations are needed every single day. In times of catastrophes and in the summer months when schools are no longer holding blood drives, there are major shortages of blood due to the lack of donors. ABC News reported that last year that the United States faced one of the worst shortages the Red Cross has ever seen. As Yezak explained, “to continue to exclude people despite the entirely reasonable arguments of the organizations that supply blood themselves is both discriminatory to them and harmful to everybody.” He said, “someone needs a blood donation every two seconds in the U.S., and you never know when that someone is going to be you.”

The bottom line is, we should not be turning away anyone’s blood. So long as it has been tested, there is no reason that everyone, regardless of sexual orientation, should be banned from donating. Hopefully the second annual National Gay Blood drive will prompt the FDA to lift this outdated and discriminatory ban.

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Brittany Alzfan (@BrittanyAlzfan) is a student at the George Washington University majoring in Criminal Justice. She was a member of Law Street’s founding Law School Rankings team during the summer of 2014. Contact Brittany at staff@LawStreetMedia.com.

Featured image courtesy of [Matt Buck via Flickr]

Brittany Alzfan

Brittany Alzfan is a student at the George Washington University majoring in Criminal Justice. She was a member of Law Street’s founding Law School Rankings team during the summer of 2014. Contact Brittany at staff@LawStreetMedia.com.

The post The National Gay Blood Drive: A Call for Change appeared first on Law Street.

Three years ago, the Food and Drug Administration said it would regulate e-cigarettes.

Although it took longer than expected, the FDA kept its promise.

While certain states and cities across the country have already taken steps to ban the increasingly popular battery-powered devices, the FDA proposed restrictions for the first time Thursday.

Similar to the way it currently regulates traditional cigarettes, the FDA is planning to take the following steps against their electronic counterparts:

• Banning the sale of e-cigarettes to minors.
• Prohibiting the distribution of free samples.
• Banning the sale of e-cigarettes in vending machines – unless the vending machines are located in places where young people aren’t admitted.
• Requiring e-cigarettes to include warning labels, making it clear they contain the addictive chemical nicotine.
• Requiring e-cigarette companies to publicly disclose their products’ ingredients.

Additionally, the proposal would require FDA approval before any new e-cigarettes can be sold. Current products would have to “provide a justification for remaining on the market.”

Despite the urging of many tobacco critics, the FDA’s regulations fall short of broader restrictions. No action will be taken regarding online sale of e-cigarettes, TV advertisements, and the use of various flavorings and sweeteners – all deemed by critics as a way of attracting young smokers.

Pegged as a safer alternative to traditional smoking, e-cigarettes are marketed as a way to not only draw people away from traditional cigarettes but also as a means of helping smokers kick the habit completely.

While it’s generally accepted that e-cigarettes are safer than traditional cigarettes, many point to the lack of substantial research into possible health risks as a serious concern.

“Right now, for something like e-cigarettes, there are far more questions than answers,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, told NPR.

One of the most pressing questions is how safe are electronic cigarettes really? One FDA study found that e-cigarettes “potentially release carcinogens and toxic chemicals.” Further research is needed to confirm the FDA’s findings, but supporters of e-cigarettes point to the fact that electronic cigarettes, unlike traditional cigarettes, do not emit tar, carbon monoxide, or hydrogen cyanide.

Still, the main concern is that the e-cigarette industry has been rapidly evolving without any form of regulation. According to Zeller, the goal of the proposed restrictions is to “create a framework.” “We’re calling this the first step,” he said and continued that “for the first time, there will be a science-based, independent regulatory agency playing a vital gate-keeping function.”

As Zeller puts it, the proposal puts the FDA in “a position to ensure that the products are as safe as they could possibly be.”

Safety, as it turns out, is one area where the FDA and e-cigarette industry have found common ground.

“We are extremely relieved that all e-cigarette companies will be regulated, and forced to achieve and maintain the same high standards that Vapor Corp., and several of our responsible competitors, have been imposing on ourselves for years,” said Jeffrey Holman, president and director of Vapor Corp, in an interview with NPR.

Other players in the industry patted the FDA on the back as well, commending the agency for committing to a science-based regulatory process.

“What they did today was very encouraging. […] We’ve already done many things to prepare ourselves and act responsibly,” Miguel Martin, president of the e-cigarette company Logic Technology Development, told The Washington Post. He went further to say that “at least speaking for my company, this will not be the tobacco wars of the 80s and 90s.”

Despite a largely positive reception, there are those – on both sides of this issue – who are not happy with the FDA’s new proposal.

“This is worse than I expected,” said American Vaping Association board member Greg Conley in an interview with the Post. Conley said he agreed with the age restrictions but had hoped existing products would be grandfathered in. Instead, existing e-cigarette companies will have to file applications for their products to remain on the market. “A lot of these companies, they are supporting several employees, investing any profits back into their business. They can’t afford this, and it’s going to lead to a whole lot of consolidation and increased prices for consumers,” he said.

Some public health advocates, while accepting of the proposed regulations, are upset the FDA was not more aggressive when e-cigarettes first hit the shelves.

Matthew Myer, president of the Campaign for Tobacco-Free Kids, says the FDA’s action is long overdue. “It is inexcusable that it has taken the FDA and the administration so long to act,” Myers told NPR, and “this delay has had serious health consequences as these unregulated tobacco products have been marketed using tactics and sweet flavors that appeal to kids.”

As far as immediate change goes, don’t expect anything too soon. Before the new regulations can be made official, there will be a 75 day period where the public will be able to comment on the FDA’s proposal. Once the restrictions are finalized, e-cigarette companies will be required to comply with the age and ID restrictions almost immediately. Although their products will be able to stay on the shelves, companies will have to submit applications for approval of their products within two years.

[NPR] [The Washington Post] [USA Today]

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Matt DiCenso

Featured image courtesy of [Michael Dorausch via Flickr]

Matt DiCenso

Matt DiCenso is a graduate of The George Washington University. Contact Matt at staff@LawStreetMedia.com.

The post FDA Regulations: The Future of E-Cigarettes appeared first on Law Street.

Recently, Johnson & Johnson had a $2.2 billion settlement, rendering it the third highest pharmaceutical fraud settlement made with the United States government. Will this trend continue, or will Johnson & Johnson learn from their mistakes as well as those of their predecessors?

Although consultant pharmacists purported to provide “independent recommendations based on their clinical judgment, Johnson & Johnson viewed the pharmacists as an ‘extension of [J&J’s] sales force,” the Justice Department claimed. That, more or less, is what Johnson & Johnson was sued for; drug-makers are legally only allowed to promote their product for cures in the way that the FDA has approved of them.

In a class action case, Johnson & Johnson was said to have wrongfully marketed their drugs created to treat schizophrenia, Risperdal and Invega, as dementia medication for elderly patients. Furthermore, the company allegedly lied about Risperdal’s side effects and withheld information that the medication led to diabetes. Although legally settling, the company still denied the allegations. Claiming innocence, Johnson & Johnson stated, “the settlement of the civil allegations is not an admission of any liability or wrongdoing, and the company expressly denies the government’s civil allegations.” In defending their drug, they claimed Risperdal to be “safe and effective for its approved indications”, and “an important treatment option for people with serious mental illness.”

Sure, the government has cracked down on Johnson & Johnson, and now the company is paying $2.2 billion, but does that actually mean anything? Johnson & Johnson has a net worth of $65.03 billion. In preparation for this case, the company set aside money to pay their penalties, rendering the fine insignificant for a company of great wealth and success.

So, will anything change from this settlement? Michael Ullmann, Vice President and General Counsel of Johnson & Johnson reflected, “today we reached closure on complex legal matters spanning almost a decade. This resolution [which] allows us to move forward and continue to focus on delivering innovative solutions that improve and enhance the health and well-being of patients around the world.”

I speculate that the government will tighten the reigns and harshly proctor the company, as well as extend this strict scrutiny to others drug-providers. But as a result of the simple nature of medications, being that they were released to the public shortly after their creation, and the system of pharmaceutical representatives, a heavily corrupted system, long term changes or consequential changes seem extremely unlikely to occur.

Shedding light on the impact of this case, Attorney General Eric Holder said “every time pharmaceutical companies engage in this type of conduct, they corrupt medical decisions by healthcare providers, jeopardize the public health, and take money out of taxpayers’ pockets.” Pharmaceutical representation is a capitalist system that encourages sales people to push drugs onto doctors, hospitals, and nursing homes which economically resonates, and yet morally conflicts with our way of conducting business. People become less important than businesses, as finances dictate our capitalist ways. C’est la vie. Being third in the country sounds significant, but the ranking, like China’s GDP, its just an arbitrary number in this case, meaningless.

[NPR] [NYTimes] [CNN] [J&J]

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Featured image courtesy of [DraconianRain via Flickr]

Vasudha Sadana

The post Our Everyday Drug Dealer appeared first on Law Street.

The Food and Drug Administration’s recent decision to curb the use of prescribed painkillers has quickly become a topic of huge media speculation. A debate focusing on the pros and cons of this verdict has been sparked between the drug-selling companies, health providers and the Centers for Disease Control and Prevention (CDC).  While few health providers argue that this might have serious consequences on patients suffering from acute pain, others believe that this is an attempt to reduce the increasing number of deaths caused due to the abuse of household painkillers.

According to the CDC, painkiller overdose death rates have more than tripled since the 1990. In 2009, abuse of prescription painkillers was the major reason behind all 475,000 emergency department visits across the nation.  Hydrocodone-the main ingredient behind most household painkillers included in the variety of opioid narcotics, is seen as the dominant cause for the increasing number of deaths.  In the past, hydrocodone was classified as a low-risk drug that permitted doctors to prescribe it over phone, and allowed patients to use it for a period of six months on a single prescription. Although, these rules eased the access to the drug and pushed the sales to new heights, it additionally fueled the widespread dependence and related deaths.

Last week, almost after a decade and a half of careful cross-examination, the FDA took a step forward to reduce the harmful effects of the drug. The new proposal eliminates the conveniences of prescribing painkilling drug. It reclassifies Hydrocodone under Schedule II drugs, thus bar phone-in prescriptions and place a 90-day limit on refills.  Most opponents of FDA’s decision complain that this will force ailing patients to schedule more frequent visits to the doctors, which might prove to be burdensome for most middle-income families. In response to this, FDA reaffirms that a change in regulations for Hydrocodone containing drug supply was absolutely necessary as it kills more people than any other forms of narcotics.

Controlling substance abuse has always posed a challenge for the FDA, and extension of this malpractice into the prescribed drug sector; could lead to results much more uglier than ever imagined. In my personal opinion, the FDA’s recent drug restrictions should be applauded as this initiative could save lives and mitigate the overall narcotic abuse rates. Hydrocodone supplying companies could experience an initial down surge in sale revenue, but that should not lead them to undermine the dangers of selling the drug.  It is time for drug-selling giants to realize and act on their social responsibilities.

[CDC]

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Featured image courtesy of [Eric Norris via Flickr]

Tanzoom Ahmed

Tanzoom Ahmed is a graduate of George Mason University with a Master of Public Policy. Contact Tanzoom at staff@LawStreetMedia.com.

The post Memo to FDA: Kill the Pain, Not the Patient appeared first on Law Street.