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.

The post Will Snorting Cacao Powder Become Popular? The FDA May Need to Decide appeared first on Law Street.

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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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.

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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.

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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.

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.

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.

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.

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