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FDA Regulations: The Future of E-Cigarettes
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]
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