In 2009, Congress for the first time gave the Food and Drug Administration authority to regulate tobacco. In April 2014, the agency proposed to regulate e-cigarettes and similar products. In a short paper in the Journal of the American Medical Association entitled E-Cigarettes, Vaping, and Youth, Larry Gostin and Aliza Glasner have provided their views on the FDA's proposal and what they think the agency should do. They note that "[t]he conundrum is how to regulate e-cigarettes given scientific uncertainty about the nature and extent of harms." Here is the abstract:
E-cigarettes, a relatively new product, storming the tobacco industry are causing a massive stir among public health advocates. While e-cigarettes have the potential to serve as an effective harm reduction tool for existing smokers, they also may present an equally tempting pathway to first time smoking, particularly among youth. Many fear that e-cigarettes will revive the popular smoking culture that has taken decades to dismantle. In April 2014, the FDA issued proposed rules to “deem” or extend its authority over tobacco products to regulate electronic cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco, and orally ingested dissolvable tobacco products. As proposed, FDA’s rules, among other things, would set a federal minimum age of 18 years to use e-cigarettes, require identification to purchase them (currently, just more than half of states impose age restrictions), prohibit most sales in vending machines, mandate warning labels on packaging, and prohibit manufacturers from providing free samples. Further, companies would be permitted to make claims for reduced risk only if the agency confirms the claim based on scientific evidence while also finding a benefit to the health of the public. While the proposed rules represent a watershed moment in tobacco control, they still leave major regulatory gaps affecting the most vulnerable population, youth. FDA’s silence when it comes to the use of flavored nicotine and marketing practices is certain to have negative consequences for youthful smokers. The agency should move boldly and rapidly to prevent companies from exploiting youth. By bolstering the proposed rules to limit advertising and prohibit flavored nicotine, the agency could prevent proliferation of e-cigarette use among adolescents, while not undermining its regulatory goal of reducing harm. The public health community must speak with a clear voice to urge meaningful and effective regulation to protect US youth against the reinvention of Big Tobacco.