We write to comment on the April 25, 2014, proposed regulation issued by the Food and Drug Administration ("FDA"), which would deem certain tobacco products to be covered by the Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act ("Tobacco Control Act"). Our comment focuses on the proposed regulation's treatment of one of those products, electronic cigarettes ("e-cigarettes").
E-cigarettes are much safer than cigarettes because they do not have the carcinogenic tars and harmful gases produced by cigarettes. At this time, there is no evidence that e-cigarettes serve as a gateway to cigarettes. Although e-cigarettes are not completely safe and do provide nicotine, the risks are much lower than those from cigarettes. Although further research will be needed on their long-term effects, it is clear that e-cigarettes can play an important harm reduction role. Unfortunately, the proposed regulation threatens to prevent e-cigarettes from playing that role.
Although the proposed regulation's prohibition on sales to minors and its requirement of a nicotine warning would be beneficial, other provisions would essentially destroy the wide product variety available in today's highly competitive market. The problem is that deeming e-cigarettes to be subject to the Act would automatically subject them to the statutory requirement of premarket review. The FDA's own analysis indicates that the administrative burdens of the review process would drive the overwhelming majority of e-cigarette products out of the market. The dramatically reduced variety and availability of e-cigarettes would undermine efforts to persuade cigarette smokers to switch to e-cigarettes, thereby endangering public health. The proposed regulation is therefore unacceptable in its present form.