FDA Proposes Rule to Regulate E-Cigarettes

The agency’s proposal would lead to regulation of e-cigarettes as well as other currently unregulated tobacco products, such as cigars, pipe tobacco, nicotine gels, and waterpipe or hookah tobacco.

The FDA has proposed a new rule that would give the agency authority over tobacco products that are currently unregulated, including electronic cigarettes (e-cigarettes).

The new rule, proposed on April 24, 2014, would operate as part of the Family Smoking Prevention and Tobacco Control Act of 2009, allowing the FDA to regulate cigars, pipe tobacco, nicotine gels, waterpipe or hookah tobacco, e-cigarettes, and other unregulated products. Under the rule, manufacturers of such products would be required to register with the FDA and report product ingredients, market new products only after FDA review, and would be able to make claims regarding reduced risk only after confirmation from the FDA that evidence supports the statements.

Manufacturers of tobacco products included in the proposed rule would be required to implement minimum age and identification restrictions and to include health warnings with the products. In addition, the rule would prohibit makers of the products from distributing free samples and from selling the products in vending machines, except in locations that do not permit underage patrons.

The FDA hopes that the new regulation will deter youth from starting tobacco habits.

"This proposed rule is the latest step in our efforts to make the next generation tobacco-free," said HHS Secretary Kathleen Sebelius in a press release.

Public comment on the proposed rule will be accepted for 75 days, and the FDA has requested submissions of research, data, and any other information on regulation concerning cigars and e-cigarettes. The FDA is asking for suggestions on the amount of regulation appropriate for e-cigarettes, which do not actually burn tobacco but simulate the smoke by producing vapor that contains nicotine. E-cigarettes are often marketed as a tool to help smokers quit their tobacco habit, but some have argued that they may actually be a stepping stone for adolescents who will go on to smoke cigarettes.

“Especially in the shadow of alarming increases in the number of youths using unregulated products like electronic cigarettes and cigars, it’s more crucial than ever to help prevent early tobacco use that could lead to a lifetime of nicotine addiction,” FDA Commissioner Margaret A. Hamburg, MD, wrote in a blog post.