FDA Releases Proposed Rule on Electronic Cigarettes

Agency exercises its authority under the Tobacco Control Act to regulate e-cigarettes and prevent minors from purchasing the products.

April 24, 2014

WASHINGTON – The U.S. Food and Drug Administration (FDA) has released a proposed rule that would prevent minors from purchasing electronic cigarettes and give the FDA authority over e-cigarettes, cigars, pipe tobacco, nicotine gels, hookah and dissolvables.

However, it could be another year before the restrictions take effect, reports Politico, as the public will have 75 days to comment on the proposal. The news source writes that e-cigarette companies welcome federal regulation and many support bans on sales of their products to minors.

“NuMark supports FDA extending the appropriate regulation over all tobacco products, including those containing tobacco-derived nicotine,” David Sutton, a spokesman for Altria Inc., whose subsidiary NuMark manufactures e-cigarettes, told Politico. “We think that this comprehensive regulatory framework … can contribute to resolving many of the complex issues” surrounding e-cigarettes.

The FDA proposes including the additional items in several provisions that apply to regulated tobacco products, such as age and identification requirements to restrict sales to youths under 18 and prohibitions on free samples and vending machine sales. These provisions would go into effect 30 days after the final rule is released.

The proposed rule does not include restrictions on online sales or television advertising. The FDA is also not banning flavoring, as many cigars and e-cigarette products come in flavors such as peach and cherry. Such restrictions would require separate rulemaking.

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) provides FDA with immediate authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. The Tobacco Control Act also permits FDA to issue regulations deeming other tobacco products that meet the statutory definition of "tobacco product" to also be subject to the Food Drug & Cosmetic Act (FD&C Act). This regulation is necessary to afford FDA the authority to regulate these products, which include hookah, electronic cigarettes, cigars, pipe tobacco, other novel tobacco products and future tobacco products.

An unpublished version of the proposed rule is available on the Federal Register’s website (PDF).

On March 14, NACS issued a statement of position that encourages stores selling e-cigarettes to adopt, as a best practice, a policy of treating these products as age-restricted, subjecting them to the same age-verification procedures as those applicable to tobacco products.

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