FDA proposes to extend tobacco regulation with e-cigarettes
The U.S. Food and Drug Administration has proposed a new rule that would extend the agency’s tobacco authority to cover additional tobacco products. This is part of its implantation of the Family Smoking Prevention and Tobacco Control Act, in efforts to make the next generation tobacco-free.
The FDA currently regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Products that would be subject to FDA regulation under the proposed rule are those that meet the statutory definition of a tobacco product, including currently unregulated marketed products, such as electronic cigarettes (e-cigarettes), cigars, pipe tobacco, nicotine gels, waterpipe (or hookah) tobacco, and dissolvables not already under the FDA’s authority.
The proposed rule implies that newly deemed tobacco products would have to be registered with the FDA to report product and ingredient listings and that direct and implied claims of reduced risk can only be made if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole. New tobacco products can only be marketed after FDA review, and free samples may not be distributed.
Furthermore, a minimum age and identification restrictions will apply to prevent sales to underage youth. Health warnings will be required and vending machine sales will be prohibited, unless in a facility that never admits youth.
The proposed rule will be available for public comment for 75 days.