Abstract
The FDA recently announced a plan to combat underage use of nicotine products by targeting flavors that appeal to adolescents. The proposal outlines restrictions on sales of flavored cartridges for electronic cigarettes, and a ban on menthol-flavored combustible cigarettes and all flavored cigars.
The FDA announced plans to combat what its commissioner, Scott Gottlieb, MD, calls “the epidemic use of electronic cigarettes [e-cigarettes] and nicotine addiction among kids,” in mid-November. The proposal would restrict sales of flavored cartridges for e-cigarettes and ban menthol-flavored combustible cigarettes and all flavored cigars.
Recent data indicate that between 2017 and 2018, the use of e-cigarettes—devices that vaporize a nicotine-containing liquid that is then inhaled—increased by 78% among high schoolers and 48% among middle schoolers, with 67.8% opting for flavored cartridges. Under the plan, the FDA would require more stringent age verification online, and that cartridges containing flavors other than menthol, mint, and tobacco be sold in age-restricted stores or sections of stores.
Gottlieb says that the proposed restrictions exclude menthol, mint, and tobacco flavors for e-cigarettes due to their potential utility for smoking cessation, adding that the FDA aims to balance the importance of helping adults switch to noncombustible products with the need to “make nicotine products less accessible and less appealing to children.”
“This is a step in the right direction for restricting sale of e-cigarettes to youths,” says Benjamin Toll, PhD, of the Medical University of South Carolina in Charleston. However, he says more research is needed on whether e-cigarettes are less harmful than combustible cigarettes and might help adult smokers quit. If so, they should be sold as smoking-cessation tools.
Dennis Henigan, JD, of the Campaign for Tobacco-Free Kids, calls for the FDA to do more than enforce age restrictions online and in stores: “We think that these flavored e-cigarettes that have proven to be so spectacularly appealing to kids need to come off the market.”
Henigan notes that although the Tobacco Control Act of 2009 gives the FDA the authority to regulate e-cigarettes, the agency has been slow to act. The Campaign for Tobacco-Free Kids, the American Lung Association, and other organizations are suing the FDA for allowing e-cigarette products on the market in August 2016 to remain on the market until 2022 without FDA public health review.
Under pressure from the FDA and other groups, some companies are taking action on their own. For example, Juul Labs, which makes popular e-cigarettes that resemble flash drives, announced in November that it will temporarily stop selling flavors such as mango and crème and will halt social media advertising. However, Erika Sward of the American Lung Association emphasizes that the FDA cannot rely on voluntary action from e-cigarette companies, citing prior failures by tobacco companies to self-regulate.
The FDA also proposed a ban on combustible menthol cigarettes and all flavored cigars. Gottlieb noted that 54% of smokers ages 12 to 17 use menthol cigarettes, and the rate is even higher among African Americans. “The menthol serves to mask some of the unattractive features of smoking,” he says. The FDA banned cigarettes in all flavors except menthol in 2009, but flavored cigars are still sold.
Toll, Henigan, and Sward agree that banning all menthol cigarettes and flavored cigars could have far-reaching benefits. “The proposal to prohibit menthol in cigarettes is one of the strongest actions FDA could take to promote public health, and certainly what they've also proposed to do on flavored cigars is extremely important,” Henigan says.
The FDA has not announced a timeline for implementing the proposed restrictions. –Catherine Caruso
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