FDA Bans Most Flavored Cartridge-Based E-Cigarettes
The U.S. Food and Drug Administration (FDA) has announced a ban on most flavors of cartridge-based e-cigarettes, including fruit and mint varieties, that have not received FDA authorization through the premarket tobacco application (PMTA) process. The ban, which was announced on January 2, 2020, requires companies to cease the manufacture, distribution, and sale of these unauthorized flavored products within 30 days or risk enforcement actions from the agency.
The FDA’s decision seeks to strike a balance between addressing public health concerns, particularly regarding youth vaping, and the needs of adult cigarette smokers who may use e-cigarettes as a means to reduce their tobacco consumption. The ban excludes tobacco and menthol flavors, which the FDA considers less appealing to minors based on data from the 2019 National Youth Tobacco Survey.
Industry Reaction and Advocacy Efforts
The National Association of Convenience Stores (NACS) has been a vocal advocate for the equal treatment of retailers selling tobacco products. While the organization initially opposed the FDA’s efforts to permit flavored e-cigarette sales only in “adult-only” retail stores, it appears that the agency has taken these concerns into account in its final guidance. Lyle Beckwith, senior vice president of government relations for NACS, stated, “It would appear that FDA heeded our concerns regarding a level playing field among retailers and adjusted their final guidance policy accordingly.”
Affected Products and Manufacturer Responsibilities
The ban applies to cartridge-based electronic nicotine-delivery systems (ENDS) products that involve a cartridge or pod designed to hold liquid for aerosolization. This includes any flavored cartridge-based ENDS product, aside from tobacco or menthol flavors, as well as products for which the manufacturer has failed to take adequate measures to prevent minors’ access or that are targeted to or likely to promote use by minors.
Manufacturers must take steps to prevent minors from purchasing their products, and the ban will remain in effect until these products receive FDA authorization through the PMTA process. Applications for this process are due by May 12, 2020.
Raising the Minimum Age for Tobacco Products
In addition to the flavored e-cigarette ban, President Donald Trump signed a federal spending bill on December 20, 2019, that raised the minimum age to purchase tobacco products from 18 to 21. This legislation amended the Federal Food, Drug and Cosmetic Act, granting the FDA authority to regulate all tobacco products, including cigarettes, electronic cigarettes, cigars, and hookah tobacco.
As the vaping industry navigates these new regulations, it remains to be seen how the ban on flavored cartridge-based e-cigarettes will impact public health, particularly among youth, and how manufacturers will respond to the FDA’s enforcement of the PMTA process.
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