FDA Steps Up Enforcement Actions Against Tobacco Manufacturers, Wholesalers and Retailers

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In the first months of 2024, the Food and Drug Administration (FDA) has increased its enforcement actions against sellers of flavored disposable e-cigarette products that do not have pre-market authorizations.  The FDA has described these actions as responsive to the number of illegal e-cigarette products imported primarily from China and to the results of the 2023 National Youth Tobacco Survey (NYTS), which indicated that six out of ten current youth e-cigarette users reported using a flavored disposable e-cigarette brand.  In a recent release, the FDA’s Center for Tobacco Products (CTP) stated, “The FDA will continue to take compliance and enforcement action against those making, distributing, importing, or selling unauthorized e-cigarette products…”

In January, the FDA filed Civil Money Penalty (CMP) complaints against 21 brick-and-mortar retailers selling flavored disposable vapor products marketed under the Esco Bar brand, which the FDA noted was the second most commonly used brand among youth e-cigarette users according to NYTS.  In these cases, the amount being sought against each of the retailers is $20,678, which is the maximum penalty allowed for a single violation of the Federal Food, Drug, and Cosmetic Act.

On Feb. 1, the FDA also issued warning letters to 14 online retailers for selling unauthorized products marketed under brands such as Elf Bar/EB Design, Lava Plus, Funky Republic/Funky Lands, Lost Mary, Cali Bars, Cali+, and Kangvape.

With these recent FDA enforcement efforts, the tobacco industry needs to be aware of ongoing compliance with federal law, including the FDA’s enforcement priorities, since the agency can take enforcement action against not only retailers but also wholesalers, importers, and manufacturers that sell or distribute tobacco products that lack required FDA authorizations or that otherwise violate the law.

The National Association of Tobacco Outlets (NATO) has been tracking the FDA’s recent enforcement actions, and below are the brands of products the FDA has cited when taking action.  We expect this list to expand as the FDA continues to ramp up enforcement actions.

David Spross is the executive director of NATO, a tobacco retailing association based in Lakeville, Minnesota. Reach him at david.spross@natocentral.org.  To learn more about NATO, visit www.natocentral.org.

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