FDA will continue strong enforcement against illegal e-cigarettes

In December, the U.S. Food and Drug Administration (FDA) issued warning letters to online retailers, stating that they allegedly sold unauthorized e-cigarette products. In line with the recent focus of the Center for Tobacco Products (CTP), these letters target unauthorized products that the FDA believes particularly appeal to teenagers, including Lost Mary, Funky Republic/Funky Lands, and Elf Bar/EB Design. These warning letters follow the FDA's recent civil penalty actions against 25 brick-and-mortar retailers for failing to comply with previous warning letters. These civil penalty actions, which we discussed here earlier, continue the agency's practice of pursuing the maximum fines allowed by law.

The FDA may also be signaling a broader enforcement strategy. In 2020, the agency indicated that it would focus enforcement on unauthorized e-cigarette products for which it had not received timely pre-market tobacco applications (PMTAs). Similarly, when Congress expanded the FDA's authority over tobacco products in 2022 to include e-cigarettes using non-tobacco-derived nicotine, the agency seemed to take an ambiguous approach, not taking enforcement action against synthetic nicotine products with timely applications.

However, in the FDA's press release accompanying the December warning letters, CTP Director Dr. Brian King clarified that the FDA's enforcement may not be so limited. In a relevant section, he warned: "For products that have submitted applications and are awaiting review, we can issue warning letters, and we have done so. For unauthorized tobacco products, pending applications do not provide any safe harbor for selling those products." If the products involved include those with timely pending PMTAs, this action could be seen as a shift in the FDA's approach, indicating that the FDA may prioritize enforcement against e-cigarettes it believes appeal to teenagers, even if they have timely applications.

Concerns about certain e-cigarettes appealing to teenagers continue to dominate the FDA's enforcement focus. In the press release accompanying the December warning letters, the FDA cited results from its recent 2023 National Youth Tobacco Survey, noting that "Elf Bar is the most commonly used e-cigarette brand among teenagers." The FDA further pointed out that other illegal e-cigarette varieties targeted in its warning letters were also found to be popular among teenagers in the survey.

The recent warning letters and civil penalty actions, along with Dr. King's warnings regarding enforcement during pending applications, reflect the FDA's relatively new focus on the sale of illegal e-cigarettes. As of December 2023, the FDA has issued over 400 warning letters to retailers regarding unauthorized e-cigarettes and has initiated over 65 civil penalty actions against retailers and manufacturers for such products. We expect this enforcement pattern to continue into 2024, taking action against manufacturers, distributors, and retailers of e-cigarettes that are unauthorized by the FDA.