In December, the U.S. Food and Drug Administration (FDA) issued warning letters to online retailers for reportedly selling unauthorized e-cigarette products. Consistent with the Center for Tobacco Products’ (CTP) recent focus, the letters target unauthorized products which FDA states are particularly appealing to youth—including Lost Mary, Funky Republic/Funky Lands, and Elf Bar/EB Design. These warning letters follow FDA’s recent issuance of civil money penalty complaints against 25 brick-and-mortar retailers for failing to comply with prior warning letters. Those civil money penalty complaints, which we previously discussed here, continued the agency’s approach of seeking the maximum penalty approved by law.
FDA may also be signaling a shift to a more wide-ranging enforcement strategy. In 2020, agency stated that it would prioritize enforcement against unauthorized e-cigarettes for which it had not received a timely premarket tobacco application (PMTA). Similarly, when Congress extended FDA’s tobacco product authorities to cover e-cigarettes using non-tobacco-derived nicotine in 2022, it appeared the agency had taken an unstated approach of not bringing enforcement action against synthetic nicotine products with timely applications.
In an FDA press release accompanying the issuance of the December warning letters, however, CTP Director Dr. Brian King clarified that FDA’s enforcement may not be so constrained. In pertinent part, he warns, “We can issue, and have issued, warning letters for products for which an application has been submitted and is pending review. For unauthorized tobacco products, the pendency of an application does not create any sort of safe harbor to sell that product.” If any of the products at issue have timely pending PMTAs, then this action may be considered a shift in FDA’s approach, demonstrating that FDA may prioritize enforcement against e-cigarettes that it believes appeal to youth even if they have a timely application.
Concerns of youth appeal of certain e-cigarettes continue to drive FDA’s enforcement priorities. In a press release accompanying the issuance of the December warning letters, FDA cited a finding by its recent 2023 National Youth Tobacco Survey that “Elf Bar was the most commonly used e-cigarette brand among youth.” FDA further noted that the other illegal e-cigarette varieties targeted in its warning letters were likewise identified in the survey as popular with youth.
The recent warning letters and civil money penalty complaints—coupled with Director King’s warning regarding enforcement during application pendency—reflect FDA’s relatively new focus on sales of illicit e-cigarettes. As of December 2023, FDA has issued more than 400 such warning letters to retailers regarding unauthorized e-cigarettes and filed more than 65 civil money penalty complaints to retailers and manufacturers regarding such products. We expect this pattern of enforcement to continue into 2024 against manufacturers, distributors, and retailers of e-cigarettes lacking FDA authorization.
