The FDA has issued warning letters to 80 retailers in 15 different states for selling unauthorized e-cigarette products, including Elf Bar and Lost Mary. The FDA also announced the filing of complaints for civil money penalties (CMPs) against eight other retailers who failed to take action after being previously warned about selling unauthorized e-cigarettes.

The agency said these products are popular with youth, and the warning letters and CMPs are a result of the FDA’s “monitoring of multiple surveillance systems to identify products that are popular among youth or have youth appeal. The 2023 National Youth Tobacco Survey found that more than 50% of youth who use e-cigarettes reported using the brand Elf Bar. Additionally, the brand Lost Mary—which is manufactured by the same firm as Elf Bar—was identified as popular or youth-appealing following agency review of retail sales data and emerging internal data from a survey among youth.”

Warning letter recipients have 15 working days to respond with the steps they will take to correct current violations and prevent future violations, and failure to do so results in CMPs. For the retailers receiving the eight CMPs, FDA previously issued warning letters for their sale of unauthorized tobacco products and is now seeking $20,678 from each retailer.

To date, FDA has authorized 34 e-cigarette products and devices—the most recent being seven Vuse Alto Pod e-cigarettes from R.J. Reynolds Vapor Company—and has issued more than 690 warning letters and more than 140 civil money penalty actions to retailers for the sale of unauthorized e-cigarettes.

In March, FDA launched a searchable database that lists which products can be legally marketed. NACS has expressed concerns that the database is incomplete and lacks clarity because it fails to include all categories of products that can be on the market, like products that are subject to administrative stays and review.