On Apr. 23. FDA announced the issuance of complaints for civil money penalties (CMPs) against 20 brick and mortar retailers and two online retailers for the sale of unauthorized e-cigarettes, including Elf Bar, a popular youth-appealing brand. FDA previously issued warning letters to these retailers for their sale of unauthorized tobacco products, however, follow-up inspections revealed that the retailers had failed to correct the violations. Accordingly, the agency is now seeking a CMP of approximately $20.000 from each retailer.

According to the 2023 National Youth Tobacco Survey, Elf Bar was the most commonly used brand among middle and high school students who reported using e-cigarettes in the past 30 days, with 56.7% of youth e-cigarette users reporting current use of Elf Bar and about one-third (31.1%) reporting it was their “usual” brand.

The approximately $20.000 CMP sought from each retailer is consistent with similar CMPs sought against retailers for the sale of unauthorized Elf Bar products over the last few months, including in Sept., Nov., Dec. and Feb. The retailers can pay the penalty, enter into a settlement agreement, request an extension to respond, or request a hearing. Retailers that do not take action within 30 days after receiving a complaint risk a default order imposing the full penalty amount.

Today’s CMP actions continue the comprehensive effort by FDA to take action across the supply chain to remove unauthorized e-cigarettes, particularly those that are popular among youth, from the marketplace. As of April 2024. FDA has issued more than 550 warning letters and 108 CMPs to retailers, including brick and mortar and online retailers, for selling unauthorized tobacco products. In addition to actions involving retailers, FDA has issued more than 670 warning letters to manufacturers, importers, and distributors for illegally selling and/or distributing unauthorized new tobacco products, including e-cigarettes. The agency has also filed civil money penalty complaints against 55 e-cigarette firms for manufacturing unauthorized products and sought injunctions in coordination with the U.S. Department of Justice against seven manufacturers of unauthorized e-cigarette products.

To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. These are the only e-cigarette products that currently may be lawfully marketed and sold in the U.S。