May 30, 2024

On May 30, FDA announced it is seeking civil money penalties (CMPs) from nine brick and mortar retailers and one online retailer for the sale of Elf Bar, a popular youth-appealing e-cigarette 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 $20,678 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 $20,678 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 February and April of this year. 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.

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. Further information on tobacco products that may be legally marketed in the United States is available in FDA’s new Searchable Tobacco Products Database.