February 26. 2024

On Feb. 26. FDA announced the filing of complaints for civil money penalties (CMPs) against 20 brick and mortar retailers for the sale of unauthorized Elf Bar e-cigarettes, a popular youth-appealing brand. FDA previously issued each retailer a warning letter relating to their sale of unauthorized e-cigarettes. However, follow-up inspections revealed that the retailers had failed to correct the violations, and the agency is now seeking the maximum penalty amount of $20.678 for a single violation from each retailer.

Including the complaints announced today, FDA has filed more than 100 CMP complaints against retailers for the illegal sale of Elf Bar e-cigarettes. Data indicate these products are appealing to youth. According to the 2023 National Youth Tobacco Survey, Elf Bar was the most commonly used brand among U.S. youth e-cigarette users; among middle and high school students who reported using e-cigarettes in the past 30 days, more than half said they used Elf Bar products during that period.

“These retailers have not adequately addressed the violations noted in previous warnings from FDA regarding the sale of unauthorized e-cigarettes,” said Brian King, Ph.D., M.P.H., director of FDA’s Center for Tobacco Products. “Their continued failure to comply with the law is inexcusable, and as is evidenced by today’s actions, we’re committed to holding them accountable for it.”

Currently, $20.678 is the maximum civil money penalty amount FDA can seek for a single violation from each retailer, which is consistent with similar CMPs sought against retailers for the sale of unauthorized Elf Bar products in Sept., Nov., and Dec. of 2023. The retailers can pay the penalty, enter into a settlement agreement based on mitigating factors, request an extension of time to file an answer to the complaint, or file an answer and 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.

“We closely monitor the entire supply chain, including retailers, for compliance with the law,” said Ele Ibarra-Pratt, M.P.H., acting director of the Office of Compliance and Enforcement in the FDA’s Center for Tobacco Products. “This includes follow-up inspections and surveillance of those who have received a warning letter, and taking enforcement actions, including filing civil money penalty complaints and seeking seizures and injunctions, as appropriate.”

Today’s CMP actions are the latest in the continued, comprehensive push 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 Feb. 15. FDA has issued more than 440 warning letters to and filed 100 CMP actions against retailers, including brick and mortar and online retailers, for selling unauthorized tobacco products. In addition to actions involving retailers, FDA has issued more than 660 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 CMP complaints against 50 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.

FDA will continue to take compliance and enforcement action against those making, distributing, importing, or selling unauthorized e-cigarette products, including seeking CMPs against retailers who violate the law.