FDA Continues to File Complaints Against Retailers

The agency announced it filed 20 complaints for CMPs against retailers for the sale of unauthorized e-cigarettes.

February 28, 2024

The FDA announced that it filed another 20 complaints for civil money penalties (CMPs) against brick-and-mortar retailers for the sale of unauthorized Elf Bar e-cigarettes. The agency stated that it had previously issued each retailer a warning letter relating to their sale of the e-cigarettes.

Including these new complaints, the FDA has filed more than 100 CMP complaints against retailers for the illegal sale of Elf Bar e-cigarettes.

The agency is now seeking the maximum penalty amount for a single violation from each retailer. 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 September, November, and December of 2023.

The FDA said that 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 act within 30 days of 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, 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.”

As of February 15, the 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.