FDA fines retailers for illegally selling e-cigarette products

Key takeaways:

• The FDA has fined 22 retailers for selling illegal e-cigarette products.
• More than 400 retailers have received a warning letter from the FDA for selling illegal tobacco products as of Sept. 19.

Twenty-two U.S. retailers have received a civil money penalty complaint from the FDA for selling unauthorized Elf Bar/EB Design e-cigarettes, which is a “popular youth-appealing brand,” according to a press release from the agency.

Prior to receiving the FDA complaint, every retailer was warned of the consequences that would take place if they did not stop selling the illegal e-cigarette products, according to the release.

The release notes that this is the first time the FDA is asking for the maximum amount of $19,192 linked to the civil money penalty complaint (CMP) for a single violation from each retailer.

Eight of the fined retailers are in Florida, according to the FDA’s list.

The agency orders the fined retailers to perform one of four actions: “pay the penalty, enter into a settlement agreement, request an extension of time to file an answer to the complaint or file an answer and request a hearing.” Retailers will have to pay the full penalty amount if they fail to act within 30 days following receipt of the complaint.

As of Sept. 28, the FDA has sent 168 more warning letters to retailers selling Elf Bar/EB Design products, bringing the total number of warning letters sent to retailers for selling unauthorized tobacco products to more than 400.

“We continue to monitor closely all those in the supply chain, including retailers, for compliance with federal law,” Ann Simoneau, JD, MBA, director of the Office of Compliance and Enforcement in the FDA’s Center for Tobacco Products, said in the release. “This includes follow-up inspections and surveillance of those who have received a warning letter, and taking additional action, as appropriate, to enforce the law.”

The FDA also recently filed CMPs against four e-cigarette manufacturers for producing and selling products without market authorization. As of Sept. 19, 2023, 31 manufacturers have been fined by the FDA and more than 600 firms have been warned to stop manufacturing and distributing illegal tobacco products.

Reference:

• Elf Bar/EB Design civil money penalty complaints - September 28, 2023 announcement. https://www.fda.gov/media/172548/download?attachment. Published Sept. 28, 2023. Accessed Sept. 28, 2023.