The U.S. Food and Drug Administration has fined 22 retailers for the illegal sale of Elf Bar/EB Design e-cigarettes, a popular youth-appealing brand.
The FDA said it previously warned each retailer in the form of a warning letter to stop selling unauthorized tobacco products. During follow-up inspections, the FDA observed the retailers had not corrected the violations, which resulted in these civil money penalty actions.
The complaints seek the maximum civil money penalty of $19,192 for a single violation from each retailer. While the FDA has issued civil money penalty complaints to retailers for selling unauthorized tobacco products in the past, this is the first time the agency is seeking CMPs for the maximum amount against retailers for this type of violation. The retailers can 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. Those that do not take action within 30 days after receiving the complaint risk a default order imposing the full penalty amount.
The FDA issued additional 168 warning letters to retailers for illegally selling Elf Bar/EB Design products. FDA sent warning letters after conducting nationwide inspection in August.
“We continue to monitor closely all those in the supply chain, including retailers, for compliance with federal law,” said Ann Simoneau, J.D., M.B.A, 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 additional action, as appropriate, to enforce the law.”
The collective actions announced today mark yet another step in the agency’s continued efforts to remove illegal e-cigarettes from the market, particularly those that appeal to youth. As of Sept. 19, 2023, the FDA has issued more than 400 warning letters to retailers, including brick-and-mortar and online retailers, for selling unauthorized tobacco products. Additionally, the FDA has issued more than 600 warning letters to firms for manufacturing and/or distributing illegal tobacco products, including e-cigarettes, and filed civil money penalty complaints against 31 e-cigarette manufacturers.
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