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FDA Seeks Penalties From 22 Retailers Over Sales of Unauthorized E-Cigarettes

The agency has issued more than 550  warning letters to retailers for selling unauthorized tobacco products as of April.
Woman smoking an e-cigarette

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has upped the ante against certain retailers by issuing complaints for civil money penalties (CMPs) to stores that have continued to sell unauthorized e-cigarettes, including Elf Bar. 

The FDA previously issued warning letters to the 20 brick-and-mortar retailers and two online retailers for their sale of unauthorized tobacco products. However, follow-up inspections revealed the retailers failed to correct the violations. Accordingly, the agency is now seeking a CMP of approximately $20,000 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 reporting it as their "usual" brand. 

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The approximately $20,000 CMP sought in the current circumstance is consistent with similar CMPs sought against retailers for the sale of unauthorized Elf Bar products over the last few months. 

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.  

As of April 2024, the FDA has issued more than 550 warning letters and 108 CMPs to retailers for selling unauthorized tobacco products. In addition to actions involving retailers, the agency has issued more than 670 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 55 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.  

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 United States. 

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

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