FDA Seeks $20,000 From 22 Retailers for Selling Unauthorized E-Cigs

The 20 brick-and-mortar retailers and two online retailers received civil money penalties.

April 24, 2024

The U.S. Food and Drug Administration announced the issuance of complaints for civil money penalties (CMPs) against 20 brick-and-mortar retailers and two online retailers for the sale of unauthorized e-cigarettes, including Elf Bar.

FDA previously issued warning letters to these retailers for their sale of unauthorized tobacco products, however, the agency stated that follow-up inspections revealed that the retailers had failed to correct the violations.

The agency is now seeking a CMP of approximately $20,000 from each retailer.

According to the FDA, the CMP fee sought from each retailer is consistent with similar CMPs sought against retailers for the sale of unauthorized Elf Bar products over the last few months (including September, November and December of 2023 and earlier this year).

Fined 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, the agency said.

As of April 2024, FDA has issued more than 550 warning letters and 108 CMPs to retailers, including brick-and-mortar and online retailers, for selling unauthorized tobacco products. In addition to actions involving retailers, FDA 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. Last month, the FDA released its Searchable Database for Tobacco Products.

However, the database is an incomplete picture of what can be marketed. FDA has only approved less than two dozen e-cigarette products and that is reflected in the database. The database fails to include all categories of products that can be on the market, like products that are subject to administrative stays and review.

“We have asked FDA numerous times for complete information about what can—and cannot—be sold in stores and they have declined to provide it,” Jeff Lenard, NACS vice president of strategic initiatives, told the New York Times. “It is long past time for FDA to provide that clarity and aggressively enforce the law.”