FDA Levels Penalties Against Retailers Over Elf Bar Sales

The brick-and-mortar operators had previously been issued warning letters.
Melissa Kress
A gavel on top of money

SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) is once again taking action against tobacco retailers for selling Elf Bar vapor products.

On Feb. 26, the agency filed civil money penalty (CMP) complaints against 20 brick-and-mortar retailers over sales of Elf Bar products. The FDA has not granted the products market authorization. 

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The FDA previously issued each retailer a warning letter relating to their sale of unauthorized electronic cigarettes. However, follow-up inspections revealed that the retailers had failed to correct the violations, and the agency is now seeking the maximum penalty amount of $20,678 for a single violation from each retailer, according to a release from the FDA.  

[Read more: FDA Fines More Retailers Over Illegal Youth-Appealing E-Cigarette Sales]

Including these complaints, the FDA has filed more than 100 CMP complaints against retailers for the illegal sale of Elf Bar e-cigarettes. According to the "2023 National Youth Tobacco Survey," Elf Bar was the most commonly used brand among U.S. youth e-cigarette user. Among middle and high school students who reported using e-cigarettes in the past 30 days, more than half said they used Elf Bar products during that period. 

"These retailers have not adequately addressed the violations noted in previous warnings from FDA regarding the sale of unauthorized e-cigarettes," said Brian King, director of the FDA's Center for Tobacco Products. "Their continued failure to comply with the law is inexcusable, and as is evidenced by today's actions, we're committed to holding them accountable for it."

Currently, $20,678 is the maximum civil money penalty amount the agency 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 last year. 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 who do not take action within 30 days after receiving a complaint risk a default order imposing the full penalty amount, the agency added. 

"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." 

The actions on Feb. 26 are the latest in the FDA's continued push to remove unauthorized e-cigarettes, particularly those that are popular among youth, from the marketplace. As of Feb. 15, the agency 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. 

The FDA has also issued more than 660 warning letters to manufacturers, importers and distributors for illegally selling and/or distributing unauthorized new tobacco products, including e-cigarettes. Additionally, the agency has filed CMP complaints against 50 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. 

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