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FDA Levels Penalties Against Retailers for Elf Bar Sales

Operators who sold unauthorized tobacco products may be liable for more than $20,000 each.
A magnifying glass over the letters FDA

WASHINGTON, D.C. — This week, the U.S. Food and Drug Administration (FDA) filed civil money penalties (CMPs) against nine brick and mortar retailers and one online retailer for the sale of Elf Bars, a popular youth-appealing e-cigarette brand. 

The FDA previously issued warning letters to these retailers for their sale of unauthorized tobacco products. However, follow-up inspections revealed that the retailers had failed to correct the violations. Accordingly, the agency is now seeking penalties of $20,678 from each seller.

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 approximately one-third reporting it was their "usual" brand.

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The $20,678 CMP sought from each retailer is consistent with similar CMPs sought against other retailers over the last few months, including February and April of this year. 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.

The illegal sale and marketing of Elf Bar and similar youth-appealing vapor products have been an ongoing source of consternation for the agency. Earlier in the month, a joint operation between the FDA and U.S. Department of Justice seized unauthorized e-cigarette products valued at more than $700,000 from a warehouse believed to be owned by several California-based distributors.

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 U.S. Further information on legal tobacco products, including vapes and e-cigarettes, is available in the FDA's new Searchable Tobacco Products Database.

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