FDA Fines 10 More Retailers for E-Cigarette Sales

The agency filed CMPs for the unauthorized sale of Elf Bar e-cigarette products.

June 03, 2024

The U.S. Food and Drug Administration (FDA) announced that it is seeking civil money penalties (CMPs) from 10 retailers (nine brick-and-mortar and one online) for the sale of Elf Bar. The agency stated it previously issued warning letters to these retailers, and follow-up inspections showed that the violation for the sale of unauthorized tobacco products was not corrected.

The CMP 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. The FDA stated that 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 of receiving a complaint risk a default order imposing the full penalty amount.

To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. Earlier this year, 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.”

In May, the FDA coordinated with the U.S. Department of Justice and announced that the U.S. Marshals Service seized unauthorized e-cigarette products valued at more than $700,000.

According to the FDA, the e-cigarettes were located in a warehouse in Alhambra, California, and are believed to be owned by several California-based distributors. The seized products were mostly flavored, disposable e-cigarette products, including brands such as Puff Bar/Puff, Elf Bar/EB Design, Esco Bar, Kuz, Smok and Pixi.