Failure to correct violations puts retailers at risk of further action, including civil money penalties.

March 28, 2024

The U.S. Food and Drug Administration (FDA) has issued warning letters to 61 brick-and-mortar retailers for selling unauthorized e-cigarette products. These warning letters cite the sale of disposable e-cigarette products marketed under the brand names Elf Bar, EB Design and Lava.

The FDA stated that the retailers receiving these warning letters sold or distributed e-cigarette products in the United States that lack authorization from FDA, in violation of the Federal Food, Drug, and Cosmetic Act. The warning letter recipients are given 15 working days to respond with the steps they will take to correct the violation and to prevent future violations. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure and/or civil money penalties.

According to the agency, these warning letters were a result of the FDA’s ongoing monitoring of multiple surveillance systems to identify products that are popular among youth or have youth appeal. According to the findings from the 2023 National Youth Tobacco Survey, more than 50% of youth who use e-cigarettes reported using the brand Elf Bar.

These warning letters are the latest in FDA’s ongoing efforts to address the marketing and sale of unauthorized e-cigarettes that appeal to youth, including previous warning letters to online retailers selling similar unauthorized e-cigarettes. To date, FDA has issued more than 550 warning letters and more than 100 civil money penalty actions to retailers for the sale of unauthorized e-cigarettes.

Earlier this month, a group of senators petitioned chief executives from top convenience retailers earlier this week to end the sale of illegal flavored vapes, reported the New York Times.

“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.”