FDA issues 14 warning letters for the sale of unauthorized e-cigarettes

On By Vaseline

The agency’s efforts focused on online retailers selling Elf Bar and Esco Bar products.

By means of Kevin McIntyre |

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The Food and Drug Administration (FDA) has sent warning letters to 14 online retailers for selling unauthorized e-cigarette products.

The warning letters mention the sale of products under brand names, including Elf Bar, Esco Bars, Funky Republic, Hyde, Kang, Cali Bars and Lost Mary.

The FDA cited the 2023 National Youth Tobacco Survey, which reported that Elf Bar and Esco Bar are brands popular among young people.

“The retailers who received these warning letters sold or distributed e-cigarette products in the U.S. without FDA authorization, in violation of the Federal Food, Drug, and Cosmetic Act,” the FDA noted in a statement. “Recipients of the warning letter will have 15 business days to respond with the steps they will take to address the violations identified in the warning letter and to prevent future violations.”

Retailers that do not address the violations could face additional action from the FDA, such as an injunction or civil penalties.

These warning letters are the latest in the FDA’s ongoing efforts to crack down on unauthorized tobacco products throughout the supply chain. The agency has:

  • Has issued more than 670 warning letters to manufacturers, importers and distributors
  • Issued more than 550 warning letters to retailers for selling unauthorized tobacco products
  • Filed civil complaints against more than 55 manufacturers and more than 100 retailers
  • In collaboration with the U.S. Department of Justice (DOJ), sought injunctions against seven manufacturers of unauthorized e-cigarette products
  • In collaboration with DOJ, unauthorized e-cigarette products worth more than $700,000 have been seized

To date, the FDA has approved 23 tobacco-flavored e-cigarette products and devices. These are the only e-cigarette products that can currently be legally marketed and sold in the US; further information on tobacco products legally marketable in the US is available in the FDA’s new Searchable Tobacco Products Database.