FDA Warns 14 Online Retailers for Selling Illegal Flavored Vapes

FDA warning letters unauthorized e-cigarettes

In a recent development, the U.S. Food and Drug Administration (FDA) has issued warning letters to 14 online retailers for selling unauthorized vape products that have gained significant popularity among youth. The warning letters, announced on May 1, specifically target disposable e-cigarette products marketed under well-known brand names such as Elf Bar/EB Design, Esco Bars, Funky Republic, Hyde, Kang, Cali Bars, and Lost Mary.

Youth Vape Use Linked to Unauthorized Products

The FDA’s action comes in response to the alarming findings of the 2023 National Youth Tobacco Survey, which revealed that among the more than 2.1 million youth who reported current use of e-cigarettes, over 50 percent used Elf Bar products, and more than 20 percent used Esco Bar products. The FDA also identified additional brands included in the warning letters as popular or appealing to youth based on retail sales data and emerging internal survey data.

Retailers Violate Federal Law by Selling Unauthorized Products

The online retailers receiving the warning letters have been found to be selling or distributing vape products in the United States without the required authorization from the FDA, which is a violation of the Federal Food, Drug, and Cosmetic Act. The recipients of the warning letters have been given 15 working days to respond with the steps they will take to address the cited violations and prevent future occurrences. Failure to promptly address these violations can result in further FDA actions, including injunctions, seizures, and/or civil money penalties.

Download the Warn Letters and List

FDA’s Ongoing Efforts to Combat Unauthorized Tobacco Products

The issuance of these warning letters is part of the FDA’s ongoing efforts to address unauthorized tobacco products throughout the supply chain. To date, the FDA has:

  • Issued more than 670 warning letters to manufacturers, importers, and distributors for illegally selling and/or distributing unauthorized new tobacco products, including e-cigarettes.
  • Issued more than 550 warning letters to retailers for the sale of unauthorized tobacco products.
  • Filed civil money penalty complaints against more than 55 manufacturers and more than 100 retailers for the manufacture and/or sale of unauthorized tobacco products.
  • Sought injunctions against seven manufacturers of unauthorized e-cigarette products in coordination with the U.S. Department of Justice (DOJ).
  • Seized unauthorized e-cigarette products valued at more than $700,000 in coordination with DOJ.

Authorized Vape Products in the United States

As of now, the FDA has authorized only 23 tobacco-flavored vape products and devices. These are the only vape products that can be legally marketed and sold in the United States. The FDA maintains a Searchable Tobacco Products Database that provides further information on tobacco products that may be legally marketed in the country.

The FDA’s recent warning letters serve as a reminder of the agency’s commitment to protecting public health, particularly that of youth, by cracking down on the sale of unauthorized e-cigarette products. As the e-cigarette market continues to evolve, the FDA remains vigilant in its efforts to ensure that only authorized products are sold and distributed in the United States.

Matthew Ma