FDA Issues Warning Letters to 14 Online Retailers for Selling Unauthorized E-Cigarettes
Brands Include Elf Bar and Esco Bars, the Two Most Commonly Used E-Cigarettes Among Youth
May 1, 2024
On May 1, FDA announced the issuance of warning letters to 14 online retailers for selling unauthorized e-cigarette products popular among youth. These warning letters cite the sale of disposable e-cigarette products marketed under popular brand names such as Elf Bar/EB Design, Esco Bars, Funky Republic, Hyde, Kang, Cali Bars, and Lost Mary.
According to the 2023 National Youth Tobacco Survey, among the more than 2.1 million youth who reported current use of e-cigarettes, more than 50 percent reported using Elf Bar products and more than 20 percent reported using Esco Bar products. Additional brands included in these warning letters were identified as popular or youth-appealing by the agency following review of retail sales data and emerging internal data from a survey among youth.
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. Warning letter recipients are given 15 working days to respond with the steps they will take to address the violation(s) cited in the warning letter and to prevent future violations. Failure to promptly address the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties.
These warning letters are the latest in FDA’s ongoing efforts to address unauthorized tobacco products throughout the supply chain. 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
To date, 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 United States; further information on tobacco products that may be legally marketed in the United States is available in FDA’s new Searchable Tobacco Products Database.