February 28, 2024

On Feb. 28, FDA announced the issuance of warning letters to five online retailers for selling unauthorized e-cigarette products. These warning letters cite the sale of disposable e-cigarette products marketed under popular brand names such as Elf Bar/EB Design/EB Create, Funky Republic, Lost Mary, Hyde, Breeze, and Cali Bars.

FDA continues to issue warning letters informed by the agency's ongoing monitoring of multiple surveillance systems to identify products that data indicate are popular among youth or have youth appeal. Findings from the 2023 National Youth Tobacco Survey found that e-cigarettes remained the most commonly used tobacco product among both high school and middle school students for the 10th year in a row. Among the more than 2.1 million youth who reported current use of e-cigarettes, more than half reported using Elf Bar products. In addition, the other brands 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.

"Protecting our nation's youth from the harms of tobacco products is crucial to our center’s public health mission,” said Brian King, Ph.D., M.P.H., director of FDA’s Center for Tobacco Products. “We’re committed to continuing to use a data-driven approach to identify and prevent the sale of unauthorized tobacco products, and to take compliance and enforcement action, when appropriate."

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 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 (CMPs).

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, and build upon 14 warning letters issued earlier this month to online retailers for selling similar unauthorized e-cigarettes. As of Feb. 26, FDA has issued more than 440 warning letters to and filed 100 CMP actions against retailers for the sale of unauthorized e-cigarettes.