FDA Warns Online Retailers to Stop Selling Illegal E-Cigarettes Popular Among Youth
December 13, 2023
On Dec. 13, CTP issued warning letters to 11 online retailers selling unauthorized e-cigarette products marketed under the brand names Lost Mary, Funky Republic/Funky Lands, Elf Bar/EB Design, Kangvape, Cali, and Breeze. Warning letter recipients are given 15 working days to respond with the steps they’ll take to correct the violations discussed in the warning letter and to prevent future violations. Failure to promptly correct the violations can result in FDA enforcement actions such as an injunction, seizure, and/or civil money penalties.
The warning letters were informed by FDA’s ongoing monitoring of multiple surveillance systems to identify products that are popular among youth or have youth appeal. Findings from the 2023 National Youth Tobacco Survey found that Elf Bar was the most commonly used e-cigarette brand among youth. Following a trademark infringement lawsuit earlier this year, the manufacturer of Elf Bar began marketing the product as “EB Design” in the United States; the same company also markets the e-cigarette brand Lost Mary. In addition to these brands, Funky Republic/Funky Lands, Kangvape, Cali, and Breeze 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.
Selling or distributing e-cigarette products in the United States that lack authorization from the FDA is a violation of the Federal Food, Drug, and Cosmetic Act. For a new tobacco product to be legally marketed in the United States, it must receive a written order from FDA authorizing the marketing of the product. A new tobacco product may receive marketing authorization through one of three pathways.
“It is illegal to sell, import, distribute, or offer for sale or distribution to U.S. consumers any e-cigarette that has not been authorized by FDA” said Brian King, Ph.D., M.P.H., Director of FDA’s Center for Tobacco Products. “The products identified in these warning letters are being marketed without the required authorization. We can issue, and have issued, warning letters for products for which an application has been submitted and is pending review. For unauthorized tobacco products, the pendency of an application does not create any sort of a safe harbor to sell that product.”
These warning letters are the latest in a series of FDA’s efforts among retailers to address the marketing and sale of unauthorized e-cigarettes that appeal to youth. As of December 2023, FDA has issued more than 400 warning letters to retailers for the sale of unauthorized e-cigarettes, and filed civil money penalty complaints against more than 65 retailers and manufacturers for the manufacture or sale of unauthorized products.
To date, FDA has authorized 23 e-cigarette devices and tobacco-flavored e-cigarette products. The distribution or sale of unlawfully marketed products is subject to compliance and enforcement action. For retailers looking for information on the e-cigarette products and devices that are legal to sell, FDA created a printable, one-page flyer of these authorized products. This information is also available on FDA’s website.