September 14, 2023
On Sept. 14, 2023, FDA issued warning letters to 15 online retailers and 3 manufacturers and/or distributors for selling or distributing unauthorized e-cigarette products. Additionally, in one case, the retailer illegally sold a product to an underage purchaser. The warning letters cite a range of popular and youth-appealing e-cigarette products, including disposable products, marketed under the brand names Elf Bar, EB Design, Lava, Cali, Bang, and Kangertech.
The youth-appealing e-cigarette products of focus were identified through rapid surveillance and a data-driven approach to investigations. Retail sales data, emerging internal data from surveys of youth, as well as other data sources helped FDA to identify the rising popularity of these youth-appealing products, which were subsequently prioritized for investigation across the supply chain, from manufacturers to distributors to retailers.
“Given the rapidly evolving nature of the e-cigarette landscape, it’s essential that we have nimble surveillance tools that can best keep pace to protect public health,” said Brian King, Ph.D., M.P.H., Director of FDA’s Center for Tobacco Products. “They’re a critical component of our comprehensive surveillance toolbox, so that we can proactively identify and swiftly stave off emerging threats, particularly those affecting our nation’s youth.”
The companies receiving warning letters today 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. Recipients of warning letters are given 15 working days to respond with the steps they’ll take to correct the violation and to prevent future violations.
Today’s warning letters are the latest in a series of FDA’s efforts across the supply chain to address tobacco products that appeal to youth. A majority of warning letter recipients take corrective action. Failure to promptly correct the violations can result in additional FDA actions such as injunctions, seizures, or civil money penalties. Within the past year, FDA issued its first injunctions and civil money penalties against e-cigarette manufacturers, as well as its first warning letter for a distributor for distribution of illegal e-cigarettes. Since January 2023, the agency has issued civil money penalties against 29 manufacturers for the illegal sale of e-cigarettes.
To help inform these compliance and enforcement efforts, the agency continues to expand its surveillance capabilities to rapidly identify and act on emerging products to protect public health. In June, FDA and the National Institutes of Health (NIH) awarded funding for a new Center for Rapid Surveillance of Tobacco (CRST). Through rapid surveillance and reporting of information, CRST will augment FDA’s and the research community’s ability to understand, document, and quantify rapid changes in the tobacco product marketplace and tobacco use patterns. CRST will add to FDA’s armament of time-sensitive data sources that provide potentially actionable information more swiftly than traditional data collection methods.