WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) issued warning letters to 15 online retailers and three manufacturers for selling or distributing unauthorized electronic cigarette products. This included at least one retailer which 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. According to the agency, the products of focus were identified through rapid surveillance and a data-driven approach to investigations, which used, among other things, retail sales data and emerging internal survey data to identify products with rising popularity among youth users and which should subsequently be prioritized for investigation.
"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, director of the 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 which received 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. Recipients of warning letters were given 15 working days to respond with the steps they'll take to correct the violation and to prevent future violations.
The letters served as the latest FDA effort to address the issue of youth access to tobacco products across the supply chain.
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 to a distributor for the distribution of illegal e-cigarettes.