FDA Issues Warnings to Distributors for Selling Illegal Disposable Vapor Products
The federal agency widens the scope of its crackdown on tobacco products known for youth appeal.
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) issued warning letters to three distributors — ABS Distribution Inc., EC Supply Inc. and Easy Wholesale LLC — for selling and/or distributing multiple unauthorized e-cigarette products.
The illegal products listed in the letters included e-cigarette products Elf Bar/EB Design, Esco Bars and Puff Max, the former two of which have been the focus of earlier FDA actions on retailers, aimed at cutting down on illegal sales of youth-appealing tobacco products.
"FDA is committed to keeping a finger on the pulse of the rapidly evolving e-cigarette landscape, including through a variety of scientific assets equipped to quickly identify products with high youth appeal," said Brian King, director of the FDA's Center for Tobacco Products (CTP). "We will continue to use this data-driven approach to inform actions across the entire supply chain, including against those who distribute illegal products between manufacturers and the point of sale."
The distributors who received warning letters sell and/or distribute e-cigarettes in the United States that lack authorization from FDA, which is a prohibited act under the Federal Food, Drug, and Cosmetic Act. All of the cited brands have been identified as being among the most popular e-cigarettes among U.S. youth, with numerousstudies highlighting their rising use and potential dangers for young people.
"Warning letters are generally the first step once an inspection reveals a violation of the law," said Ann Simoneau, director of the office of compliance and enforcement within the CTP. "We will monitor to ensure these violations are corrected, and if they are not, the recipient is at risk of further actions such as civil money penalties, seizures and injunctions."
Recipients of warning letters are given 15 working days to voluntarily respond with the steps they'll take to correct the violation and to prevent future violations, with the majority of recipients usually taking corrective action. However, failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure and/or civil money penalties. Within the past year, FDA issued its first injunctions and monetary penalties against e-cigarette manufacturers.