July 27, 2023
On July 27, 2023, 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 warning letters include the popular and youth-appealing e-cigarette products Elf Bar/EB Design, Esco Bars, and Puff Max.
“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, Ph.D., M.P.H., Director of FDA’s Center for Tobacco Products. “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 receiving warning letters today 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 brands cited in these warning letters have been identified as being among the most popular e-cigarettes among U.S. youth. Today’s warning letters are the latest in a series of FDA’s efforts across the supply chain to address these youth appealing brands. Other recent actions include:
- Warning letter issued to a firm responsible for Esco Bars
- Warning letters issued to retailers and a distributor for selling/distributing Puff
- Warning letters issued to retailers for selling Elf Bar/EB Design and Esco Bars
- An import alert for all Elf Bar/EB Design and Esco Bars
“Warning letters are generally the first step once an inspection reveals a violation of the law,” said Ann Simoneau, J.D., M.B.A, director of the Office of Compliance and Enforcement within FDA’s Center for Tobacco Products. “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.”
In an attempt to achieve voluntary compliance, 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. A majority of warning letter recipients voluntarily take 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 civil money penalties against e-cigarette manufacturers. It is the agency’s intent to make these actions a routine component of its enforcement portfolio moving forward; for example, since January 2023, the agency has issued 15 civil money penalties against manufacturers for the illegal sale of e-cigarettes.
In addition to taking action against illegal products across the supply chain, FDA will continue to assess and enhance its surveillance capabilities to best monitor the rapidly evolving tobacco product landscape. For example, the FDA and the National Institutes of Health announced last month that funding was awarded for a new Center for Rapid Surveillance of Tobacco (CRST). This specialized center will complement CTP’s internal surveillance efforts by providing additional rapid information about changes in the tobacco product marketplace and tobacco use patterns.