The U.S. Food and Drug Administration (FDA) has issued warning letters to three distributors of e-cigarettes that the FDA claims are popular with youth — ABS Distribution, EC Supply and Easy Wholesale — for selling or distributing unauthorized e-cigarette products.
The illegal products listed in the warning letters include the popular 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, 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 sell and/or distribute e-cigarettes in the U.S. 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 by the FDA as being among the most popular e-cigarettes among U.S. youth. The warning letters are the latest in a series of FDA’s efforts across the supply chain to address the youth vaping problem.
“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 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.
In addition to taking action against illegal products across the supply chain, the FDA has noted that it will continue to assess and enhance its surveillance capabilities to best monitor the rapidly evolving tobacco product landscape.
