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In July the U.S. Food and Drug Administration (FDA) took action against the distribution and sale of certain unauthorized e-cigarette products that have gained popularity among youth. FDA issued warning letters to three distributors, ABS Distribution Inc., EC Supply, Inc., and Easy Wholesale, LLC, for their involvement in selling and distributing the prohibited e-cigarette brands Elf Bar, also known as EB Design, and Esco Bars, among others.
FDA had previously issued warning letters to other firms and retailers involved in the distribution of these products. Additionally, an import alert was issued for all Elf Bar/EB Design and Esco Bars.
The distributors who received warning letters in July were found to be selling or distributing e-cigarettes in the U.S. without proper authorization, a violation of the Federal Food, Drug, and Cosmetic (FD&C) Act. These brands and their products have been identified as some of the most popular choices among American youth.
The warning letters mark the first step in addressing violations. Recipients have been given 15 working days to respond with a corrective action plan to rectify the violations and prevent future occurrences. While most recipients voluntarily comply, failure to do so can lead to further FDA actions, such as civil money penalties, seizures, and injunctions.
FDA has stated that the agency will continue to closely monitor the e-cigarette market, especially products with high youth appeal. According to Brian King, Director of FDA's Center for Tobacco Products (CTP), the agency employs various scientific tools to identify such products and take appropriate actions across the supply chain.
Do you sell any of the products mentioned? Have you received a warning letter? Are you concerned about the threat of one? Have other compliance issues? We are determined to help you. Our firm can assist businesses in navigating FDA regulations and help ensure compliance with the law. Give our office a call today at (917) 546-6997 and we would be happy to speak with you.
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