FDA WARNING_LETTER - The Vapor Emporium, LLC - February 26, 2021
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The FDA Center for Tobacco Products issued a Warning Letter to Elmer P. Bailey, III, regarding e-liquid products sold on thevaporemporium.com. The FDA determined that e-liquid products, including TVE Bubblegum, TVE Blueberry Glazed, and TVE Banana Cream, are tobacco products under the FD&C Act and are subject to FDA jurisdiction.
The primary violation is the marketing of "new tobacco products" without the required premarket authorization order. These e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.
The firm, a registered manufacturer with over 3,600 products listed with FDA, is responsible for ensuring compliance across all sales and advertising platforms. Failure to address these violations may result in civil money penalties, seizure, and/or injunction. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for future compliance.
ID · 247b5e29-ecb5-4da7-96c6-6a0494863c67
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