American Legends E-Liquid, LLLP – FDA Warning Letter, Jan 29, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Connie Hawley and Chuck W. Hawley of American Legends E-Liquid on January 29, 2021. The letter states that a review of their website, https://american-legends-e-liquid.myshopify.com, revealed the manufacture and sale of e-liquid products, specifically "Avalon" and "Bazoo," which are considered tobacco products under the FD&C Act.

The core violation is that these e-liquid products are "new tobacco products" that were not commercially marketed in the U.S. as of February 15, 2007, and lack the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because the necessary premarket notification or information was not provided.

The FDA emphasizes that the firm, a registered manufacturer with over 600 listed products, is responsible for ensuring compliance across all advertising and sales platforms. Failure to address these violations may result in regulatory actions including civil money penalties, seizure, and/or injunction. The company is required to submit a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a