Meddle Vapes – FDA Warning Letter, Aug 17, 2022

On August 17, 2022, the FDA issued a Warning Letter to Meddle Vapes, identifying violations related to the manufacture and distribution of e-liquid products. The FDA determined that Meddle Vapes' e-liquid products are tobacco products subject to FDA jurisdiction under the FD&C Act.

During an inspection, the FDA observed two primary violations: 1. **Unregistered Establishment:** Meddle Vapes failed to register its manufacturing establishment at 8251 North Belt Line Road, Suite 150, Irving, TX 75063, as required by section 905(c) of the FD&C Act. This failure renders all tobacco products manufactured at this establishment misbranded under section 903(a)(6) and constitutes prohibited acts under sections 301(k) and 301(p). 2. **Unlisted Tobacco Products:** Meddle Vapes' tobacco products were not included in a list required by section 905(i) of the FD&C Act. This omission also results in the products being misbranded under section 903(a)(6) and constitutes prohibited acts under sections 301(k) and 301(p).

The FDA requires Meddle Vapes to take prompt action to address these violations and ensure compliance with the FD&C Act and relevant regulations (21 C.