BC VAPIN’APE – FDA Warning Letter, Jan 11, 2024

On January 11, 2024, the FDA issued a Warning Letter to BC VAPIN’APE, identifying that the company manufactures and distributes e-liquid products, including "Pink Dragon," which are considered tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA determined these products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization.

Specifically, the e-liquid products are deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) because the required notice or information under section 905(j) was not provided. The failure to provide such reports and the marketing of these products without authorization constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

BC VAPIN’APE is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the non-compliant products and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.