FDA WARNING_LETTER - Velvet Vapor - November 02, 2023

On November 2, 2023, the FDA issued a Warning Letter to The Velvet Vapor, owned by Chang Yi and Rhonda Yi, for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that The Velvet Vapor's e-liquid products, specifically "Blackberry Champagne," are "new tobacco products" under section 201(rr) of the FD&C Act because they contain nicotine and were not commercially marketed in the U.S. as of February 15, 2007.

The products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of FDA marketing authorization orders or exemption. The introduction or delivery of adulterated or misbranded tobacco products into interstate commerce is a prohibited act under sections 301(a) and 301(k) of the FD&C Act. Failure to provide required reports under section 905(j) is also a prohibited act under section 301(p).

The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuation of violative sales and distribution, and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.