FDA WARNING_LETTER - Dot Com Vapor - August 03, 2023

On August 3, 2023, the FDA issued a Warning Letter to Dot Com Vapor, identifying violations related to the manufacturing and distribution of e-liquid products. The FDA determined that Dot Com Vapor's e-liquid products, specifically "Malibu’s Most Wanted," 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 primary violation is that these products are being marketed without the required premarket authorization from the FDA, as mandated by section 910(a) 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, due to the lack of required notice or information under section 905(j). The failure to provide such reports is a prohibited act under section 301(p).

The FDA requires Dot Com Vapor to submit a written response within 15 working days, detailing actions taken to address these 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.