FDA WARNING_LETTER - Desert Vapors II Inc d/b/a Desert Vapors - August 02, 2022

The FDA issued a Warning Letter to Desert Vapors II Inc d/b/a Desert Vapors for manufacturing and distributing e-liquid products, specifically "Custard 0.3% TFN Nicotine 60ML e-liquid product," without required marketing authorization. The FDA determined these e-liquid products are "tobacco products" under the FD&C Act, including those containing nicotine from any source, and are subject to FDA jurisdiction.

The "Custard 0.3% TFN Nicotine 60ML e-liquid product" is considered a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information was not provided.

The FDA has not received a marketing authorization application for this product. The letter states that any new tobacco product on the market without premarket authorization is subject to enforcement actions, including civil money penalties, seizure, and/or injunction. Desert Vapors must submit a written response within 15 working days detailing actions taken to address violations, including discontinuation of sales/distribution and a plan for compliance.