FDA WARNING_LETTER - Flavor Vapors, LLC/Mob Liquid Labs - February 14, 2023

On February 3, 2023, the FDA's Center for Tobacco Products issued a Warning Letter to Brandi Mazzola regarding e-liquid products sold on mobliquid.com. The FDA determined these products are "tobacco products" under section 201(rr) of the FD&C Act, as amended on March 15, 2022, to include nicotine from any source.

The inspection revealed the firm manufactures and sells "new tobacco products" without required premarket authorization, specifically "FF-BB 'Friggin Fruits Blueberry Blast-TFN'" and "DEZ-CC 'Dezzertz Caramel Cheesecake-TFN'". These products are considered "new" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization or exemption.

Consequently, these products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required premarket authorization and failure to provide necessary information under section 905(j).

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