FDA WARNING_LETTER - Five Pawns, LLC - August 02, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Five Pawns regarding e-liquid products sold on fivepawns.com. The FDA determined these e-liquid products are "tobacco products" under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, because they contain nicotine from any source and are intended for human consumption.

The primary violation is the marketing of "new tobacco products" without required premarket authorization. Specifically, Five Pawns - Queenside, Five Pawns - Gambit, and Five Pawns - Grandmaster e-liquid products are considered new tobacco products because they were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order or exemption. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter requires a written response within 15 working days detailing actions taken to address violations, including discontinuing sale/distribution of non-compliant products and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.