FDA WARNING_LETTER - Gentleman’s Draw LLC - August 02, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Jonathan Risteen for manufacturing and selling e-liquid products via gentlemansdraw.com without required marketing authorization. The FDA reviewed the website and determined that products like Banana Pudding, Crumb Cake, and Fruit Cereal e-liquids are "new tobacco products" under section 201(rr) of the FD&C Act, as they contain nicotine and were not commercially marketed in the U.S. before February 15, 2007.

These products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because they lack an FDA marketing authorization order and no notice or information was provided as required by section 905(j). The letter emphasizes that the definition of "tobacco product" expanded on March 15, 2022, to include products with nicotine from any source.

The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The letter also notes that imported products appearing adulterated or misbranded may be detained.