FDA WARNING_LETTER - Stuff-N-Puffs 102, LLC d/b/a Stuff-N-Puffs - June 01, 2023

On June 1, 2023, the FDA issued a Warning Letter to Stuff-N-Puffs 102, LLC d/b/a Stuff-N-Puffs for manufacturing and distributing e-liquid products, specifically "Green Apple," without required marketing authorization. The FDA determined these e-liquid products are "new tobacco products" under section 201(rr) of the FD&C Act, as they were not commercially marketed in the U.S. as of February 15, 2007, and contain nicotine from any source.

The company's e-liquid products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because they lack FDA marketing authorization and no notice or information was provided as required by section 905(j). The failure to provide such reports and the sale of adulterated/misbranded products are prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

Stuff-N-Puffs must submit 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, and/or injunction.