FDA WARNING_LETTER - Stuff N Puffs 101, LLC d/b/a Stuff-N-Puffs - March 23, 2023

The FDA issued a Warning Letter to Stuff N Puffs 101, LLC d/b/a Stuff-N-Puffs on March 23, 2023, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, specifically "Green Apple e-liquid products," which are classified as tobacco products under the FD&C Act, including those containing nicotine from any source as per the Consolidated Appropriations Act, 2022.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. The Green Apple e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions. This renders the products adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notices under section 905(j).

These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and distribution, and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.