AAA Strate Vape – FDA Warning Letter, Sep 7, 2023

The FDA issued a Warning Letter to AAA Strate Vape on September 7, 2023, following a review of inspection records. The letter states that AAA Strate Vape manufactures and distributes e-liquid products, which are considered tobacco products under section 201(rr) of the FD&C Act due to containing nicotine from any source and being intended for human consumption.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the 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, as required notices or information were not provided.

The FDA considers the sale and distribution of these unauthorized products a prohibited act under sections 301(k) and 301(p) of the FD&C Act. The letter mandates that AAA Strate Vape submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing sales/distribution and outlining a plan for future compliance. Failure to comply could result in regulatory actions such as civil money penalties, seizure, and/or injunction.