Top Shelf Vaping LLC – FDA Warning Letter, Sep 21, 2023

On September 21, 2023, the FDA issued a Warning Letter to Top Shelf Vaping LLC, following a review of inspection records. The FDA determined that Top Shelf Vaping LLC manufactures and distributes e-liquid products, specifically citing "Top Shelf Vaping Cranberry Menthol 4mg," which are considered tobacco products under section 201(rr) of the FD&C Act due to containing nicotine.

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization. The FDA states that "Top Shelf Vaping Cranberry Menthol 4mg" was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information was not provided.

The letter emphasizes that marketing such products without authorization is unlawful and a prohibited act under sections 301(k) and 301(p) of the FD&C Act. Top Shelf Vaping LLC is required to submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and distribution of non-compliant products, and a plan for maintaining compliance. Failure to comply may result in regulatory actions