Craving Vapor Industries, LLC – FDA Warning Letter, Mar 15, 2022

The FDA issued a Warning Letter to Craving Vapor Industries, LLC, for manufacturing and distributing e-liquid products without required premarket authorization. The FDA determined that products like Axiom Creamy RY4 3mg 60ml, Axiom Stuffberry 18mg 60ml, and Axiom Strawberry Cloud Rat 3mg 60ml are "new tobacco products" as they were not commercially marketed before February 15, 2007, and lack FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act.

These products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required premarket authorization or substantial equivalence reports. The company's Premarket Tobacco Product Application (PMTA), STN PM0002095, covering 2102 products, received a Refuse To Accept determination on July 6, 2021.

The FDA considers all new tobacco products on the market without statutory premarket authorization to be unlawfully marketed and subject to enforcement actions, including civil money penalties, seizure, and injunction. Craving Vapor Industries must 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