FDA WARNING_LETTER - Craving Vapor Industries, LLC - February 23, 2022

On February 23, 2022, the FDA issued a Warning Letter to Craving Vapor Industries, LLC, for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that e-liquid products are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The violations include marketing "new tobacco products" without premarket authorization, specifically Axiom Creamy RY4 3mg 60ml, Axiom Stuffberry 18mg 60ml, and Axiom Strawberry Cloud Rat 3mg 60ml. These products are considered new because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

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.

Craving Vapor Industries, LLC must submit a written response within 15 working days detailing actions