FDA WARNING_LETTER - Wyoming Vapor Company - November 10, 2021

On November 10, 2021, the FDA issued a Warning Letter to Wyoming Vapor Company for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that products like "WYOMING VAPOR CO Fireball 3mg 10ml," "Wyoming Vapor Company Panama 3mg," and "Wyoming Vapor Company Watermelon 3mg" are "new tobacco products" as they were not commercially marketed before February 15, 2007.

These products are deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) because they lack FDA marketing authorization orders and no required notice was provided under section 905(j). The company's Premarket Tobacco Product Application (PMTA) STN PM0003458, covering 1,398 products, received a Marketing Denial Order on September 3, 2021.

The FDA considers new tobacco products on the market without premarket authorization to be unlawfully marketed and subject to enforcement. The company 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 outlining a plan for future compliance. Failure to comply may result in civil money penalties, seizure, and/or injunction.