Mountain Vaporz LLC – FDA Warning Letter, Jul 20, 2023

On July 20, 2023, the FDA issued a Warning Letter to Mountain Vaporz, LLC, following a review of submissions and inspection records. The FDA determined that Mountain Vaporz manufactures and distributes e-liquid products, including "MVZ59," which are considered tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. A "new tobacco product" is defined as any tobacco product not commercially marketed in the U.S. as of February 15, 2007, or any modified product marketed after this date. Mountain Vaporz's e-liquid products, specifically MVZ59, were not commercially marketed by the February 15, 2007, predicate date and lack FDA marketing authorization orders or exemptions.

Consequently, 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 notice under section 905(j). The sale or distribution of adulterated or misbranded tobacco products is a prohibited act under section 301(k) and 301(p)