Mountain Oak Vapors LLC – FDA Warning Letter, Dec 7, 2023

On December 7, 2023, the FDA issued a Warning Letter to Mountain Oak Vapors LLC following a review of inspection records. The FDA determined that the company manufactures and distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, as they are derived from tobacco or contain nicotine from any source and are intended for human consumption.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the products "Mountain Oak Vapors Strawberry Breeze 100ml 3mg/ml" and "Mountain Oak Vapors Americano 60ml 6mg/ml" were found to be new tobacco products, as they were not commercially marketed in the U.S. as of February 15, 2007, 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 and failure to provide necessary information under section 905(j). The introduction of adulterated or misbranded tobacco products into interstate commerce, or the failure to provide required reports, constitutes prohibited acts under sections 301(a) and 301(p) of the FD