HomeTown Vapor – FDA Warning Letter, Nov 2, 2023

The FDA issued a Warning Letter to HomeTown Vapor on November 2, 2023, following a review of inspection records. The FDA determined that HomeTown Vapor manufactures and distributes e-liquid products, including "Hometown Custard," which are considered tobacco products under section 201(rr) of the FD&C Act, as they contain nicotine and are intended for human consumption.

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 that date. HomeTown Vapor's e-liquid products, specifically "Hometown Custard," were not commercially marketed by the February 15, 2007, predicate date and lack the necessary 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 notification (section 905(j)). The sale or distribution of adulterated or misbranded tobacco products, or the failure to provide required reports, constitutes prohibited acts under sections 301(k) and 301(p) of the FD&C Act.