FDA WARNING_LETTER - Advanced Vapor - September 15, 2023

The FDA issued a Warning Letter to Advanced Vapor on September 14, 2023, following a review of inspection records. The letter states that Advanced Vapor manufactures and distributes e-liquid products, including "Unicorn Vomit," which are considered tobacco products under the FD&C Act, specifically section 201(rr), due to containing nicotine from any source and being 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 this date. Advanced Vapor's e-liquid products, including "Unicorn Vomit," were not commercially marketed by the February 15, 2007, predicate date and lack the necessary FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act.

Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because required notices or information under section 905(j) were not provided. The sale or distribution of adulterated or misbranded tobacco products, and the failure to provide required reports, are prohibited acts under sections 30