FDA WARNING_LETTER - Preferred Vapor Manufacturing & Distribution, LLC d/b/a Preferred Vapor Vape Shop & Lounge - August 24, 2023

The FDA issued a Warning Letter to Preferred Vapor Manufacturing & Distribution, LLC d/b/a Preferred Vapor Vape Shop & Lounge, following a review of inspection records. The company manufactures and distributes e-liquid products, including "Dirty Jersey," which are classified as tobacco products under the FD&C Act.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. "Dirty Jersey" and other e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notices or information were not provided.

The letter cites sections 201(rr), 901(b), 910(a), 910(c)(1)(A)(i), 905(j), 902(6)(A), 903(a)(6), 301(k), and 301(p) of the FD&C Act. The FDA emphasizes that products containing nicotine from any source are now subject to FDA jurisdiction.

Preferred Vapor must submit a written response within 15 working days detailing actions to address violations, including discontinuing sales/distribution of