FDA WARNING_LETTER - KingPin Cigarettes, Inc. d/b/a Blackhat Vapor Company - September 28, 2023

The FDA issued a Warning Letter to KingPin Cigarettes, Inc. d/b/a Blackhat Vapor Company for manufacturing and distributing unauthorized e-liquid tobacco products, specifically citing "Island Breeze." These products are classified as "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket marketing authorization. Consequently, these e-liquid 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 notices or information. The letter also highlights that the sale of adulterated or misbranded tobacco products (section 301(k)) and the failure to provide required reports (section 301(p)) are prohibited acts. KingPin Cigarettes, Inc. must submit a written response within 15 working days, outlining corrective actions, including discontinuing violative sales and a plan for sustained compliance. Failure to address these violations could result in civil money penalties, product seizure, or injunctions.