Kokomo Pure Vapors LLC – FDA Warning Letter, Dec 16, 2021

The FDA issued a Warning Letter to Kokomo Pure Vapors, LLC on December 16, 2021, following a review of submissions and inspection records. The FDA determined that Kokomo Pure Vapors manufactures and distributes e-liquid products, specifically citing "Kokomo Pure Vapors Horney Parrot 60ml 12mg e-liquid product," which are deemed tobacco products under section 201(rr) of the FD&C Act.

The primary violation is that this e-liquid product is a "new tobacco product" as it was not commercially marketed in the U.S. as of February 15, 2007, and lacks the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because the required notice or information under section 905(j) was not provided.

The FDA states that manufacturing, selling, or distributing such products constitutes prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The letter emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure,