KC Vape LLC – FDA Warning Letter, Nov 30, 2021

The FDA issued a Warning Letter to KC Vape LLC on November 30, 2021, following a review of submissions and inspection records. The FDA determined that KC Vape LLC manufactures and distributes e-liquid products, which are deemed tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

The primary violation identified is the marketing of a "new tobacco product," specifically "KC Vape Lounge Western 12 Nicotine 60/40 VG/PG 50 ml e-liquid product," without the required premarket authorization. This product is considered "new" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption.

Consequently, this product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information under section 905(j) was not provided. Prohibited acts include holding for sale an adulterated or misbranded product (section 301(k)) and failing to provide a required report (section 301(p)).

KC Vape LLC, a registered manufacturer with over 550 listed products, is responsible for ensuring all tobacco products comply with the FD&C Act. Failure to address these violations