FDA WARNING_LETTER - Vapor Tek USA LLC - December 16, 2021

The FDA issued a Warning Letter to Vapor Tek USA LLC on December 16, 2021, following a review of submissions and inspection records. The FDA determined that Vapor Tek USA LLC manufactures and distributes e-liquid products, specifically identifying "Vapor Tek USA Grape Berry 12mg e-liquid product," which are deemed tobacco products under section 201(rr) of the FD&C Act.

The primary violation is the marketing of a "new tobacco product" without the required premarket authorization. The "Vapor Tek USA Grape Berry 12mg e-liquid product" was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, nor is it exempt. Consequently, this product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required notice or information under section 905(j).

The FDA cited prohibited acts under section 301(k) for holding for sale an adulterated or misbranded product, and section 301(p) for failing to provide a required report under section 905(j). The letter emphasizes that all new tobacco products on