Xtreme Vapour – FDA Warning Letter, Apr 8, 2021

The FDA issued a Warning Letter to Xtreme Vapour, identifying that their e-liquid products, specifically "Babylon Vape Juice Pineapple 30ml," are tobacco products subject to FDA jurisdiction. The letter states that this product is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act.

Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j). The manufacture, sale, and/or distribution of such a product constitutes prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

Xtreme Vapour, a registered manufacturer with over 80 listed products, is responsible for ensuring compliance. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and distribution, and a plan for ongoing compliance. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, and/or injunction.