Team Full Steam LLC d/b/a Full Steam Vapor – FDA Warning Letter, May 17, 2023

The FDA issued a Warning Letter to Team Full Steam LLC d/b/a Full Steam Vapor on July 6, 2023, following a review of submissions and a May 17, 2023, compliance check inspection. The company manufactures and distributes electronic nicotine delivery system (ENDS) products, including e-liquids, which are deemed tobacco products subject to FDA regulation.

The primary violation identified is the marketing of "new tobacco products" without required premarket authorization. Specifically, the e-liquid product "RY4 Caramel Vanilla Tobacco 3MG 60 ML" and the ENDS product "Esco Bars Blue Razzleberry Pomegranate" were found to be new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization orders. This renders these products adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notices were not provided under section 905(j).

The FDA cited sections 201(rr), 901(b), 910(a), 910(c)(1)(A)(i), 905(j), 301(k), and 301(p) of the FD&C Act. The company is required to submit a written response within