VapinUSA WI LLC d/b/a VapinUSA – FDA Warning Letter, Mar 12, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Brian Schroeder and Elliott Boldon of VapinUSA, following a review of their website, https://vapinusa.com. The FDA determined that e-liquid products, specifically "VapinUSA Evolution Orange" and "VapinUSA Evolution Blueberry Cotton Candy," are manufactured and offered for sale in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The core violation is that these e-liquid products are "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed 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.

VapinUSA is a registered manufacturer with over 60 products listed with FDA. The letter emphasizes the firm's responsibility to ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations (21 C.F.R. Parts 1140, 1