Vape NV LLC – FDA Warning Letter, Aug 16, 2022

The FDA issued a Warning Letter to Vape NV LLC on August 16, 2022, following a review of submissions and inspection records. The FDA determined that Vape NV LLC manufactures and distributes "Bomberry e-liquid products" for commercial distribution in the U.S. These e-liquid products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation identified is that Bomberry e-liquid products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. Vape NV LLC is manufacturing, selling, and/or distributing these products without 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, as no notice or information was provided as required by section 905(j). The failure to provide such a report is a prohibited act under section 301(p), and the sale of adulterated or misbranded products is a prohibited act under section 301(k).

Vape NV LLC is required to submit a written response within 15 working days, detailing