FDA WARNING_LETTER - Vapewell Supply LLC - August 16, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Arman Espinosa and Claire McPherson of Vapewell Supply after reviewing their website, vapewellsupply.com. The FDA determined that e-liquid products offered for sale, including Camarosa, Oak with TFN, and Burley with TFN, are tobacco products under section 201(rr) of the FD&C Act, especially following the March 2022 legislation expanding jurisdiction to products with nicotine from any source. The primary violation is that these are "new tobacco products" that were not commercially marketed before February 15, 2007, and are being sold without the required FDA 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 due to the absence of required premarket notification under section 905(j). The FDA has not received an application for these products. Vapewell Supply must submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.