FDA WARNING_LETTER - Cavalry Industries d/b/a Select Vape - July 31, 2024

The FDA's Center for Tobacco Products reviewed selectvape.com and found electronic nicotine delivery system (ENDS) products offered for sale in the U.S. These products, including specific Geek Bar Pulse, Lost Mary MO5000, and Bang XXL Switch DUO disposable vapes, are considered 'new tobacco products' under section 201(rr) of the FD&C Act, as they were not commercially marketed before February 15, 2007. The firm failed to obtain the required premarket authorization orders under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these unauthorized products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) because the necessary notice or information was not provided as required by section 905(j). The FDA mandates prompt action to address these violations, discontinue the sale and distribution of the non-compliant products, and submit a written response within 15 working days detailing corrective actions and a compliance plan. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction, and imported products may be detained or refused admission.