FDA WARNING_LETTER - Team MC Inc. d/b/a Community Vapor - September 13, 2022

The FDA issued a Warning Letter to Team MC Inc. d/b/a Community Vapor on September 13, 2022, following a review of submissions and inspection records. The FDA determined that the company manufactures and distributes e-liquid products, specifically citing "COMMUNITY Vapor BLING BLING BERRY 120ML 12MG e-liquid product," which are deemed tobacco products under the FD&C Act.

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization. The cited e-liquid product was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required information under section 905(j). These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

The FDA requires Team MC Inc. to submit a written response within 15 working days detailing actions taken to address the violations, including dates of discontinued sales/distribution and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.