FDA WARNING_LETTER - McVapour LLC - March 07, 2025

The FDA's Center for Tobacco Products issued a Warning Letter to McVapour LLC on March 6, 2025, following a review of inspection records. The letter states that McVapour LLC manufactures, sells, and/or distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act due to containing nicotine from any source and being intended for human consumption.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the product "Caribou Lou" e-liquid is cited as a new tobacco product that 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.

McVapour LLC is required to submit a written response within 15 working days detailing actions taken to address the violations, including dates of discontinued sale/distribution and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The letter emphasizes the firm's responsibility to ensure all tobacco products and related advertising comply with the FD&C Act and FDA regulations.