FDA WARNING_LETTER - Mean Street Vapor LLC - May 26, 2023

On May 25, 2023, the FDA issued a Warning Letter to Mean Street Vapor LLC for manufacturing and distributing e-liquid products, specifically "STRAWBERRY BANANA SMOOTHIE SYN," without required marketing authorization. The FDA determined these e-liquid products are "new tobacco products" under section 201(rr) of the FD&C Act, as they were not commercially marketed in the U.S. as of February 15, 2007, and contain nicotine from any source.

The products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because they lack FDA marketing authorization orders and 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).

Mean Street Vapor LLC must submit a written response within 15 working days detailing actions to address violations, including discontinuing sales and distribution of non-compliant products, and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.