FDA WARNING_LETTER - Modern Smoking Solutions, LLC - October 31, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to Modern Smoking Solutions, LLC, following a review of inspection records. The company sells and distributes e-liquid products in the U.S., which are classified as tobacco products under section 201(rr) of the FD&C Act, including those containing nicotine from any source as per the Consolidated Appropriations Act, 2022.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order. Specifically, the products "Modern Vape Klown Resurrection 3 MG 100 ML" and "Coastal Clouds Apple Watermelon 3MG 60 ML" were found to be new tobacco products, as they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization. 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).

Modern Smoking Solutions, LLC is required to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing the sale and distribution of the non-compliant products and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and