FDA WARNING_LETTER - Good Smokes LLC, d/b/a Vape N Vapor - March 13, 2025

The FDA Center for Tobacco Products issued a Warning Letter to Good Smokes LLC, d/b/a Vape N Vapor, on March 13, 2025, based on a review of inspection records. The company 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 order. Specifically, the product "JUICE HEAD FREEZE STRAWBERRY KIWI 3MG/ML" was cited. This product is considered "new" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks the necessary FDA marketing authorization or exemption. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j).

The letter emphasizes the company's responsibility to ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. Good Smokes LLC is required to submit