FDA WARNING_LETTER - Dream Vapor LLC - August 12, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to Dream Vapor LLC on August 12, 2024, based on a review of inspection records. The letter states that Dream Vapor LLC sells and/or distributes Electronic Nicotine Delivery System (ENDS) products, which are classified as tobacco products under section 201(rr) of the FD&C Act, as amended on March 15, 2022, to include products containing nicotine from any source.

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization order. Specifically, the product "GEEK BAR PULSE FROZEN STRAWBERRY 50MG/ML 16mL" 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 due to the absence of required notice or information under section 905(j).

Dream Vapor LLC is required to take prompt action to address these violations and bring all tobacco products into compliance with the FD&C Act and its implementing regulations. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or