Southeast Distro Inc. – FDA Warning Letter, Sep 27, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to Southeast Distro Inc. on September 25, 2024, following a review of inspection records. The company sells and distributes Electronic Nicotine Delivery System (ENDS) products, which are regulated as tobacco products under 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 a "new tobacco product," VOZOL GEAR 10000 STRAWBERRY KIWI Nicotine 5% w/v 16ML, without the required premarket authorization. This product is considered "new" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order 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, due to the absence of required notice or information under section 905(j).

Southeast Distro Inc. is required to submit a written response within 15 working days, detailing actions taken to address the violations, including discontinuing the sale and distribution of the violative products, and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure