FDA WARNING_LETTER - Vape Hut, LLC d/b/a Vape Hut Kratom-CBD - June 05, 2025

On June 5, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Vape Hut, LLC, d/b/a Vape Hut Kratom - CBD, based on a review of inspection records. The company sells and distributes Electronic Nicotine Delivery System (ENDS) products in the United States, 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 a "new tobacco product," specifically "North Clear 10ml 5% nicotine," without the required premarket authorization order. This product 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).

The FDA requires Vape Hut to promptly address these violations and bring all products into compliance with the FD&C Act. Failure to do so may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days, detailing