FDA WARNING_LETTER - FT DISTRO INC., d/b/a Happy Global - March 17, 2025

On March 13, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to FT DISTRO INC., d/b/a Happy Global, following a review of inspection records. The company sells and distributes Electronic Nicotine Delivery System (ENDS) products in the U.S., 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," "adjust myFlavor Black Razz Baja 50mg/mL 20mL," 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, as no required notice or information was provided under section 905(j).

The FDA requires FT DISTRO INC. to submit a written response within 15 working days detailing actions taken to address these violations, including the discontinuation of violative sales and distribution, and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction. Imported products