FDA WARNING_LETTER - You Suck Vapes & CBD - April 15, 2025

The FDA Center for Tobacco Products issued a Warning Letter to You Suck Vapes & CBD after reviewing inspection records, determining the firm manufactures and distributes e-liquid products in the U.S. These e-liquids are classified as tobacco products under section 201(rr) of the FD&C Act, especially following the 2022 amendment extending jurisdiction to products with nicotine from any source. The primary violation is the marketing of "new tobacco products," specifically "Lemon Cheesecake" e-liquid, without the required premarket authorization order. These products were not commercially marketed before February 15, 2007, and lack FDA marketing authorization or exemption under section 910(a) of the FD&C Act. Consequently, these unauthorized products are 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 under section 905(j). The FDA requires a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a compliance plan. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.