FDA WARNING_LETTER - You Suck Vapes Altus - March 27, 2025

On March 27, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to You Suck Vapes, identifying that the company manufactures, sells, and/or distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act. These products, including "Lemon Cheesecake" e-liquid, are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is the marketing of these new tobacco products without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j).

The FDA requires You Suck Vapes to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing the sale and distribution of the non-compliant products and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.