FDA WARNING_LETTER - You Suck Vapes Altus - March 20, 2025

The FDA's Center for Tobacco Products issued a Warning Letter to You Suck Vapes on March 20, 2025, following a review of inspection records. The letter states that You Suck Vapes manufactures, sells, and/or distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act (21 U.S.C. § 321(rr)) due to containing nicotine from any source and being intended for human consumption.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the e-liquid product "Lemon Cheesecake" was cited as a new tobacco product not commercially marketed in the U.S. as of February 15, 2007, and lacking an FDA marketing authorization order or exemption. This renders the product adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)) and misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) because required notice or information under section 905(j) was not provided.

You Suck Vapes is required to submit a written response within 15 working days detailing