FDA WARNING_LETTER - You Suck Vapes Altus - March 06, 2025

The FDA Center for Tobacco Products issued a Warning Letter to You Suck Vapes on March 6, 2025, following a review of inspection records. 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, 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 that was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information under section 905(j) was not provided.

The FDA requires You Suck Vapes to submit a written response within 15 working days from receipt of the letter. The response must detail actions taken to address the violations, including dates of discontinued sale/distribution of the violative products, and a plan for maintaining compliance with the FD&C Act. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.