FDA WARNING_LETTER - You Suck Vapes Altus - December 07, 2021

The FDA issued a Warning Letter to You Suck Vapes after reviewing submissions and inspection records, determining the company manufactures and distributes e-liquid products, specifically You Suck Vapes Lumos 0.3% 30ml nicotine e-liquid, which are deemed tobacco products subject to FDA regulation. The identified e-liquid is a "new tobacco product" that was not commercially marketed in the U.S. as of February 15, 2007, and lacks the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notice or information under section 905(j). The introduction of adulterated or misbranded tobacco products into interstate commerce is a prohibited act under section 301(a), and the failure to provide a required report under section 905(j) is a prohibited act under section 301(p). The FDA emphasizes that all new tobacco products on the market without authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and injunction. You Suck Vapes, a registered manufacturer with over 72,000 listed products, must submit a written response within 15 working days detailing actions to address these violations, including discontinuing violative sales and outlining a compliance plan.