FDA WARNING_LETTER - You Suck Vapes Altus - November 04, 2025

On November 13, 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to You Suck Vapes, identifying violations related to the marketing of e-liquid tobacco products. The FDA"s Center for Tobacco Products determined that You Suck Vapes sells and distributes e-liquid products, which are regulated as tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The primary issue highlighted was the sale of a specific "new tobacco product," "Sad Boy Cake Line Funnel Cake 3 MG 100 ML," without the necessary premarket authorization. Under the FD&C Act, such products require an FDA marketing authorization order or an exemption to be legally marketed. Since this product lacked the required authorization and was not commercially marketed before February 15, 2007, it is considered both adulterated and misbranded. You Suck Vapes is mandated to promptly address these violations by immediately ceasing the sale and distribution of all non-compliant tobacco products. Furthermore, the company must provide a written response to the FDA within 15 working days from the letter"s receipt, detailing the corrective actions taken and outlining a plan to ensure ongoing compliance with the FD&C Act and all applicable FDA regulations, thereby avoiding further regulatory enforcement.