FDA WARNING_LETTER - Tasty Vape Shop - June 30, 2021

The FDA issued a Warning Letter to Tasty Vape Shop after reviewing submissions and inspection records, determining the firm manufactures and distributes e-liquid products, specifically "Tasty Vapes Extacy 3mg 50ml e-liquid product," which are deemed tobacco products subject to FDA regulation. The primary violation is the commercial distribution of this e-liquid product without the required premarket authorization. As a "new tobacco product" not marketed before February 15, 2007, it requires an FDA marketing authorization order or exemption, which it lacks. Consequently, the product is deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) due to the failure to provide required notice under section 905(j). These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The firm, a registered manufacturer with over 9,700 listed products, is responsible for ensuring compliance. Tasty Vape Shop must submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for future compliance, to avoid further regulatory actions such as civil money penalties, seizure, or injunction.