FDA WARNING_LETTER - Bradley Jaramillo LLC d/b/a Trinity Vapor Lounge - July 30, 2021

The FDA issued a Warning Letter to Bradley Jaramillo LLC d/b/a Trinity Vapor Lounge for manufacturing and distributing an e-liquid product, Trinity Vapor Lounge XXX Nicotine Solution 3 mg, without the required premarket authorization. Under section 201(rr) of the FD&C Act, e-liquids are deemed tobacco products subject to FDA regulation. The product is considered a "new tobacco product" as it was not commercially marketed before February 15, 2007, and lacks an FDA marketing authorization order or exemption under section 910(a) of the FD&C Act. Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) for failing 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 1,800 listed products, is responsible for ensuring compliance. The FDA requires a written response within 15 working days detailing corrective actions, including dates of discontinuing violative sales and a plan for maintaining compliance, to avoid further regulatory action such as civil money penalties, seizure, or injunction.