FDA WARNING_LETTER - Nicfixed, LLC d/b/a Good Karma Vapor - May 27, 2021

The FDA issued a Warning Letter to Nicfixed, LLC d/b/a Good Karma Vapor after reviewing submissions and inspection records, determining the firm manufactures and distributes e-liquid products, which are deemed tobacco products subject to FDA regulation. The letter states that the firm is manufacturing, selling, and distributing "GOOD KARMA VAPOR Orange GO Mango 3mg 60ml e-liquid product" without the required premarket authorization. This product is considered a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order. Consequently, the product is 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). The firm's actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. As a registered manufacturer with over 1,400 listed products, Nicfixed, LLC is responsible for ensuring compliance. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for future compliance. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, or injunction.