FDA WARNING_LETTER - Vapor Magic - September 21, 2022

The FDA issued a Warning Letter to Vapor Magic on September 21, 2022, following a review of submissions and inspection records, determining the company manufactures and distributes e-liquid products. These products, including "twisted OHM BOI 3mg 30ml" and "GAMBLER JACKS OR BETTER 3mg 30ml," are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The core violation is that these e-liquid products are "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because the required notice or information under section 905(j) was not provided.

The FDA states that marketing these products without authorization is unlawful and constitutes prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The letter emphasizes that failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction. Vapor