FDA WARNING_LETTER - TVC Management Corp d/b/a The Vapor Chef - September 06, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Charles Sweeney and Aros Azuolas of The Vapor Chef on August 26, 2022, following a review of their website, https://thevaporchef.com. The FDA determined that e-liquid products, including "Miley Pearus," "ROYGBIV Gum," and "Unicorn Poop," are manufactured and offered for sale or distribution in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. Since these e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization or exemption, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA has not received an application for marketing authorization for these products. The letter states that failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The company is required to submit a