FDA WARNING_LETTER - MadTown Vapor LLC - August 17, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Dino Spinelli of MadTown Vapor on August 13, 2021, following a review of their website, madtownvap.com. The FDA determined that MadTown Vapor manufactures and sells e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, and thus subject to FDA jurisdiction and regulation.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order. Specifically, the e-liquid products "MadTown Vapor - Alota Horchata Nicotine Juice" and "MadTown Vapor - Banana Rama Nicotine Juice" were found to be new tobacco products, as they were not commercially marketed in the U.S. as of February 15, 2007. These products lack the necessary FDA marketing authorization under section 910(c)(1)(A)(i) of the FD&C Act and are not exempt. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required information under section 905(j).

MadTown Vapor is a registered manufacturer with over 90 products listed with the FDA. The letter emphasizes the firm's responsibility to ensure all tobacco products, labeling