FDA WARNING_LETTER - Carolina Vapor Mill, LLC d/b/a Carolina Vapor Mill - January 29, 2021

The FDA issued a Warning Letter to David Lee Lance of Carolina Vapor Mill on January 29, 2021, following a review of their website, https://carolinavapormill.com. The FDA determined that the e-liquid products offered for sale are "new tobacco products" under section 201(rr) of the FD&C Act (21 U.S.C. § 321(rr)) and are subject to FDA jurisdiction.

The primary violation identified is the marketing and distribution of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act (21 U.S.C. § 387j(a)). Specifically, the products "V-SHINE handcrafted e-juice MANGO" and "V-SHINE handcrafted e-juice FUN DRIP" were found to be new tobacco products not commercially marketed in the U.S. as of February 15, 2007, and lacking FDA marketing authorization. This renders the products adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 129,700 products listed with FDA, to ensure compliance with all applicable provisions of