FDA WARNING_LETTER - FF Vapors, LLC - May 18, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Angela Duschl of FF Vapors on May 7, 2021, following a review of their website, ffvapors.com. The review determined that e-liquid products, specifically "FF Vapors Chocolate Banana" and "FF Vapors Grandma’s Candy," were manufactured and offered for sale in the U.S. without required marketing authorization.

These e-liquid products are classified as "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007. Consequently, they require a premarket authorization order or an exemption, which they lack. This renders the products adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j).

The letter emphasizes the firm's responsibility, as a registered manufacturer, to ensure compliance with the FD&C Act and FDA regulations (21 C.F.R. Parts 1140, 1141, and 1143). Failure to correct these violations may result in regulatory actions, including civil money penalties, seizure, injunction, or refusal of import. FF V