FDA WARNING_LETTER - Fast Eddie's Vape Distribution - April 05, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Matthew Kleizo of Fast Eddie's Vape Distro on February 4, 2022, following a review of their website, https://fasteddiesvapedistro.com. The review determined that e-liquid products, specifically "Taffy Splash Banana" and "Taffy Splash Strawberry," were 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 and are subject to FDA jurisdiction.

The primary 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 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.

The letter notes that the firm is a registered manufacturer with over 440 products listed with FDA and had a Premarket Tobacco Product Application (PMTA) (STN PM0003768) covering 104 products, which received a Marketing Denial Order on October 14, 2021