FDA WARNING_LETTER - Worlds Finest Vape Shop, LLC d/b/a World's Finest Victory Club - July 05, 2022

The FDA's Center for Tobacco Products issued a Warning Letter to Michael Scavello, dated June 24, 2022, after reviewing the website https://wfvclub.com. The review determined that e-liquid products, specifically "Got Milk Juice" and "Monster Juice," are manufactured and offered for sale or distribution in the United States.

These e-liquid products are classified as "tobacco products" under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction. The FDA deemed e-liquids subject to regulation effective August 8, 2016. The primary violation identified is that these e-liquid products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. They lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt.

Consequently, these products are deemed 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 FDA states that unlawfully marketed new tobacco products are subject to enforcement action, including civil money penalties, seizure, and/or injunction.

The letter requires a