SS Vape Brands Inc. d/b/a Monster Vape Labs d/b/a The Monster Group – FDA Warning Letter, Sep 13, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to Sonny Westmoreland Jr. regarding e-liquid products sold on monstervapelabs.com. The FDA determined that products like Blueberry Lemon Juice Monster, Peach Pear Juice Monster, and Pineapple Grapefruit Juice Monster are tobacco products under the expanded definition, which includes nicotine from any source. These products are classified as "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. The primary violation is the lack of required premarket authorization orders 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 for failing to provide the necessary notice as required by section 905(j). The firm must submit a written response within 15 working days, detailing actions taken to address these violations, including discontinuing sales and distribution, and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, product seizure, and/or injunction.