VPR Brands, LP d/b/a Krave Nic – FDA Warning Letter, Aug 18, 2022

The FDA's Center for Tobacco Products issued a Warning Letter to Kevin Frija regarding nicotine gummy products sold on kravenic.com. The FDA determined these products, including Krave Nic Blueraz, Cherry Bomb, and Pineapple gummies, are tobacco products under section 201(rr) of the FD&C Act, as they contain nicotine from any source. Recent legislation expanded the definition of "tobacco product" to include non-tobacco derived nicotine. The FDA found that these nicotine gummy products are "new tobacco products" because 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 due to the absence of required notice under section 905(j). The firm must submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing violative sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.