FDA WARNING_LETTER - MVRB2, LLC, d/b/a Kure CBD & Vape - May 27, 2025
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On May 22, 2025, the FDA Center for Tobacco Products issued a Warning Letter to Kure CBD & Vape, identifying violations related to the manufacturing, sale, and distribution of e-liquid products. The FDA determined that Kure CBD & Vape manufactures and offers for sale or distribution the "Sweet Carolina" e-liquid product, which is considered a "new tobacco product" under section 910(a) of the FD&C Act (21 U.S.C. § 387j(a)).
The key violation is that "Sweet Carolina" lacks the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)). As a result, this product is deemed adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)) and misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) because the required notice or information under section 905(j) was not provided.
The letter emphasizes that all new tobacco products marketed without statutory premarket authorization are unlawful and
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