FDA WARNING_LETTER - Alohma, LLC d/b/a Kure CBD & Vape - June 26, 2025

On June 26, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Kure CBD & Vape for selling and distributing unauthorized e-liquid products. The FDA determined that Kure CBD & Vape sells e-liquid products, which are considered tobacco products under section 201(rr) of the FD&C Act (21 U.S.C. § 321(rr)) because they contain nicotine from any source and are intended for human consumption.

The specific violation identified is the marketing of "new tobacco products" without the required premarket authorization order. The FDA cited BSX SERIES CREAMY RY4 BUTTERSCOTCH RESERVE 60ML 0.3% as an example of such a product. This product is deemed a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks the necessary FDA marketing authorization. Consequently, the product is 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)) due to the absence of required notice or information under section 9