FDA WARNING_LETTER - Alohma LLC d/b/a Kure CBD & Vape - July 23, 2024
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On July 23, 2024, the FDA's Center for Tobacco Products issued a Warning Letter to Alohma LLC d/b/a Kure CBD & Vape, following a review of inspection records. The letter states that Alohma LLC manufactures, sells, and/or distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act (21 U.S.C. § 321(rr)) due to containing nicotine from any source and being intended for human consumption.
The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the product "Sugar Kookie" e-liquid is cited as a new tobacco product that was not commercially marketed in the U.S. as of February 15, 2007, and lacks FDA marketing authorization under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)). Consequently, this product is deemed adulterated under section 902(6)(A) (21 U.S.C. § 387b(6)(A)) and misbranded under section 903(a)(6) (21 U.S.C. § 387c
ID · aee3b17f-d269-40aa-af7b-3b6329f43ce4
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