FDA WARNING_LETTER - Alohma LLC d/b/a Kure CBD & Vape - August 07, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to Alohma LLC d/b/a Kure CBD & Vape for manufacturing, selling, and/or distributing e-liquid products, specifically "Sweet Moro," without the required premarket authorization. These products are classified as tobacco products under section 201(rr) of the FD&C Act, subject to FDA jurisdiction, and must comply with the FD&C Act and its implementing regulations. The FDA determined that "Sweet Moro" is a new tobacco product, as it was not commercially marketed before February 15, 2007, and lacks the necessary marketing 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 information under section 905(j). The FDA emphasizes that marketing new tobacco products without premarket authorization is unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. Alohma LLC must submit a written response within 15 working days, detailing corrective actions, including discontinuing violative sales and a plan for maintaining compliance with the FD&C Act.