FDA WARNING_LETTER - Alohma, LLC d/b/a Kure CBD & Vape - July 24, 2024

On July 24, 2024, the FDA issued a Warning Letter to Alohma, LLC d/b/a Kure CBD & Vape, based on a review of inspection records. The FDA determined that Alohma manufactures, sells, and/or distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, as they contain nicotine from any source and are intended for human consumption.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the product "Cinnamon Danish" e-liquid was cited. This product is considered a new tobacco product because it was not commercially marketed in the United States as of February 15, 2007, and lacks the necessary FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, this product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA requires Alohma to submit a written response within 15 working days from the receipt date. This response must detail actions taken to address the violations, including the discontinuation dates for the sale and/or distribution of the violative products, and a plan for maintaining future compliance with the FD&C Act. Failure to