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

On July 24, 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 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 order, as mandated by section 910(a) of the FD&C Act. Specifically, the product "Riptide" is cited as a new tobacco product that was not commercially marketed in the U.S. as of February 15, 2007, and lacks the necessary FDA marketing authorization. Consequently, this product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Alohma LLC is required to submit a written response within 15 working days, detailing actions taken to address the violations, including discontinuing the sale and distribution of the non-compliant products, and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.