FDA WARNING_LETTER - Alohma, LLC d/b/a Kure CBD & Vape - July 24, 2025

The FDA"s Center for Tobacco Products issued a warning letter to Alohma, LLC, operating as Kure CBD & Vape, on July 24, 2025. The letter follows an inspection revealing that the company sells e-liquid products in the U.S. without the necessary premarket authorization, specifically citing the product Skwezed Watermelon 6mg 100ml. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), these e-liquids are classified as tobacco products due to their nicotine content, which now includes nicotine from any source as per the Consolidated Appropriations Act, 2022.

The FDA identified that these products are considered "new tobacco products" as they were not marketed in the U.S. before February 15, 2007, and lack the required marketing authorization order. Consequently, these products are deemed adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act.

Alohma, LLC is required to take immediate corrective actions to address these violations, including ceasing the sale and distribution of the unauthorized products and ensuring compliance with the FD&C Act. The company must submit a written response within 15 working days detailing the steps taken to rectify the issues and prevent future violations. Failure to comply may result in enforcement actions, such as civil penalties or product seizures. The letter serves as a formal notification and an opportunity for the company to address the identified compliance issues.