FDA WARNING_LETTER - MVRB2, LLC, d/b/a Kure CBD & Vape - October 01, 2025

The FDA Center for Tobacco Products issued a Warning Letter to Kure CBD & Vape on October 16, 2025, based on a review of inspection records. The company manufactures, sells, and distributes e-liquid products, which are classified as tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act), encompassing those with nicotine from any source following a March 2022 amendment.

The main violation identified is the marketing of new tobacco products without the required premarket authorization. Specifically, Kure CBD & Vape offers "Cucumbersome" e-liquid, which was not commercially available in the U.S. before February 15, 2007, and lacks an FDA marketing authorization order. Consequently, this product is considered adulterated under FD&C Act section 902(6)(A) and misbranded under section 903(a)(6).

Kure CBD & Vape is required to take immediate action to resolve these violations, including halting the sale and distribution of the non-compliant e-liquid products. The company must provide a written response to the FDA within 15 working days, detailing the corrective actions undertaken and outlining a plan to ensure ongoing compliance with all applicable provisions of the FD&C Act and FDA regulations. Failure to comply could lead to further regulatory measures, such as civil money penalties, product seizure, or injunction.