Kure Corporation-Outlet – FDA Warning Letter, Oct 1, 2025

Kure Corporation received an FDA Warning Letter dated October 23, 2025, following a review of inspection records. The letter identifies that Kure Corporation manufactures, sells, and distributes unauthorized e-liquid products, specifically naming "Baby Beetle," within the United States. These products are deemed "new tobacco products" under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they were not commercially marketed before February 15, 2007. A primary violation is the absence of required premarket authorization orders from the FDA, rendering these products unlawfully marketed. Under the FD&C Act, and specifically section 201(rr) which expanded the definition of tobacco products to include those with nicotine from any source, such unauthorized products are considered both adulterated and misbranded. The FDA mandates that all new tobacco products have a premarket authorization order or be found substantially equivalent to a predicate product. Kure Corporation is required to take prompt action to address these violations. This includes immediately ceasing the sale and distribution of the non-compliant e-liquid products. Furthermore, the company must submit a written response to the FDA within 15 working days. This response needs to detail the specific actions taken to discontinue the violative sales, the dates of these actions, and outline a clear plan for maintaining ongoing compliance with all applicable provisions of the FD&C Act. Failure to comply could result in severe regulatory consequences, including civil money penalties or product seizure.