FDA WARNING_LETTER - Kure Vaporium & Lounge - October 01, 2025

On October 23, 2025, the FDA"s Center for Tobacco Products issued a Warning Letter to Kure Vaporium & Lounge, identifying the firm as a manufacturer, seller, and/or distributor of e-liquid products. The letter, based on a review of inspection records, asserts that Kure Vaporium & Lounge is unlawfully marketing "new tobacco products" without the required premarket authorization. Specifically, the e-liquid product named "Baby Beetle" was cited for this violation. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), e-liquid products, particularly those containing nicotine from any source as defined by a 2022 amendment, are classified as tobacco products subject to FDA jurisdiction and its stringent marketing requirements. The FDA determined that "Baby Beetle" is a new tobacco product because it was not commercially marketed in the U.S. prior to February 15, 2007, and lacks the necessary marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are considered adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the Act. Kure Vaporium & Lounge is required to submit a written response within 15 working days of receiving the letter. This response must detail the corrective actions taken, including the discontinuation of sales and distribution of the non-compliant products, and outline a comprehensive plan for maintaining compliance with the FD&C Act. Failure to address these violations promptly may lead to further regulatory actions.