JSS Retail, LLC, d/b/a Kure CBD & Vape – FDA Warning Letter, May 9, 2025

On May 8, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to JSS Retail, LLC, d/b/a Kure CBD & Vape, following a review of inspection records. The letter states that JSS Retail manufactures, sells, and/or distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include nicotine from any source.

The primary violation identified is the marketing of "Cherry Pom" e-liquid without the required premarket authorization order. This product is deemed a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks FDA marketing authorization or exemption. Consequently, the product is cited as adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice or information under section 905(j).

JSS Retail is required to submit a written response within 15 working days, detailing actions taken to address the violations, including dates of discontinued sales/distribution and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.