JSS Retail, LLC, d/b/a Kure CBD & Vape – FDA Warning Letter, Apr 15, 2025

The FDA's Center for Tobacco Products issued a Warning Letter to JSS Retail, LLC, d/b/a Kure CBD & Vape, after reviewing inspection records, determining the firm manufactures and distributes e-liquid products. These products, including "Baby Beetle," are classified as tobacco products under section 201(rr) of the FD&C Act, especially following the March 2022 amendment extending jurisdiction to nicotine from any source. The primary violation identified is the marketing of new tobacco products without the required premarket authorization order, as mandated by section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) due to the absence of required information under section 905(j). The FDA requires JSS Retail to submit a written response within 15 working days, detailing actions taken to cease the violative sale and distribution of these products and outlining a plan for maintaining compliance. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, injunction, and potential import detention or refusal.