Green Rush, LLC d/b/a XHALE CITY – FDA Warning Letter, Oct 30, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to Aleem Wadhwania and Nuruddin Wadhwania after reviewing their website, xhalecity.com, and identifying electronic nicotine delivery system (ENDS) products offered for sale in the United States. These products, including Halo Vapor Synix 30000 Puffs Disposable, are classified as tobacco products under section 201(rr) of the FD&C Act, including those containing nicotine from any source. The primary violation is the marketing of these "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 expressed particular concern regarding the products' youth appeal, noting their design and advertising imitate smartphones with features like a "full-touch screen," "Bluetooth connectivity," "AI Chat," and "games," which could also conceal their nature as tobacco products. The firm is required to immediately cease the violative sale and distribution of these products and submit a written response within 15 working days detailing corrective actions and a plan for sustained compliance. Failure to comply may result in regulatory actions such as civil money penalties, product seizure, injunctions, and import detentions.