FDA WARNING_LETTER - Silver Moon Nutraceuticals - April 28, 2025

The FDA's Center for Tobacco Products issued a Warning Letter to Silver Moon Nutraceuticals, LLC, d/b/a Mountain Vapormanufactures, after determining the firm manufactures and distributes e-liquid products, including "Sweetleaf," which are classified as tobacco products under the FD&C Act. These products, containing nicotine from any source, are subject to FDA jurisdiction and require premarket authorization. The inspection records revealed that the firm is marketing "new tobacco products" that lack the necessary marketing authorization order, as they were not commercially marketed in the U.S. as of February 15, 2007, and do not have an FDA marketing authorization order in effect under section 910(c)(1)(A)(i) or an exemption. Consequently, these unauthorized products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, due to the failure to provide required information under section 905(j). The FDA mandates a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for sustained compliance. Non-compliance may lead to severe regulatory actions, including civil money penalties, seizure, or injunction, emphasizing the firm's responsibility to ensure all products and associated marketing adhere to federal regulations.