FDA WARNING_LETTER - Nice Cloud LLC d/b/a/ Nicecloud Vapor - March 27, 2025

On March 27, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Nicecloud LLC d/b/a Nicecloud Vapor, following a review of inspection records. The letter states that Nicecloud Vapor manufactures, sells, and/or distributes e-liquid products in the United States, which are classified as tobacco products under section 201(rr) of the FD&C Act due to containing nicotine from any source and being intended for human consumption.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order. Specifically, the product "Julia" e-liquid was cited as a new tobacco product that was not commercially marketed in the U.S. as of February 15, 2007, and lacks FDA marketing authorization. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j).

Nicecloud Vapor is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the violative products and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The letter emphasizes that this is