FDA WARNING_LETTER - Nimbus Imports Inc, d/b/a Nimbus Wholesale

The FDA issued a warning letter to Nimbus Imports Inc., operating as Nimbus Wholesale, on September 25, 2025, following an inspection by the Center for Tobacco Products. The inspection revealed that Nimbus Wholesale sells or distributes electronic nicotine delivery system (ENDS) products in the U.S. without the necessary premarket authorization, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The key violation involves the sale of the HQD CLICK PRO POD 35000 PUFFS BAJA SPLASH 5% NICOTINE, a product classified as a "new tobacco product" because it was not commercially available in the U.S. before February 15, 2007. This product lacks an FDA marketing authorization order, making it adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act.

Nimbus Wholesale is required to ensure compliance with the FD&C Act and its implementing regulations, which include obtaining premarket authorization for all new tobacco products. The FDA has requested a written response within 15 working days detailing actions taken to address these violations, including cessation of the unlawful sale and distribution of the products in question. Failure to comply may result in regulatory actions such as civil penalties, seizure, or injunction.

Nimbus Wholesale is advised to submit their response to the FDA"s Office of Compliance and Enforcement, including any reasoning or supporting information if they believe the products are not in violation. The FDA provides resources and further guidance on its website for compliance.