Nepa Wholesale Inc. – FDA Warning Letter, Jun 30, 2025

On June 26, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Nepa Wholesale Inc. for selling and distributing unauthorized electronic nicotine delivery system (ENDS) products. The FDA determined, based on inspection records, that Nepa Wholesale Inc. markets ENDS products, which are classified as "tobacco products" under section 201(rr) of the FD&C Act, including those containing nicotine from any source as per the Consolidated Appropriations Act, 2022.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the product "RAZ TN9000 BLACK CHERRY PEACH 5% NIC 12ml" was cited as a new tobacco product not commercially marketed in the U.S. before February 15, 2007, and lacking an FDA marketing authorization order. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no required notice or information was provided under section 905(j).

Nepa Wholesale Inc. is required to submit a written response within 15 working days, detailing actions taken to address the violations, including discontinuing sales and distribution of the violative products, and a plan for maintaining compliance. Failure to comply may result in