FDA WARNING_LETTER - Prior Lake Smokes Inc - May 09, 2025

On May 8, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Prior Lake Smokes Inc. following a review of inspection records. The company manufactures, sells, and/or distributes Electronic Nicotine Delivery System (ENDS) products, which are classified as tobacco products under 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 "eBlue Creamy Tobacco 5%" was cited as a new tobacco product not commercially marketed in the U.S. as of February 15, 2007, and lacking an FDA marketing authorization order or exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information under section 905(j) was not provided.

The FDA requires Prior Lake Smokes Inc. to take prompt action to address these violations and ensure all tobacco products comply with the FD&C Act and its implementing regulations. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days detailing actions taken, including discontinuation of violative sales and a