Midwest Service & Supply, Inc. – FDA Warning Letter

The FDA Center for Tobacco Products reviewed the eBay Store, Midwest Service Closeouts, and determined that smokeless tobacco products were offered for sale to U.S. customers. These products are subject to FDA jurisdiction under the FD&C Act.

The FDA found that certain smokeless tobacco products, specifically Ariva Cinnamon, Ariva Citrus, Ariva Mint, and Ariva Wintergreen, are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. This is because they are "new tobacco products" requiring premarket review under section 910(a)(2) but lack a marketing authorization order under section 910(c)(1)(A)(i). Furthermore, a notice or other information regarding these products was not provided as required by section 905(j) of the FD&C Act, subsequent to FDA issuing Not Substantially Equivalent (NSE) orders for them on August 28, 2014.

The letter requires immediate correction of these violations and similar issues, ensuring all tobacco products and promotional materials comply with the FD&C Act and FDA regulations. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Adulterated and misbranded tobacco products imported into the U.S. are subject to detention and refusal of admission. A