Specialty Brands of America – FDA Warning Letter

The FDA issued a Warning Letter to Specialty Brands of America regarding their "Bear Creek Country Kitchens Navy Bean Soup Mix" product, citing misbranding under section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR Part 101. The product label bears the nutrient content claim "0g Trans Fat" on the principal display panel. However, the Nutrition Facts section declares 940 mg of sodium per serving. According to 21 CFR 101.13(h)(1), a food bearing a nutrient content claim and containing over 480 mg of sodium per serving must include the disclosure statement "See nutrition information for sodium content" immediately adjacent to the claim. The product label fails to include this required disclosure statement. The FDA requires prompt corrective action to address this violation, warning that failure to comply may result in regulatory actions such as seizure or injunction. Specialty Brands of America must respond in writing within 15 working days, detailing specific corrective actions, including revised labels, and explaining any delays.