Case Details for "Specialty Brands of America"

FDA sends warning to Specialty Brands of America re labeling of Bear Creek Country Kitchens Navy Bean Soup Mix

The Food and Drug Administration (FDA) has reviewed the label for Specialty Brands of America's "Bear Creek Country Kitchens Navy Bean Soup Mix" product. Based on our review, we have concluded that this product is misbranded under section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(r)(1)(A)] and the applicable regulations in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101) because the product label bears a nutrient content claim but does not meet the requirements to make the claim.

Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation promulgated by the Secretary (or by delegation, FDA) authorizing the use of such a claim. Characterizing the level of a nutrient in the labeling of a food without complying with the applicable nutrient content claim requirements misbrands the product under section 403(r)(1)(A) of the Act.

Your "Bear Creek Country Kitchens Navy Bean Soup Mix" product is misbranded because the product label bears a nutrient content claim but fails to bear the sodium disclosure statement required by 21 CFR 101.13(h). Your product label bears the claim "0g Trans Fat" on the principal display panel, and the Nutrition Facts section of the label declares that the product contains 940 mg of sodium per serving ("1/4 Cup Dry (38g) 1 Cup Prepared"). The phrase "0g Trans Fat" meets the definition of a nutrient content claim [21 CFR 101.13(b)] because it characterizes the product’s level of trans fat, which is a nutrient of the type required to be in nutrition labeling [21 CFR 101.9(c)(2)(ii)]. A food that bears a nutrient content claim and that contains more than 480 mg of sodium per labeled serving must bear the disclosure statement "See nutrition information for sodium content" immediately adjacent to the claim, as required in 21 CFR 101.13(h)(1). The label of your product fails to bear the required disclosure statement.

Posted on:08/25/2010
Company: Specialty Brands of America
Affected Class:
Scope: Nationwide

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