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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Specialty Brands of America 8/25/10

 

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 College Park, MD 20740

August 25, 2010

WARNING LETTER

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

Mr. Dominique Bastien

President

Specialty Brands of America

1400 Old Country Road Suite 103

Westbury, New York 11590

Re: CFSAN-OC-10-25

Dear Mr. Bastien:

The Food and Drug Administration (FDA) has reviewed the label for your “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. You can find copies of the Act and these regulations through links in FDA’s home page at http://www.fda.gov.

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.

This letter is not intended to be an all-inclusive review of your products and their labeling. It is your responsibility to ensure that all of your products comply with the Act and its implementing regulations. You should take prompt action to correct this violation. Failure to do so may result in regulatory action without further notice. Such action may include, but is not limited to, seizure or injunction. 

Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct this violation and to prevent similar violations. You should include in your response documentation such as revised labels or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when you will correct any remaining violations.

Your written response should be sent to Judith G. Dausch, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions please contact Ms. Dausch at 301-436-2040. 

 

Sincerely,

/s/

Jennifer Thomas 

Acting Director

Office of Compliance

Center for Food Safety

and Applied Nutrition