Saputo Cheese USA Inc.

Department of Health and Human Services	Public Health Service Food and Drug Administration
	5100 Paint Branch Parkway College Park, MD 20740

WARNING LETTER

August 2, 2010
 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Lino A. Saputo, Jr.
President and Chief Executive Officer
Saputo Cheese USA Inc.
25 Tri-State International Office Centre, Suite 250
Lincolnshire, IL 60069
 

Re: CFSAN-OC-10-23 

Dear Mr. Saputo:

The Food and Drug Administration (FDA) has reviewed the label for your "Treasure Cave® Reduced Fat Crumbled Blue Cheese" product. Based on our review, we have concluded that this product is in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). This product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] 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)(2)(B) of the Act, if a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food is made with respect to a nutrient in a food and the Secretary (or by delegation, FDA) makes a determination that the food contains a nutrient at a level that increases to persons in the general population the risk of a disease or health related condition that is diet related, the label or labeling of such food shall contain, prominently and in immediate proximity to such claim, the following statement: "See nutrition information for __ content." The blank shall identify the nutrient associated with the increased disease or health-related condition risk. Characterizing the level of a nutrient in food labeling of a product without bearing the required disclosure statement for a nutrient at a level that may increase the risk of a disease or health-related condition that is diet related, misbrands the product under section 403(r)(1)(A) of the Act.

Your "Treasure Cave® Reduced Fat Crumbled Blue Cheese" product is misbranded because the product label bears a nutrient content claim but fails to bear the disclosure statement required by 21 CFR 101.13(h). Your product declares the nutrition label value of 380 mg of sodium and 3.5 g of saturated fat per serving ["1/4 cup (28g)"], and bears the claim "Reduced Fat" on the principal display panel (PDP). "Reduced Fat" is a nutrient content claim provided for in 21 CFR 101.62(b)(4). Pursuant to 21 CFR 101.13(h)(1), a food that bears a nutrient content claim and that contains more than 13 g of total fat, 4 g of saturated fat, 60 mg of cholesterol, or 480 mg of sodium per reference amount customarily consumed (RACC), per labeled serving, or, for a food with a RACC of 30 g or less or 2 tablespoons or less, per 50 g, must bear a statement (prominently and in immediate proximity to such claim) disclosing that the nutrient exceeding the specified level is present in the food as follows: "See nutrition information for __content." The nutrition facts panel for this product lists the serving size as 1/4 cup (28 g), the sodium content as 380 mg, and the saturated fat content as 3.5 g. This amounts to 679 mg of sodium and 6.25 g of saturated fat per 50 g. Therefore, your label must bear a disclosure statement such as: "See nutrition information for sodium and saturated fat content"; however, 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 these violations. 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 these violations 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 Seyra Hammond, 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. Hammond at 301-436-3064.
 

Sincerely,
/S/
Jennifer Thomas
Acting Director
Office of Compliance
Center for Food Safety
     and Applied Nutrition
 

cc: Chicago District Office
 

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