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Letter to General Mills Concerning Cheerios® Toasted Whole Grain Oat Cereal Labeling

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DEPARTMENT OF HEALTH & HUMAN SERVICES 
Food and Drug Administration
College Park, MD 20740


May 3, 2012

Roderick Palmore
Executive Vice President, General Counsel and Secretary
Number One General Mills Boulevard
Minneapolis, Minneapolis 55426

Dear Mr. Palmore:

As we discussed previously, FDA would not have any objection to Cheerios® Toasted Whole Grain Oat Cereal labeling bearing the claims below; the optional language portion of the health claim must be included as part of the health claim as required under 21 CFR 101.81(d)(3).

Cheerios® helps lower cholesterol as part of a heart healthy diet. Studies show that three grams of soluble fiber daily from whole grain oat foods, like Cheerios® cereal, in a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. Cheerios® cereal provides 1 gram per serving.

Cheerios® has been shown to help lower cholesterol as part of a heart healthy diet. Studies show that three grams of soluble fiber daily from whole grain oat foods, like Cheerios® cereal, in a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. Cheerios® cereal provides 1 gram per serving.

Cheerios® has been shown in clinical studies to help lower cholesterol as part of a heart healthy diet. Studies show that three grams of soluble fiber daily from whole grain oat foods, like Cheerios® cereal, in a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. Cheerios® cereal provides 1 gram per serving.

We understand that General Mills does not have any issues with respect to the use of the above claims. As such, we view all other issues raised in correspondence related to the warning letter dated May 5, 2009 as moot, and therefore requiring no further action.

Sincerely,

/S/

Michael M. Landa
Director
Center for Food Safety and Applied Nutrition

cc:
Ms. JoAnne Givens
Acting Director
Minneapolis District
Marquette Plaza
Minneapolis District Office
250 Marquette Ave, Suite 600
Minneapolis, MN 55401

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