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Federal Law
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Of Note:


In a May 5 warning letter sent to the company and posted on the FDA's Web site Tuesday, the agency said statements that the product is"clinically proven to help lower cholesterol" make the product a drug under federal law.

The FDA said such specific cholesterol-lowering claims can be made only for drugs, and it suggested that if General Mills wants to keep the box labeling as is, it should file a new-drug application for Cheerios.

The FDA said General Mills must "promptly" correct the violations outlined in the letter or the agency could take enforcement action, such as seizing products.


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Ok maybe the Frosted Mini-Wheats claim is a stretch - clinically shown to improve children's attentiveness by nearly 20%.

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Cheerios' Health Claims Break Rules, FDA Says




By JENNIFER CORBETT DOOREN
The Wall Street Journal
May 13, 2009

The Food and Drug Administration slapped General Mills Inc. with a warning over its Cheerios cereal, saying the box's claims about heart benefits contain "serious violations" of federal law.

In a May 5 warning letter sent to the company and posted on the FDA's Web site Tuesday, the agency said statements that the product is "clinically proven to help lower cholesterol" make the product a drug under federal law.

Stephen Sundlof, the director of the FDA's food-safety center, said the agency has noticed a tendency by food companies to cross the line into the drug category by making specific health claims on packaging.

He said the FDA is ready to send out more warning letters if it finds more violators, although it has "no specific campaign" to go after food manufacturers.

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FDA warning letter to General Mills


General Mills spokesman Tom Forsythe said the Cheerios box's message saying the cereal can "lower your cholesterol 4% in six weeks" has been used for more than two years. The box cites a clinical study involving Cheerios as part of a diet low in saturated fat and cholesterol.

Mr. Forsythe said the broader claims on the box about heart health have been permitted by the FDA for 12 years. "The clinical study supporting Cheerios' cholesterol-lowering benefit is very strong," he said.

The FDA said such specific cholesterol-lowering claims can be made only for drugs, and it suggested that if General Mills wants to keep the box labeling as is, it should file a new-drug application for Cheerios.

Mr. Forsythe said the company would work with the agency to reach a "resolution" on the Cheerios labeling.

"We try to make a bright line here between what can be said about a drug and what can be said about a food," said Dr. Sundlof. He said a more general claim about reduction in heart-disease risk from eating whole-grain foods may be permissible as long as specific language is used.

The FDA also took issue with a company-sponsored Web site mentioned on the Cheerios box. The Web site discusses the benefits of eating whole grains, but the FDA said some of the health claims about reducing cancer and heart-disease risk don't comply with agency rules.

The FDA said General Mills must "promptly" correct the violations outlined in the letter or the agency could take enforcement action, such as seizing products.

Dr. Sundlof said the FDA's review of Cheerios was prompted by a September 2008 letter from the National Consumers League that expressed concerns about the labeling on Cheerios.

The FDA isn't the only Washington agency in the Obama administration taking a close look at food makers' health claims. Last month the Federal Trade Commission settled a complaint with Kellogg Co. involving claims that its Frosted Mini-Wheats cereal was clinically shown to improve children's attentiveness by nearly 20%.

FTC Chairman Jon Leibowitz said the commission would start paying more attention to national advertisers.

The FDA is showing signs of taking a more aggressive stance toward the companies it regulates under acting Commissioner Joshua Sharfstein, who is slated to become principal deputy commissioner once President Barack Obama's nominee for commissioner, Margaret Hamburg, is confirmed.

Dr. Sharfstein wrote a letter to lawmakers released this week saying he wants to review the agency's approval in the final days of the Bush administration of a knee device. The device was cleared over the objections of several scientists and managers at the agency.


The Wall Street Journal






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CNN: Cheerios Cereal "Busted By The Feds"