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FDA: Cholesterol Claim Makes Cheerios an 'Unapproved Drug'

MedpageToday

WHEELING, W.Va., May 12 -- Cereal maker General Mills can continue to claim Cheerios cereal lowers cholesterol only if it wins FDA approval for the product as a drug, the agency told the company.


In a warning letter to to the company, the FDA cited statements on the Cheerios box about its cholesterol-lowering ability as "unauthorized health claims."


As a result, Cheerios is an "unapproved new drug" under FDA regulations, the letter said.


Consider these statements from the box: "Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is . . . clinically proven to lower cholesterol. A clinical study showed that eating two 1-1/2 cup servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol."


In the letter to General Mills, FDA's Minneapolis district director, W. Charles Becoat, said the wording indicates that Cheerios is intended for use "in preventing, mitigating, and treating the disease hypercholesterolemia."


Becoat added that the claim suggests a use in treating and preventing heart disease by lowering total and "bad" cholesterol.


Since Cheerios was not FDA approved under a new drug application, Becoat said, "it may not be legally marketed with the above claims."


The letter also took issue with additional health-related boasting on the Cheerios website.


They included assertions that "heart-healthy diets rich in whole grain foods can reduce the risk of heart disease" and that such diets may "reduce the risk of certain types of cancers . . . especially cancers of the stomach and colon."


Becoat said the FDA permits whole-grain products to carry certain claims about reducing heart disease and cancer risk.


But these must state explicitly that such products need to be part of diets that are also low in saturated fats and cholesterol, and high in fiber-rich fruits and vegetables as well as grains.


"The claim on your website leaves out any reference to fruits and vegetables, to fiber content, and to keeping the levels of saturated fat and cholesterol in the diet low," Becoat told the company.


He also pointed out that FDA regulations forbid claims of any specific degree of risk reduction associated with high-fiber products or diets.


General Mills issued a statement saying the clinical research supporting the cholesterol-lowering claim "is very strong."


"We look forward to discussing this with FDA and to reaching a resolution," the statement said.


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