PhotoThe Food and Drug Administration has fired off a warning letter to cereal maker General Mills, taking issue with its claim that Cheerios Toasted Whole Grain Oat Cereal can reduce cholesterol.

In a letter to Ken Powell, Chairman and CEO of General Mills, the FDA said its review of the Cheerios label found serious violations of the Federal Food, Drug and Cosmetic Act. The agency said that if Cheerios reduced cholesterol the way the label said it does, then Cheerios isn't a cereal, its a drug. And an unapproved drug, at that.

Based on claims made on your product's label, we have determined that your Cheerios Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease, the agency wrote.

Specifically, the FDA took issue with the following label claims:

• "You can Lower Your Cholesterol 4 percent in 6 weeks"

• "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."

The FDA says these claims indicate that Cheerios is intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia. And that's not all.

According to the FDA's interpretation of the cereal box label, Cheerios is intended for use in the treatment, mitigation, and prevention of coronary heart disease through, lowering total and "bad" (LDL) cholesterol.

Elevated levels of total and LDL cholesterol are a risk factor for coronary heart disease and can be a sign of coronary heart disease.

Because of these intended uses, the product is a drug within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. 321 (g)P)(B)], the agency said. The product is also a new drug under section 201(p) of the Act [21 U.S.C. 321(p)] because it is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease. Therefore,under section 505(a) of the Act [21 U.S.C. 355(a)], it may not be legally marketed with the above claims in the United States without an approved new drug application.

FDA has issued a regulation authorizing a health claim associating soluble fiber from whole grain oats with a reduced risk of coronary heart disease.

Like FDA's other regulations authorizing health claims about a food substance and reduced risk of coronary heart disease, this regulation provides for the claim to include an optional statement, as part of the health claim, that the substance reduces the risk of coronary heart disease through the intermediate link of lowering blood total and LDL cholesterol, the agency said.

The FDA said the claims made on the cereal box are not part of the soluble fiber/coronary heart disease health claim authorized under 21 CFR 101.81, and are therefore not permitted.

The agency said Cheerios is a misbranded product because it bears unauthorized health claims in its labeling. It also determined that the company's Web site, wholegrainnation.com, is part of the Cheerios label because the address appears on the product label.

That's problematic, the agency says, because the Web site makes several unauthorized health claims, including heart-healthy diets rich in whole grain foods can reduce the risk of heart disease.

The agency said General Mills must respond to the warning letter within 15 days outlining specific steps it has taken to correct the violations.

In a statement, the company said Cheerios soluble fiber heart health claim has been FDA-approved for 12 years, and Cheerios lower your cholesterol 4% in 6 weeks message has been featured on the box for more than 2 years.

The science is not in question, the statement said. The scientific body of evidence supporting the heart health claim was the basis for FDAs approval of the heart health claim, and the clinical study supporting Cheerios cholesterol-lowering benefit is very strong. The FDA is interested in how the Cheerios cholesterol-lowering information is presented on the Cheerios package and website. We look forward to discussing this with FDA and to reaching a resolution.