Based on label claims made for Cheerios Toasted Whole Grain Oat Cereal, FDA has issued a warning to General Mills that the product is being promoted as an unapproved new drug.

Product claims include: “you can Lower Your Cholesterol 4% in 6 weeks”; and “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 product’s website also bears the following unauthorized health claim, according to FDA: “Heart-healthy diets rich in whole grain foods, can reduce the risk of heart disease.”

According to an FDA warning letter sent to General Mills, “These claims indicate that Cheerios is intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia. Additionally, the claims indicate that Cheerios is intended for use in the treatment, mitigation, and prevention of coronary heart disease through, lowering total and “bad” (LDL) cholesterol.”

General Mills reportedly defended the claims on Cheerios packaging, saying in a statement that Cheerios’ soluble fiber heart health claim has been FDA-approved for 12 years, and that its “lower your cholesterol four percent in six weeks” message has been featured on the box for more than two years.

FDA has authorized a health claim associating soluble fiber from whole grain oats with a 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.

Although the lower left corner of the Cheerios front label contains an authorized soluble fiber/coronary heart disease health claim, the two claims about lowering cholesterol are not made as part of that claim, but rather are presented as separate, stand-alone claims through their location on the package and other label design features, FDA said.

The cholesterol claim that mentions the clinical study is on the back of the Cheerios box, completely separate from the health claim on the front label. Although the other cholesterol claim is on the same panel as the authorized health claim, its prominent placement on a banner in the center of the front label, together with its much larger font size, different background, and other text effects, clearly distinguish it from the health claim in the lower left corner.

Also, to use the soluble fiber health claim, companies cannot attribute any degree of risk reduction for coronary heart disease to diets that include foods eligible to bear the claim.