FDA calls cheerios an unapproved new drug.

Based on label claims made for Cheerios Toasted Whole Grain Oat Cereal, FDA has issued a warning letter to General Mills, Minneapolis, MN, 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 11/2 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."

FDA's warning letter further states: "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 cholesterol'." In defense of these claims, General Mills responded in a statement saying that Cheerios' soluble fiber heart health claim has been FDA-approved for 12 years, and that its "lower your cholesterol 4% in 6 weeks" message has been featured on the box for more than two years.