JULY 2009

Are those toasted-oat “Os” in your breakfast bowl of cereal really an “unapproved new drug”? That’s what the US Food and Drug Administration (FDA) says in a warning letter to General Mills, maker of Cheerios. Citing “unauthorized health claims,” the FDA said Cheerios can continue to make its cholesterol-lowering boasts only if General Mills applies for approval of the cereal as a drug. The agency singled out claims both on cereal boxes and the product’s website that Cheerios can “reduce bad cholesterol by an average of 4%“ in six weeks.

Such language violates FDA rules against claims of any specific degree of risk reduction. W. Charles Becoat, the agency’s Minneapolis district director, said the claim suggests that Cheerios can be used much like a prescription drug to treat and prevent heart disease by lowering total and LDL (“bad”) cholesterol. Since the cereal has not been approved under FDA drug rules, Becoat stated, “it may not be legally marketed with the above claims.”

Claims on the Cheerios website, Becoat added, fail to include complete FDA language that soluble fiber from whole-grain oats can improve cholesterol only as part of an overall healthy diet. He told the company the claim “leaves out any reference to fruits and vegetables, to fiber content, and to keeping the levels of saturated fat and cholesterol low.”

A General Mills statement said, “We look forward to discussing this with FDA and to reaching a resolution.”