Cheerios Claim, “lower your cholesterol 4% in six weeks” Makes it a Drug, Says FDA

The Food and Drug Administration gave General Mills Inc. a warning over its Cheerios cereal, saying the box’s claims about heart benefits contain “serious violations” of federal law. The FDA claims statements that the product is “clinically proven to help lower cholesterol” make the product a drug under federal law.

The FDA also took issue with a company-sponsored Web site mentioned on the Cheerios box. The Web site discusses the benefits of eating whole grains, but the FDA said some of the health claims about reducing cancer and heart-disease risk don’t comply with agency rules.

Cheerios response is as follows on

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 two years.

The science is not in question. The scientific body of evidence supporting the heart health claim was the basis for FDA’s approval of the 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 are in dialog with FDA, and we look forward to reaching a resolution.