Processing Magazine

Cheerios'' health claims break rules, FDA says

May 13, 2009
The Food and Drug Administration slapped General Mills Inc. with a warning over its Cheerios cereal, saying the box''s claims about heart benefits contain "serious violations" of federal law, reports the Associated Press. In a May 5 warning letter sent to the company and posted on the FDA''s Web site, the agency said statements that the product is "clinically proven to help lower cholesterol" make the product a drug under federal law. Stephen Sundlof, the director of the FDA''s food-safety center, said the agency has noticed a tendency by food companies to cross the line into the drug category by making specific health claims on packaging. He said the FDA is ready to send out more warning letters if it finds more violators, although it has "no specific campaign" to go after food manufacturers. General Mills spokesman Tom Forsythe said the Cheerios box''s message saying the cereal can "lower your cholesterol 4% in six weeks" has been used for more than two years. The box cites a clinical study involving Cheerios as part of a diet low in saturated fat and cholesterol. The FDA has permitted the broader claims on the box about heart health for 12 years. The FDA said such specific cholesterol-lowering claims can be made only for drugs, and it suggested that if General Mills wants to keep the box labeling as is, it should file a new-drug application for Cheerios. Mr. Forsythe said the company would work with the agency to reach a "resolution" on the Cheerios labeling. 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. The FDA said General Mills must "promptly" correct the violations outlined in the letter or the agency could take enforcement action, such as seizing products. Dr. Sundlof said a September 2008 letter from the National Consumers League that expressed concerns about the labeling on Cheerios prompted the FDA’s review of Cheerios. The FDA isn''t the only Washington agency in the Obama administration taking a close look at food makers'' health claims. Last month the Federal Trade Commission settled a complaint with Kellogg Co. involving claims that its Frosted Mini-Wheats cereal was clinically shown to improve children''s attentiveness by nearly 20%.