Cheerios Called On the Carpet by FDA

Cheerios, first introduced as Cheeri Oats in 1941, has become America’s favorite cereal; popularity that, by the manufacturer’s own admission, was influenced by the marketing of the breakfast food’s health benefits. Statements from the box include: “Cheerios is clinically proven to lower cholesterol” and “Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent?” The company sponsored website mentioned on the box goes on to suggest that eating the whole grain O’s can “reduce the risk of heart disease and help reduce the risk of certain types of cancers, especially of the stomach and colon.” These claims may have helped to win over an increasingly health conscious public, but they have drawn fire from U.S. regulators who say the language is in “serious violation” of federal rules.

In a letter to Cheerios’ manufacturer General Mills, the U.S. Food and Drug Administration (FDA) warned that the wording on the cereal’s box suggests it is intended for use in preventing or treating heart disease by lowering cholesterol, claims only FDA-approved drugs are allowed to make. They also pointed out that federal regulations do not permit companies to quantify the benefit of their foods, which General Mills does when it claims an average 4 percent reduction in bad cholesterol. “We certainly don’t have any issues with the safety of Cheerios,” Stephen Sundlof, director of the FDA’s Center for Food Safety and Applied Nutrition, said in an interview. “We just believe that the labeling on this particular product has gone beyond what the science supports.”
 
The agency says it does allow whole-grain products to carry certain claims about reducing heart disease and cancer risk, but they must state explicitly that such foods need to be part of diets that are also low in saturated fats and cholesterol and high in fiber-rich fruits and vegetables as well as grains. “The claim on your website leaves out any reference to fruits and vegetables, to fiber content, and to keeping the levels of saturated fat and cholesterol in the diet low,” the FDA letter said. “Therefore, your claim does not convey that all these factors together reduce the risk of heart disease and does not enable the public to understand the significance of the claim in the context of total daily diet.”

General Mills responded by saying the “lower your cholesterol 4 percent in 6 weeks” has been featured on the box for more than two years and claims about heart health have been FDA-approved for twelve years. “The science is not in question,” spokesman Tom Forsythe said in a statement. “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 Web site,” Forsythe said. “We look forward to discussing this with FDA and to reaching a resolution.” General Mills now has 15 business days to correct the violations outlined in the letter. Failure to respond can result in enforcement actions, such as fines or seizure of products.

In recent years, the FDA has begun to crack down on manufacturers who overstate the benefits of their products. In April, Kellogg settled charges that it falsely advertised its Frosted Mini-Wheats cereal to improve children’s attentiveness. The Federal Trade Commission said the clinical study Kellogg cited found that only half the children who ate the cereal showed any improvement in their attentiveness.

“We stand behind the clinical results,” David Mackay, Kellogg’s Chief Executive Officer said in an April interview. “Their concern was that it may have tried to say something that we weren’t intending to say. We made that modification and we move on with life”