FDA sinks Cheerios health claims; calls cereal an ‘unapproved drug'

In a recent warning letter to General Mills, the Food and Drug Administration said that some of the health claims made on Cheerios boxes, and on promotional websites go far beyond what is allowed for foods, and that based on those claims, the cereal would be more properly classified as an unapproved drug. The warning letter may be a sign that the FDA is forging a tougher line against misleading health claims.

Among the claims that the FDA singled out is the banner on the Cheerios box claiming, "you can lower your cholesterol 4 percent in 6 weeks." In 2005, the Nutrition Action Healthletter*, published by the Center for Science in the Public Interest, looked into the study that this claim is based on and found it lacking. Paid for by General Mills, the 1997 study found that given three servings of Cheerios a day (along with a diet low in saturated fat), the average subject with high LDL (bad) cholesterol saw a drop-off of seven points, from 160-153, but still far above the optimal level of 100, according to the Nutrition Action Healthletter.

While the industry-funded study suggests that Cheerios, along with a diet low in saturated fat, may have a moderate cholesterol lowering effect, does it really warrant the banner claims on the cereal boxes?

That's where the FDA picks up. The agency said that the claim to prevent, mitigate, or treat diseases, including high cholesterol, heart disease, and some cancers, classified the cereal as a drug, and that because it is not generally recognized as safe and effective for those uses, it would be a new, or unapproved drug.

The agency also admonished General Mills' labeling for promoting the benefits of the whole grains in Cheerios without providing context of other important dietary factors. An FDA approved health claim would include that diets rich in fiber from fruits, vegetables, and whole grains and low in fat and cholesterol, may reduce the risk of heart disease, as well as certain cancers. Finally, the Cheerios labels went beyond what food labels are allowed to say by claiming specific degrees of risk reduction the product supposedly offers.

It's not that Cheerio's is unhealthy. In fact, when we rated children's cereals last year, Cheerios rated highest out of 27 brands we tested. It is relatively low in sugar and high in fiber, the two most important factors in cereals. But cereal isn't a medicine that can cure a disease. A healthy diet can play an important role in preventing disease, and mitigating its effects, but when food manufacturers make overly broad claims, it doesn't help anyone but those selling it.

Here are some of the other health claims the FDA cited:

• "Cheerios is...clinically proven to lower cholesterol."
• "Heart healthy diets rich in whole grain foods can reduce the risk of heart disease."
• "Regular consumption of whole grains as part of, a low-fat diet reduces the risk for some cancers, especially cancers of the stomach and colon."

 —Kevin McCarthy, associate editor

*links to PDF