FDA: Cheerios Can't Claim Cholesterol Health Benefits

Photo: Lara Robby / Studio D

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Just weeks after Kellogg agreed to stop a national advertising campaign that misleadingly claimed its Frosted Mini Wheats boost kids' attention spans, General Mills has been ordered by the Food and Drug Administration to scale back its claims about what Cheerios can do for your health. In essence, General Mills had been claiming that a box of Cheerios is a powerful drug designed to lower cholesterol, fight heart disease and high blood pressure, when in fact ... it is a breakfast cereal.

This is a strong reminder to consumers that the health claims on food packaging can often be misleading. We sometimes tend to think of food as medicine, when it is not. A varied, balanced diet, with more plants than meat, and fewer processed foods, is the most commonsense diet for most people. Cereal can be a part of that diet, for sure, but we shouldn't think of fortified cereals or processed whole wheats as the solution to our health problems, or the key to losing weight. The Daily Green promotes simple guidelines like eating real food. If it isn't packaged, it can't make misleading health claims, and you know exactly what it is (an apple is an apple is an apple). For more tips on how to green your diet, and avoid misleading advertising claims, see The Daily Green's Earth Day Diet.

In a strongly worded letter, the FDA told General Mills:

Based on claims made on your product's label, we have determined that your Cheerios Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease. Specifically, your Cheerios product bears the following claims on its label:

• "you can Lower Your Cholesterol 4% in 6 weeks"
• "Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is ... clinically proven to lower cholesterol. A clinical study showed that eating two 1 1/2 cup servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol."

These claims indicate that Cheerios is intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia. Additionally, the claims indicate that Cheerios is intended for use in the treatment, mitigation, and prevention of coronary heart disease through, lowering total and "bad" (LDL) cholesterol. Elevated levels of total and LDL cholesterol are a risk factor for coronary heart disease and can be a sign of coronary heart disease. Because of these intended uses, the product is a drug (by law).... The product is also a new drug ... (by law) because it is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease. Therefore ... it may not be legally marketed with the above claims in the United States without an approved new drug application....

Your Cheerios product is misbranded ... because it bears unauthorized health claims in its labeling.... This website bears the following unauthorized health claims:

• "Heart-healthy diets rich in whole grain foods, can reduce the risk of heart disease" ....
• "Including whole grain as part of a healthy diet may ... [h]elp reduce the risk of certain types of cancers. 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." ....

This letter is not intended to be an all-inclusive review of your products and their labeling. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations.

Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.

Can you just imagine a government raid to seize "violative products" when those products are boxes of Cheerios?

General Mills responded to the complaint by stating that "Cheerios' health claims were 'not in question' and that the complaint focused on how 'cholesterol-lowering information is presented on the Cheerios package and web site,'" according to a Financial Times report.

The Center for Science in the Public Interest, which applauded the FDA enforcement as "long overdue" and called this action the strongest to date by the FDA in cracking down on misleading health claims. It summed up the enforcement this way:

"The company claims that Cheerios can reduce "bad" cholesterol levels by 4 percent in just 6 weeks and ward off heart disease and cancers of the colon and stomach. The claims are plastered on Cheerios packages, the General Mills web site, and are even announced on supermarket public address systems. The FDA has approved a more general health claim that eating diets low in saturated fat and cholesterol, and high in fiber-containing fruit, vegetable, and grain products may reduce the risk of heart disease. But the claims for Cheerios portrayed the mentioned diseases not included in the FDA-authorized claim and failed to mention the importance of eating a diet low in saturated fat and cholesterol."

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