I Need a New Drug

One of the holy grails for food companies is nutraceuticals: food that improve health.

General Mills thought it had a breakthrough with the cholesterol-lowering claims for its Cheerios brand of cereal. Unfortunately for them, the U.S. Food and Drug Administration (FDA) has a different idea. It has told the food giant to change its packaging or risk an injunction and even seizure of product. The FDA specifically took issue with claims on the box that say “you can Lower Your Cholesterol 4% in 6 weeks” and “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 classify the cereal as a drug according to section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act. Additionally, it falls under the “new drug” section 201(p) of the Act because it is not GRAS (generally recognized as safe) and effective in treating or preventing hypercholesterolemia and coronary heart disease. General Mills is basing its claim on FDA-approved science for soluble fiber, not on any specific studies.

The FDA says it was upset about the Cheerios claim being unsupported by any specific studies, as well as claims for a specific percentage reduction (not allowed under FDA guidelines). The agency also includes the company’s website as part of the “labelling” issue. The allowable health claims for soluble fiber can say “diets low in saturated fat and cholesterol and high in fiber-containing fruit, vegetable, and grain products may reduce the risk of heart disease.” General Mills omitted any reference to fruits and vegetables, implying that Cheerios alone would reduce cholesterol significantly.

The company says it will work with the FDA to resolve the issue, which is sort of like saying you’ll work with a truck bearing down on you to prevent an accident.

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