By Lorraine Heller, 13-May-2009
General Mills has been told to change the marketing of its popular Cheerios whole grain cereal, as the health claims it currently uses classify it as an unapproved drug.
The food giant has until next week to inform the US Food and Drug Administration (FDA) of steps it intends to take to correct its product marketing, or it may be faced with an injunction or product seizure.
In a warning letter sent last week, the regulatory agency said the cholesterol lowering claims made on Cheerios Toasted Whole Grain Oat Cereal implied the product was intended to treat or prevent a disease – hypercholesterolemia and heart disease.
Problem claims
FDA specifically took issue with the following claims, made on the cereal packet:
• “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.”
According to the agency, these claims classify the product as a drug within the meaning of section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act, as it is intended for use in the prevention, mitigation and treatment of a disease. The product is also considered a new drug under section 201(p) of the Act because it is not generally recognized as safe and effective in treating or preventing hypercholesterolemia and coronary heart disease.
What’s allowed?
The line between functional foods and drugs is a fine one, and often depends on the intricacies of the wording used in health claims.
General Mills said it based its product statements on the FDA-approved soluble fiber heart health claim. The science supporting its product is not in question, it said.