Thanks to pressure from a complaint filed in September by the National Consumer League, a consumer advocacy group, the FDA has accused General Mills of marketing Cheerios as a drug and disputes the misleading claims that’s printed on all their Cheerios cereal boxes about lowering cholesterol and reducing the risks of heart disease.
FDA Warning letter to General Mills:
Chairman of the Board and CEO
One General Mills Boulevard
Minneapolis, Minnesota 55426
Dear Mr. Powell:
The Food and Drug Administration (FDA) has reviewed the label and labeling of your Cheerios® Toasted Whole Grain Oat Cereal. FDA’s review found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR). You can find copies of the Act and these regulations through links in FDA’s home page at http://www.fda.gov.
Unapproved New Drug
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 ort 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.”
“This is the strongest action that the US FDA has taken against misleading health claims for food in almost a decade, and it represents a major reversal from the lack of consumer enforcement under the Bush administration,” said Bruce Silverglade, legal director of the Center for Science in the Public Interest.
“The science is not in question,” said [General Mills] spokesman Tom Forsythe in a statement. “The clinical study supporting Cheerios’ cholesterol-lowering benefit is very strong.”