Does anybody really think a breakfast cereal will lower cholesterol? Two New Jersey residents swear they fell for General Mills' claims that certain types of Cheerios would prevent heart disease by reducing harmful cholesterol in the bloodstream.
Edward Myers and Elsa Acevedo, both of Hudson County, N.J., have filed a class action suit against General Mills and a federal court judge in Newark has consolidated the case with other, similar suits filed by more than 100 other plaintiffs across the country.
In May, the Food and Drug Administration fired off a warning letter to General Mills, taking issue with its claim that Cheerios Toasted Whole Grain Oat Cereal can reduce cholesterol.
In a letter to Ken Powell, Chairman and CEO of General Mills, the FDA said its review of the Cheerios label found serious violations of the Federal Food, Drug and Cosmetic Act. The agency said that if Cheerios reduced cholesterol the way the label said it does, then Cheerios isn't a cereal, its a drug. And an unapproved drug, at that.
The plaintiffs claim they were misled to believe Cheerios had drug-quality properties to reduce their cholesterol levels. The plaintiffs are seeking in excess of $5 million in relief from General Mills.
Science 'not in question'
In a statement issued after the FDA warning last May, the company said Cheerios soluble fiber heart health claim has been FDA-approved for 12 years, and Cheerios lower your cholesterol 4% in 6 weeks message has been featured on the box for more than 2 years.
The science is not in question, the statement said. The scientific body of evidence supporting the heart health claim was the basis for FDAs approval of the heart health claim, and the clinical study supporting Cheerios cholesterol-lowering benefit is very strong. The FDA is interested in how the Cheerios cholesterol-lowering information is presented on the Cheerios package and website. We look forward to discussing this with FDA and to reaching a resolution.
In its warning, the FDA said: 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, the agency wrote.
Specifically, the FDA took issue with the following label claims:
• "You can Lower Your Cholesterol 4 percent 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."
The FDA says these claims indicate that Cheerios is intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia. And that's not all.
According to the FDA's interpretation of the cereal box label, Cheerios is intended for use in the treatment, mitigation, and prevention of coronary heart disease through, lowering total and "bad" (LDL) cholesterol.