FDA warns General Mills over Cheerios cholesterol claims
Cheerios…the wonder drug?
That's what the Food and Drug Administration appears to be wondering.
The FDA has sent a warning letter to General Mills, telling the company that its claims about the health benefits of eating Cheerios "would cause it to be a drug because the product is intended for use in the prevention, mitigation and treatment of disease."
The problem: Cheerios are a food not a drug, the FDA notes in the letter, which was sent May 5 but was posted on the agency's website today. Thus, claims that the 68-year-old whole-grain oat cereal lowers cholesterol and reduces the risk of heart disease and cancer violates federal law, the agency said.
The FDA allows some health benefits of foods to be advertised but within strict limits. For instance, a company can say that a diet low in saturated fat and high in fiber-rich foods such as fruit, vegetables and whole grains may reduce the risk of heart disease.
"The claim on your website leaves out any reference to fruits and vegetables, to fiber content and to keeping the levels of saturated fat and cholesterol in the diet low," the agency said. “Therefore, your claim does not convey that all these factors together help to reduce the risk of heart disease and does not enable the public to understand the significance of the claim in the context of the total daily diet.”
The FDA was particularly unhappy about assertions on Cheerios boxes and its website that eating the cereal can "lower your cholesterol 4% in 6 weeks." The FDA counters that the cereal must be approved as a drug before making such specific health claims.
General Mills spokesman Tom Forsythe said the cholesterol-lowering claim has been featured on the Cheerios box for more than two years and that the heart health claim was approved by the FDA 12 years ago. On April 20, General Mills announced results of a clinical study that showed eating two daily servings of Cheerios (1 1/2 cups each) can reduce cholesterol 10% in just a month.
"The science is not in question," he said. "The scientific body of evidence supporting the heart health claim was the basis for FDA's approval of the heart health claim, and the clinical study supporting Cheerios' cholesterol-lowering benefits is very strong."
Forsythe said the company looks forward "to discussing this with the FDA and to reaching a resolution." General Mills faces seizure of products or an injunction against making and distributing Cheerios.
-- Tiffany Hsu
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