General Mills is hoping to brave out the FDA directive that it had better stop claiming that its Cheerios can lower cholesterol or apply to promote the breakfast cereal as a drug.
The labeling on Cheerios boxes is in "serious violation" of federal rules, FDA said.
Food makers can point out that soluble fiber from whole grain oats has been associated with a reduced risk of coronary heart disease. But the wording on the Cheerios labeling doesn't follow the rules for making that sort of health claim, the letter says.
Cheerios was created on June 19, 1941 and is marketed by the General Mills cereal company of Golden Valley, Minnesota, as the first oat-based, ready-to-eat cold cereal. It was called Cheeri Oats at first, later changed to Cheerios because of a trade name dispute.
General Mills defended itself saying:
The science is not in question ... 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."
On its website, the company answers some questions on the issue:
Does FDA's warning letter mean that CheeriosŪ is not eligible to claim that it may lower the risk of coronary heart disease when eaten as part of a diet low in saturated fat and cholesterol?
A. No, CheeriosŪ can make this claim. FDA has issued a regulation authorizing a health claim associating soluble fiber from certain foods, including oats, with a reduced risk of coronary heart disease (21 CFR 101.81). FDA allows this health claim based on significant scientific agreement among qualified experts to support the relationship between soluble fiber in whole oats and coronary heart disease.
Q. Did the warning letter address the appropriateness of CheeriosŪ in a balanced diet?
A. No. In fact, the Dietary Guidelines for Americans encourages the consumption of whole grain foods, which includes whole oats found in products such as CheeriosŪ.
Q. Does the warning letter call into question the safety of CheeriosŪ?
A. There are no safety concerns with CheeriosŪ.
Q. What additional actions is FDA taking?
A. FDA will meet with General Mills and other food companies at their request to discuss how they can make appropriate, evidence-based labeling claims.