WASHINGTON — The Food and Drug Administration on May 5 issued a warning letter to General Mills, Inc. advising the Minneapolis-based company that the label and labeling of its Cheerios Toasted Whole Grain Oat cereal is in violation of the Federal Food, Drug and Cosmetic Act.
According to the F.D.A., the claims made on the Cheerios packages are such that the cereal is promoted for conditions that cause it to be a drug. The claims in question include "You can Lower Your Cholesterol 4% in 6 weeks" and "Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4%? Cheerios is … clinically proven to lower cholesterol. A clinical study showed that eating two 11/2 cup servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol."
"These claims indicate that Cheerios is intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia," the F.D.A. wrote in its May 5 letter. "Additionally, the claims indicate that Cheerios is intended for use in the treatment, mitigation and prevention of coronary heart disease through lowering total and ‘bad’ (L.D.L.) cholesterol."
These intended uses, the F.D.A. said, qualify Cheerios as a drug, and therefore require that the product must not be marketed with such claims in the United States without an approved new drug application.
The F.D.A. also pointed out that while it has issued a regulation authorizing a health claim associating soluble fiber from whole grain oats with a reduced risk of coronary heart disease, the Cheerios claims fail to meet the requirement because the two claims about lowering cholesterol are not made as part of the approved heart health claim in the lower left corner of the box, but instead are presented as separate, stand-alone claims through their location on the package and other label design features.
"The cholesterol claim that mentions the clinical study is on the back of the Cheerios box, completely separate from the health claim on the front label," the F.D.A. said. "Although the other cholesterol claim is on the same panel as the authorized health claim, its prominent placement on a banner in the center of the front label, together with its much larger font size, different background, and other text effects, clearly distinguish it from the health claim in the lower left corner."
The claims in question also violate the provisions of the soluble fiber health claim in that they specifically attribute a degree of risk reduction for coronary heart disease, the F.D.A. noted.
In addition to labeling on Cheerios, the F.D.A. took exception to the manner in which General Mills has branded the product on its www.wholegrainnation.com web site. By bearing the claim "Heart-healthy diets rich in whole grain foods can reduce the risk of heart disease," General Mills has failed to fully convey the authorized health claim that states "Diets rich in whole grain foods and other plant foods, and low in saturated fat and cholesterol, may help reduce the risk of heart disease." By omitting "other plants foods" the F.D.A. said General Mills’ is not conveying that all these factors together help to reduce the risk of heart disease, not just whole grains alone.
General Mills has 15 days from the receipt of the letter to inform the F.D.A. as to what steps it has taken to correct the violations and ensure they don’t occur in the future. But Tom Forsythe, a spokesman for General Mills, said "Cheerios’ soluble fiber heart health claim has been F.D.A.-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 scientific body of evidence supporting the heart health claim was the basis for F.D.A.’s approval of the heart health claim, and the clinical study supporting Cheerios’ cholesterol-lowering benefit is very strong. The F.D.A. is interested in how the Cheerios cholesterol-lowering information is presented on the Cheerios package and web site. We look forward to discussing this with F.D.A. and to reaching a resolution."The full letter is available at www.accessdata.fda.gov/scripts/wlcfm/recentfiles.cfm.