MINNEAPOLIS — Six months after the Food and Drug Administration 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, the two sides appear no closer to a resolution.
At the heart of the matter appears to be General Mills’ unwavering support for specific studies that back its claim versus the F.D.A.’s desire for a totality of evidence beyond just the studies provided by General Mills.
In its warning letter issued in May, the F.D.A. said 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."
In response to the F.D.A.’s warning, General Mills provided the F.D.A. with the results of several studies supporting its claims. But according to a subsequent letter from the F.D.A., those studies all used Cheerios and therefore do not provide an accurate picture of the claim in question.
"To decide whether the total body of publicly available scientific evidence supports amending the soluble fiber/coronary heart disease health claim to provide for an optional statement that soluble fiber from whole oats can reduce L.D.L. cholesterol by a scientific percentage, we would have to review all relevant studies that have evaluated the relationship between soluble fiber from whole oats and L.D.L. cholesterol reduction for a sufficient duration, not just the Cheerios studies you submitted," the F.D.A. said in an Oct. 9 letter. "Four studies submitted by General Mills evaluated the effect of consuming soluble fiber from whole oats on blood cholesterol levels. These studies all used Cheerios as the dietary source of soluble fiber from whole oats."
General Mills followed up with another letter to the F.D.A. on Nov. 3 stating its case for the claim and on Nov. 17 posted a response on its web site stating its position regarding the cholesterol-lowering benefits of the soluble oat fiber in Cheerios has been consistent.
"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 two years," General Mills said Nov. 17. "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 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 are in dialog with F.D.A., and we look forward to reaching a resolution."