General Mills Posts Response to FDA

General Mills said today that discussions with the U.S. Food and Drug Administration (FDA) regarding the cholesterol-lowering benefits of the soluble oat fiber in Cheerios continue.

FDA posted to its website today its October 9, 2009, letter to General Mills. In that letter, FDA states that the Johnston study (the clinical study supporting Cheerios’ claim) “appears to provide data that soluble fiber from whole oats can lower LDL cholesterol by an average of 4% in six weeks.”

In conjunction, General Mills also posted its response to FDA on its website today stating, “We agree that this study supports the factual claim on our Cheerios package.” General Mills had also cited several studies that “reinforce that the Cheerios studies are consistent with the body of scientific literature relied upon by FDA when it approved the soluble fiber from oats [coronary heart disease] health claim,” and responded in its letter to questions about those studies.

FDA first contacted General Mills about the cholesterol-lowering benefit claim on packages of Cheerios in May. Since that time, the company has been engaged with FDA in discussions about the matter.

The company has been consistent in its position, stating:

“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 two years. The science is not in question. The scientific body of evidence supporting the heart health claim was the basis for FDA’s approval of the 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 are in dialog with FDA, and we look forward to reaching a resolution"

General Mills repeated that statement today, adding, “Discussions with FDA continue, and we continue to look forward to reaching a resolution.”