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The FDA Warns Cheerios© Makers to Cease Cholesterol Claims

General Mills Receives Warning for Marketing Cheerios©  as an Unapproved New Drug » Misbranded Food

The FDA recently sent a warning letter to Ken Powell, Chairman and CEO of General Mills, Inc., citing the marketing for Cheerios© is claiming the food is intended to treat the disease hypercholesterolemia.  The product labeling contains specific claims to "Lower Cholesterol by 4 percent in 6 weeks" and that Cheerios©  was "Clinically proven to lower cholesterol ... A clinical study showed that eating two 1 1/2 cup servings daily of Cheerios© cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol."

General Mills responded by stating the claims were valid if the cereal was eaten in conjunction with a diet low in cholesterol and saturated fat. The Cheerios© cholesterol reduction claims go far beyond what the FDA considers approved food marketing.

The Head of the FDA's Center for Food Safety, Dr Steven Sundloff, stated the action was "not to impugn Cheerios©", which he claimed is "a product that can be part of a healthy diet." However, he said, "The packaging clearly carries a drug claim ... The industry is really looking at these health claims as a good marketing tool, and we’re seeing more and more companies trying to differentiate their product through health claims. As they do that, they do have a tendency to go too far ..."

Mr. Silverglade continued by stating, "This is the strongest action that the US FDA has taken against misleading health claims for food in almost a decade, and it represents a major reversal from the lack of consumer enforcement under the Bush administration ... "

According to General Mills, the cholesterol reduction claims for Cheerios©  were "not in question" and the FDA's complaint targeted how "cholesterol-lowering information is presented on the Cheerios package and web site." The action for the FDA's complaint followed notification from The National Consumer League consumer advocacy group.