The Food and Drug Administration apparently is getting serious about cracking down on cereal makers who love to claim that their products can lower cholesterol or cure club foot or something. The first on the FDA hit list is Cheerios, with its cheery label noting that the toasted whole-grain O’s are “Clinically PROVEN to Help Reduce Cholesterol!”

In a warning letter to Ken Powell, chairman and CEO of General Mills, the FDA wrote:

Based on claims made on your product’s label, we have determined that your Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease. Specifically, your Cheerios® product bears the following claims ort its label:

• “you can Lower Your Cholesterol 4% in 6 weeks”
• “Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is … 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.”

The letter goes on to say:

The product is also a new drug under section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease. Therefore,under section 505(a) of the Act [21 U.S.C. § 355(a)], it may not be legally marketed with the above claims in the United States without an approved new drug application.

As Marion Nestle points out over at the Atlantic Food Channel, Cheerios’ cholesterol-lowering claim is based on some rather generous General Mills eating habits. “[T]he trial on which General Mills bases this claim substitutes one serving of Cheerios for each of two meals a day. Hey—that ought to work!”

The interesting thing to me is that General Mills doesn’t seem embarrassed or even bowed by all this negative publicity. In a statement submitted to the Dow Jones Newswires, the company had this to say:

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.