If FDA Says Cheerios is a Drug then I must be an Addict

The FDA is going after General Mills for claiming that Cheerios is "clinically proven to lower cholesterol" without getting approved as a new drug.

In a letter to General Mills, the FDA says that the labeling on the Cheerios boxes is "in serious violation" of federal rules and that Cheerios, " may not be legally marketed with the above claims in the United States without an approved new drug application." The letter further states,

"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."


The Cheerios box states the following :

"Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is the only leading cold cereal 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.

W. Charles Becoat, Minneaplis district director for the FDA says that the wording on the box implies that Cheerios is intended for use in "preventing, mitigating, and treating the disease hypercholesterolemia" Becoat goes on to say that the claims suggests that Cheerios can be used to treat and prevent heart disease by lowering total and "bad" cholesterol.

Becoat explains that because Cheerios was not FDA approved as a new drug, "it may not be legally marketed with the above claims."

Even though food producers can prove that soluble fiber from whole grain oats can reduce the risk of coronary heart disease, the Cheerios box label does not follow the FDA's rules for making such a claim.

General Mills sent a statement to the Dow Jones newswires this morning:
"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.”

Though people are saying this is a silly argument over semantics, it's one that should definitely be addressed due to the seriousness of such medical claims.