FDA Warns General Mills: Cheerios Is a Drug

The Wall Street Journal | May 12, 2009
By Jacob Goldstein

Hey, General Mills: If you want to say Cheerios is “clinically proven to lower cholesterol,” you better get your whole-grain Os approved as a new drug by the FDA.

That’s what the FDA told the company in this letter, which says the labeling on Cheerios boxes is in “serious violation” of federal rules. The letter continues:

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.
What’s more, the letter says, Cheerios “may not be legally marketed with the above claims in the United States without an approved new drug application.”

Food makers can point out that soluble fiber from whole grain oats has been associated with a reduced risk of coronary heart disease. But the wording on the Cheerios labeling doesn’t follow the rules for making that sort of health claim, the letter says.

Here’s a chunk of the statement General Mills sent to 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.”