When is breakfast cereal a "drug"? When it's Cheerios

General Mills, maker of Cheerios, received a letter from the FDA yesterday warning that the health claims about fiber and heart disease on Cheerios boxes are unauthorized and make the cereal into a "drug." The claims about  fiber show that the product is "intended for use in the prevention, mitigation, or treatment of a disease." 

Some Cheerios boxes say "You can lower cholesterol 4% in 6 weeks."

The letter also states that the Cheerios website is treated part of its labeling because the URL is printed on the box, and the website says "Heart-healthy diets rich in whole grain foods can reduce the risk of heart disease." This statement is not an authorized health claim.

Here are some of the requirements for "qualified health claims" regarding fiber and coronary heart disease from 21 CFR 101.77(c)(2)(i):

(A) The claim states that diets low in saturated fat and cholesterol and high in fruits, vegetables, and grain products that contain fiber may or might reduce the risk of heart disease;

(B) In specifying the disease, the claim uses the following terms: heart disease or coronary heart disease;

(C) The claim is limited to those fruits, vegetables, and grains that contain fiber;

(D) In specifying the dietary fiber, the claim uses the term fiber, dietary fiber, some types of dietary fiber, some dietary fibers, or some fibers; the term soluble fiber may be used in addition to these terms;

(E) In specifying the fat component, the claim uses the terms saturated fat and cholesterol; and

(F) The claim indicates that development of heart disease depends on many factors; and

(G) The claim does not attribute any degree of risk reduction for coronary heart disease to diets low in saturated fat and cholesterol and high in fruits, vegetables, and grain products that contain fiber.