The FDA recently sent General Mills a Warning Letter informing General Mills that certain statements made in the advertisements for Cheerios violate the Food and Drug Act. The FDA determined that these claims were improper because the claims would cause Cheerios to be classified as a drug, rather than a food. This would violate the Food and Drug Act because General Mills has not taken the proper steps to have Cheerios approved as a drug.

The claims made by General Mills that would cause Cheerios to be categorized as a drug, rather than a food, are:

• "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 problem with these statements, according to the FDA, is that they are not adequately supported by scientific studies. However, this appears more to be an issue of semantics than safety, as the FDA recognizes that soluble fiber from whole grain oats (the main ingredient in Cheerios) is associated with lowering cholesterol and reducing the risk of heart disease. General Mills does state on the front of the Cheerios box that the whole grain oats found in Cheerios contain soluble fiber, which can lower cholesterol and the risk of heart disease. However, the above claims about lowering cholesterol appear on the back of the Cheerios box. The FDA suggests that the claims regarding cholesterol on the back of the box would have been proper if General Mills had put them on the same side of the box as the claim about soluble fiber.

Adverse events associated with pharmaceutical drugs and devices are suffered and reported on a daily basis. Many of these drugs and devices cause serious, life-threatening injuries. In the case of Cheerios, however, the FDA recognizes that there are no safety concerns associated with Cheerios, and in fact, consumption of whole grain foods such as Cheerios is encouraged. The public would be better served if the FDA focused their efforts toward policing these dangerous drugs and devices, rather than picking on Cheerios, which the FDA admits is safe and encourages people to consume as part of a healthy diet.

Labels: Cheerios, cholesterol, coronary, drugs, FDA, fiber, food, heart disease, oats, soluble fiber, whole grain