According to the FDA, Cheerios is a drug, and must be regulated as such.
The FDA sent a warning to Cheerios maker General Mills Inc. that it is in serious violation of federal rules.
“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 FDA letter said. “[Cheerios] may not be legally marketed with the above claims in the United States without an approved new drug application.”
If the FDA were to win its enforcement action against Cheerios, all the boxes would have to be pulled from grocery-store shelves, and children could only get their morning “fixes” with a prescription from their doctors.
Two claims on the Cheerios cereal box upset the FDA: “Cheerios is clinically proven to reduce cholesterol 4 percent in 6 weeks” and, “Cheerios can help reduce the risk of coronary heart disease, by lowering the ‘bad’ cholesterol.”