FDA: Don't Advertise Cheerios as a Drug

May 13, 2009 — -- For decades, a sunny yellow box of Cheerios has dominated breakfast tables across the nation. But this morning, the Food and Drug Administration warned the maker of the country's top-selling cereal to clean up its advertising.

The FDA said ads promoting Cheerios as a drug that can "lower your cholesterol 4 percent in six weeks" violates the federal Food, Drug and Cosmetic Act.

The federal agency claims the language on the Cheerios box suggests the cereal is designed to prevent or treat heart disease. Regulators say that only FDA-approved drugs are allowed to make such claims.

The FDA warns that if General Mills doesn't "correct the violations," it risks having its cheery-looking boxes seized by federal agents right off store shelves.

In a letter to the chairman of General Mills, the FDA warned that the company's marketing tactics "cause [Cheerios] to be a drug because the product is intended for use in the prevention, mitigation and treatment of disease."

"Because of these intended uses, the product is a drug ..." the FDA states. "Therefore ... it may not be legally marketed with the above claims in the United States without an approved new drug application."

The letter claimed Cheerios is "misbranded" and that a Cheerios Web site, www.wholegrainnation.com, includes "unauthorized health claims" such as "Heart-healthy diets rich in whole grain foods can reduce the risk of heart disease."

The problem, the letter said, is that the FDA-approved claim must also state that the heart-healthy diet contains "high in fiber-containing fruit, vegetable and grain products. ..."

At the end of the letter, the FDA warned that offending boxes could be taken off the shelves.

"Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products," it said.

FDA Claims Dispute Science or Semantics?

General Mills contended that the fuss is over a disagreement in semantics, not science, and that the health claims on Cheerios have been there for more than two years.

"The scientific body of evidence supporting the heart health claim was the basis for FDA's approval of the heart healthy claim, and the clinical study supporting Cheerios' cholesterol-lowering benefits is very strong," General Mills spokesman Tom Forsythe said in a statement. "The FDA is interested in how the Cheerios' cholesterol-lowering information is presented on the Cheerios package and Web site."

"We look forward to discussing this with the FDA and to reaching a resolution," the statement said.

Regardless of how it is advertised, nutritional experts told "Good Morning America" that whole-grain cereals like Cheerios are crucial to a healthy diet.

"Whole grains help combat high cholesterol because they're high in fiber," Health Magazine contributor Samantha Heller said. "They have vitamins, minerals, proteins, antioxidants. They're really the whole package."

The Cheerios' Web site, which offers a section dedicated to "heart healthy eating," includes a certification by the American Heart Association for products that "meet American Heart Association food criteria for saturated fat and cholesterol for healthy people over age 2."