FDA Warns Cheerios Over False Cholesterol Claims
General Mills Says its Cereal is Clinically Proven Heart Healthy
May 14, 2009
For years, nutritionists have stressed the importance of diets low in fat and high in fiber to curtail heart disease and control cholesterol levels. Cheerios, the General Mills-manufactured whole grain cereal made from oats, has been chanting its FDA-approved “soluble fiber heart healthy” mantra for more than 12 years to the tune of gleeful success.
Consumers in search of healthy food choices reacted favorably to the two year-old message on the box, lauding how eating Cheerios would “lower [your] cholesterol 4% in six weeks,” making the food product a billion dollar top seller. Then, seemingly out of the blue, a red flag was raised and the much-loved cereal came under fire from federal regulators for promoting “unauthorized health claims in its labeling.” Suddenly, General Mills was not smiling so much anymore.
A Letter of Warning
In a May 5, 2009 letter, the US Food and Drug Administration warned General Mills that the company’s claims regarding the cholesterol-lowering, cancer-fighting benefits of its Cheerios brand cereal were “inappropriate,” and that advertising Cheerios as such was in "serious violation of the federal Food, Drug and Cosmetic Act." Issuing letters to manufacturers who exaggerate the benefits of their products, and/or fail to comply with federal regulations in production and marketing, is routine for the FDA.
In September 2008, the FDA initiated a review of the purported health benefits of Cheerios when a Washington-based advocacy group, the National Consumers League, voiced concerns over the cereal’s medicinal claims. A cautionary letter was later sent to General Mills chairman, Ken Powell, requesting that the company address the issues presented within 15 business days, or face removal of Cheerios boxes from grocery store shelves.
Cereal As A Heart Disease Drug?
The FDA alerted General Mills and Cheerios to the insinuations within its marketing slogans, which "cause [Cheerios] to be a drug” because the claims "indicate that Cheerios is intended for use in lowering cholesterol … and ( in the ) prevention of coronary heart disease.” Therefore, Cheerios "may not be legally marketed with the above claims in the United States without an approved new drug application.”
General Mills was quick to respond by defending its position that a high fiber diet, which includes Cheerios, can help lower cholesterol. While it is perfectly legal for food manufacturers to assert the health benefits of their products, the FDA reports that the claims advertised by General Mills on behalf of Cheerios implicitly mislead the public by failing to clarify exactly how the cereal figures into an overall healthy diet designed to lower bad cholesterol levels.
The Devil Is In The Details
In the end, it all comes down to language and placement. The Cheerios website clearly states “Cheerios is the only ready-to-eat cereal clinically proven to lower cholesterol when eaten as part of a diet low in saturated fat and cholesterol.” However, the FDA contends that the actual labeling on the Cheerios cereal box is not as explicit, and that the placement of the authorized, soluble fiber health benefit claim is not adjacent to the claim pertaining to lower cholesterol, thereby constituting separate claims. The agency also reports that the product’s advertising does not adhere to a “specific requirement that the claim not attribute any degree of risk reduction for coronary heart disease.”
In this respect, General Mills erred by asserting that a quantifiable decrease in cholesterol levels of 4% could result from eating Cheerios for precisely six weeks. According to FDA regulators, only drugs approved by the federal agency are allowed to make such claims. Until such a time as Cheerios is classified as a drug (which it won’t, because it is not), the cereal giant remains in violation and, unless it changes the wording on its packaging, may end up in court.
Stay tuned.
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