The food giant has until next week to inform the US Food and Drug Administration (FDA) of steps it intends to take to correct its product marketing, or it may be faced with an injunction or product seizure.
In a warning letter sent last week, the regulatory agency said the cholesterol lowering claims made on Cheerios Toasted Whole Grain Oat Cereal implied the product was intended to treat or prevent a disease – hypercholesterolemia and heart disease.
FDA specifically took issue with the following claims, made on the cereal packet:
• "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."
According to the agency, these claims classify the product as a drug within the meaning of section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act, as it is intended for use in the prevention, mitigation and treatment of a disease. The product is also considered a new drug under section 201(p) of the Act because it is not generally recognized as safe and effective in treating or preventing hypercholesterolemia and coronary heart disease.
The line between functional foods and drugs is a fine one, and often depends on the intricacies of the wording used in health claims.
General Mills said it based its product statements on the FDA-approved soluble fiber heart health claim. The science supporting its product is not in question, it said.
”The FDA is interested in how the Cheerios cholesterol-lowering information is presented on the Cheerios package and website,” said General Mills, adding that it will work with the agency to reach a resolution.
FDA was particularly concerned that the claims relating to cholesterol reduction were presented as stand-alone claims and not as part of the authorized health claim that soluble fiber from whole grain oats can help reduce the risk of heart disease.
In addition, a claim must not attribute any degree of risk reduction, whereas the Cheerios product states that it can help lower cholesterol by 4 percent in six weeks.
FDA also highlighted similar claims made on the company’s website, which is considered part of the Cheerios labeling. The website states: "Heart-healthy diets rich in whole grain foods, can reduce the risk of heart disease."
However, FDA wrote in its letter that: “Although FDA has issued a regulation authorizing a health claim associating fiber-containing grain products with a reduced risk of coronary heart disease (21 CFR 101.77), the claim on your website does not meet the requirements for this claim.”
“For example, under section 101.77(c)(2), the claim must state that diets low in saturated fat and cholesterol and high in fiber-containing fruit, vegetable, and grain products may reduce the risk of heart disease. The claim on your website leaves out any reference to fruits and vegetables, to fiber content, and to keeping the levels of saturated fat and cholesterol in the diet low.”
To read the full warning letter, click here.