In fact, General Mills has been told to change the marketing of its popular Cheerios whole grain cereal, as the health claims it currently uses classify it as an unapproved drug.
The food giant has until next week to tell the FDA the steps it intends to take to correct its product marketing, or it may be faced with an injunction or product seizure.
They sent Cheerios a letter, stating that their cholesterol lowering claims implied the product was intended to treat or prevent a disease – hypercholesterolemia and heart disease.
Here are the Problem Claims
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."
What’s allowed? Better Symantics
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.