14 DAY TRIAL // The US Food and Drug Administration (FDA) has issued a warning letter to General Mills, maker of Cheerios Toasted Whole Grain Oat Cereal, which claims to lower cholesterol by 4 percent in just 6 weeks. Because the product makes claims specific to a drug, the FDA is asking for the package to be changed – otherwise, General Mills must submit the cereals for approval as a drug to the FDA.
The letter was sent on May 5 but, as of now, General Mills has not yet responded in any way to it. The FDA is saying that the labeling of the product is not only misleading, it’s also making claims that only a drug could perhaps render real. Since labeling is something that the FDA is concerned with, it wants the company to change it, or undergo the strict procedure of having the cereals approved as cholesterol-targeted drug.
“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. Specifically, your Cheerios product bears the following claims on its label:
• ‘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’.” FDA says in the warning letter.
Since General Mills is so intent on marketing Cheerios as an effective ally in the fight against high cholesterol, then it should get it approved with the FDA as a drug, the letter further says. “These claims indicate that Cheerios is intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia. Additionally, the claims indicate that Cheerios is intended for use in the treatment, mitigation, and prevention of coronary heart disease through lowering total and ‘bad’ (LDL) cholesterol. […] It may not be legally marketed with the above claims in the United States without an approved new drug application.” reads the letter.
General Mills has been given 15 days to do something about the “misbranded food” and to offer evidence and documentation of doing so. Should it fail to comply, the FDA will take “enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.”