FDA Says Cheerios Cereal is a Drug

By Wes Siegner & Ricardo Carvajal –      

FDA has issued a warning letter to General Mills in which the agency alleges “serious violations” of the FDC Act in the label and labeling of Cheerios cereal.  Specifically, FDA contends that the following label claims make Cheerios an unapproved new drug under FDC Act § 505(a) because they indicate that the cereal is intended to prevent, mitigate, and treat hypercholesterolemia:

• "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."

Based on its view that a website constitutes labeling if the website address appears on a product label, FDA further asserts that Cheerios is misbranded under FDC Act § 403(r)(1)(B) because the website includes unauthorized health claims.  According to FDA, the claims featured on the website differ from relevant authorized claims “in significant ways,” such that they do not “enable the public to understand the significance of the claim in the context of the total daily diet,” among other flaws.  The labeling claims at issue are:

• Heart-healthy diets rich in whole grain foods, can reduce the risk of heart disease.
• Including whole grain as part of a healthy diet may … [h]elp reduce the risk of certain types of cancers. Regular consumption of whole grains as part of, a low-fat diet reduces the risk for some cancers, especially cancers of the stomach and colon.

Of late, FDA has devoted few resources to the policing of label and labeling claims made for conventional foods, and it is clear that, as a result, some companies have taken advantage of the lack of enforcment.  However, FDA's choice of target in this case is questionable, as the claims to which FDA has objected appear consistent with information that FDA has included in the health claim regulation concerning the relationship of cholesterol levels to coronary heart disease risk, and FDA's regulation specifically states that information from the section of the regulation that contains this information may be included in the health claim.  Therefore, General Mills could argue that the claims that FDA identifies as violative are the types of claims FDA has authorized under the applicable health claim regulation.

Nonetheless, the issuance of this warning letter against a high profile target suggests that FDA is trying to get a message across to the food industry and should prompt food companies to undertake a review of their existing marketing materials to ensure that they are not similarly vulnerable.  Any such review should include advertising, given the National Advertising Division’s traditional deference to FDA’s interpretation of its requirements.