FDA Says Cheerios Cereal is a DrugFDA Says Cheerios Cereal is a Drug
June 2, 2009
In an action of importance to health claims for dietary supplements and conventional foods, on May 5, 2009, FDA issued a warning letter to General Mills in which the agency alleged “serious violations” of the Federal Food, Drug and Cosmetic Act (FDC Act) in the label and labeling of Cheerios® Toasted Whole Grain Oat Cereal. Specifically, FDA stated the following label claims make Cheerios an unapproved new drug under FDC Act § 505(a) because they indicate the cereal is intended to prevent, mitigate and treat hypercholesterolemia:
“You Can Lower Your Cholesterol 4 percent 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 FDA’s view that a Web site constitutes labeling if the Web site address appears on a product label, FDA further asserted Cheerios is misbranded under FDC Act § 403(r)(1)(B) because the Web site includes unauthorized health claims. According to FDA, the claims featured on the Web site 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 grains 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 health claims generally and label and labeling claims made for conventional foods in particular; it is clear that, as a result, some companies have taken advantage of the lack of enforcement. However, FDA’s choice of target in this case is questionable, as the claims to which FDA has objected appear consistent with information FDA has included in the health claim regulation concerning the relationship of cholesterol levels to coronary heart disease risk. Further, FDA’s regulation specifically states information from the section of the regulation that contains this information may be included in the health claim. Therefore, General Mills could argue the claims 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 FDA is trying to get a message across to the food and dietary supplement industry, and should prompt companies to undertake a review of their existing marketing and advertising materials to ensure they are not similarly vulnerable.
Wes Siegner is a director at the firm of Hyman, Phelps & McNamara P.C., with primary practice focused on FDA and FTC regulatory and enforcement matters. Formerly associate chief counsel at FDA, Ricardo Carvajal is of counsel with Hyman, Phelps & McNamara, where his practice focuses on food and dietary supplement safety, labeling and advertising issues. This INSIDER contribution is based on a blogpost from the FDA Law Blog.
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