FDA Censures Cheerios® for Heart Health Claims
The Food and Drug Administration has issued a warning letter to General Mills, Inc., alleging that labeling for the company’s Cheerios® Toasted Whole Grain Oat cereal contains “serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR).” FDA has specifically alleged that this Cheerios product “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.” The warning letter singles out claims suggesting that Cheerios can “lower your cholesterol 4 percent in 6 weeks” and “reduce bad cholesterol by an average of 4 percent,” as well as a claim that “Cheerios is.. clinically proven to lower cholesterol. A clinical study showed that eating 1½ cups servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol.”
Meanwhile, General Mills has noted that “Cheerios’ soluble fiber heart health claim has been FDA-approved for 12 years, and Cheerios’ ‘lower your cholesterol 4 percent in 6 weeks’ message as been featured on the box for more than two years.” The company has described the disagreement with FDA as one of language, not content. “The science is not in question,” the company stated. “The scientific body of evidence supporting the heart health claim was the basis for FDA’s approval of the claim, and the clinical study supporting Cheerios’ cholesterol-lowering benefit is very strong.” See MSNBC.com and Center for Science in the Public Interest Press Release, May 12, 2009; Advertising Age and FoodNavigator-USA.com, May 13, 2009.
