General Mills was greeted by a warning letter from the U.S. Food and Drug Administration (FDA) on May 11 aimed at its popular Cheerios cereal. In the more than 1,800-word letter, the FDA takes issue with the cholesterol-lowering claims the cereal giant makes on the package label and Website for its Cheerios Toasted Whole Grain Oat Cereal. The agency said the product’s label and Website, which claim that Cheerios can reduce bad cholesterol by an average of 4% in six weeks, represent “serious violations” of the Federal Food, Drug and Cosmetic Act and render Cheerios a new, unapproved drug under the act.

FDA has authorized the use of a health claim associating soluble fiber from whole grain oats with a reduced risk of coronary heart disease, and General Mills does include this legal claim on its Cheerios box. However, the agency said the cholesterol-lowering claims do not fall under the allowed soluble fiber health claim because they are presented as separate, stand-alone claims through their location on the package and other label design features. In addition, the claims language being used by General Mills attributes a degree of risk reduction for coronary heart disease to eating Cheerios, and this is not permitted under the soluble fiber health claim.

General Mills has 15 days to inform the agency in writing regarding the specific steps the company has taken to correct the violations noted in the FDA warning letter and to ensure that similar violations do not occur in the future.

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