FDA WARNS CHEERIOS ON HEALTH CLAIMS
The US Food and Drug Administration (FDA) issued a warning letter to General Mills, the manufacturer of the popular cereal, Cheerios, on May 5, 2009. The letter advised General Mills that the FDA has reviewed the label and labeling of cheerios and found "serious violations of the Federal Food, Drug, and Cosmetic Act."
Cheerios claims on its label that "you can lower your cholesterol 4% in 6 weeks," and that "Cheerios...is clinically proven to lower cholesterol." According to the FDA, these claims indicate that Cheerios is intended for use in lowering cholesterol and in preventing, mitigating and treating high cholesterol. Because of these intended uses, Cheerios is a "drug" within the meaning of the Federal Food, Drug and Cosmetic Act. Cheerios is also a "new drug" pursuant to the Act because it is not generally recognized as safe and effective for use in preventing or treating high cholesterol. The FDA warned General Mills that Cheerios may not be legally marketed with the above claims without an approved new drug application.
Moreover, the FDA found that Cheerios is misbranded within the meaning of the Act because it bears unauthorized health claims in its labeling. The FDA considers Cheerios' website to be misleading because it bears an unauthorized health claim, stating, "Hearth-healthy diets rich in whole grain foods, can reduce the risk of heart disease." Although the FDA has issued a regulation authorizing a health claim associating fiber-containing grain products with a reduced risk of coronary heart disease, the FDA has concluded that the claim on the Cheerios website does not meet the requirements for this claim. The claim must state that diets low in saturated fat and cholesterol and high in fiber-containing fruit, vegetable, and grain products may reduce the risk of heart disease. The Cheerios website, however, makes no mention of fruits and vegetables and does not reference fiber content or the importance of keeping saturated fat and cholesterol levels low.
The FDA further warned that failure to promptly correct the labeling violations may result in enforcement action, which may include seizure of violative products and/or injunction against the manufacturers and distributors of the violative products.
General Mills defended its heart health claim saying that its have been FDA-approved for 12 years and the message about lowering cholesterol has appeared on Cheerios boxes for more than two years.
