FDA Calls Cheerios an “Unapproved Drug”

The US Food and Drug Administration (FDA) issued a warning letter to cereal manufacturer General Mills for claiming on its cereal box that Cheerios can help lower cholesterol, and saying on their website that “diets rich in whole grain foods can reduce the risk of heart disease.” The letter, dated May 5, called the above claims “serious violations” of the Federal Food, Drug, and Cosmetic Act and applicable regulations. FDA stated that based on the claims made, Cheerios is now an unapproved drug, and must go through FDA new drug approval process.
FDA has issued warning letters in the past to various food producers to keep them from telling consumers about the healthful nature of their products. For example, cherry growers were targeted and enjoined from referencing peer-reviewed scientific articles proving cherries’ health benefits for gout and arthritis. For years, FDA barred health claims about the benefits of fish oil for heart, cancer, depression, body pain, and various other conditions until a drug company paid a great deal of money to take its fish oil through the approval process. That particular fish oil, now FDA-approved, sells at many more times the cost of regular fish oil. This type of enforcement effectively censors scientific information, greatly restricts consumer access to scientific studies that provide valuable information, and drives up healthcare costs.
As AAHF Legislative Director Tami Wahl noted, “FDA is not questioning the validity of the claims made by General Mills. Instead, FDA is saying General Mills cannot tell consumers that Cheerios may have beneficial health effects. The policy behind FDA’s action is government censorship, plain and simple. For General Mills not to be able to inform the public about the scientific evidence that Cheerios can help lower cholesterol—a rising health concern for Americans—serves no purpose. American consumers want to take charge of their personal health, and need as much valid information as possible to help them make responsible choices.”
What is the FDA’s motivation? Would the FDA prefer that consumers not eat healthy foods, so they can be treated after the fact with FDA-approved drugs? The FDA drug approval process is a time-consuming and incredibly expensive process that is inappropriate for food products.
Moreover, FDA apparently believes that they alone should control all scientific information related to public health. We, on the other hand, believe it is in the best interest of consumers for science-based claims about food and food products to be freely cited. AAHF believes consumers have the right to access all scientific studies about food and food products—not just the studies the government has approved because a manufacturer has paid for the privilege.

If you haven’t done so already, please join our Reform FDA campaign by clicking here to sign our petition.