FDA warns General Mills over Cheerios cholesterol claims

Cheerios…the wonder drug?

That's what the Food and Drug Administration appears to be wondering.

The FDA has sent a warning letter to General Mills, telling the company that its claims about the health benefits of eating Cheerios "would cause it to be a drug because the product is intended for use in the prevention, mitigation and treatment of disease."

The problem: Cheerios are a food not a drug, the FDA notes in the letter, which was sent May 5 but was posted on the agency's website today. Thus, claims that the 68-year-old whole-grain oat cereal lowers cholesterol and reduces the risk of heart disease and cancer violates federal law, the agency said.

The FDA allows some health benefits of foods to be advertised but within strict limits. For instance, a company can say that a diet low in saturated fat and high in fiber-rich foods such as fruit, vegetables and whole grains may reduce the risk of heart disease.

"The claim on your website leaves out any reference to fruits and vegetables, to fiber content and to keeping the levels of saturated fat and cholesterol in the diet low," the agency said. “Therefore, your claim does not convey that all these factors together help to reduce the risk of heart disease and does not enable the public to understand the significance of the claim in the context of the total daily diet.”

The FDA was particularly unhappy about assertions on Cheerios boxes and its website that eating the cereal can "lower your cholesterol 4% in 6 weeks." The FDA counters that the cereal must be approved as a drug before making such specific health claims.

General Mills spokesman Tom Forsythe said the cholesterol-lowering claim has been featured on the Cheerios box for more than two years and that the heart health claim was approved by the FDA 12 years ago. On April 20, General Mills announced results of a clinical study that showed eating two daily servings of Cheerios (1 1/2 cups each) can reduce cholesterol 10% in just a month.

"The science is not in question," he said. "The scientific body of evidence supporting the heart health claim was the basis for FDA's approval of the heart health claim, and the clinical study supporting Cheerios' cholesterol-lowering benefits is very strong."

Forsythe said the company looks forward "to discussing this with the FDA and to reaching a resolution." General Mills faces seizure of products or an injunction against making and distributing Cheerios.

-- Tiffany Hsu

Credit: Getty Images

Comments

[Jim]

This from the same FDA that allows vaccines contaminated with SV40 to be given to everyone, Aspartame in nearly all processed foods, Mercury contaminated High Fructose Corn Syrup in nearly all processed foods, Vioxx, and water Fluoridation even though no scientific study can show any positive benefits. Maybe Cheerios should try a new slogan: "Cheerios...It's FDA approved and it will kill you!" Then the FDA will leave them alone!

[Gimme A BREAK!]

I have another 'wonder' meal - I guarantee you that compared with those steak, eggs, bacon, sausage, and hash brown breakfasts, you normally have, eating toilet paper for breakfast every day, WILL likely, under the right conditions, providing you're NOT already terminal, lower your potentially damaging cholesterol, by some indeterminate amount. Eating fruits and green veggies too, may prove to provide some measure of potentially enhancing benefits, when you exercise, avoid drugs and alcohol, and eat a balanced, nutritious meal, 3x a day for the rest of your life.....this guarantee NULL and VOID when you do 1 no-no!

[Uhoh]

YOU AIN'T TAKIN AWAY MY CHEERIOS!!!! I PUT MAH BOXES IN A SAFE!!!

First they take away Booberry, now Cheerios. B'strds.

[RoyC]

General Mills (GM) has managed to litigate themselves into a corner. They make claims that are not consistent with the facts. This has been going on with oatmeal for years. They should not be allowed to mislead the public. We need to pressure Congress to require independent confirmation of meaningful, relevant details. Clinical studies can seriously mislead people when the conclusion is cited without a sound disinterested, scientific, medical analysis of data, available for review. How do we know what GM puts in their products? Do a bunch of dogs have to die for us to notice that "clever substitutions" are made in the contents (remember gluten)?

[larissa]

I totaly agree with you Jim. The same FDA puts fomyldehyde in vaccines and personal products and just now they are agreeing that it DOES cause cancer. So it's ok to poison people but not to make them healthy??? I don't know why we even have FDA? Most of their "approved" drugs cause so many health problems and deaths that they later pull the drug off the market, and yet nobody takes a second look at the FDA itself to see if they're doing their job like they're suppose to, and not for the money.

[rjjrdq]

I'm going to buy some Cheerios right now. The current boxes may be worth something in the near future. This is ridiculous. The science is already there regarding whole grains. What's even more ridiculous is the FDA suggestion that foods cannot mitigate medical conditions. Big pharma doesn't want to hear that they MAY not be needed. They understand that if food and supplement makers were able to make claims, they would be out of business.

[Disgusted taxpaying U.S. citizen]

It is disgusting how the pharmaceutical companies in the U.S. are busier lining their own pockets instead of promoting what is truly healthy for the general public. My own doctor recently apologized that he could not give me any information on anything other than FDA approved drugs which I would have to be on for the rest of my life (with a myriad of terrible side-effects), instead of natural and cost-effective supplements because our own doctors in this country do not have this information presented to them in their academic schooling. The greed of money is dismantling our country brick by brick. I'm all for capitalism, but not when it's at the expense of good, hard-working, taxpaying citizens. It's not capitalism any longer, but a warped version of what made this the greatest nation on earth. Government is supposed to be for the people, by the people. Not govt. courting big business for big bucks! God help us all.