CHEERIOS!

Popular Cheerios cereal is a 'drug': U.S. FDA

The Food and Drug Administration has issued a warning letter to Cheerios maker General Mills telling the company to stop making claims in its advertising the Cheerios will lower cholesterol and treat heart disease.
Photograph by: Justin Sullivan, Getty Images

WASHINGTON — Popular U.S. breakfast cereal Cheerios is a drug, at least if the claims made on the label by its manufacturer General Mills are anything to go by, the U.S. Food and Drug Administration (FDA) has said.

"Based on claims made on your product's label, we have determined that your Cheerios Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug," the FDA said in a letter to General Mills which was posted on the federal agency's website Tuesday.

Cheerios labels claim that eating the cereal can help lower bad cholesterol, a risk factor for coronary heart disease, by four per cent in six weeks.

Citing a clinical study, the product labels also claim that eating two servings a day of Cheerios helps to reduce bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol, the FDA letter says.

Those claims indicate that Cheerios — said by General Mills to be the best-selling cereal in the United States — is intended to be used to lower cholesterol and prevent, lessen or treat the disease hypercholesterolemia, and to treat and prevent coronary heart disease.

"Because of these intended uses, the product is a drug," the FDA concluded in its letter.

Not only that, but Cheerios is a new drug because it has not been "recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease," the FDA said.

That means General Mills may not legally market Cheerios unless it applies for approval as a new drug or changes the way it labels the small, doughnut-shaped cereal, the FDA said.

General Mills defended the claims on Cheerios packaging, saying in a statement that Cheerios' soluble fiber heart health claim has been FDA-approved for 12 years, and that its "lower your cholesterol four per cent in six weeks" message has been featured on the box for more than two years.

The FDA's quibble is not about whether Cheerios cereal is good for you but over "how the Cheerios cholesterol-lowering information is presented on the Cheerios package and website," said General Mills.

"We look forward to discussing this with FDA and to reaching a resolution."

Meanwhile, the FDA warned in its letter that if General Mills fails to "correct the violations" on its labels, boxes of Cheerios could disappear from supermarket and wholesaler shelves around the United States and the company could face legal action.

According to General Mills, one in eight boxes of cereal sold in the United States is a box of Cheerios. The cereal debuted on the U.S. market in 1941.

© Copyright (c) AFP

this one is bewildering. i suppose it is only because cheerios markets itself in a certain way has this happened, because what about all sorts of fruits and vegetables that have similar effects?

yo man whachoo need. i got some granny smiths right here!

i figured this guy would be the focus of a drug story before Cheerios.

fucking absurd

That article is another example of the failure of our press corps. Physicians, scientists and consumer groups have been after the FDA to do something about Cheerios' claims for years. They are completely absurd. Even food consortiums have been a bit surprised that FDA has let Cheerios indulge itself for so many years. Cheerios are not much better for you than Breakfast with Barbie cereal or Count Chocula. This issue has been around so long I'm actually surprised that the FDA finally acted.

This is a 2005 article from BNET.

Hook, line, and cheerios: when labels and ads don't quite add up

Nutrition Action Healthletter , Oct, 2005 by David Schardt

Lose those extra pounds. Watch your cholesterol fall. Keep your mind sharp. Laugh at infections.

Deceptive ads come in all stripes--out and out lies, half truths, and exaggerations. Some of the products in these ads are worthless, while others are worth less than their ads would have you believe.

Three Cheerios?

The hook: "I lowered my cholesterol," the annoying characters tell startled strangers in the TV ads for Cheerios.

The truth: Cheerios doesn't lower cholesterol very much.

Based largely on studies of oatmeal, in 1997 the Food and Drug Administration approved a health claim that the soluble fiber in oats can help lower cholesterol. (That's the claim you'll see on Cheerios boxes.) Are there any studies on the cereal itself?

In a General-Mills-sponsored study published in 1998, people with high cholesterol levels were told to follow an American Heart Association diet (which is low in saturated fat) for six weeks. Those who were assigned to eat three cups of Cheerios a day lowered their cholesterol more than those who ate three cups of cornflakes.

But the average LDL ("bad") cholesterol of the Cheerios eaters fell by only 7 points (from 160 to 153). To look at the ecstatic people in the Cheerios ad, you'd think their LDL had tumbled all the way down to the recommended level (100 or below).

In fact, a 7-point fall would be a decent drop from just one food, but it was actually three servings of one food. On average, participants ate 450 calories' worth of cereal a day (3 cups of Cheerios plus 1 1/2 cups of fat-free milk). That's a big chunk of the average American's 2,200-calorie diet, especially for such a modest payoff.

And it would take even more than 450 calories to get the same LDL drop from Honey Nut or Berry Burst Cheerios (both of which contain less soluble fiber and more sugar than regular Cheerios).

There's nothing wrong with people who have high cholesterol eating a bowl of Cheerios every morning. There's everything wrong with General Mills trying to make consumers think that Cheerios is the key to a healthy heart.

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it's fine that the FDA came after them for false or exaggerated claims, but it's absurd that something must be classified as a drug in order to claim it has substantial health benefits.

They aren't making the claim that Cheerios "has substantial health benefits." The people who sell broccoli and strawberries make that claim. And most consumer groups would be fine if that's all that General Mills was doing, even if Cheerios don't have substantial health benefits. Cheerios claims that eating three cups per day will lower an individual's total blood cholesterol 7 points. That is a highly specific claim, not substantiated in the scientific literature. Generally, such a claim is what defines a drug. In the scientific literature no studies were done on Cheerios, they were done on standardized samples of oatmeal or purified soluble fiber. Cheerios has not provided information to anyone, not consumers, not the FDA, that substantiates the quantity of fiber in Cheerios. We have only their word for it. Furthermore, the data they cite on the cholesterol-lower ability of Cheerios was not peer-reviewed, the methodology was not approved by an internal IRB, nor is the raw data available. The last time I read about this, General Mills would not even disclose who did the study. Their advertising is grossly misleading and in the realm of snake-oil.

i had two bowls this morning, and i thought i didn't do drugs : (

Y'know the first step is admitting you have a problem.

I had two bowls this morning, and then I ate a shitload of cereal.

I kinda want some honey nut cheerios.

we don't all do the cool underlord drugs like marijannyna

You don't. Cheerios wants to be a drug. That doesn't mean that it is. Ever try smoking lawn clippings?

yeah i ended up just mowing my lawn

You guys are weak. I mainline this shit.