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


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.





This boondoggle makes me RAGE on so many different levels!
FDA better make sure EVERY item we put in our bodies should be so scrutinized. How many people have DIED from eating Cheerios?
How many people had such adverse reactions that they will NEVER have a normal life?

I totally agree with you Birdbomb.

Here they are wasting precious time and resources hassling General Mills over the labeling of Cheerios. If someone eats Cheerios every morning would that person be considered a drug addict ?

<_< I was shaking my head listening to the news regarding this issue.

I really think the FDA should have better things to do regarding labeling of a product ***umhum Cyberonics*** versus hassling General Mills.

I too would like to know who has had adverse events and serious side effects by eating Cheerios?

I'm with you guys, this is soooo ridiculous.

B)

Cheerios is my all time favorite cereal if I had to choose only one ceral to eat for the rest of my life, it would be Cheerios, they are just so darn tasty! So by this new anally motivated labeling, I guess that makes me a junkie.

I understand the reasoning behind the "TRUTH IN ADVERTISING" and if the FDA wants to go on a witch hunt then so be it, but let's not allow them to pick and choose about it. If they are going to enforce correct product labeling then it has to enforced on ALL products, especially on products that have potential to maim or kill.

Cheerios never caused psychosis, seizures, heart stoppages, nerve damage, yet the VNS has and Cyberonics seems to just slide under the radar way too many times.

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:ROFLMAO:

I guess since I am a Cheerios eater, I am a junkie too.

B)

Hell what about all our children!!! Isn't it the first finger food we ALL feed our children. LOL

It was the first finger food I gave my three kids.

The FDA is not claiming that Cheerios are bad for anyone or even that Gen. Mills health claims for it are invalid. They are merely saying that marketing foods for their health benefits is verboten. You can be sure that big pharma doesn't want to allow a precedent where real food competes with their products.

:D

:Yeah That:

B)