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FDA says that "Cheerios" is bad for you.

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  • May 15 2009 11:07 PM
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Posted 15 May 2009 - 11:07 PM

What's next? "Water is bad for you so drink this rum all day." :rolleyes:

Link

Food and Drug Administration slapped General Mills Inc. with a warning over its Cheerios cereal, saying the box's claims about heart benefits contain "serious violations" of federal law. In a May 5 warning letter sent to the company and posted on the FDA's Web site Tuesday, the agency said statements that the product is "clinically proven to help lower cholesterol" make the product a drug under federal law.







Stephen Sundlof, the director of the FDA's food-safety center, said the agency has noticed a tendency by food companies to cross the line into the drug category by making specific health claims on packaging.
He said the FDA is ready to send out more warning letters if it finds more violators, although it has "no specific campaign" to go after food manufacturers.
General Mills spokesman Tom Forsythe said the Cheerios box's message saying the cereal can "lower your cholesterol 4% in six weeks" has been used for more than two years. The box cites a clinical study involving Cheerios as part of a diet low in saturated fat and cholesterol.
Mr. Forsythe said the broader claims on the box about heart health have been permitted by the FDA for 12 years. "The clinical study supporting Cheerios' cholesterol-lowering benefit is very strong," he said.
The FDA said such specific cholesterol-lowering claims can be made only for drugs, and it suggested that if General Mills wants to keep the box labeling as is, it should file a new-drug application for Cheerios.
Mr. Forsythe said the company would work with the agency to reach a "resolution" on the Cheerios labeling.
"We try to make a bright line here between what can be said about a drug and what can be said about a food," said Dr. Sundlof. He said a more general claim about reduction in heart-disease risk from eating whole-grain foods may be permissible as long as specific language is used.
The FDA also took issue with a company-sponsored Web site mentioned on the Cheerios box. The Web site discusses the benefits of eating whole grains, but the FDA said some of the health claims about reducing cancer and heart-disease risk don't comply with agency rules.
The FDA said General Mills must "promptly" correct the violations outlined in the letter or the agency could take enforcement action, such as seizing products.
Dr. Sundlof said the FDA's review of Cheerios was prompted by a September 2008 letter from the National Consumers League that expressed concerns about the labeling on Cheerios.
The FDA isn't the only Washington agency in the Obama administration taking a close look at food makers' health claims. Last month the Federal Trade Commission settled a complaint with Kellogg Co. involving claims that its Frosted Mini-Wheats cereal was clinically shown to improve children's attentiveness by nearly 20%.
FTC Chairman Jon Leibowitz said the commission would start paying more attention to national advertisers.
The FDA is showing signs of taking a more aggressive stance toward the companies it regulates under acting Commissioner Joshua Sharfstein, who is slated to become principal deputy commissioner once President Barack Obama's nominee for commissioner, Margaret Hamburg, is confirmed.
Dr. Sharfstein wrote a letter to lawmakers released this week saying he wants to review the agency's approval in the final days of the Bush administration of a knee device. The device was cleared over the objections of several scientists and managers at the agency.

Replies (31)

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Posted 16 May 2009 - 12:12 AM

This is ridiculous. The cheerios thing I don't care much about specifically. But I definitely see this as part of a broader agenda. This out of control agency needs to be put in their place!

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Posted 16 May 2009 - 12:26 AM

FDA says that "Cheerios" is bad for you.



Bullshit. Where in that article did it claim that the FDA said that the product was "bad for you"? They said no such thing.

The article was about how the FDA was enforcing the rules regarding unproven claims, such as those made by General Foods that Cheerios can lower cholesterol, prevent cancer, prevent heart disease, etc.

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Posted 16 May 2009 - 12:27 AM

well

they didnt exactly say it's bad for you, they just noticed that it doesnt provide all the heart benefits that general mills claims it does

but then i read on about the FDA seizing products and shit, which is COMPLETELY unnecessary, so fuck the FDA yet again

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Posted 16 May 2009 - 12:30 AM

They're saying that such claims would qualify cheerios not as a food, but as a drug, whether the so-called "clinical studies" are legitimate or not.

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Posted 16 May 2009 - 12:32 AM

I remember hearing a lady warn about this four or five years ago on Art Bell.

She was warning that the World Health Org and the FDA were planning to make essential vitamins a controlled substance. She went so far as to say that even apples would be tightly controlled. The idea is that a sick and unhealthy society requires more government and pharmaceutical dependency.

I guess she turned out to be right because the WHO is forcing us to implement Codex Alimentarious at the end of 2009.

Cheerios Conspiracy & FDA Corruption

Is the FDA’s attack on Cheerios motivated by political donations? Lobbying matters, don’t kid yourself. 2008 reports from Bongs and Glass Pipes - Grasscity.com

Total For Food Processing & Sales: $6,700,516— Subtotal for Parent General Mills: $769,300— Total For Crop Production & Basic Processing: $5,265,275— Subtotal for Parent Food Marketing Institute: $6,248,130— Subtotal for Parent Smithfield Foods: $350,000— Total For Poultry & Eggs: $841,342— The United Egg Producers $80,000— Subtotal for Parent National Chicken Council: $120,000.

The numbers pale in comparison to the Pharmaceuticals/Health Products lobby efforts pending, $235,315,408, the subtotal for Parent Pharmaceutical Rsrch & Mfrs of America: $20,220,000. Frig that knowledge is power- money talks. The money trail to who has the power over what you eat must certainly be influenced by the FDA who’s member have ties primarily to the pharmaceutical industry- not the agricultural, egg, pork, dairy, chicken industries. “Recent press reports revealed extensive evidence of serious wrongdoing by Dr. Andrew von Eschenbach, Dr. Frank M. Torti, top FDA attorneys, center and office directors, and many others in prominent positions of authority at FDA. As a result, Dr. Frank M. Torti, acting commissioner and the FDA’s first chief scientist, abruptly left the Agency,” writes http://www.theepocht...ent/view/16742/


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Posted 16 May 2009 - 12:42 AM

well

they didnt exactly say it's bad for you, they just noticed that it doesnt provide all the heart benefits that general mills claims it does

but then i read on about the FDA seizing products and shit, which is COMPLETELY unnecessary, so fuck the FDA yet again

Let me get this straight: You're in favor of allowing food companies sell snake oil to the public, and it would be better is these companies were self-regulated and no government enforcement was used. If some body has a serious life-threatening condition from eating, say, peanuts, and a product does not list it on the box, the FDA is wrong to seize those products to keep those who may die from it from getting poisoned.

The world of business, finance, and health is more complicated than your idealism takes into account. There are such things as greed, corruption, human error, and corporate crime - and all of them are wrapped in lies and untruths.

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Posted 16 May 2009 - 01:17 AM

.........http://www.theepochtimes.com/n2/content/view/16742/

I didn't get that far in the article yet, which may have some truth in it, but it is in the Epoch Times, which is owned by the outlawed China-based religous/political wacko group Falun Gong (aka Falun Dafa).

These people are Totally F-U-C-K-I-N-G C-R-A-Z-Y........They are conditioned and brainwashed so bad that they make most other crackpot cults look like pillars of sanity and reason. They've been on the streets of NYC, and other cities, for years trying to drum up support for their organization, giving out that paper and bitching about being "persecuted" in the People's Rebpulic of China.

Falun Gong a.k.a. Falun Dafa

Just thought you'd be interested.


:wave:

Edited by garrison68, 16 May 2009 - 01:19 AM.


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Posted 16 May 2009 - 01:31 AM

The same people that told you Aspartame is safe is sending warnings to cheerios about a label? Why is reality looking more and more like Alice in Wonderland?

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Posted 16 May 2009 - 01:45 AM

Let me get this straight: You're in favor of allowing food companies sell snake oil to the public, and it would be better is these companies were self-regulated and no government enforcement was used. If some body has a serious life-threatening condition from eating, say, peanuts, and a product does not list it on the box, the FDA is wrong to seize those products to keep those who may die from it from getting poisoned.

The world of business, finance, and health is more complicated than your idealism takes into account. There are such things as greed, corruption, human error, and corporate crime - and all of them are wrapped in lies and untruths.


On one hand you have the libertarian who is opposed to anything related to government. In his eyes, government is bad, and the private sector is good.

On the other hand, you have the statist who defends the government from the crimes of the private sector, saying that we need government regulation in the market.

Both are ideologies that came out of the capitalist class. Different sections of the bourgeoisie, bickering amongst themselves on how to best run capitalism, but the system is beyond reform.

The state is not simply a neutral arbiter, it is an instrument of class dictatorship and domination. It's the apparatus of the dictatorship of the bourgeoisie. In no way does it look out for the good of the public, or human needs. It only cares about protecting capitalism, the capitalists, and their wealth and power, either from themselves or capitalism's own grave diggers, the proletariat.

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Posted 16 May 2009 - 01:46 AM

The same people that told you Aspartame is safe is sending warnings to cheerios about a label? Why is reality looking more and more like Alice in Wonderland?

If General Foods can prove, to an impartial group of experts, that their product Cheerios prevents cancer and heart disease, then they should be able to say so - but I strongly doubt that these claims can be proven. Until they can do so, I say don't let them advertise that Cheerios can accomplish these things.

Nobody is running them out of business, the FDA is just drawing the line between what is appropriate and what is not.

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Posted 16 May 2009 - 02:55 AM

If General Foods can prove, to an impartial group of experts, that their product Cheerios prevents cancer and heart disease, then they should be able to say so - but I strongly doubt that these claims can be proven. Until they can do so, I say don't let them advertise that Cheerios can accomplish these things.


It would really help if you read the article.

Mr. Forsythe said the broader claims on the box about heart health have been permitted by the FDA for 12 years. "The clinical study supporting Cheerios' cholesterol-lowering benefit is very strong," he said.

The FDA said such specific cholesterol-lowering claims can be made only for drugs, and it suggested that if General Mills wants to keep the box labeling as is, it should file a new-drug application for Cheerios.



It has nothing to do with the health claims, it has do to with the FDA trying to get Cheerios classified as a drug... for some reason.

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Posted 16 May 2009 - 03:11 AM

These people are crazy, the FDA, the food and drug administerers need to be abolished as well as half the other crooked govt agencies. What are they doing letting aspartame and msg be allowed in foods. Who the fuck regulates them.

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Posted 16 May 2009 - 03:43 AM

It would really help if you read the article.


It has nothing to do with the health claims, it has do to with the FDA trying to get Cheerios classified as a drug... for some reason.

I did read the article. Forsythe is the spokesman for Cheerios, he works for General Foods and is paid to say what they want him to say.

Here is the actual warning letter that the FDA sent to General Foods.

Posted ImagePosted ImagePosted Image
Posted ImagePosted Image




May 5,2009
WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 09 -18

Ken Powell
Chairman of the Board and CEO
General Mills
One General Mills Boulevard
Minneapolis, Minnesota 55426

Dear Mr. Powell:


The Food and Drug Administration (FDA) has reviewed the label and labeling of your Cheerios® Toasted Whole Grain Oat Cereal. FDA's review found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR). You can find copies of the Act and these regulations through links in FDA's home page at U S Food and Drug Administration Home Page

Unapproved New Drug


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 because the product is intended for use in the prevention, mitigation, and treatment of disease. Specifically, your Cheerios® product bears the following claims ort its label:

• "you can Lower Your Cholesterol 4% in 6 weeks" "

• "Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is ... clinically proven to lower cholesterol. A clinical study showed that eating two 1 1/2 cup servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol."

These claims indicate that Cheerios® is intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia. Additionally, the claims indicate that Cheerios® is intended for use in the treatment, mitigation, and prevention of coronary heart disease through, lowering total and "bad" (LDL) cholesterol. Elevated levels of total and LDL cholesterol are a risk factor for coronary heart disease and can be a sign of coronary heart disease. Because of these intended uses, the product is a drug within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321 (g)P)(B)]. The product is also a new drug under section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease. Therefore,under section 505(a) of the Act [21 U.S.C. § 355(a)], it may not be legally marketed with the above claims in the United States without an approved new drug application.

FDA has issued a regulation authorizing a health claim associating soluble fiber from whole grain oats with a reduced risk of coronary heart disease (21 CFR 101.81). Like FDA's other regulations authorizing health Claims about a food substance and reduced risk of coronary heart disease, this regulation provides for the claim to include an optional statement, as part of the health claim, that the substance reduces the risk of coronary heart disease through the intermediate link of lowering blood total and LDL cholesterol. See 21 CFR 101.81(d)(2),-(3). Although the lower left corner of the Cheerios® front label contains a soluble fiber/coronary heart disease health claim authorized under 21 CFR 101.81, the two claims about lowering cholesterol are not made as part of that claim but rather are presented as separate, stand-alone claims through their location on the package and other label design features. The cholesterol claim that mentions the clinical study is on the back of the Cheerios® box, completely separate from the health claim on the front label. Although the other cholesterol claim is on the same panel as the authorized health claim, its prominent placement on a banner in the center of the front label, together with its much larger font size, different background, and other text effects, clearly distinguish it from the health claim in the lower left corner.

Additionally, even if the cholesterol-lowering claims were part of an otherwise permissible claim, under 21 CFR 101.81, the resulting claim language still would not qualify for the use of the soluble fiber health claim. To use the soluble fiber health claim, a product must comply with the claim specific requirements in 21 CFR 101.81, including the requirement that the claim not attribute any degree of risk reduction for coronary heart disease to diets that include foods eligible to bear the claim. See 21 CFR 101.81©(2)(E). However, the label of your Cheerios® cereal claims a degree of risk reduction for coronary heart disease by stating that Cheerios® can lower cholesterol by four percent in six weeks. High blood total and LDL cholesterol levels are a surrogate endpoint for coronary heart disease; therefore, the cholesterol-lowering claims on the Cheerios® label attribute a degree of risk reduction for coronary heart disease because if total and LDL cholesterol levels decline, the risk of coronary heart disease declines as well.

Misbranded Food:

Your Cheerios ® product is misbranded within the meaning of section 403®(1)(B) of the Act [21 U.S.C. § 343®(1)(B)] because it bears unauthorized health claims in its labeling. We have determined that your website Welcome to the Whole Grain Nation is labeling for your Cheerios® product under section 201(m) of the Act [21 U.S.C. § 321 (m)] because the website address appears on the product label. This website bears the following unauthorized health claims:


  • "Heart-healthy diets rich in whole grain foods, can reduce the risk of heart disease."
This health claims misbrands your product because it has not been authorized either by regulation [see section 343®(3)(A)-(B) of the Act [21 U.S.C. § 343®(3)(A)(B)]] or under authority of the health claim notificati6n provision of the Act [see section'343®(3)© of the Act [21 U.S.C. § 343®(3)(G)]]. Although FDA has issued a regulation authorizing a health claim associating fiber-containing grain products with a reduced risk of coronary heart disease (21 CFR 101.77), the claim on your website does not meet the requirements for this claim. For example, under section 101.77©(2), 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 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.

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 (see section 343®(3)(B)(iii) of the Act [21 U.S.C.§ 343®(3)(B)(iiill].


In addition to the health claim authorized by regulation in 21 CFR 101.77, other health claims linking the consumption of whole grain foods to a reduced risk of heart disease have been authorized through the notification procedure in section 403®(3)© of the Act. Of those authorized claims, the one closest to the claim on your website states: "Diets rich in whole grain foods and other plant foods, and low in saturated fat and cholesterol, may help reduce the risk of heart disease.1" Although the claim on your website also concerns whole grains and reduced risk of heart disease, it is different from the authorized claim in significant ways. To meet the requirements of the authorized claim, the claim must state that diets that are (1) rich in Whole grains and other plant foods, and (2) low in saturated fat and cholesterol will help reduce the risk of heart disease) Instead, the claim on your website only states that diets rich in whole grains can reduce the risk of heart disease, with no mention of other plant foods or of low saturated fat and cholesterol.


  • "Including whole grain as part of a healthy diet may ... [h]elp reduce the risk of certain types of cancers. Regular consumptionof whole grains as part of, a low-fat diet reduces the risk for some cancers, especially cancers of the stomach and colon."
This health claim misbrands your product because it has not been authorized either by regulation [see section 343®(3)(A)-(B) of the Act [21 U.S.C. § 343®(3)(A)(B)]] or under authority of the health claim notification provision of the Act [see section 343®(3)© of the Act [21 U.S.C. § 343®(3)©]]. Although FDA has issued a regulation authorizing a health claim associating fiber-containing grain products with a reduced risk of cancer (21 CFR 101.76), the claim on your website does not meet the requirements for the authorized claim.For example, under section 101.76©(2) the claim must state that diets high in fiber-containing grain products, fruits, and vegetables may reduce the risk of some cancers. The claim on your website leaves out any reference to fruits, vegetables, and fiber content. 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 [see section 343®(3)(B)(iii) of the Act [21 U.S.C. § 343®(3)(B)(iii)]].

In addition to the health claim authorized by regulation in 21 CFR 101.76, a health claim linking the consumption of whole grain foods to a reduced risk of certain cancers has been authorized through the notification procedure in section 403®(3)© of the Act. The authorized claim is: "Diets rich in whole grain foods and other plant foods ... may help reduce the risk of... certain cancers."2 Although the claim on your website also concerns whole grains and reduced risk of some cancers, it is different from the authorized claim in significant ways. For example, the authorized claim states that diets rich in whole grain foods and "other plant foods" may help reduce the risk for certain cancers. However,the claim on your website does not mention "other plant foods." Also, by using the language "especially cancers of the stomach and colon" the claim on your website emphasizes the relationship between whole grain foods and stomach and colon cancers as compared to other cancers, suggesting a greater degree of risk reduction or stronger evidence for the relationship between whole grain foods and risk of those two cancers. The claim authorized through the notification procedure does not emphasize the relationship between whole grain foods and stomach and colon cancer as compared to other cancers.

This letter is not intended to be an all-inclusive review of your products and their labeling. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations.

Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.

Please advise this office in writing 15 days from your receipt of this letter of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the date by which you will complete the corrections.

Please send your reply to the attention of Tyra S. Wisecup, Compliance Officer, at the address in the letterhead. If you have any questions regarding this letter, please contact Ms. Wisecup at (612) 758-7114.
Sincerely,

/s/

W. Charles Becoat
Director
Minneapolis District

TSW/cd


General Mills, Inc., Warning Letter

Edited by garrison68, 16 May 2009 - 03:50 AM.


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Posted 16 May 2009 - 04:04 AM

After smoking all the confiscated weed they need cereal, who can blame them?
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Posted 16 May 2009 - 05:35 AM

the fda is just doing its job by pointing out that the cheerios' box label has very specific claims for improving health (much like a drug). why did they do it? because if one food product is allowed to advertise its particular, and alleged, health benefits, then it sets a risky precedent for others to do the same. cheerios may very well ""lower your cholesterol 4% in six weeks," but it needs to be made clear that when someone has a problem with their cholesterol, they cannot simply rely on eating a cereal as a treatment. it's pretty important that drugs are the only products allowed to make such particular claims. this whole thing really isn't a big issue.

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Posted 16 May 2009 - 05:36 AM

Looks like Cheerios forgot to pay the FDA bribe money.

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Posted 16 May 2009 - 06:10 AM

the fda is just doing its job by pointing out that the cheerios' box label has very specific claims for improving health (much like a drug). why did they do it? because if one food product is allowed to advertise its particular, and alleged, health benefits, then it sets a risky precedent for others to do the same. cheerios may very well ""lower your cholesterol 4% in six weeks," but it needs to be made clear that when someone has a problem with their cholesterol, they cannot simply rely on eating a cereal as a treatment. it's pretty important that drugs are the only products allowed to make such particular claims. this whole thing really isn't a big issue.

Exactly. Another thing to keep in mind is that you could take any oats and receive the same benefits, or lack of, as Cheerios. I would also think that most high quality hot oat cereals would be better than Cheerios in a scientific test of nutritional value, simply because they are less processed and retain more vitamins, minerals, bran, etc., than Cheerios.

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Posted 16 May 2009 - 06:49 AM

The cheerios claim is specific and insignificant. But this opens doors for them to start saying hemp seed oil needs to apply for a drug application if it ever wants to highlight any of its benefits.

Edited by Salvial, 16 May 2009 - 06:57 AM.


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Posted 16 May 2009 - 04:27 PM

Why would you trust anything about the FDA? They have approved more foods and drugs that have killed people than the military, in my opinion.

The only people the FDA answers to are the pharmaceutical companies and their money.
They don't give 2 shits about our well being.

Until they remove all truly harmful things from our foods and drugs, I don't trust anything they say.

I believe they should be put on trial for crimes against humanity, quite frankly.
In fact, most of our federal government should be thoroughly inspected for infractions and crimes against the people.

Imagine. . .
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