In non-shocking news

[Kaustikos]

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http://www.medicalnewstoday.com/articles/149857.php

The US Food and Drug Administration has written a warning letter to General Mills, the makers of the popular breakfast cereal Cheerios, explaining that they have reviewed the labelling of the product and found it contains "serious violations" of federal regulations.

The details of the FDA findings are in a letter dated May 5th, from W Charles Becoat, FDA Director for the Minneapolis District, to Ken Powell, Chairman and CEO of Minneapolis-based General Mills, who make Cheerios.

According to the FDA, General Mills is breaking federal regulations on two counts: they are marketing Cheerios like an "unapproved new drug" and misbranding the product by making "unauthorized health claims".

The FDA letter to the food company states:

"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)."

The FDA said that the Cheerios product label promotes it like a drug intended for use in the "prevention, mitigation, and treatment of disease". The letter drew particular attention to phrases that say the product lowers cholesterol by "4 per cent in 6 weeks", that it can also reduce bad cholesterol by 4 per cent, and that it is "clinical proven" to lower cholesterol.

The letter does not address the veracity of the claims, it addresses the point that by making such claims then the product is really a drug and should go through the proper channels for obtaining drug approval.

For example, as the letter explains, the claims indicate that Cheerios is:

"Intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia."

And by claiming that the product lowers total and bad cholesterol, then it is also claiming to treat heart disease, for which total and bad (LDL) cholesterol are known risk factors. This is what puts the product in the "new drug" category, and the letter quotes several sections of "the Act" to support their case.

The FDA said another reason that the product is considered to be a "new drug" was because under another section of "the Act", it is "not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease".

The letter acknowledged that General Mills had observed regulations correctly in respect of a health claim associating "soluble fiber from whole grain oats with a reduced risk of coronary heart disease", but the two claims about lowering cholesterol are not part of that, and goes into great detail about the positioning on the packet label and how the words are shown to make its case.

The FDA said that even if the cholesterol-lowering claim could be argued to be part of an otherwise permissible claim, the wording disqualifies it from use in the soluble fiber health claim.

On the issue of misbranding, the FDA said that Cheerios bears "unauthorized health claims in its labeling" and cites text on the company's website, which under the Act is considered to be part of the product labelling, as being faulty in this respect. The text says "heart-healthy diets rich in whole grain foods, can reduce the risk of heart disease."

According to the FDA, the claim does not meet the requirements of the Act which requires such assertions to 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 Cheerios labelling neither mentions fruits, vegetables and fiber, nor the need for the diet to be low in saturated fat and cholesterol.

Thus the label does not have enough information to "enable the public to understand the significance of the claim in the context of the total daily diet," said the FDA letter.

The letter also refers to another labelling claim about reduction in cancer risk.

The FDA said the claim, which includes the statement "regular consumption of whole grains as part of, a low-fat diet reduces the risk for some cancers, especially cancers of the stomach and colon", fails to meet the authorized format because, for example, like the other claim, it does not mention fruits and vegetables and fiber content and again denies the public the chance to see the overall context of the healthy diet.

The agency also takes issue with the added phrase "especially cancers of the stomach and colon" which goes beyond what an authorized claim is allowed to say. As the FDA letter explains:

"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."

General Mills has 15 days to reply with an explanation of how they intend to "correct the violations" and to ensure that "similar violations do not occur".

Long story short - the FDA further proves its inability to regulate and act like an organization that should take care of serious matters appropriately and instead pick on matters that shouldn't be dealt with in the first place. Fitting considering they're acting like a high school kid who got into a fight and lost to another high schooler and then decided to bully/fight a 4th grader.👎
The laughing stock of all healthcare-related organization - known for being bribed, influenced and tricked by other companies - is deciding to unleash its bitter/childish attitude towards a product people should be eating instead of some of the things people are known to eat. Regardless of the medicine, it doesn't take medical school courses to understand general mills statement about eating cheerios having a positive impact on a persons health. Let's also not forget the NUMEROUS (And I mean NUMEROUS) products the FDA lets slip by its fingers because of brilliant bribary/trickery by companies who know what a joke the FDA is and how easily manipulated it is (Fish Oil never actually showing the impact it claims to have, the diet pill disaster (fen-phen) to name a few). And last but not least, the recent medical break-through by lilly pharmaceuticals with Prasugrel being pushed and forced and bribed by numerous people to release/accept it into the market despite findings by 1 of 7 people who were to vote on the matter saying how bad the drug actually was. The end result being that person was "kicked out" because of bias against the medication (the publications he released detailing how bad the drug was).

TLDR - FDA is a ****hole organization that shouldn't even exist at this moment.

 

[witness23]

why so serious?

 

[Kaustikos]

why so serious?

You're right


/rant

Discuss

 

[Depakote]

The warning letter to General Mills cited them for making these specific claims:

• "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."

Those are pretty specific claims indicating that cheerios will modify that aspect of your health if taken as directed.


So if I take their product and it fails to perform, who is accountable?

 

[Kaustikos]

The warning letter to General Mills cited them for making these specific claims:



Those are pretty specific claims indicating that cheerios will modify that aspect of your health if taken as directed.


So if I take their product and it fails to perform, who is accountable?

I don't understand, they say can and may and 4% on average. Do people who tale atenolol and don't see the recorded reduction in bp have a right to go against the pharmaceutical company? Do people who take prozac/cymbalta who don't see an improvement in their depression have Lilly accountable? Narcotics not relieving pain, migraine medications not having the indicated effects, etc etc and FDA is going after a company who promotes a NON-prescribed diet food with NO contraindications or heatlh risks? Come on

 

[witness23]

hydroxycut thing was pretty funny too. about two years ago, there was a documentary on roids and they interviewed the model in the commercial (not the doctor/resident). He admitted that he was talking steroids but also uses hyrdoxycut (so "he's not lying"). He also said that if people took them and assumed that they didn't need to take anything else, then the consumer was at fault. Even after the confession, hydroxycut has been relatively successful on the market. Until recently, of course.

 

[Kaustikos]

hydroxycut thing was pretty funny too. about two years ago, there was a documentary on roids and they interviewed the model in the commercial (not the doctor/resident). He admitted that he was talking steroids but also uses hyrdoxycut (so "he's not lying"). He also said that if people took them and assumed that they didn't need to take anything else, then the consumer was at fault. Even after the confession, hydroxycut has been relatively successful on the market. Until recently, of course.

I'm just trying to discuss this because I'm trying to understand the logic behind this. I presented my case (in a rather harsh/rantish attitude, which I apologize) and I'm trying to see what the other view is.

 

[Depakote]

I'm just trying to discuss this because I'm trying to understand the logic behind this. I presented my case (in a rather harsh/rantish attitude, which I apologize) and I'm trying to see what the other view is.

The FDA exists to protect consumers.

If a product doesn't have proven purity or efficacy, it shouldn't be marketed as having specific health effects.

This might give some perspective:
http://en.wikipedia.org/wiki/Fda#History

 

[DrJonesss]

Poor cheerios. I'll still eat you.

Regardless of whether or not the whole cholesterol statement is entirely true, doesn't the FDA have better things to do? A cereal made of whole grains and not drowning in sugar never hurt anyone.

 

[Omni]

This should be exciting. Will they want us to use prescriptions to buy Cheerios now?

 

[Arzt67]

This should be exciting. Will they want us to use prescriptions to buy Cheerios now?

It would be pretty funny to see med school applicants trying to explain their convictions for illegal possession of cheerios without a prescription on applications.

 

[Raryn]

The FDA exists to protect consumers.

If a product doesn't have proven purity or efficacy, it shouldn't be marketed as having specific health effects.

This might give some perspective:
http://en.wikipedia.org/wiki/Fda#History

Unless its a "nutritional supplement" or "dietary supplement" or whatever nonsense homeopaths peddle their "drugs" as.

 

[Forthegood]

Unless its a "nutritional supplement" or "dietary supplement" or whatever nonsense homeopaths peddle their "drugs" as.

...traditional Chinese medicine, naturopaths, osteopaths, herbalists, chiropracters, energy healers, hypnotherapists, acupuncturists, religious healers... aka kooks (this list is a well that never runs dry).

All with their "published" works and "clinical studies"... the FDA has failed at educating the public of this current state of affairs. In fact, the NIH has a Complementary and Alternative Medicine branch, and even previous research directors of this branch (eg Barker Bausell) have spoken out against the placebo-effect charade that these kooks swear by.

 

[Kaustikos]

The FDA exists to protect consumers.

If a product doesn't have proven purity or efficacy, it shouldn't be marketed as having specific health effects.

This might give some perspective:
http://en.wikipedia.org/wiki/Fda#History

It has no liability to the consumer whatsoever. Massive consumption of cheerios would have the same liability as eating massive quantities of any other whole-grain food. The FDA is supposed to protect consumers but this is ridiculous

http://www.cheerios.com/

front and center that they HAVE support. What the FDA has done is not only unprofessional but reeks of desperation in my opinion. The FDA could have handled this privately instead of scaring consumers with this "letter" saying what General Mills did is in violation of the FDA. How are you protecting consumers by scaring them away from eating something that the manufacturer states it has proof that it does just that - lowers cholesterol?

 

[MadEvans]

I'm with you Kaustikos. Instead of the FDA utilizing its resources to disparage Cheerios for stepping slightly over the line on its health claims, they should assist other food products market themselves as well as Cheerios has.

Maybe they are concerned that Cheerios is trying to control the market on cholesterol reducing food products? If this is so, then assist bean/legume products, stanol ester butters, and other whole grain oat products like oatmeals with marketing their cholesterol lowering effects as well as Cheerios has.

Or maybe statin prescription fills are down, and the FDA is looking for a way to get them back up.

 

[rocketbooster]

I think cheerios should keep the labeling, be branded a dietary supplement, and placed in the dietary supplement section of stores. I'd like to see that section filled with a bunch of cereal boxes. 👍

 

[Kaustikos]

I'm with you Kaustikos. Instead of the FDA utilizing its resources to disparage Cheerios for stepping slightly over the line on its health claims, they should assist other food products market themselves as well as Cheerios has.

Maybe they are concerned that Cheerios is trying to control the market on cholesterol reducing food products? If this is so, then assist bean/legume products, stanol ester butters, and other whole grain oat products like oatmeals with marketing their cholesterol lowering effects as well as Cheerios has.

Or maybe statin prescription fills are down, and the FDA is looking for a way to get them back up.

That's what I'm thinking. I'm just completely puzzled as to what made them think "Well, this just isn't right. Can't have some company pushing cereal as a healthy alternative to breakfast... because we know no other http://www.quakeroats.com/home.aspx company has ever made those claims before.