Cheerios Warned about Health Claims

[jasonpatterson]

The Food and Drug Administration has warned General Mills regarding the claims made on the Cheerios box. The complaint wasn't about the general claims of healthfulness that the cereal box makes, but instead about specific medical claims (that Cheerios has been clinically proven to lower cholesterol by a specific amount, for instance.) The spokesman for the FDA suggested that if they wish to keep those statements on the box, General Mills should apply to have Cheerios approved as a drug.

The FDA's approach makes sense to me, but there seem to be two major issues people are bringing up. The first is that of all of the crazy things that potentially hazardous "food" products claim (think hydroxycut,) why pick on a fairly innocuous and possibly true statement made by a cereal that is about as wholesome as you could ask for? One good reason would be distribution, as Cheerios is probably more widely consumed than any supplement or other "food cure." According to the article the FDA fined Kellogs over claims made about Frosted Mini-Wheats recently as well, likely for similar reasons.

The second point is that the claim is based in clinical trials, so what's the problem? The problem with this is that for an otherwise innocuous drug to make the same claim, it has to prove that it not only is safe, but that it actually has an effect through a series of rigorous tests. Cheerios have not undergone that level of testing and thus should not be able to make claims of the same strength. Posters on this forum should be familiar with the general pattern that a great many of these claims take. A small study, often sponsored by an interested party, finds that X has some beneficial effect. This study is popularized, sales of X go through the roof, and two years later larger replications of the study find no effect at all. The public thinks scientists can't make up their minds and 10 years later people are still selling X as a panacea.

 

[davefoc]

I think you make some interesting points in your post jasonpatterson.

I hope somebody replies that has an informed opinion about this, but in lieu of that my thoughts.

1. Are the GM claims unique or unusually specific for a processed food?

It doesn't seem like it. At least similar claims are made for Quaker oats and probably for other products as well.

2. Is it legitimate for a processed food manufacture to make a specific claim about the health benefits of their food?

I don't know why not if the claim is backed up by testing. Perhaps if the testing is general and not specific for their product the claim should be couched so as to indicate that the claim is for a general class of products of which they are one.

3. Should health claims for food be subject to the same stringent requirements that drugs are?

I'm not sure, but my sense right now is no. I suspect that wasn't the intent of congress when it established the FDA.

4. Is there a gray area between a food and a drug?

I'm not sure, but if Cheerios consists entirely of ingredients generally considered to be food, I'd say it's a food.

5. Why is the FDA doing this?

a. Maybe it's a power grab.
b. Maybe somebody doesn't believe the claim and thinks it should be tested more thoroughly.
c. Maybe it's part of a general strategy to eliminate all but very general health claims from food products in the US.
d. Maybe to improve the sales of cholesterol reducing drugs by eliminating competition from food that claim similar benefits.
e. Maybe the FDA is trying to increase the demand and fees available for people who do drug testing.

 

[boloboffin]

Hydroxycut and other substances like that specifically eschew validation by the F.D.A. on the box. That's how they get away with their loosely worded claims.

If Cheerios does indeed have the medicinal value it advertises, it should apply to be considered a drug. It would be O.T.C. from the get-go, and a rigorous validation of the claim can only help sales.

 

[macdoc]

I think there is more to this....

The gov is set to allow fortified foods a wider spot BUT want to control claims over the benefits.....

ie a supplement is in a different category than a drug - Vitamin A in not a drug but making claims about adding Vitamin D or fish oils say to milk will have some boundaries placed on them.

Iodine in salt has a known benefit...that should be the platinum standard.

 

[BenBurch]

And there is no controversy over claims about folic acid added to foods. In fact I think it is mandated.

 

[Beerina]

If Cheerios does indeed have the medicinal value it advertises, it should apply to be considered a drug. It would be O.T.C. from the get-go, and a rigorous validation of the claim can only help sales.

Umm. No.


That food is healthy for you needs to get government approval as if it were a drug? Hahahaha!

I can't say as to how strong their claim is -- that's a job for scientists and, ultimately, the government, if it is not true. But assuming it's true, they are simply relating the truth of real studies, and I hope a court throws the government's case out on it's badonkadonk as attempting to limit free speech.

 

[blutoski]

I think you make some interesting points in your post jasonpatterson.

I hope somebody replies that has an informed opinion about this, but in lieu of that my thoughts.

1. Are the GM claims unique or unusually specific for a processed food?

It doesn't seem like it. At least similar claims are made for Quaker oats and probably for other products as well.

2. Is it legitimate for a processed food manufacture to make a specific claim about the health benefits of their food?

I don't know why not if the claim is backed up by testing. Perhaps if the testing is general and not specific for their product the claim should be couched so as to indicate that the claim is for a general class of products of which they are one.

3. Should health claims for food be subject to the same stringent requirements that drugs are?

I'm not sure, but my sense right now is no. I suspect that wasn't the intent of congress when it established the FDA.

4. Is there a gray area between a food and a drug?

I'm not sure, but if Cheerios consists entirely of ingredients generally considered to be food, I'd say it's a food.

5. Why is the FDA doing this?

a. Maybe it's a power grab.
b. Maybe somebody doesn't believe the claim and thinks it should be tested more thoroughly.
c. Maybe it's part of a general strategy to eliminate all but very general health claims from food products in the US.
d. Maybe to improve the sales of cholesterol reducing drugs by eliminating competition from food that claim similar benefits.
e. Maybe the FDA is trying to increase the demand and fees available for people who do drug testing.

You're asking general questions about the regulatory environment, and the answers need to be nation-specific. Since you're asking in context of FDA, I'll assume you're talking about the US.

Basically, all products are covered by the Trade Act. Claims need to be truthful, regardless of the product.

In addition, foods, drugs, and dietary supplements are three categories that are regulated differently, with different objectives.

Drugs are regulated for a balance between safety and efficacy. They can make claims that they treat specific illnesses. eg: reduces inflammation to treat lupus

Foods are regulated for safety. They cannot make claims that they treat specific illnesses. (this where GM crossed the line) They have a habit of making vague health-like claims, skirting the edge of legality.

Dietary supplements are not regulated for food or safety, and cannot make claims that they treat specific illnesses. But unlike foods, they can make what are called 'function/structure' claims, for which they need to provide very low standards of evidence of efficacy ("It worked for me," is sufficient) An example of a 'function/structure' claim is "enhances the immune system." (omitting "... to treat lupus.")

 

[NobbyNobbs]

Isn't this a very common thing, though? For example, the Dannon yogurt that Jamie Lee Curtis is shilling?

Why is Cheerios being singled out?

 

[JoeTheJuggler]

I don't think chastising General Mills for a false or unproven claim about Cheerios in any way reduces the FDA's ability to go after other bad actors. In fact, I think it sends a message that they're not afraid of going after a big company or a more mainstream company. I have no problem with it.

The FDA does stay pretty busy: http://www.casewatch.org/

 

[JoeTheJuggler]

But unlike foods, they can make what are called 'function/structure' claims, for which they need to provide very low standards of evidence of efficacy ("It worked for me," is sufficient) An example of a 'function/structure' claim is "enhances the immune system." (omitting "... to treat lupus.")

Or my pet peeve, the weasel word "supports"--as in, this product "supports the immune system" or "supports hair regrowth" and so on.

 

[blutoski]

Isn't this a very common thing, though? For example, the Dannon yogurt that Jamie Lee Curtis is shilling?

It's not very common. What medical claim is Danon making? eg: what illness are they specifying their product treats?

Why is Cheerios being singled out?

I don't think they're being singled out. I think this is just the most recent, familiar brand, and for some reason, the media's making a bigger deal out of it than other brands. Slow news day?

Kellog's was nailed last month for claims associated with Frosted Mini Wheats.

 

[blutoski]

Dietary supplements are not regulated for food or safety

I should have said, "Dietary supplements are not regulated for efficacy or safety."

Sorry.

 

[boloboffin]

Umm. No.


That food is healthy for you needs to get government approval as if it were a drug? Hahahaha!

I can't say as to how strong their claim is -- that's a job for scientists and, ultimately, the government, if it is not true. But assuming it's true, they are simply relating the truth of real studies, and I hope a court throws the government's case out on it's badonkadonk as attempting to limit free speech.

Umm. Yes.

If General Mills wants to advertise a medicinal use for their product, they need to do the appropriate tests and get F.D.A. approval, or note that the statement hasn't been evaluated by the F.D.A.

 

[Ernie M]

Would Cheerios® be having this problem from the FDA if it were sold as a homeopathic preparation, such as HeadOn?

Imagine:
OATSin
Ingest directly to the stomach.

 

[RemieV]

Just posted an article on this here:

http://weirdthings.com/archives/2495

Cheer(io)s!

 

[empeake]

Would Cheerios® be having this problem from the FDA if it were sold as a homeopathic preparation, such as HeadOn?

Imagine:
OATSin
Ingest directly to the stomach.

Let me correct it for you:

OATSon
Rub gently on belly.

That way, it would be just as effective as HeadOn.

 

[NobbyNobbs]

It's not very common. What medical claim is Danon making? eg: what illness are they specifying their product treats?

From their website:

Activia with Bifidus Regularis is scientifically proven to help with slow intestinal transit when eaten daily for two weeks, as part of a balanced diet and healthy lifestyle.

On the up side, they seem to place quite an emphasis on clinical trials and peer review.

 

[JoeTheJuggler]

I should have said, "Dietary supplements are not regulated for efficacy or safety."

And they are actually sort of regulated for safety, but only after the fact.

The manufacturer doesn't have to have upfront evidence of the product's safety (as an actual drug does), but if the FDA finds out the product is dangerous AFTER it's been marketed, they can ban it.

 

[macdoc]

No question active yogurt is effective for intestinal fauna - you could also just swallow acidophelous.

 

[fuelair]

Umm. No.


That food is healthy for you needs to get government approval as if it were a drug? Hahahaha!

I can't say as to how strong their claim is -- that's a job for scientists and, ultimately, the government, if it is not true. But assuming it's true, they are simply relating the truth of real studies, and I hope a court throws the government's case out on it's badonkadonk as attempting to limit free speech.

So, and I am not trying to speak for you, but...I understand you to be saying a food product should be able to advertise a specific aid/amelioritive ability of it's ingredients based on a standard far below that for drugs, thus implying you can use it like a real medicine for the condition without actual evidence. IF that is the case, I cannot possibly agree. NO product that has not faced proper testing should be able to claim ANY health effects/benefits of any kind. If they do, that is false advertising (or potential murder in my preferred words). Granted, since it is encouraging people to use it over tested materials by these misleading (and they are misleading even if unintentionally so due to incomplete/nonexistant testing)words/phrases/implications -even if the sellers actually believe them- it is potential indirect murder as the victims do not die from the product but rather die if they have a condition and do not treat it in the belief that the product is helping them. Perhaps I should phrase it as manslaughter.
Freedom of speech is certainly not intended for this (or, if it is, then false advertising should not be a crime). OR perhaps we should remember, as so many want to forget, freedom of speech does not mean freedom from punishment for that speech - just means you can't legally be stopped from it (and even that is not fully true). Injunctions.