Cheerios a Drug?

Posted by Sean on May 13th, 2009

cheerios

Alison Smith Reports:

The United States Food and Drug Administration, apparently bored to tears by microbial face paint contamination, took a stand against General Mills in a warning issued on 5 May 2009 for claims made by the #1 toddler finger food – Cheerios.

The FDA’s warning stated that the claims made by General Mills regarding the health benefits of eating Cheerios (specifically, that doing so lowers cholesterol and prevents heart disease) would qualify Cheerios as a drug. Ignoring all the fun drug slang phrases I can come up with for this (“Dude, I’m so Cheerioed”), let’s get to the heart of the issue here.

First of all, a note to crappy researchers like David Theroux of The Independent Institute and Behind Blue Lines – oh my God, please Google before posting.

Theroux stated in his post:

According to CBS News, now the FDA has sent a letter to General Mills, the makers of Cheerios, warning them to stop including health claims in their advertising not because they are false, but because such claims make Cheerios a “drug” which “may not be legally marketed with the above claims in the United States without an approved new drug application.”

Mr. Theroux… let’s talk about regulatory institutions in the United States. The Food and Drug Administration of the United States regulates things like food, cosmetics, medical devices, veterinary medicine, etc, etc. They do not give a damn about advertising – false or otherwise. That falls under the purview of the Federal Trade Commission. The FDA is not concerned with how Cheerios is advertised, but how it is branded – and only researches advertising for a product if they are deciding whether to treat a product as a food or a drug… which, you may have noticed, is precisely what happened here. Additionally, the FDA didn’t even really need to look at Cheerios advertising. The claim is, after all, handily printed directly on the Cheerios box. That’s not advertising. That’s labeling.

And no one ever said the claims Cheerios makes are false. In fact, General Mills claims to have conducted a double-blind study of 135 individuals on Cheerios’ ability to lower cholesterol (though they have not offered the publication that contained the study).

As for the folks at Behind Blue Lines – well, they said the following:

At the rate we’re going, apples will be deemed an unapproved drug because of the old saying ‘an apple a day keeps the doctor away’.

No, Behind Blue Lines, that’s not the case at all. The FDA would, however, go after Dole if they put on their apple bags, “Also cures leukemia!”

The FDA’s definition for what constitutes a drug is as follows:

The FD&C Act defines drugs, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”

If General Mills says “Hey, our cereal prevents heart disease!” then they’d better damn well publish their clinical study and fill out that drug application unless you want there to be a bunch of dead people who say with their last dying breath “Screw you, Cheerios.”

Yeah, it’s totally weird that the FDA is this concerned with cereal, but that’s why they exist. I cannot fathom of a person who would eat Cheerios in lieu of taking medication, but then again, I know people go for chiropractic, and we all know that’s bull hockey.

  • CasaRojo

    Great article Alison! :-)

  • http://www.fatoneinthemiddle.com Heidi Anderson

    I am so glad you posted this and I WILL argue with you!

    Where the HELL do you get off claiming that Cheerios are the number #1 toddler finger food in America? Where is your evidence? Do you have any proof?

    Everyone knows that it is Goldfish crackers.

  • http://mully410.blogspot.com/ Mully410

    I know you asked for arguments but I totally agree. Cheerios should put up or shut up.

  • http://suburbanpanic.com Oskar Kennedy

    I think it's a measure of seriously out of whack priorities that the FDA is pursuing this, while Kevin Trudeau and his ilk are prosecuted (if at all) by the FTC. While the Cheerios claims should be backed up with published evidence, I doubt seriously that anyone is going to ditch their statin drugs in favor of an all-Cherios diet. Meanwhile, naturopaths and big pharma conspiracy wonks can actively try to convince people to replace real medicine with their snake oil; as long as their claims are vague enough, FDA can't say word one.

  • Alison Smith

    There is some definite overlap between the purview of the FTC and the FDA – and that's a good thing. It means that both can take a company down simultaneously.

    The reason the FDA started the investigation into Cheerios was based on a letter written to them informing them of the claims General Mills was making. So – you know what this means… everyone get your pens, sit down, and write a letter to the FDA about whatever alternative treatment pisses you off. Be sure to cite the precise FDA regulation that is being violated. Get as many people as possible to sign your letter, and send it off.

    I think this action is a great thing – the FDA is clearly not afraid of big companies or backlash from the public. This is a fantastic time to be on the skeptical side of alternative medicine. I think this action illustrates a window of opportunity.

    P.S. Goldfish crackers are overrated :D

  • Alison

    I just wrote you a kind of lengthy reply and it seems to have disappeared. Let's try that one again.

    The purview of the FTC and the FDA does overlap some – and I think that's a good thing. It means that both institutions can simultaneously take down the same company.

    I think the fact that the FDA has given an official warning to General Mills is a great sign of things to come. Clearly, they have no issue with going after a big company, and no fear of backlash from the public.

    The way the investigation into General Mills started, by the way, was by a group of individuals who pointed out the claims in a letter to the FDA. So, you know what this means… grab a pen, sit down, and write a letter about the alternative medicine that really pisses you off. Be sure to cite the FDA regulation that the product is in defiance of. Then go out and get as many people as possible to sign your letter. The FDA is apparently willing to take action.

    This is, I hope, a sign of things to come – of more stringent regulations on what we call a treatment, and what we call a cure. Fingers crossed for the future.

  • Alison

    I just wrote kind of a lengthy reply and it seems to have disappeared. Let's try that one again.

    The purview of the FTC and the FDA does overlap some – and I think that's a good thing. It means that both institutions can simultaneously take down the same company.

    I think the fact that the FDA has given an official warning to General Mills is a great sign of things to come. Clearly, they have no issue with going after a big company, and no fear of backlash from the public.

    The way the investigation into General Mills started, by the way, was by a group of individuals who pointed out the claims in a letter to the FDA. So, you know what this means… grab a pen, sit down, and write a letter about the alternative medicine that really pisses you off. Be sure to cite the FDA regulation that the product is in defiance of. Then go out and get as many people as possible to sign your letter. The FDA is apparently willing to take action.

    This is, I hope, a sign of things to come – of more stringent regulations on what we call a treatment, and what we call a cure. Fingers crossed for the future.

  • http://www.independent.org/ David Theroux

    Alison,

    The FDA most definitely has and does restrict advertising which is the point of their letter to General Mills. As such, FDA policies are clear infringements on the First Amendment. And despite your claims to the contrary, my posting at The Beacon (http://www.independent.org/blog/?p=2154) clearly notes that the FDA is not disputing the claims by General Mills, but simply that the FDA insists that Cheerios be registered as a drug for the firm to be allowed to continue communicating its product's proven merits. In other words, there is no issue of fraud here, other than the fact that the FDA's claims themselves to be protecting the public from eating Cheerios.

    Again, those interested in in-depth examinations of the fraud, waste, and health risks created by the FDA should go to http://www.fdareview.org/.

  • Alison Smith

    David,

    That is incorrect. Re-read the article above. The issue is not with the advertising – the issue is with the labeling.

    Here is an example of an advertisement:

    http://www.youtube.com/watch?v=OJRRYOfoXEM

    Here is an example of a label:

    http://www.historyofthings.com/wp-content/uploa…

    The label above is the type of label the FDA has taken issue with.

    You might also want to re-read the letter the FDA sent General Mills. It does not, in fact, address advertisements. The first segment of the letter says:

    “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 http://www.fda.gov.http://www.fda.gov/foi/warning_letters/s7188c.htm

    ***

    Note: label; labeling.

    Again, false advertising is under the purview of the FTC, and if false advertising is suspected, the FTC can certainly take action as well.

    I even went ahead and searched the words 'advertise,' 'advertisement,' and 'advertising' within the letter with zero results whereas there are fourteen forms of the word 'label'.

    The FDA is not “protecting the public from eating Cheerios.” Again, try re-reading the article. The FDA is protecting the public from potentially harmful alternative medical treatments – and it doesn't matter if the entire universe is smart enough to take medication for their cholesterol issue rather than eat Cheerios. The problem arises when there is no way to regulate products that claim to treat diseases unless you define them as drugs. It's an arbitrary definition, but so is every classification. There is simply currently no regulation to keep companies from claiming their product cures diseases unless that product is first classified into a category that has those regulations.

    The Dole example still stands – would you think it was acceptable for a company to claim that their apples cured leukemia? If so, why? If not, why not?

    I do not see how this is a first amendment issue whatsoever. Are you suggesting that any company should be able to claim any thing about their product because that would be free speech?

    That actually doesn't make any sense. The regulatory body for foods and drugs is the FDA – in other words, the FDA can be called, in this instance, the officers who respond to imminent lawless action.

    Free speech, according to Brandenburg vs. Ohio, is not protected in cases where the violation of a law will occur faster than an officer of the law can reach the scene. Shall we post FDA officers in every grocery store to prevent people from buying products if, as I said earlier, Dole starts labeling their products to say that they cure leukemia?

    That is pure insanity, Mr. Theroux.

    – Alison

  • KingMerv00

    David said, “The FDA most definitely has and does restrict advertising which is the point of their letter to General Mills. As such, FDA policies are clear infringements on the First Amendment.”

    To which legal precedent are you referring? Gitlow v. New York? Debs? Dennis? Yates? Schenck? Texas v. Johnson maybe?

    The fact that you brought up the 1st Amendment in your reply tells me that you don’t have the first clue regarding constitutional law. Being ignorant of case law is nothing to be ashamed of but the moment you make a legal claim, you’d better know what the hell you are talking about.

    Next time? Look. It. Up.

  • KingMerv00

    David said, “The FDA most definitely has and does restrict advertising which is the point of their letter to General Mills. As such, FDA policies are clear infringements on the First Amendment.”

    To which legal precedent are you referring? Gitlow v. New York? Debs? Dennis? Yates? Schenck? Texas v. Johnson maybe?

    The fact that you brought up the 1st Amendment in your reply tells me that you don't have the first clue about constitutional law. Being ignorant of case law is nothing to be ashamed of. But the moment you make a legal claim, you’d better know what the hell you are talking about.

    Next time? Look. It. Up.

  • Jon Lindsay

    Regarding the First Amendment issue:

    It has been held from the very beginning of our rights under constitutional law that “commercial speech” does not get a free pass. So there's 200 years worth of precedent you have to overcome to make your case on this issue.

  • Sincerely

    Um…you quote the FDA definition of a drug as saying a drug is something that is “other than food.” Cheerios are food. I'm confused.

  • Alison Smith

    “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”

    The two sets of quotes are two different, applicable definitions. Since all food 'affects the structure or any function of the body' (particularly beans, if you believe some people) all food would fall into the category of 'drug' using the second definition unless they added the parenthetical to point out that, at that point, they are no longer talking about food.

  • Alison Smith

    “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”

    The two sets of quotes are two different, applicable definitions. Since all food 'affects the structure or any function of the body' (particularly beans, if you believe some people) all food would fall into the category of 'drug' using the second definition unless they added the parenthetical to point out that, at that point, they are no longer talking about food.