May 13 2009

The FDA is going after health claims? At last!

cheerios1It looks like the FDA is finally getting around to looking at the absurd health claims on boxes of breakfast cereals.  And about time too, I’d say.  For starters, the FDA picked on General Mills’ Cheerios.  Cheerios boxes display banners claiming that if you eat this cereal, you will reduce your cholesterol by 4% is 6 weeks (see previous post on this).  This, General Mills says, is “clinically proven.”  Yes, but the trial on which General Mills bases this claim substitutes one serving of Cheerios for each of two meals a day.  Hey – that ought to work!

In its warning letter, the FDA says that if Cheerios lowers cholesterol, it is claiming to work like a statin drug.  If Cheerios acts like a drug, it has to be treated like a drug.  Cheerios, says the FDA, “is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease. Therefore…it may not be legally marketed with the above claims in the United States without an approved new drug application.”

So what’s going on here?  I collect cereal boxes and I’m guessing that I bought the one shown here at least two years ago.  The boxes have changed since then but similar claims appear on the Cheerios website.  Maybe in this new administration the FDA can get a grip on silly and misleading health claims.  Let’s hope.

Update May 18: Advertising Age advises marketers about how to avoid FDA interference: know the rules, don’t assume that breaking them is OK even if you have done so for a long time, follow the rules.  Seems like good advice.

Update May 25: Europeans applaud this FDA action. They think we have gone much too far with health claims.

Update January 18, 2010: At a visit to the FDA last week, I saw a more recent Cheerios box that I somehow missed – lower your cholesterol by 10% in one month.  This one disappeared quickly, but I found a good description of what happened on the Consumer World Mouse Print site.  General Mills sponsored a study and rushed the box into print.

  • Sara

    I just saw an interview with a woman (missed her name) on Today – she basically said this is going to look bad for the FDA because they should be worried about ‘bigger things like samonella’.

  • http://www.culinate.com Mark

    Now we can expect a concentrated effort through their lobbyists in DC and new ad campaigns to revise history.

    There is where the real battle should be held… how to cut lobbyists out of the discussion. I used to think we had to live with them since some worked for the “good” of the public, but I am starting to wonder, if the “good” is worth the “bad”. Alas, too many battles for the administration right now, but maybe in a year or two I hope!

  • Anthro

    Finally! The supermarket is filled with this nonsense and it needs to stop. These companies need to be held accountable and stop their fraudulent marketing scams.

    NY Times had a piece recently about a well performed study that says vitamins (antioxidants especially) can interfere with exercise benefits. Better to eat the food that contains antioxidants they say–as MN, et. al., have said all along. Whenever I tell people who complain about spending so much for all their supplements that they don’t need them and that there is NO scientific evidence to support their use, they look at me in astonishment which quickly turns to scorn (as if they pity me because I am the one who is being deceived!). So I think this is a good start; hope it holds up through the lobbying and media onslaught that is sure to follow.

  • http://www.findyourbalancehealth.com Michelle @ Find Your Balance

    I hope they actually do something substantial to stop confusing consumers. Advertisers will jump through amazing hoops to get their skewed messaging across.

  • sid

    Cereal box health claims are not fully supported by science?

    Gosh, I wonder what other amazing too-good-to-be-true claims on products are not true?

    Um, all of them?

  • Auralee

    I have long suffered from IBS, and my gastoenterologist–must have been an early whole foods advocate because this was many years ago–recommended shredded wheat ‘n’ bran because it was a high fiber cereal that was closest to the natural state of the food. If you look at the label: two ingredients–whole grain wheat and wheat bran. Plus a preservative, BHT (what doesn’t have a preservative, I guess). I don’t even look at cereal boxes anymore (shudder…) Funny that you said you collect them!

  • http://www.changebecomeschange.typepad.com Gina

    Yes, it’s encouraging to see the FDA protect the laws in place and do their job, but it does seem like they could have made a better choice for their first brand to go after. Cheerios is every child’s first finger food. A brand we all grew up with. There had to be a better choice to make them look like the hero.

  • http://front-porchanarchist.blogspot.com/ Charles Hennessey

    The FDA is claiming General Mills is making an “unauthorized health claim” on its website by saying, “Heart-healthy diets rich in whole grain foods, can reduce the risk of heart disease.”

    Isn’t this just a little bit ridiculous?

  • Anthro

    Charles,

    The problem with these claims is that they imply (and not very subtly at that) that eating their product will prevent or treat heart disease, when in fact, it is eating whole grains (without the added sugar) and lots of other things, like fruits and vegetables, in moderation (in order to maintain a healthy weight), plus regular exercise, that helps stave off heart disease. A diet of Cheerios is of little practical value.

  • http://front-porchanarchist.blogspot.com/ Charles

    I hope no one ever says “an apple a a day keeps the doctor away” in the presence of an FDA enforcer. :)

    I know Cheerios is junk, most cereal is – and informed people know that. But I do not want to relive the nightmare that was David Kessler. Remember him? He tried to ban a number of herbs and vitamins.

    http://reason.com/news/show/29410.html

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  • Anthro

    Charles, you are on the wrong blog! Kessler is a hero and what has happened to the FDA since he left is a travesty for science-based policy. Please read Professor Nestle’s book “Food Politics”.

    Vitamins and supplements should be regulated and tested. They should not be able to make ANY claims that are not clearly scientifically established. There is no credible scientific support for the routine use of vitamins and other supplements.

    I think most people who follow Dr. Nestle’s work are very pleased that the FDA is showing a glimmer of its former self with the Cherrios decision.

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  • Anthro

    I noticed this as well, but really, they are not “going after them” in the sense that they are banning Cheerios, they just don’t want the false claims on the packaging. People so often jump to conclusions.

  • Daniel Ithaca, NY

    A heart healthy diet would include more whole grains and LESS sugar (keep those triglycerides down!)

    Cheerios seems to have a large amount of “modified corn STARCH” as well as sugar with some whole grain. Why do so many consider this a healthy food?
    http://www.generalmills.com/stream_image.aspx?rid=27042

    What’s much worse is the Whole Grains label on boxes of Lucky Charms. Why isn’t this considered fraudulent?
    A pile of sugar and starch with a sprinkle of whole grains = Whole Grains? Come on FDA!
    12g SUGAR/ 27g Serving = 44.4% Sugar,
    Ingredients:
    Whole Grain Oats (Includes the Oat Bran), Marshmallow Bits (SUGAR, Modified Corn Starch, CORN SYRUP, DEXTROSE, Gelatin, Calcium Carbonate, Artificial Flavor, Yellow 5 & 6, Red 40, Blue 1, Methylcellulose, Sodium Lauryl Sulfate), SUGAR, CORN SYRUP, Corn Starch, Salt, Calcium Carbonate, Color Added, Trisodium Phosphate, + various vit.s & min.s

    a less confusing list:
    >ingredients: Oats, SUGARS, SUGAR, CORN SYRUP, CORN STARCH…
    Wow now I see that it has a lot of sugar!
    It is very confusing to list “marshmallow bits” as an ingredient.
    If a product isn’t, let’s say 90% whole grain, then WHY is it allowed to be sold with prominent Whole Grain advertising on the package?
    As always, avoid the ‘more than 5 ingredient foods’.

  • http://front-porchanarchist.blogspot.com/ Charles

    Anthro,
    Kessler succeeded in banning l-tryptophan, an amino acid that is a mild seratonin reuptake inhibitor. Many people used it as an aid to quitting smoking before the ban. I used it in 1987, it took the edge off and was useful in helping me quit. Coincidentally, mere weeks after the ban pharmaceutical companies rolled out their quitting smoking kits – patches, nicotine gum, etc. Prozac, another seratonin reuptake inhibitor, debuted not long after the ban. I do not trust this guy.

    We have the right to self medicate in this country. I take 5-HTP, (re-legalized l-tryptophan in a different form) Ginkgo, and Ginseng regularly and feel good taking it. You may think I’m being duped. That’s also a right. :)

  • Daniel Ithaca, NY

    Charles:
    “The FDA is claiming General Mills is making an “unauthorized
    health claim” on its website by saying, “Heart-healthy diets rich in
    whole grain foods, can reduce the risk of heart disease.”

    Isn’t this just a little bit ridiculous?”

    The problem isn’t that a cereal is making such a health claim, it is that the cereal is mostly processed starch and sugar with SOME whole grains. Cheerios are not “whole grain” but they contain some whole grains.
    If you had a zinc bar and plated it with gold it doesn’t become a gold bar anymore than this and other such cereals should be considered “whole grain”.
    Yes Charles it is ridiculous that a highly processed food is allowed to advertise itself using the term Whole Grain.
    Truth in labeling!