Uh-Oh Cheerios: FDA Finds Holes In Your Health Claims

Cheerios (General Mills)General Mills got its hands slapped over the cholesterol-lowering claims on those bright yellow boxes of Cheerios. FDA sent a warning letter that said the company crossed the line by promoting the cereal as a drug. The specific complaints were focused on these 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.

You’ve probably seen these claims because they’ve been on the package for more than two years. But now FDA says the boxes are misbranded and the health claims turn those toasted Os into an “unapproved new drug.”

I certainly agree that health claims have gotten out of control, and many foods and beverages go too far, but is this the example that FDA should call out as abuse?  At least the ads for Cheerios don’t say you can cheat death!pom-wonderful-ad-0013


I can certainly think of a lot of other products that I’d start with first.  If you’re swayed by the messages on the box, what’s the harm of sitting down to a whole grain bowl of Cheerios in the morning?  You’ve certainly made a better choice than dashing to the drive-thru for a sausage-egg biscuit or grabbing a 600-calorie chocolate chip muffin.

Some of the media coverage I’ve seen about the FDA warning makes it sound like there’s something seriously wrong with the cereal:  “Cheerios, the world’s best-selling cereal, isn’t so wholesome as its maker General Mills Inc. contends.”  Huh?  I don’t think that’s the issue.  Even though a lot of people are applauding FDA’s crackdown on health claims, I think it has also confused the public.  That’s probably why the FDA issued a  follow-up Q & A to help clear up any confusion.  For example, the warning letter does not question the safety of Cheerios.  And what appears to be a bit of a back peddle, FDA emphasized that the warning letter was not intended to discourage people from including  Cheerios in a balanced diet:  “No. In fact, the Dietary Guidelines for Americans encourages the consumption of whole grain foods, which includes whole oats found in products such as Cheerios.”   FDA even reinforced that Cheerios is eligible to make the FDA-approved health claim related to soluble fiber (including oats) and a reduced risk of heart disease.

Currently, the FDA recognizes 17 specific health claims, each linking a food or ingredient to a disease or health-related condition.  You can argue all you want about the merits of health claims, but those are the current regulations, and Cheerios does qualify to make a heart health claim. FDA does not have the same control over the claims made by dietary supplements, and that’s where you can find tremendously misleading claims. total-cleanse-banner5

So what’s the issue with Cheerios?  FDA did not challenge the science supporting the soluble fiber heart health claim, but the agency had problems that the claim was presented as a separate stand-alone message.  Basically the layout of the box troubled them because some of the qualifying language was on the back.  Also, the claim was not supposed to identify any degree of risk reduction, and the Cheerios box specified a 4% reduction in cholesterol in 6 weeks.  That’s what the clinical trial found (although keep in mind, the research involved eating a serving of Cheerios for two meals a day).

FDA also pointed out problems with the General Mills web site, which the agency considers part of the Cheerios labeling (so the same rules apply).  The claim needed to include messages about the total diet — such as the importance of fruits and vegetables and keeping saturated fat and cholesterol low.

Sure, Cheerios is not a silver bullet to lower cholesterol or avoid heart disease.  Indeed, it’s the total diet that counts.  But eating more whole grain foods that are rich in soluble fiber is a good thing. Maybe a single bowl of Cheerios in the morning may not bring miraculous results, but it is one positive step.  Studies have shown that if you take several positive steps like this (a portfolio approach of many different cholesterol-lowering foods), then you can make a big difference.

Yes, it’s good to be skeptical.  But here’s a case where I hope people don’t over-react.  This is not an example of a fraudulent marketing scam.  Plenty of other products come to mind — not this humble  oat cereal. So whether you enjoy a bowl of Cheerios, oatmeal or other  fiber-rich cereal in the morning, keep it up.   Skip the “total cleanse” and go for the grains  instead.

 

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  • Great post, Janet. It’s a shame things like this get so blown out of proportion. It truly does end up confusing folks even more.

  • I also found this news quite interesting and included it in this week’s Five for Fridays on my blog. In my opinion, the claim about lowering cholesterol is a little troublesome even though it seems to be supported by “clinical data”. Where is that clinical data and who has evaluated it? This kind of a claim needs to be verified through an independent review, which is what the FDA is supposed to do as part of a new drug submission.

    How should consumers react to it? If they have a cholesterol problem, should they ask their doctors for a recommendation on Cheerios? Should they cut down on approved cholesterol lowering drugs, which I would venture to guess cost a lot more than a box of Cheerios? I think if General Mills wants to make a cholesterol lowering claim, they should also include language to properly manage consumer expectations.

    I agree with you about claims on nutritional supplements. But that is why they are supposed to write that their claims have not been evaluated and verified by the FDA. Probably, Cheerios should add similar language on their box.

    We do like Cheerios and buy it regularly. However, I can totally understand why FDA would act in this manner. And frankly, I am glad that they did.

    I don’t have that big a problem about their “stand alone” claim regarding heart health by eating whole grains.

  • This kind of a claim needs to be verified through an independent review, which is what the FDA is supposed to do as part of a new drug submission.

  • I think if General Mills wants to make a cholesterol lowering claim, they should also include language to properly manage consumer expectations.

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