May 22, 2009

Shhh-- Don't Tell Anyone Cheerios Lowers Cholesterol

FDA criticizes Cheerios maker for health claims. 

The primary business of medicine is business.

So I think, come on, eating Cheerios may be healthy for you in that you are not eating a bacon bits donut, but "lowers cholesterol?"  Isn't that a bit of a stretch?

At the same time, is this really a good use of the FDA's time?  Don't they have Abilify ads to police?


Imagine my surprise: the FDA doesn't dispute that it lowers cholesterol.  The claim that Cheerios can cut your cholesterol by 4% in 6 weeks is apparently backed by a real study (cheerios.pdf) in a real journal that is not available anywhere on the Pubmed.  Of course.  Pubmed's too full of  fake studies that are still online.

But you can't accuse Cheerios of being misleading about the extent of the effect: it doesn't say "gigantosaurously," it says "4%," right there on the box.   And that's been there for ten years, the FDA just noticed it?

So why now?  And if they don't have a problem with saying it lowers cholesterol, then what are they upset about?


If Seroquel says it is good for "bipolar," that's a violation, because it isn't indicated for "bipolar" but only certain phases of bipolar.  Lexapro is indicated for Major Depression, but they can't say it's good for post-partum depression, or dysthymia, even if there is good data, because it doesn't have FDA approval.  The FDA is very rigid about language.  You can only claim to do the thing that the FDA agreed you could do, even if it is established by everyone else that it can do something else.  No extrapolations.

Here are the claims that upset the FDA:

Specifically, your Cheerios® product bears the following claims ort [sic] its label:

• "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."

I've taken the liberty of underlining the words "hypercholesterolemia" and "coronoary heart disease" in the above claims.  I did this, because the very next sentence in the warning letter is:

These claims indicate that Cheerios® is intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia. Additionally, the claims indicate that Cheerios® is intended for use in the treatment, mitigation, and prevention of coronary heart disease through, lowering total and "bad" (LDL) cholesterol.

Got that?  The FDA is upset because Cheerios improperly made claims that it never actually made in reality.  Consistently, over the past ten years.


If you're confused, this may help:

the label of your Cheerios® cereal claims a degree of risk reduction for coronary heart disease by stating that Cheerios® can lower cholesterol by four percent in six weeks. High blood total and LDL cholesterol levels are a surrogate endpoint for coronary heart disease; therefore, the cholesterol-lowering claims on the Cheerios® label attribute a degree of risk reduction for coronary heart disease because if total and LDL cholesterol levels decline, the risk of coronary heart disease declines as well.

Translation: saying it lowers cholesterol is the same thing as saying it lowers coronoary heart disease, because everyone knows they're the same thing.

First, this isn't even true.  I'm not an Atkins nut, but the cholesterol connection is one of correlation, not causality.    Lowering your cholesterol if it is high is a good idea, but we don't know why; and simply lowering it does not equate to awesome reductions in heart disease.    Lipitor is undisputedly good at lowering cholesterol, but only reduces heart attacks from the baseline rate of 8% down to 4%, which may not be worth the price of Lipitor.

Second, Cheerios isn't overreaching-- the FDA is.  Since when does the FDA allow conflating endpoints?   It doesn't let antidepressants say they reduce the risk of suicide; yet here it puts those words into Cheerios's mouth.


Still confused?

Based on claims made on your product's label, we have determined that your Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug

Not that Cheerios is pretending to be a drug, or comparing itself to Lipitor.  The very expression of a claim of health makes it a drug.

Again, the FDA does not have any issue with the veracity of the claim; only that by making the accurate claim Cheerios becomes a drug, which it isn't, so it can't make the claim.

There are a quadrillion "chemicals" that make explicit drug-like claims (penis enlargement, calming, cleaning your colon of spackle and paste, etc) that are much more egregious than Cheerios.  Compare to the previous FDA warning letter for claims by  Tropical Traditions that also "cause it to be a drug:"

"[C]oconut oil is converted by the body into "Monolaurin" a fatty acid with anti-viral properties that might be useful in the treatment of AIDS:"

See the difference? Tropical Traditions is actually saying it is a drug; Cheerios is merely describing what it does, and the FDA conflates that with a completely different clinical outcome.

Next would be saying fish is good for your heart; milk is good for teeth and bones; chicken soup is good for the soul, etc.

If the hypocrisy here is not sufficient, I'll give you this: if the FDA agrees with the claims, but says the claims make Cheerios a drug, then why wouldn't they mandate that Cheerios get approval as a drug?  Instead, they prefer that people keep eating Cheerios but be unaware that it is a drug.  Now: ponder all the "supplements" out there.  The FDA knows; it doesn't care.  It has Abilify ads to police.  Do you know why?  Because Abilify has a lot of money to pay in fines.

All agencies, private or public, have survival as the primary outcome.  No agency exists to close itself.

Don't believe it? 

fda doubles.JPGYes, that's the same Minneapolis FDA that sent the Cheerios warning letter.

The [FDA] has nearly doubled the number of inspectors in its Minneapolis office over the past year, marking a rebuilding of its local presence.

...The "surge" in FDA operations doesn't mean, however, that the agency is gearing up for a crackdown on local businesses, said Charles Becoat, director of the regional office, at the meeting in February. "We're not the big bad police," he said.

So what was the hiring for, then?

FDA's Minneapolis office has also had a reputation of being "rational and sensible," he said.
He's got a point; this is an entirely rational approach to transferring wealth from one party to another.