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No Weight Loss Claims for Supplements?

A year or so from now, you may well turn on CNN and hear the following:
All supplement makers will no longer be allowed to make any weight loss claims for their products. Any such claims will now have to be pre-approved by the FDA.

And if you're like most Americans with limited attention to spend on the details and backgrounds of such reports, you'll probably come away with the impression that these regulations were passed because the FDA considers weight loss claims for supplements to be bogus. And, after all, the FDA knows what it's talking about, and they're looking out for you, right?

So it must be true. And another nail will be hammered into the coffin of the supplement industry and righteous doctors will talk about how this stuff isn't regulated, all of this natural medicine stuff is unproven, and, hey, it's about time somebody did something about it!

You'll also probably hear (correctly, as it turns out) that this all happened because of a Citizens Petition to the FDA to "stop weight loss claims" for dietary supplements.

Ah, Democracy in action! Citizens were fighting back against these unscrupulous makers of green tea supplements!

So I thought you might like to know a little behind the scenes scoop about how this scenario is likely to come into being.

Right now, as we speak (or read) there is indeed a Citizens Petition to Disallow Weight Loss Claims for Dietary Supplements. (It sounds so "grass roots", doesn't it?)

The "Citizens Petition" was filed, on April 17, 2008. But not by a bunch of your citizen neighbors. Rather, it was filed by GlaxoSmithKline (GSK) one of the world's leading pharmaceutical companies. The "Citizens Petition" requests that the FDA now classify weight loss claims as "disease claims" effectively requiring all nutritional supplements that have any effect on metabolism or weight to be treated as drugs and regulated similarly.

The petition was also filed on behalf of the wonderful, always-lookin'-out-for-you American Dietetic Association, which was given a substantial financial grant as a reward for its participation.

GSK is the manufacturer of Alli, a watered down over the counter version of the weight loss drug Orlistat (Xenical) which even at full strength is next to useless. You may remember from an earlier newsletter item that GlaxoSmithKline spent over 150 million bucks marketing Alli the first year it came out. Largely due to the superb marketing campaign, Alli is a cash cow- so far, it's generated cumulative sales of about 315 million and counting.

The GSK petition claims that dietary supplements are ineffective in treating overweight conditions. The language of the argument is incredibly arcane and hinges on all kinds of paper thin legal distinctions. For example: "Petitioners are not asking FDA to conclude that the state of being overweight is a disease…petitioners are requesting FDA to restrict weight loss claims because they purport to treat an unhealthy condition that is a risk factor for disease- not the disease itself". (I could not make this up.)

The bottom line: the Pharmaceuticals don't want any competition from natural products and will use any lobbying they can to influence regulatory agencies to use their powers to keep the competition off the market.

Some of the specific supplements the petition is mentioning by name include

  • CLA (conjugated linolenic acid)

  • Garcina Cambogia (Super CitriMax)

  • chromium picolinate


Green tea extract wasn't specifically mentioned, though you can be sure there will be collateral damage to all supplements if this ridiculous petition goes through. (Studies have shown that green tea extract can reduce body weight and increase metabolism.)

The point is that this "Citizens Petition" filed by one of the biggest pharmaceutical companies in collusion with the American Dietetic Association has nothing whatsoever to do with protecting your health and everything to do with protecting their turf.

The sad part is that almost no one knows that this stuff goes on- and it does-- all the time. You only hear the end result- "no claims allowed" and, if you're like most people, assume that must be because there's something fishy about the claims and the FDA is looking out for you.

Without getting too political, I think one of the reasons that the vast majority of my colleagues in the natural health movement were so crazy about the Ron Paul candidacy is that he was the only candidate who actually cared about health freedom and would have done something about the wholesale corruption and abuse of power that keeps people from having access to information and products that could really help them. (I personally had a few problems with some of his other positions, but on that particularly one, he was on the money!)

The FDA normally has to respond to such a petition within 180 days of receiving it. You can read comments from nutritionists, doctors, supplement manufacturers, health foods store owners, concerned citizens, and (hopefully) leave your own comment at regulations.gov.
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Blogger Benjamin said...

I am dietetics student at GA State University and so far my professors have been uber-anti supplements. Last year I made a suggestion on how to increases insulin sensitivity with a low-carb diet and supplements in pregnant women so they don't get gestational diabetes and I received the most cold-hearted stare ever and was told 'to stop reading too many magazines'. I haven't bought a magazine in 3 years. On a side note, I am looking to buy your PICP Nutritional Manual but was wondering if you're going to come out with a new edition soon, or should I just go ahead and get the current one?
Thanks,
Benjamin

September 03, 2008 5:29 PM  
Blogger Dr. Jonny Bowden said...

Hi Benjamin

Thanks for writing. On ocassion- not often, but once in a while- I start to soften my position on the incredibly stupid American Dietetic Association, then I hear something like this and it brings me back to my senses. Don't even bother with these people, it's like trying to talk tolerance to the Taliban.

No plans to update the nutrition manual soon- everything in there is pretty up to date except the research citations which continue to grow..

Warmly
jb

September 03, 2008 5:59 PM  
Blogger Davin said...

Hi Johnny,

I have to say it appears you hit the nail on the head and have GSK and the ADA sussed out (like you hadn't already!). For starters, CLA and in particular EGCG have have been proven! I'm not advocating that all bodybuilding supplements work, but look at any fat burner or fat reduction supplement and it will nearly always contain EGCG! Like you said, this is what seems to be a successful attempt by a pharmaceutical company getting their own way.....what's new?

September 04, 2008 1:59 AM  
Blogger Davin said...

Hi Johnny,

I have to say it appears you hit the nail on the head and have GSK and the ADA sussed out (like you hadn't already!). For starters, CLA and in particular EGCG have have been proven! I'm not advocating that all bodybuilding supplements work, but look at any fat burner or fat reduction supplement and it will nearly always contain EGCG! Like you said, this is what seems to be a successful attempt by a pharmaceutical company getting their own way.....what's new?

September 04, 2008 2:00 AM  
Blogger dark_one said...

My name is Vivian Brown and i would like to show you my personal experience with Xenical.

I am 28 years old. Have been on Xanax for 2 weeks now. Needed to lose 20 lbs. I'm 5 foot 7 and about 165 pounds...would like to get around 145 or less. I lost 7 pounds within 7 days of starting. Worked very good for me since I'm only overweight because I eat fatty foods. If you are dieting and exercising and eating all of the right foods it may not do much, but if you are like me and have a decent metabolism but do not eat the right foods it seems to work wonders. Also I'm only taking half of the normally prescribed dose.

I have experienced some of these side effects -
Orange Oily Stool, very minor stomach cramping, sudden urge to use the bathroom after eating food with heavy amount of fat.

I hope this information will be useful to others,
Vivian Brown

Xenical Prescription Information

February 05, 2009 12:08 PM  

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