FDA plans more scrutiny of supplements

[zakur]

Story (http://www.cnn.com/2004/HEALTH/diet.fitness/01/20/fda.supplements/) The Food and Drug Administration is planning to move beyond its recent actions on ephedra and step up its scrutiny of the health effects of various other herbal supplements.

FDA Commissioner Mark McClellan was expected to unveil the new policy at a speech Tuesday in Mississippi. :clap:

[BillHoyt]

Originally posted by zakur
Story (http://www.cnn.com/2004/HEALTH/diet.fitness/01/20/fda.supplements/) :clap:

This is a great move. Unfortunately, the cranks and quacks have already demonstrated their great capacity to turn it on its head. The FDA's oversight role was all but decimated by DSHEA. This attempt to turn up the heat on the most dangerous snake oil out there will be accompanied by a large disinformation campaign that implies the FDA is somehow giving the nod to the vast majority of "supplements."

A recent example of this ploy was the TV ads for Avacor. A "doctor" (he must be; he's in a white lab coat in an office) speaks into the camera:

"The FDA has recognized the body chemical, Di-hydotesterone, or DHT, as the leading cause of baldness. Avacor fights DHT to restore your natural hair growth..."

Wow, the FDA reviewed and approved Avacor?

[HarryKeogh]

This is absolutely fantastic, non-reactionary regulation. But if our government is going to start banning us from putting more stuff into our bodies they should really start with the useless things that kill the most people first then go in descending order from there.

I'm sure no one would mind the government telling us we can't smoke a cigarette because they're bad for us. Just think of the thousands of lives saved every week! But hey, don't get me wrong, by banning these herbal supplements we may prevent scores of deaths over the next 10 years.

[BillHoyt]

Originally posted by HarryKeogh
This is absolutely fantastic, non-reactionary regulation. But if our government is going to start banning us from putting more stuff into our bodies they should really start with the useless things that kill the most people first then go in descending order from there.

I'm sure no one would mind the government telling us we can't smoke a cigarette because they're bad for us. Just think of the thousands of lives saved every week! But hey, don't get me wrong, by banning these herbal supplements we may prevent scores of deaths over the next 10 years.

I think perhaps you are misconstruing what the "ban" actually means. It does not mean you cannot use the substance. If you want to grow the herb, grind it and add it to your meals you are free to do so. The "ban" is against the quacks who want to profit from selling it to you and who wish to have you believe it will make you healthy or powerful or virile or attractive to female kangaroos. It is a snake-oil-salesman-centric ban. They can no longer show up at your county fairs, pull up a milk box and bull horn and tell you why the Bible commands you to buy their product. Nobody can appear on TV, dressed in a white coat, and imply to you it is healthy. Imply to you it is safe. Imply to you it is efficacious.

[BTox]

Originally posted by zakur
Story (http://www.cnn.com/2004/HEALTH/diet.fitness/01/20/fda.supplements/) :clap:

Great news. Now if only the politicians would repeal DSHEA...

[BTox]

Originally posted by HarryKeogh
I'm sure no one would mind the government telling us we can't smoke a cigarette because they're bad for us. Just think of the thousands of lives saved every week!

I wouldn't mind at all. But you know that already. ;)

[HarryKeogh]

Originally posted by BTox


I wouldn't mind at all. But you know that already. ;)

believe me, i know!;)

[crimresearch]

"If you want to grow the herb, grind it and add it to your meals you are free to do so..."

Errmmm... the version of the regulation that I recall reading clearly banned the 'herb' itself.... a common mallow root that grows wild.

No mention was made of banning for example, pseudo-ephedrine.

Paul Nunis

[uneasy]

I'm glad because someone I know spends a lot of money on supplements. He read one book that said take vitamins and did until he read one book that said supplements were better. But the FDA won't be credible to him. He will consider it big government interference. sigh

[BillHoyt]

Originally posted by crimresearch
"If you want to grow the herb, grind it and add it to your meals you are free to do so..."

Errmmm... the version of the regulation that I recall reading clearly banned the 'herb' itself.... a common mallow root that grows wild.

No mention was made of banning for example, pseudo-ephedrine.

Paul Nunis

Here is the FDA information on ephedra. (http://www.fda.gov/oc/initiatives/ephedra/december2003/) I see nothing here and have seen nothing elsewhere that supports your interpretation. Can you provide evidence for this?

[zakur]

Oh, the irony!

The USAToday.com version of this story (http://www.usatoday.com/news/health/2004-01-21-dietary-supplements_x.htm) is accompanied by ads for web sites proudly touting the fact that they sell products with ephedra.

[crimresearch]

I believe that the confusion may stem from the FDA's insistence on referring to 'Ma Huang' in their press releases. Ma Huang is the Chinese botanical name for the herb ephedra sinica, thus leading the media to run headlines that the FDA had banned the 'herb' . There was less mention of the fact that the FDA granted an exemption for TCM practitioners, although I don't know on what basis they plan to authenticate their status..

Paul
***************************************
"Questions about the herb ephedra and its ban by the FDA
Dec. 30, 2003 Provided by: Canadian Press"

" Reuters - Jan 20 5:57 PM
U.S. regulators who decided to ban the weight-loss herb ephedra..."

"The pending ban on ephedra, an amphetamine-like herb, was announced Dec. 30...."

" Reuters - Dec 30 5:19 AM
The U.S. Food and Drug Administration is expected to announce on Tuesday that it will ban the weight-loss herb ephedra..."

"St. Petersburg Times. Dec. 31 2003: .... selling ephedra products beforethe federal ban takes effect. Ephedra, an herb also known as ma huang..."

"... FDA bans sale of weight-loss herb." www.tobacco.org/news/147979.html

.

[BillHoyt]

Originally posted by crimresearch
I believe that the confusion may stem from the FDA's insistence on referring to 'Ma Huang' in their press releases. Ma Huang is the Chinese botanical name for the herb ephedra sinica, thus leading the media to run headlines that the FDA had banned the 'herb' . There was less mention of the fact that the FDA granted an exemption for TCM practitioners, although I don't know on what basis they plan to authenticate their status..

Paul
***************************************
"Questions about the herb ephedra and its ban by the FDA
Dec. 30, 2003 Provided by: Canadian Press"

" Reuters - Jan 20 5:57 PM
U.S. regulators who decided to ban the weight-loss herb ephedra..."

"The pending ban on ephedra, an amphetamine-like herb, was announced Dec. 30...."

" Reuters - Dec 30 5:19 AM
The U.S. Food and Drug Administration is expected to announce on Tuesday that it will ban the weight-loss herb ephedra..."

"St. Petersburg Times. Dec. 31 2003: .... selling ephedra products beforethe federal ban takes effect. Ephedra, an herb also known as ma huang..."

"... FDA bans sale of weight-loss herb." www.tobacco.org/news/147979.html

.
Paul,

These are press reports, not the regulation you previously mentioned. I am still unaware of anywhere the FDA says you can't grow or use the herb. This includes TCM, which is not within the FDA purview. The FDA intervention comes under the limited role afforded it under DSHEA. DSHEA allows the FDA to intervene in the supplement market if and only if it can find clear pharmacological claims made by supplement manufacturers or clear evidence of danger to the public. The role of stopping the public from growing or using herbs would come under either the Agriculture department, Tobacco and Fire Arms or the DEA.

[crimresearch]

The 'version' I mentioned reading was the version misstated by the media, not the actual text of the regulation, which is why I put my impression up for clarification.

Thanks for expending dozens of words to traumatize the epidermis of a defunct equine carcass.

Paul

[BillHoyt]

Originally posted by crimresearch
The 'version' I mentioned reading was the version misstated by the media, not the actual text of the regulation, which is why I put my impression up for clarification.

Thanks for expending dozens of words to traumatize the epidermis of a defunct equine carcass.

Paul
Oh, of course, my bad. Odd, though, that your post said "version of the regulation that I recall reading," and not "media report about the regulation." Odder still, that I could engage in hippothanatology while answering an "impression up for clarification."

[BillHoyt]

Originally posted by zakur
Story (http://www.cnn.com/2004/HEALTH/diet.fitness/01/20/fda.supplements/) :clap:
zakur,

Any updates on McClellan's speech or the policy?

[zakur]

Originally posted by BillHoyt

zakur,

Any updates on McClellan's speech or the policy? The speech should be put up on the FDA's web page soon. I've been checking it regularly: http://www.fda.gov/speeches/speechli.htm

From what I've read so far, the new policy/regulations will not go into effect until later this year.