mrguy

WASHINGTON — The Bush administration plans to ban the herbal dietary supplement ephedra (search), government officials said Tuesday.

Full Article:
http://www.foxnews.com/story/0,2933,106956,00.html

What's Next!!

I Are Baboon

Bummer for ephedra users!

Can't people just get it from Canada or Mexico now?

bandaidwoman

It's also banned in canada.

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Mudge

Ephedra sucks anyway, I always liked ephedrine.

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mrguy

Since ephedrine is a dereviative of ephedra, all classes will now be banned in the US. This includes Ma Huang, all the diet stuff with alkaloids, everything.

1. ephedrine -- (white odorless powdered or crystalline alkaloid from plants of the genus Ephedra (especially Ephedra sinica) or made synthetically; used as a bronchodilator to treat bronchitis and asthma)

They have got nothing better to do in the Bush administration, so now their going after making the world safe for idiots who don't know how to read warning labels.

Was on a Ephedrine buying Frenzy before it was to late... Now, I've got enough stocked up to last 10 years!!

Mudge

Sucks doesn't it bummer.

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Prince

WOW!

How many deaths do alcohol and cigarettes cause per year?

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bandaidwoman

exactly!

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I Are Baboon

But alcohol is FUN!

Stickboy

Ahhh, but cigarettes and alcohol are the big $$$$$ makers.

Perhaps they should be banned, but there's to much money at stake and in todays world it's all about money.

JerseyDevil

That's ok, you can use amphetamines instead since their readily available, and a lot more dangerous. j/k

Mudge

When some kid takes an entire bottle of ephedrine you know its going to turn out bad, so why are the rest of us punished for a few idiots? You can overdose on alcohol just as easily.

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KataMaStEr

I only take Ephedrine on rare occasions when I really need a boost for my workout. I bought one bottle of ProLab Therma Pro about a year ago and I have used probably only about 15 capsules. About banning cigarettes and alcohol they are just not going to do it, there it way too much money involved there. And really how many of us want alcohol to be banned seriously? Not likely

Mudge

Thats why prohibition failed, too many people drink.

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Power Rabbit

well time to jump to adderall :-/

Power Rabbit

actully now that i think of it...if they drop ephedra then they might turn away intrest from the supplement industry and leav PH in tact....

for example gnc wont carry ephedra these days .....yet they carry phoromones...the media dosent know too much about PH and dont make a big stink about em..hell if it wasnt for a dumbass or too they would not have cared about ephera....

jaydawg73

guess its time to go back to the pre ritual 2 "chronic" puffs before the gym .. if i am goin to do osmething illegal might as well do something that will get me somewhere... looks like i will have to get ephedra the same way as the "chronic".. since the goverment dont like either... bitches

My body is my temple

Twin Peak

Yeah, that might happen.

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Mudge

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bandaidwoman

Unlike companies that make conventional drugs, dietary-supplement makers don't have to prove their products are safe and effective before marketing them. The FDA can take action only after it compiles enough proof that a product is a clear danger to public health.

At the same time, using the 100 deaths and the publicized death of the Orioles pitcher like Steve Bechler's death are a poor basis for government policy. Ephedra and pseudoephedrine have a long history of medical use and there's no reason to consider them especially dangerous. The campaign against ephedrine is really a campaign to overturn the DSHEA as Mudge is bringing to the fore with his link.

However, it is the DSHEA that has allowed dietary and nutritional supplement manufacturers to get away with poor quality control of their products (they can put talc powder in capsules and claim it's st john's wort ) and allow preposterous efficacy claims without clinical data (rather than testimonial claims) etc.

However, we need a balance between the bureaucratic inertia of the FDA that would prevent valuable nutricals from reaching the the public and the wanton marketing practices that the DSHEA allows. Don't know what the answer is. Perhaps the answer might be something like the German Commission E ( a regulatory commission that expeditiously looks and evaluates the herbal industry in Germany).

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Mudge

Used for thousands of years in China and its a problem here within a few years, doh.

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Twin Peak

Sorry, but that is a crock. The FDA and FTC are fully capabable of cheacking and enforcing:

* label claims for accuracy, and
* marketing claims

under DSHEA and the various other laws. DSHEA does none of what you claim in this paragraph, it simply puts the burden on FDA regarding safety and efficacy, as it should.

No company can lawfully fail to meet label claims (various federal and state laws prohibit such a practice) or make outrageous marketing claims.

Does it happen? Sure, but not because of DSHEA.

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Mudge

http://216.239.37.104/search?q=cache...hl=en&ie=UTF-8

Interesting page I ran into.

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bandaidwoman

But that's the point, by removing the power it enabled this to occur rampantly. This fatally flawed legislation declared herbs to be dietary supplements, which most assuredly they are not. In doing so, Congress shifted the burden for proof of safety away from the manufacturer and to the F.D.A. Under this law, the F.D.A. must prove after the fact that a dietary supplement presents significant or unreasonable risk of injury.

Even where overwhelming evidence of such injury exists, the F.D.A. lacks the staff and resources required to document its case in a court of law. Meanwhile, the public remains exposed to a dangerous dietary supplement.

Also, manufacturers of dietary supplements are not required to report serious adverse effects caused by their products to the F.D.A. This latter is how the DSHEA prevents the FDA from doing its job. So no, it was not in the letter of the law, but it was what it would not require them to do that essentially set free a monster.

Trust me, I have no love for the FDA which binds our hands when it comes to great anticancer drugs coming down the pipeline but the DSHEA is not the answer. There has to be a medium between the two.

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Twin Peak

You missed my point. All of this has NOTHING to do with (1) meeting label claims and (2) outrageous marketing claims, which is what I harped on before.

Your statements here are correct (re the DSHEA), though I disagree with your conclusions.

Let me ask you this, how long does a drug take to come out? If supplements were treated like drugs, we'd essentially destroy the supplement market, and the biggest loser would be the consumer.

Realistically, how many deaths or injuries occur because of a dangerous "supplement"; hardly any. I can think of a few dangerous supplements (sodium usinate/usinic acid) that hit the market, and all were removed pretty damn fast. Don't forget the power of the civil plaintiff's bar who preys on such.

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bandaidwoman

I will provide data on this later. Many a chemists have randomly pulled drugs off reputable drugs off the shelves and anlayzed them spectrographically or organically and many came back bogus.



On average 15 years to complete phase I to phase IV clinical trials. (This is preceded by at least 10 years of chemical and animal work) So I agree, No arguments about the how it would devastate the supplement industy there. But we are not asking nutriceuticals to carry out clinical trials, just basic reporting of adverse effects, like the fulminant liver failures caused by Kava kava picked up by the german commission e in germany.


Kava, kava and fulminant liver failure, dexatrim and subdural hematomas, etc etc. will get links later. since i am at work. The latter regarding plaintiffs also apply to the prescription drug arena as wellwhere many good drugs have been hapless victims of class action lawyers.

I think you and I have some common ground but I advocate one between the current status quo of the FDA and dshe.

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QuestionGuy

U.S. Bans Ephedra, Drug Linked to Deaths

4 hours ago Listen to Audio

By JOHN SOLOMON, Associated Press Writer

WASHINGTON - The federal government announced on Tuesday a ban on the sale of ephedra, an herbal supplement used for weight control that has been linked to a number of deaths and harmful side effects.

Health and Human Services Secretary Tommy Thompson said that "based on the best possible scientific evidence" his agency would issue a consumer alert about the dangers of ephedra and will send notices to manufacturers to stop selling the herbs.

"The time to stop taking this product is now," he said.

"They are just too risky to use," said the secretary.

Thompson said the decision was "well grounded" and based on extensive scientific study. The ban would take effect in 60 days.

"I don't want people turning to ephedra thinking they could lose weight," Thompson told a news conference.

Mark McClellan, head of the Food and Drug Administration, said his agency is notifying consumers and manufacturers that it will publish a rule making it illegal to sell and use ephedra.

He said the agency was concerned about young people and athletes looking to ephedra to boost their performance. Use of the supplement has led to serious health effects, he said.

"We're sending a strong and clear signal" that such products should come off the market, McClellan said.

McClellan said the FDA reviewed major studies of ephedra and publicly issued findings about the herb. He said the publication received thousands of comment and expressions of support for taking the product off the market.

The rule will go into effect in 60 days "and have the practical effect" of banning ephedra, he said.

"Ephedra raises your blood pressure and stresses your system," McClellan said. "There are far better, safer ways, to get in shape."

Critics called the federal crackdown too late. Sales nationwide already have plummeted because of publicity about roughly 155 deaths blamed on the amphetamine-like stimulant, including Baltimore Orioles baseball player Steve Bechler earlier this year. Ephedra is linked to heart attacks and strokes, even when used by outwardly healthy people at recommended doses, because it speeds heart rate and constricts blood vessels.

Ernie Bechler, Steve's father in Medford, Ore., said he was awakened by a phone call around 6 a.m. local time with word of the decision.

"It's the only thing that could make my wife and I be happy," he said. "Nothing else could have done what this is doing. I mean to get this off the market and to save other peoples' lives is just amazing to us."

Ernie Bechler testified in Congress, urging a ban. "That's the last thing I said: 'Please don't let my son die in vain.'"

At the news conference, McClellan said FDA has spent months "scouring all of the adverse effects reports." The decision was not based on adverse effects alone, he said, but also on clinical studies and expert opinion and review.

"It is the totality of the evidence" that was used to make the decision, McClellan said.

McClellan said the FDA was prepared to defend the action in court.

He said his agency was working as quickly as it can under the current law regulating diet supplements. "We are laying the strongest possible foundation to not only take the product off the market, but to keep it off," McClellan said.

Thompson said the agency "was crossing every 't' and dotting every 'i' " to make sure the action stands up in court. "We are taking every procedural accountability standard" to make sure the ban withstands court tests, he said.

McClellan said his agency has done extensive work to "make sure we can use all of our authority" to keep ephedra off the market.

Thompson said that three states already have banned ephedra and "this is the next giant step" in taking the supplement off the market.

New York, Illinois and California _ have passed their own ephedra bans; use has been banned in professional football, college athletics and minor-league baseball, and several retail chains, including supplement giant General Nutrition Centers, recently quit selling it, too.

"It's a dead product and unfortunately it has become a dead product over the backs of a lot of dead people when the FDA could have acted before," said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen, which petitioned the government for a ban in 2001.

The supplement industry's Council for Responsible Nutrition said it didn't oppose a ban, noting that very few companies still make the stimulant _ its members who once did no longer do so.

"We think the reputable players have found so much controversy and difficulty in this marketplace that they've decided to get out of it," said CRN's John Hathcock. "We recognize the controversy is a cloud over our whole industry."

Remaining ephedra manufacturers didn't immediately comment Tuesday, but have insisted that studies prove their products safe when used properly.

"Anyone who has read our label knows that we go to great lengths to inform our customers about the proper use of our products," Metabolife International chief executive Russell Schreck said over the summer.

But several scientists said that it was impossible to prove whether ephedra was safe because studies screen out participants who have health problems _ the people most likely to be hurt by the product.

The General Accounting Office, Congress' investigative arm, looked into the issue and found many people who reported problems had followed the label's instructions.

The government ban, one of the first involving a dietary supplement, comes after Thompson this summer urged Congress to rewrite a law that rolled back dietary-supplement regulations and to require manufacturers to acknowledge potential side effects.

Because ephedra is an herb, U.S. law let it sell over-the-counter with little oversight unless the FDA could prove a clear danger to public health. Manufacturers blocked a 1997 FDA attempt to restrict sales of certain dosages and to put warning labels on the herb by arguing the agency lacked enough proof of danger.

In March, FDA again proposed those warnings and said it would re-examine a ban.


Copyright 2003 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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bandaidwoman

Regarding impurities and how label claims are still rampantly violated , of course these are regarding the herbals.
http://www.medscape.com/viewarticle/409637_4

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Twin Peak

Again, BAD, I agree its a problem, I disagree that THIS problem (impurities) stems from the DSHEA.

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Monolith

I just stocked up, i suggest you do the same...

http://www.sann.net/ephedrine25.html

http://www.ncf.carleton.ca/~ek867/dexamyl.jpg