Judge Strikes Down FDA Ban on Ephedra [Forum Archive]

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Judge Strikes Down FDA Ban on Ephedra

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Posted by: redspy

SALT LAKE CITY Apr 14, 2005 — A federal judge Thursday struck down the FDA ban on ephedra, the once-popular weight-loss aid that was yanked from the market after it was linked to dozens of deaths.

The judge ruled in favor of a Utah company that challenged the Food and Drug Administration's ban. Utah-based Nutraceutical claimed in its lawsuit that ephedra "has been safely consumed" for hundreds of years.

Supplements that included ephedra have been widely used for weight loss and bodybuilding, but have linked to 155 deaths, including that of Baltimore Orioles pitching prospect Steve Bechler. The FDA ordered the substance off the market in April 2004.

http://abcnews.go.com/Health/wireStory?id=670495

Posted by: Pepper

Nice

Posted by: Du

Quote:

Originally Posted by redspy

SALT LAKE CITY Apr 14, 2005 — A federal judge Thursday struck down the FDA ban on ephedra, the once-popular weight-loss aid that was yanked from the market after it was linked to dozens of deaths.

The judge ruled in favor of a Utah company that challenged the Food and Drug Administration's ban. Utah-based Nutraceutical claimed in its lawsuit that ephedra "has been safely consumed" for hundreds of years.

Supplements that included ephedra have been widely used for weight loss and bodybuilding, but have linked to 155 deaths, including that of Baltimore Orioles pitching prospect Steve Bechler. The FDA ordered the substance off the market in April 2004.

http://abcnews.go.com/Health/wireStory?id=670495

Posted by: david

very cool... but now what???

Posted by: brodus

Holy shit--this is good news. My stock of ECAs is getting low...they might come back to the market then, in a year or two...good to know.

Posted by: JACKED

What does this mean? I'm not real clear on this ruling. Is the ban now pending?

Posted by: brodus

No, what it means is that we now have a court precedence against the ban, in the limited venue of sale and distribution--in other words, the court finds the company not guilty of selling a dangerous product.

The question is three-fold:
1. Will the FDA now say Ephedra is a "drug" (since big pharma is pushing for this), or will it be a supplement again?
2. Will the ban be modified, or totally thrown out.
3. Will new legislation come down the pipeline redefining Ephedra so

I'm excited, but truth is the legal process is lengthy (current case in point), and it takes awhile to move the machine. I do think we'll see Ephedra available in some form in the future, though--maybe not in fat-burners, but in OTC Ephedra caps.

I think selling high-dose Ephedra to collge students as "herbal X," has got to go if we're going to have OTC access again.

Posted by: nikegurl

if we jump ahead and pretend that the ban is lifted...does everyone think the companies will start manufacturing the old formulas with ephedra? i wonder if they'd worry about opening themselves up to civil liability?

it's great news but i don't want to get too excited yet.

Posted by: Dale Mabry

Quote:

Originally Posted by brodus

The question is three-fold:
1. Will the FDA now say Ephedra is a "drug" (since big pharma is pushing for this), or will it be a supplement again?

Can this be done with an herb? I mean, how can a drug company patent something that they don't create? I'll have to ask my boss about this one.

Posted by: topolo

Dale,
Why do you think the shift manager at Mcdonalds would know?

Posted by: redspy

Quote:

Originally Posted by topolo

Dale,
Why do you think the shift manager at Mcdonalds would know?

Posted by: redspy

Here's another piece with a bit more info:

Nutraceutical International Corporation has announced a court decision that has granted the company's motion for summary judgement against the Food and Drug Administration (FDA) in the company's lawsuit involving FDA's Final Rule on Ephedra.

The motion put forth by Nuraceutical International Corporation asked the court whether the Final Rule banning ephedra containing supplements was allowable, forcing the court to determine whether FDA's use of risk-based analysis is appoprriate and whther FDA had sufficient evidence to support the conclusion that products containing 10mg or less per day of ephedrine alkaloids "pose a significant or unreasonable risk of illness or injury."

The court determined that DSHEA, unlike in the case of medical device provisions, contains no provision for risk-benefit analysis, noting that Congress intended to harmonize treatment of dietary supplements with that of foods and not drugs or medical devices, further noting that by imposing a risk-benefit anlysis, FDA demanded each producer of an ephedra containing supplement to demonstrate a benefit as a precondition of sale, which "alleviates the burden congress placed squarely on the givernment to demonstrate the existence of a significant or unreasonable risk.".

The court, in evaluating whether products containing 10mg or less of ephedrine alkaloids pose a signficant or unreasonable risk, noted that the government's responsibility to produce evidence to support this can be met only if it has demonstrated risk at "conditions of use recommended or suggested in labelling" - a dose specific analysis. Yet in declaring all ephedrine alkaloid containing supplements illegal, FDA included low dose products, and in that category, relied on only one reference in the administrative record, which actually extrapolates from intravenous injection of epinephrine, not ephedrine alkaloids, and does not involve oral ingestion. The court determined that by failing to "prove by a preponderance of the evidence that a dosage of 10mg or less of ephedrine alkaloids presents a significant or unreasonable risk of illness or injury", FDA has failed to give effect to the dose-specific language of the rule.

The court ruling can be found at: http://www.nutraceutical.com/courtruling.pdf

Posted by: redspy

Here'e the response from The Council for Responsible Nutrition

Quote:

Yesterday’s decision was the next step in a legal process that serves to protect consumers. Both companies and individuals have a right to challenge laws and regulations and it is reasonable to expect regulations to conform to statutory standards in order to withstand legal challenges.

This ruling applies only to a very specific segment of the ephedra dietary supplement market and should not be misinterpreted as a complete overturn of the ephedra ban, nor should anyone leap to inappropriate conclusions about what this means for DSHEA.The standard of DSHEA that companies may not market dietary supplements that pose a significant or unreasonable risk of illness or injury is not questioned by yesterday’s decision.

The court’s ruling—which leaves in place a ban on all but those dietary supplements with 10 mg or less of ephedrine alkaloids per daily dose—demonstrates that DSHEA works, and that FDA will be held to the statutory standards of proof in the law. It further underscores that dietary supplements are not to be treated as drugs or medical devices and that FDA must acknowledge those distinctions in its administrative and enforcement measures.

Even while applauding FDA’s December 2003 decision to ban ephedra, CRN warned that FDA’s analysis and rationale for the restriction would need to be able to withstand judicial and scientific scrutiny. It appears, at least in this case, the court has questioned FDA’s basis for evaluating what is an "unreasonable risk" and the adequacy of FDA’s record for banning low dosage ephedra-containing supplements.

Posted by: nunya53

Everyone seems pretty happy about the possibility of overturning the ephedra ban, but won't you get the same results from ephedrine, which you can still get all over the place?

Nunya

Posted by: nikegurl

Quote:

Originally Posted by nunya53

Everyone seems pretty happy about the possibility of overturning the ephedra ban, but won't you get the same results from ephedrine, which you can still get all over the place?

Nunya

that seems to be the popular view but i swear i much prefer ephedra to ephedrine. i think i may be in the minority on this though. i've heard others say the prefer ephedrine or notice no difference.

Posted by: david

I truly miss my ephedra.... sad, huh? I think I'll just be patient and like anything else in life, if it's available to me and I have access, then

Posted by: nikegurl

i noticed 2 ebay auctions for "old formulas" of certain favorites (pssst - dymetadrine extreme.) $35 with free shipping and the other person was asking $40

i don't think ebay will yank them since they don't scream and shout about ephedra - they just say stuff about old formula and something to the effect of "if you know what you're looking for this is it"

Posted by: mrguy

It's about time somebody in power got a clue!!!

Posted by: musclepump

The news I was watching said it looks like Ephedra will become a food under labels instead of a drug or supplemental. They say this will happen because of the ruling and because it's an herb.

AWESOME I say

And I don't like Ephedrine because anywhere you get it, it has guarifsen in it.

Posted by: leykis1o1

screw ephedra lets bring back pro-hormones

Posted by: brodus

Quote:

that seems to be the popular view but i swear i much prefer ephedra to ephedrine. i think i may be in the minority on this though. i've heard others say the prefer ephedrine or notice no difference.

I agree completely. I also agree with musclepump--I hate guifaneisin, it gives me headaches. You can get straight E-HCL, but you have to show ID. (i've posted the links before). You can also go here: www.ephedrineforsale . com

But in my experience, even when I have a cold, I much prefer taking one of my pure Ephedra extract pills over a E-HCL W/ Guiafenisin.

Posted by: brodus

This is from Forbes.com

Health
Ephedra Ban Lifted by U.S. District Judge
-- HealthDay Staff

THURSDAY, April 14 (HealthDay News) -- Saying that the U.S. Food and Drug Administration had not met the burden of proof that any specific dosage of the controversial weight-loss drug ephedra was dangerous, a U.S. District Court judge in Salt Lake City has lifted the year-old FDA ban and sent the matter back to the agency for further evaluation.

A lawsuit against the ban, which the FDA initiated in February 2004, was brought by Nutraceutical Corp. and Solray Inc. of Park City, Utah, a nutritional supplement manufacturer. On Wednesday, Judge Tena Campbell ruled that the FDA had not proved that its arbitrarily-set dosages of 10 milligrams (mg) or less of ephedrine-alkyloid dietary supplements (EDS) were dangerous.

In fact, Campbell said in her ruling that the FDA had rested its entire case on research offered by the agency and its advisory committee that could not determine what a safe level of an EDS would be.

"A negative inference is different from the affirmative proof required..." Campbell wrote in her opinion. "There is not sufficient evidence in the administrative record to establish that the risks identified by the FDA are associated with the intake of low dose EDS."

Late Thursday afternoon, FDA officials were evaluating whether the minimum 10 mg dose was sufficient to appeal Campbell's decision or whether more research was necessary.

"The FDA is evaluating the question of appeal," spokeswoman Kimberly Rawlings said. Rawlings said she expected a decision by early Friday.

Posted by: gococksDJS

Quote:

Originally Posted by topolo

Dale,
Why do you think the shift manager at Mcdonalds would know?

hahaha, that is some funny shit...

Posted by: myCATpowerlifts

Quote:

Originally Posted by topolo

Dale,
Why do you think the shift manager at Mcdonalds would know?

Posted by: kicka19

do you think this will open the door to pro-hormones again?

Posted by: nunya53

Quote:

Originally Posted by kicka19

do you think this will open the door to pro-hormones again?

No!

Posted by: gococksDJS

Quote:

Originally Posted by kicka19

do you think this will open the door to pro-hormones again?

I heard steroids are legal now.....

Posted by: Navyguy808

Quote:

Originally Posted by kicka19

do you think this will open the door to pro-hormones again?

skip the pro-hormones, bring back AAS.....

Posted by: david

Quote:

Originally Posted by gococksDJS

I heard steroids are legal now.....

Imagine the world on steroids... everyone one of us!

Posted by: I Are Baboon

I have never used ephedra but I do believe it should have never been banned. Cripes, WATER will kill you if you consume enough of it. You can't go banning every product because a small number of people are stupid about using it.

This is good news indeed.

Posted by: brodus

The newspaper in Chicago today said the ruling was unlikely to have any significant impact?!

Posted by: Dale Mabry

Isn't ephedrine HCl without guafenisen illegal since it can be cooked into {insert any recreational drug here}

Posted by: Dale Mabry

Shift Manager at McDonalds. Fuckin hilarious.

Posted by: gopro

The ban on ephedra (not even a good full dose) MIGHT be lifted...and people seem to be talking about it like GOD himself is returning to earth!

Posted by: Prince

Quote:

Originally Posted by gopro

...like GOD himself is returning to earth!

was "he" ever here?

Posted by: Dale Mabry

Quote:

Originally Posted by gopro

The ban on ephedra (not even a good full dose) MIGHT be lifted...and people seem to be talking about it like GOD himself is returning to earth!

Don't say God, you'll attract the conservatives.

Posted by: brodus

It's not illegal, but highly tracked.

You have to provide ID to purchase any:

http://www.dnepharm.com/cgi-bin/dnestore/10082782.html

You're correct, though--the demand for meth and the epidemic of use, especially in small towns, has caused massive problems, and extreme measures--now even PSEUDO-ephedrine sales are tracked in some states:

http://www.state.ia.us/government/dps/dne/DNENEWS.HTM

It seems extreme, but the public health issue is out of control in some areas, with emergency room visits going up over 1000% and lab busts going up by about the same amount. And when you correlate meth use/addiction and violent crime, the result is overwhelming. Hell, even Tom Sizemore couldn't stay clean for more than a day.

I have no problem giving my ID to get Ep. HCL, b/c I'm not doing anything illegal.

Posted by: Dale Mabry

Hmmmmm, I may have to get me some. I never liked ephedra, but vasopro has been pretty good and I imagine it would be better w/o guaif.

Posted by: Pepper

A federal judge struck down the Food and Drug Administration's ban on the weight-loss treatment ephedra, a decision likely to spark new debate over how dietary supplements are regulated at a time when the products are a focus of renewed concern.

The ruling by Judge Tena Campbell of the U.S. District Court in Salt Lake City disputed the validity of a key legal basis for the FDA's move against ephedra, which has been linked to heart problems and strokes.

Ephedra was the first supplement the agency ever formally pulled from the market. The judge ordered the FDA to reconsider its ban, which went into effect in April 2004, and refrain from taking any enforcement actions against Nutraceutical International Corp., the company that brought the suit, for sales of its low-dose ephedra product.

Coming at a time when steroids and other performance-enhancing products are under fire, the ruling is likely to add to the questions about the 1994 law that governs dietary supplements. The law sets a high bar for restrictions on their sale. Unlike drugs, herbal supplements don't have to be approved by the FDA before going on the market, and the agency must prove that they pose a "significant or unreasonable risk" before blocking their sale.

California Democratic Rep. Henry Waxman, a longtime critic of the 1994 law, said he hopes the FDA's ban will be upheld on appeal, and "if it is not, it will clearly be time for Congress to revisit [the law] and give FDA the authority it needs to protect American consumers from dangerous supplements."

Utah Republican Sen. Orrin Hatch, an author of the 1994 supplement law, said it is "ultimately up to the FDA to determine if any supplement can be marketed safely." He added that the ruling "calls into question how the FDA applied the law in the case of ephedra," not the "fundamental structure" of the law itself.

A spokeswoman said the FDA is "evaluating the decision."

The ruling is unlikely to bar the FDA from taking action against products that are obvious health hazards. But for the vast majority of supplements, there is limited scientific evidence of their true effects, because they generally aren't tested in lengthy clinical trials the way drugs are. In the case of ephedra, the FDA spent years gathering scientific evidence that was supposed to back its contention that the product posed a danger.

At the heart of the case was a relatively narrow question: whether the FDA was justified in banning one Nutraceutical product, a low dose of an herbal formulation of ephedra. The company had argued that the FDA's scientific evidence didn't prove that the small amount of the substance in its formulation carried serious health risks, and the judge agreed.

More broadly, the judge struck at a legal underpinning for the FDA's ephedra regulation. The FDA had argued that ephedra should be banned based on the "unreasonable" part of the law's language, because it carried few benefits and yet held potentially serious risks. This is similar to the equation the agency typically applies to drugs and medical devices, where their effectiveness is balanced against their potential side effects.

Judge Campbell said Congress never intended that standard to apply to dietary supplements, which are regulated more like food. "The plain language of" the 1994 law "does not require a comparison of benefits and risks," she wrote. The FDA's "requirement that" the company "demonstrate a benefit is contrary to the clear intent of Congress...the FDA's definition of 'unreasonable' entailing a risk-benefit analysis is also improper."

Bruce Hough, president of Nutraceutical, of Park City, Utah, said the company was "happy that the court agreed with us that the FDA had not complied with the statute." The company hasn't decided whether to return to selling its ephedra product, which accounted for a small part of its revenue. It brought the suit because it was afraid FDA would apply its risk-benefit test to other supplements, Mr. Hough said, adding, "If they could do it for that product, then they could impose that standard on numerous other products."

Sales of ephedra in 2003, its last full year on the market, totaled $504 million, according to the Nutrition Business Journal, an industry publication in San Diego that tracks sales of nutritional supplements. That was down from a peak of $1.3 billion in 2001.

The FDA struggled with ephedra for years, in an example of how difficult it can be for the agency to gather scientific evidence on a potentially dangerous supplement. In 2002, the federal government commissioned a study by Rand Corp. researchers that found that scientific studies tied ephedra to nausea, anxiety, palpitations and other symptoms. The report said there were two deaths, as well as some heart attacks, seizures and psychiatric problems that could be identified as "sentinel events with prior ephedra consumption," but added that classification "does not imply a proven cause and effect relationship."

Posted by: gococksDJS

Quote:

Originally Posted by gopro

The ban on ephedra (not even a good full dose) MIGHT be lifted...and people seem to be talking about it like GOD himself is returning to earth!

And the good lord said "Let there be ephedra", and so it was...

Posted by: david

Quote:

Originally Posted by gopro

The ban on ephedra (not even a good full dose) MIGHT be lifted...and people seem to be talking about it like GOD himself is returning to earth!

Hey, if ephedra comes back, then we can see clenbuterx in it's truest form!!

Posted by: Dale Mabry

Quote:

Originally Posted by david

Hey, if ephedra comes back, then we can see clenbuterx in it's truest form!!

I think Redline RTD is better than Clenbutrx.

Posted by: topolo

Dale you VPX shill!!!!!!

Posted by: Dale Mabry

Take it back or I shall cast a hex on you.

Posted by: redspy

Quote:

Originally Posted by Dale Mabry

I think Redline RTD is better than Clenbutrx.

I think Clenbuterol is better than Clenbutrx.

Posted by: brodus

Quote:

I think Redline RTD is better than Clenbutrx.

Are you serious?!

Clenbutrx was the shiznit!

Posted by: gopro

Quote:

Originally Posted by brodus

Are you serious?!

Clenbutrx was the shiznit!

Thank goodness I came away with 2(0) or so cases

Posted by: gopro

Quote:

Originally Posted by Robert DiMaggio

was "he" ever here?

Last week...we met for coffee at Starbucks. Oh, and he had a muffin.

Posted by: david

Quote:

Originally Posted by Dale Mabry

I think Redline RTD is better than Clenbutrx.

The Redline makes me nauseated probably bc/ of the Yohimibe. I used to take the yohimibe 1,000 to 1500mgs and I didn't know what planet I was on all day!

Posted by: david

Quote:

Originally Posted by redspy

I think Clenbuterol is better than Clenbutrx.

I do agree scaringly.................

Posted by: Prince

Quote:

Originally Posted by gopro

Last week...we met for coffee at Starbucks. Oh, and he had a muffin.

cool, glad to hear that God is a he!

Posted by: Prince

this is a good article

Posted by: musclepump

Redline RTD's rock, but are too spendy

Posted by: gopro

Quote:

Originally Posted by Robert DiMaggio

cool, glad to hear that God is a he!

Yes HE is, but he is not afraid to express his feminine side.

Posted by: topolo

Quote:

Originally Posted by gopro

Yes HE is, but he is not afraid to express his feminine side.

GP, saw your ad in Muscle Fitness................very cool buddy

Posted by: gococksDJS

Quote:

Originally Posted by topolo

GP, saw your ad in Muscle Fitness................very cool buddy

Is that GP smashing the pills with a hammer in those VPX ads?

Posted by: topolo

Quote:

Originally Posted by gococksDJS

Is that GP smashing the pills with a hammer in those VPX ads?

yes it is.....cool huh?

Posted by: gopro

Quote:

Originally Posted by topolo

GP, saw your ad in Muscle Fitness................very cool buddy

Thanks buddy. That ad has been in every single magazine! I'm almost sick of seeing myself, LOL!!

Posted by: david

Quote:

Originally Posted by Robert DiMaggio

cool, glad to hear that God is a he!

Posted by: Prince

another article

Posted by: ZECH

Quote:

Originally Posted by Dale Mabry

Don't say God, you'll attract the conservatives.

What? Who? Where? You call?

Posted by: redspy

Here's an editorial on this topic from the NY Times

EDITORIAL

Time to Ban Ephedra

The recent disappointing federal court decision that the Food and Drug Administration lacks the authority to issue a blanket ban on ephedra, a dangerous herbal supplement, is a clarion call to the Bush administration and Congress to change the 1994 law on dietary supplements. The law should be amended to give health regulators clear and unambiguous power to take harmful products off the market, and to require supplement makers to report any adverse reactions.

Ephedra, an adrenalinelike stimulant promoted as a weight-loss aid and energy booster, excites the central nervous system and speeds metabolism, increasing the rate at which a person burns calories. But it can also drive up blood pressure and stress the circulatory system. It has been linked to heart attacks and strokes and dozens of deaths.

A year ago, the F.D.A. imposed a ban on all products containing ephedra on the grounds that it poses "an unreasonable risk of illness or injury." Overturning that decision, Judge Tena Campbell of the Federal District Court in Utah said the agency had erred in using a cost-benefit analysis, weighing the supplement's substantial risks against its dubious benefits. The judge also said that the 1994 law required dose-specific findings to justify a ban. The judge concluded that the agency's assertion that it was impossible to establish a level of safe use failed to meet the burden of proving that the supplement poses an unreasonable risk when taken in the 10-milligram doses contained in the product at issue.

The ruling leaves the ephedra ban intact for products containing doses above 10 milligrams. But by dismissing the F.D.A.'s voluminous evidence of potential danger, the court set an unrealistically high threshold for agency action, and that could undermine the ban even for higher-dose ephedra products.

Under current law, supplement manufacturers may sell products without first having to establish their safety or efficacy. But after the F.D.A. found a significant hazard, it was only reasonable for the agency to weigh ephedra's lack of any real health benefits in deciding on a regulatory response.

The agency should appeal, but the White House and Congress should not let the F.D.A. do all the heavy lifting. The decision is their cue to move promptly to enact overdue legal revisions that will significantly strengthen the agency's power to monitor and police the supplement industry.

Posted by: brodus

I can't believe a liberal paper like the NYT would be so anti-Ephedra.

Posted by: redspy

Quote:

Originally Posted by brodus

I can't believe a liberal paper like the NYT would be so anti-Ephedra.

It's interesting that one of the primary defenders of DSHEA is Democrat Tom Harkin. The other main supporter is Rebublican Orin Hatch.

Posted by: jphess2

NYT is probably being paid by Weight Watchers and Jenny Craig to speak out against ephedra - more money for them.

Posted by: Pepper

Quote:

Originally Posted by brodus

I can't believe a liberal paper like the NYT would be so anti-Ephedra.

Liberals only support choice if you choose what they want you to.

PS...that was said as a joke, so let's not start a war.

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Judge Strikes Down FDA Ban on Ephedra

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