Judge Strikes Down FDA Ban on Ephedra

[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

 

[Pepper]

Nice

 

[Du]

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

 

[david]

very cool... but now what???

 

[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.

 

[JACKED]

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

 

[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.

 

[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.

 

[Dale Mabry]

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.

 

[topolo]

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

 

[redspy]

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

 

[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

 

[redspy]

Here'e the response from The Council for Responsible Nutrition​

​

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.

 

[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

 

[nikegurl]

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.

 

[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

 

[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"

 

[mrguy]

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

 

[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.

 

[leykis1o1]

screw ephedra lets bring back pro-hormones

 

[brodus]

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.

 

[brodus]

More News!

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.

 

[gococksDJS]

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

hahaha, that is some funny shit...

 

[myCATpowerlifts]

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

 

[kicka19]

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

 

[nunya53]

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

No!

 

[gococksDJS]

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

I heard steroids are legal now.....

 

[Navyguy808]

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

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

 

[david]

I heard steroids are legal now.....

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

 

[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.