Ephedra Ban being Lifted

**Sholiz** · 04-14-2005, 09:06 PM

Well, not lifted but is going up for re-evaluation by the FDA as an approved dietary supplement.

Anyone want to comment on this?

Thursday, April 14, 2005 · Last updated 12:53 p.m. PT

Judge strikes down FDA ban on ephedra

By MARK THIESSEN
ASSOCIATED PRESS WRITER

SALT LAKE CITY -- 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.

Judge Tena Campbell's ruling sends the matter back to the FDA "for further rulemaking consistent with the court's opinion" and keeps the agency from enforcement action against the companies.

FDA officials did not immediately return a call seeking comment.

Company president Bruce Hough said the decision is about "protecting the public's access to safe and effective dietary supplements."

**antihero** · 04-14-2005, 09:22 PM

i think that it does need to be re-evaluated, so i think this is definetly the correct decision..

**warriors** · 04-14-2005, 10:15 PM

i'm glad someone is taking it into matters instead of just banning it without ever being evaluated.

K_muscle · 04-14-2005, 10:34 PM

I just read about this. Definitely the right decision. Ironic because I am writing a paper on the FDA's position on dietary/sports supplements for school.

Dan · 04-25-2005, 05:15 PM

Does this mean I can keep taking my old stash?

Candy · 05-11-2005, 07:04 AM

Im glad to hear about the FDA taking time to do this. I dont believe it should have been gone in the first place. If it comes back, its going to sell very fast.

MotorcityAl · 05-11-2005, 05:06 PM

http://www.getbig.com/news/2005-02/050705ephedra.htm

Ephedra: Interpreting the New Court Ruling
By Rick Collins, J.D. (May 2005)

On April 13, 2005, a federal court in Salt Lake City [U.S. District
Court for the District of Utah, Central Division] issued its decision
on a legal challenge to FDA's 2004 Final Rule banning all
ephedrine-alkaloid dietary supplements. Judge Tena Campbell's decision
made two key points:

1. It held that the analysis used by FDA was incorrect and
improper. FDA's analysis weighed risks against benefits. The Dietary
Supplement Health and Education Act (DSHEA), however, requires a
straightforward risk assessment. The court held that requiring
supplement companies to demonstrate a benefit as a pre-condition to
marketing violated DSHEA by shifting the burden from FDA to industry.
[This issue was explored in a 2004 article I co-authored with Alan
Feldstein, Esq., and published in the Sports Nutrition Review Journal
(also accessible online through www.steroidlaw.com.]

2. It held that FDA didn't have adequate scientific evidence to
find that a daily dose of 10 mg. or less of ephedrine alkaloids
presented a "significant or unreasonable risk of illness or injury"
[under 21 U.S.C. § 342(f)(1)(A)]. The court effectively held that it's
improper to ban all ephedra supplements because FDA lacks data to
determine what dosage might be safe.

The case isn't necessarily over yet. FDA may appeal, and the 10th
Circuit Court of Appeals might reverse the district court's ruling.
Meanwhile, FDA may seek a stay to block renewed ephedra sales while
the matter is pending.

So where does this leave ephedra supplements? My firm has been
besieged by calls from curious supplement manufacturers seeking
advice. Some aggressive supplement companies have already renewed
online ephedra product sales. But companies contemplating a return to
the ephedra market should first discuss the issue with knowledgeable
legal counsel familiar with what may well be a fluid and changing
landscape. The Utah decision should not be viewed as carte blanche for
everyone to sell ephedra products. The scope of the decision has yet
to be clarified, and legal minds can differ as to how "narrowly" to
interpret the ruling. For example, the narrowest interpretation would
be that the decision only applies to the products made by the company
involved in the lawsuit, since those were the only products that were
specifically the subject of the suit. One trade association has
already voted to require a pledge not to sell ephedra products at any
dose as a condition of membership. Certainly, before any company
proceeds, there are at least four issues which must be considered:

* Dosage. The ruling only addresses low-dose products (10 mg. or
less daily). Many ephedra supplements prior to the ban contained up to
100 mg. in total daily dosage. Significantly, a New Jersey lawsuit
claiming that FDA didn't demonstrate unreasonable risk with respect to
higher dose ephedra products was resolved last year in FDA's favor.
The ban remains in place for high-dose products.

* Jurisdiction. FDA may interpret the ruling as binding only in
the court's Utah district, and could take action against ephedra
products in other jurisdictions. In fact, FDA did exactly that in the
early 1990s with respect to black currant oil capsules. When the
agency lost in a Chicago court, it took action in a Boston court for
sale of the same product. Also, the federal court decision doesn't
preempt state laws banning ephedra, so sales would still be illegal in
states such as California, Illinois, New York, and other states which
may pass anti-ephedra legislation.

* Importation. Companies seeking to reenter the market also need
to think about how to obtain the raw materials. The embargo against
importing ephedra is not voided by the ruling. FDA may take
enforcement action against companies seeking to import the ingredient.

* Products liability. The court ruled that FDA failed to prove
that low doses of ephedra are dangerous, but did not affirmatively
rule that low doses of ephedra are safe. "Prior to the FDA ban, the
ephedra supplement market was being crushed by the spiraling costs of
product liability insurance - and the refusal by some carriers to
insure ephedra products at all," points out Alan Feldstein, an
authority on ephedra supplements and Of Counsel to my law firm,
Collins, McDonald & Gann. "Also, this ruling will probably not stop
trial lawyers from continuing to bring suits alleging ephedra products
are inherently dangerous," adds Feldstein.

Predictably, anti-supplement activists are denouncing the decision. A
senior policy analyst for the Consumers Union, publisher of Consumer
Reports, shrieked: "This is just nuts. Bringing ephedra back to market
even at low doses is dangerous." But the decision may have key
implications beyond ephedrine alkaloids. Critics have renewed their
cries to repeal or reform DSHEA, saying that the ruling is evidence
that DSHEA prevents FDA from pulling dangerous products from store
shelves. The watchdog group Public Citizen claims DSHEA has been a
"disaster" and should be repealed. The New York Times ran an editorial
urging the White House and Congress "to move promptly to enact overdue
legal revisions that will significantly strengthen [FDA's] power to
monitor and police the supplement industry." Voices from Capitol Hill
are joining the chorus. "If FDA can't take a supplement as dangerous
as ephedra off the market, then Congress needs to change the law to
allow it to do so," Sen. Edward Kennedy (D-Mass.) said through a
spokeswoman. Rep. Henry Waxman (D-Cal) wants to revisit DSHEA to "give
FDA the authority it needs to protect American consumers from
dangerous supplements." [Industry members concerned about the
reinvigorated attack on DSHEA and seeking advice on what to do about
it should feel free to call my office.]

But not everyone's jumping on the anti-ephedra bandwagon. "While
ephedra might be more dangerous than, say, a multivitamin, its risks,
which stem mainly from stimulating the cardiovascular system, are well
within the range considered acceptable for OTC [over-the-counter]
drugs," points out syndicated columnist Jacob Sullum in a recent
Washington Post article. "The FDA, the medical establishment and the
pharmaceutical industry all want to prevent emergence of an
alternative drug market in which consumers can obtain cheap, effective
and reasonably (though not completely) safe products without
permission from the government's gatekeepers."

Will consumers see lose-dose ephedra supplement products return to the
shelves soon? Quite possibly, but the long-term future of this
supplement remains shrouded in uncertainty. For specific advice to
industry based on the latest developments regarding ephedra, contact
my law firm at 516-294-0300 or info@cmgesq.com.

Rick Collins, J.D., is a veteran lawyer and bodybuilder. He is the
founder of www.SteroidLaw.com and the author of the groundbreaking
blockbuster LEGAL MUSCLE: Anabolics in America, available at
www.teamlegalmuscle.com. [© Rick Collins, 2005. All rights reserved.
For informational purposes only.]

Nonsequitur · 05-14-2005, 07:09 PM

This is a step back in the right direction... Ephedra, as with anything, is only as dangerous as the safety mechanism implanted between the user's ears.

IMHO Ephedra based products were the only truely effective Thermogenics that I personally have used.

Candy · 05-15-2005, 06:46 AM

Quote:

Originally Posted by Nonsequitur

This is a step back in the right direction... Ephedra, as with anything, is only as dangerous as the safety mechanism implanted between the user's ears.

IMHO Ephedra based products were the only truely effective Thermogenics that I personally have used.

I deff agree, thermos used to be way more effective.

Nonsequitur · 05-15-2005, 06:23 PM

Quote:

Originally Posted by Candy

I deff agree, thermos used to be way more effective.

Well as with most things it is the general common sense and responsible users that suffer for the mistakes of our less mentally gifted members of society who exhibit their overdosing, using in bad conditions, and lack of physical health and die due to heatstroke (but somehow Ephedra gets blamed)...

Alas I digress...

04-14-2005, 09:06 PM	#1
Sholiz Soldier In Progress Join Date: Mar 2005 Location: Michigan Posts: 3,431 Recipes: 3 Rep Power: 230	Ephedra Ban being Lifted Well, not lifted but is going up for re-evaluation by the FDA as an approved dietary supplement. Anyone want to comment on this? Thursday, April 14, 2005 · Last updated 12:53 p.m. PT Judge strikes down FDA ban on ephedra By MARK THIESSEN ASSOCIATED PRESS WRITER SALT LAKE CITY -- 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. Judge Tena Campbell's ruling sends the matter back to the FDA "for further rulemaking consistent with the court's opinion" and keeps the agency from enforcement action against the companies. FDA officials did not immediately return a call seeking comment. Company president Bruce Hough said the decision is about "protecting the public's access to safe and effective dietary supplements." __________________ You hear me before you see me, I got King Kong in the trunk

04-14-2005, 09:22 PM	#2
antihero Gold Member Join Date: Mar 2005 Location: Las Vegas Posts: 1,688 Recipes: 0 Rep Power: 33	i think that it does need to be re-evaluated, so i think this is definetly the correct decision.. __________________ ****************** Disclaimer: Information given by me is my personal opinion. It cannot be considered medical advice and does not represent the official opinion of a company that is not a sponsor here. ******************

04-14-2005, 10:15 PM	#3
warriors The world is yours Join Date: Apr 2005 Posts: 1,127 Recipes: 0 Rep Power: 29	i'm glad someone is taking it into matters instead of just banning it without ever being evaluated. __________________ Not Around...

05-11-2005, 05:06 PM	#7
MotorcityAl Motorcity God Join Date: Apr 2005 Location: The Motor City Posts: 187 Recipes: 0 Rep Power: 6	Interpreting the new court ruling. http://www.getbig.com/news/2005-02/050705ephedra.htm Ephedra: Interpreting the New Court Ruling By Rick Collins, J.D. (May 2005) On April 13, 2005, a federal court in Salt Lake City [U.S. District Court for the District of Utah, Central Division] issued its decision on a legal challenge to FDA's 2004 Final Rule banning all ephedrine-alkaloid dietary supplements. Judge Tena Campbell's decision made two key points: 1. It held that the analysis used by FDA was incorrect and improper. FDA's analysis weighed risks against benefits. The Dietary Supplement Health and Education Act (DSHEA), however, requires a straightforward risk assessment. The court held that requiring supplement companies to demonstrate a benefit as a pre-condition to marketing violated DSHEA by shifting the burden from FDA to industry. [This issue was explored in a 2004 article I co-authored with Alan Feldstein, Esq., and published in the Sports Nutrition Review Journal (also accessible online through www.steroidlaw.com.] 2. It held that FDA didn't have adequate scientific evidence to find that a daily dose of 10 mg. or less of ephedrine alkaloids presented a "significant or unreasonable risk of illness or injury" [under 21 U.S.C. § 342(f)(1)(A)]. The court effectively held that it's improper to ban all ephedra supplements because FDA lacks data to determine what dosage might be safe. The case isn't necessarily over yet. FDA may appeal, and the 10th Circuit Court of Appeals might reverse the district court's ruling. Meanwhile, FDA may seek a stay to block renewed ephedra sales while the matter is pending. So where does this leave ephedra supplements? My firm has been besieged by calls from curious supplement manufacturers seeking advice. Some aggressive supplement companies have already renewed online ephedra product sales. But companies contemplating a return to the ephedra market should first discuss the issue with knowledgeable legal counsel familiar with what may well be a fluid and changing landscape. The Utah decision should not be viewed as carte blanche for everyone to sell ephedra products. The scope of the decision has yet to be clarified, and legal minds can differ as to how "narrowly" to interpret the ruling. For example, the narrowest interpretation would be that the decision only applies to the products made by the company involved in the lawsuit, since those were the only products that were specifically the subject of the suit. One trade association has already voted to require a pledge not to sell ephedra products at any dose as a condition of membership. Certainly, before any company proceeds, there are at least four issues which must be considered: * Dosage. The ruling only addresses low-dose products (10 mg. or less daily). Many ephedra supplements prior to the ban contained up to 100 mg. in total daily dosage. Significantly, a New Jersey lawsuit claiming that FDA didn't demonstrate unreasonable risk with respect to higher dose ephedra products was resolved last year in FDA's favor. The ban remains in place for high-dose products. * Jurisdiction. FDA may interpret the ruling as binding only in the court's Utah district, and could take action against ephedra products in other jurisdictions. In fact, FDA did exactly that in the early 1990s with respect to black currant oil capsules. When the agency lost in a Chicago court, it took action in a Boston court for sale of the same product. Also, the federal court decision doesn't preempt state laws banning ephedra, so sales would still be illegal in states such as California, Illinois, New York, and other states which may pass anti-ephedra legislation. * Importation. Companies seeking to reenter the market also need to think about how to obtain the raw materials. The embargo against importing ephedra is not voided by the ruling. FDA may take enforcement action against companies seeking to import the ingredient. * Products liability. The court ruled that FDA failed to prove that low doses of ephedra are dangerous, but did not affirmatively rule that low doses of ephedra are safe. "Prior to the FDA ban, the ephedra supplement market was being crushed by the spiraling costs of product liability insurance - and the refusal by some carriers to insure ephedra products at all," points out Alan Feldstein, an authority on ephedra supplements and Of Counsel to my law firm, Collins, McDonald & Gann. "Also, this ruling will probably not stop trial lawyers from continuing to bring suits alleging ephedra products are inherently dangerous," adds Feldstein. Predictably, anti-supplement activists are denouncing the decision. A senior policy analyst for the Consumers Union, publisher of Consumer Reports, shrieked: "This is just nuts. Bringing ephedra back to market even at low doses is dangerous." But the decision may have key implications beyond ephedrine alkaloids. Critics have renewed their cries to repeal or reform DSHEA, saying that the ruling is evidence that DSHEA prevents FDA from pulling dangerous products from store shelves. The watchdog group Public Citizen claims DSHEA has been a "disaster" and should be repealed. The New York Times ran an editorial urging the White House and Congress "to move promptly to enact overdue legal revisions that will significantly strengthen [FDA's] power to monitor and police the supplement industry." Voices from Capitol Hill are joining the chorus. "If FDA can't take a supplement as dangerous as ephedra off the market, then Congress needs to change the law to allow it to do so," Sen. Edward Kennedy (D-Mass.) said through a spokeswoman. Rep. Henry Waxman (D-Cal) wants to revisit DSHEA to "give FDA the authority it needs to protect American consumers from dangerous supplements." [Industry members concerned about the reinvigorated attack on DSHEA and seeking advice on what to do about it should feel free to call my office.] But not everyone's jumping on the anti-ephedra bandwagon. "While ephedra might be more dangerous than, say, a multivitamin, its risks, which stem mainly from stimulating the cardiovascular system, are well within the range considered acceptable for OTC [over-the-counter] drugs," points out syndicated columnist Jacob Sullum in a recent Washington Post article. "The FDA, the medical establishment and the pharmaceutical industry all want to prevent emergence of an alternative drug market in which consumers can obtain cheap, effective and reasonably (though not completely) safe products without permission from the government's gatekeepers." Will consumers see lose-dose ephedra supplement products return to the shelves soon? Quite possibly, but the long-term future of this supplement remains shrouded in uncertainty. For specific advice to industry based on the latest developments regarding ephedra, contact my law firm at 516-294-0300 or info@cmgesq.com. Rick Collins, J.D., is a veteran lawyer and bodybuilder. He is the founder of www.SteroidLaw.com and the author of the groundbreaking blockbuster LEGAL MUSCLE: Anabolics in America, available at www.teamlegalmuscle.com. [© Rick Collins, 2005. All rights reserved. For informational purposes only.] __________________ Body under construction.

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04-14-2005, 10:34 PM	#4
K_muscle anger is a gift... Join Date: Mar 2005 Posts: 108 Recipes: 0 Rep Power: 5	I just read about this. Definitely the right decision. Ironic because I am writing a paper on the FDA's position on dietary/sports supplements for school.

04-25-2005, 05:15 PM	#5
Dan Unpaid Trash Collector Join Date: Apr 2005 Location: Colorado Posts: 1,725 Recipes: 0 Rep Power: 26	Does this mean I can keep taking my old stash?

05-11-2005, 07:04 AM	#6
Candy New Member Join Date: May 2005 Posts: 21 Recipes: 0 Rep Power: 0	Im glad to hear about the FDA taking time to do this. I dont believe it should have been gone in the first place. If it comes back, its going to sell very fast.

05-14-2005, 07:09 PM	#8
Nonsequitur IronMass Donator Join Date: May 2005 Location: Bay Area Posts: 19 Recipes: 0 Rep Power: 0	This is a step back in the right direction... Ephedra, as with anything, is only as dangerous as the safety mechanism implanted between the user's ears. IMHO Ephedra based products were the only truely effective Thermogenics that I personally have used.