Posted on 04/15/2005 9:10:13 PM PDT by nickcarraway
A federal judge yesterday overturned the Food and Drug Administration's ban on ephedra, the diet supplement that was pulled from the market last year after being linked to more than 150 deaths.
The FDA's ban on ephedra products went into effect last April.
U.S. District Judge Tena Campbell in Salt Lake City characterized the FDA's ban as too broad, saying the agency has not demonstrated that low doses of ephedra "pose a significant or unreasonable risk."
Jonathan Emord, the attorney who won the case, said the judge's ruling negates the ban. However, the decision was narrowly focused on a low-ephedra product from the company that challenged the ban, Nutraceutical International of Park City, Utah.
Lobbying groups for the diet supplement industry said the judge's decision is unlikely to prompt supplement-makers to reintroduce higher-dose ephedra products, such as the once-popular Metabolife 356 from San Diego's Metabolife International.
Nutraceutical had challenged the ban on the grounds that the FDA had not proven that low-ephedra products were dangerous. The company has made a dietary supplement with a daily dose of ephedra of less than 10 milligrams, while some ephedra products marketed for rapid weight loss and bodybuilding have had more than 100 milligrams.
Campbell's order prevents the FDA from stopping Nutraceutical from selling its product and sent the case back to the agency for a determination of what are safe and dangerous levels of ephedrine.
"The FDA must prove that any dose amount, no matter how small, presents a significant or unreasonable risk of illness or injury," Campbell wrote in her ruling. "The proper focus here is on the evidence the FDA presented regarding the risks of low-dose."
The FDA is evaluating the decision, said Kimberly Rawlings, an agency spokeswoman. The agency did not say whether it would appeal.
Members of the supplement industry applauded the decision.
"The court provided a very rational decision that the amount of an ingredient must be considered when evaluating the safety of that ingredient," said Michael McGuffin, president of the American Herbal Products Association.
McGuffin said the ruling should not be misinterpreted as permission to put high-dose ephedra products like Metabolife 356 back on the shelves. The decision is narrowly focused on the low-dose product sold by Nutraceutical, he said.
However, consumer groups and critics of the industry, including members of Congress, called the ruling "disappointing." They say a lifting of the ban is bad news for consumers and those concerned with product safety.
"It's a bad and irresponsible decision," said Sydney Wolfe, who on behalf of the consumer group Public Citizen was among the first to call for a ban on ephedra.
"Tests have proven that what is a low dose for one person is deadly to another," Wolfe said.
Ephedra-based supplements, which are said to increase stamina and help with weight loss, have contributed to at least 155 deaths and dozens of heart attacks and strokes in recent years. The FDA ban went into effect last April.
Metabolife, once among the industry leaders, has been the target of nearly 300 personal-injury lawsuits, and co-founder Michael Ellis was indicted last year amid allegations of lying to federal regulators about the supplement's safety.
Metabolife officials did not return phone calls seeking comment on yesterday's ruling.
Research shows that ephedra can speed heart rate and constrict blood vessels even in seemingly healthy people. But the amphetamine-like herb is particularly risky for those with heart disease or high blood pressure or who engage in strenuous exercise.
The FDA's case for the ephedra ban gained momentum in 2003 after the supplement contributed to the death of Steve Bechler, a 23-year-old pitcher for the Baltimore Orioles.
Rep. Susan Davis, D-San Diego, said the judge's ruling shows that the agency needs more power to gather reports of injuries seen in diet-supplement users.
"It's a disappointing ruling," Davis said. "People could continue to be hurt by this product."
Both Davis and Sen. Richard Durbin, D-Ill., have made unsuccessful attempts in recent years to introduce legislation requiring mandatory reporting of adverse health events from supplement use.
"It is clear that had such a system been in place today, the court would have had ample evidence of whether or not ephedra was dangerous," Durbin said.
yea! All natural speed is back online! </Sarcasm>
Now, evidently, they want to take over the functions of the Food and Drug Administration. Whats next....the Marines.
So, judges are not happy just killing Terri, now they are coming after the rest of us.
No slamming, please, I just thought I'd put it here and get it over with.
Well, in this instance, it does appear that what the FDA did violated the Dietary Supplement Health and Education Act of 1994 (sponsored by Orin Hatch). Congress may have to revisit the issue if they want ephedra banned.
Rather kneejerk response on the part of a lot of people here. The fact is that the FDA is an out of control bureaucracy, NOT elected by the people. They needed a slapdown. Their ephedra ban was not based on an interest in protecting us (from ourselves of all things).
The judge did the right thing. He restored our liberty to CHOOSE FOR OURSELVES whether or not we want to use ephedra. Personally, I don't - my adrenals can't handle it. However, I appreciate having the option, valuing freedom and all that, like many here apparently don't.
Remember, this is FREE Republic. Not "outlaw everything I personally don't like b/c I believe the stupid media" Republic.
This may be good for all that codex legislation coming down the pike.
Does this mean the "Breathe Easy" tea in my cupboard is legal again ?
First they made my tea illegal then they put my sudafed behind the counter and won't sell it to me without a cavity search.
Land of the Free my A$$.
I'm with you.
The FDA needs more slapdowns......and so does the EPA and a whole host of other alphabet soup regulatory agencies.
Not bad. Maybe this is the tagline you are holding out for?
Hay bluefish,
Before I start, I'd like to say that I do believe that ALL the bureaucracy's need to be slaped down, and that the founding fore fathers would be turning in their graves if they knew that all of the fighting and dying to be free of the british colonies taxes was a waste. Now we are taxed just as much, if not more...
On to the ephedra overturned ban...
So you think the right thing to do is to over turn the FDA's ruling, to 'help the people choose.' In the ruling the sellers were supposed to tell the consumers about the dangers, but the sellers were not going to take that 'bourden of proof' and tell their prospective customers about the problems.
Most people believed the b***s**t that people like me, who used to tell them said. All Metabilife and I'm ashamed to say me, wanted was $$$$ that was the bottom line, staying in the black, and who cares about the little peoples health.
Well if anyone would have seen the the several people I have seen go throught the pain, they would have wanted to have that warning about what ephedra could do like possibly kill you! And what about "the supplement [that] contributed to the death of Steve Bechler, a 23-year-old pitcher for the Baltimore Orioles." And all the people like him that did die or now have perminate disabilities and are in constant pain? Are there deaths/injuries just water under the bridge?? or do they even mean something???
Maybe the answer lies in the middle, like what all the drugs/cigs have; maybe a warning on the label that it could cause liver and or heart falure, and death even in small amounts of use over time. This would let us, 'we the people' choose, but get their butts off the line for any lawsuits, (**oops maybe not, remember the class action suit that marlboro lost...)
Who knows, and REALLY who does care???
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.