http://www.washingtonpost.com/wp-dyn/ar ... Apr14.html (http://www.washingtonpost.com/wp-dyn/articles/A53586-2005Apr14.html)
Judge Rules Against FDA Ban on Ephedra
Product More Food Than Drug, She Says
By Mark Thiessen
Associated Press
Friday, April 15, 2005; Page E05
SALT LAKE CITY, April 14 -- A federal judge Thursday struck down the FDA ban on supplements containing ephedra, the once-popular weight-loss aid that was yanked from the market one year ago after it was linked to dozens of deaths.
The judge ruled in favor of a Utah supplement company that challenged the Food and Drug Administration's ban. Nutraceutical International Corp. claimed that ephedra has been safely consumed for hundreds of years.
Industry groups said supplements that included ephedra were once used by 12 million people. Last year's ban of ephedra was the first such outlawing of a dietary supplement.
Research shows that ephedra -- an amphetamine-like herb -- can speed heart rate and constrict blood vessels even in seemingly healthy people but that it is particularly risky for those with heart disease or high blood pressure or who engage in strenuous exercise. Among the deaths linked to the substance was that of Baltimore Orioles pitching prospect Steve Bechler, who collapsed and died during spring training two years ago.
The judge's decision was seen by some anti-ephedra advocates as falling short of an outright reversal of the ban, though a Nutraceutical lawyer declared flatly, "The ban is gone." The company said it is too soon to say whether it will put the product back on shelves.
The FDA was evaluating the ruling, but Health and Human Services Department spokesman William Pierce said the agency "made the right decision from the standpoint of science and our statutory authority." He added, "This is exactly when the dietary supplement law should apply."
Health officials and Justice Department lawyers are examining the ruling to determine the next step, Pierce said.
U.S. District Judge Tena Campbell agreed with Nutraceutical that ephedra was wrongly being regulated by the FDA as a drug and not a food. She said a 1994 federal dietary supplement law places more restrictive rules on the FDA in determining whether to ban foods as opposed to drugs.
The judge said the law requires the FDA to prove that a dietary supplement is harmful, rather than requiring the manufacturer to prove it is safe, as is required with drugs.
"The [FDA's] statement that a safe level cannot be determined is simply not sufficient to meet the government's burden," Campbell wrote.
Her order prevents the FDA from stopping Nutraceutical from selling its product and sends the case back to the FDA for a determination of what are safe and dangerous levels of ephedrine, ephedra's active ingredient.
Nutraceutical President Bruce R. Hough said the lawsuit had little to do with ephedra and more to do with forcing the FDA to follow the rules Congress set down for it.
"This is a great affirmation for the system, that the court goes back and says, 'This is Congress's intent,' " he said.
Ephedra opponents said the language in the order applies to only a specific, lower-dosage segment of the market. The ruling's final page prohibits the FDA from enforcing the ban on Nutraceutical's supplements containing 10 milligrams or less of ephedra.
Ten milligrams per day was the dosage of Nutraceutical's products.
"No one -- not the FDA, the supplement industry, nor the public -- has been satisfied by how ephedra has been regulated," said Sen. Orrin G. Hatch (R-Utah), who helped write the 1994 law that also deregulated the supplement industry. "Millions of people have used the product with satisfaction, but there is no doubt the product has had some serious problems," he said.
Sen. Richard J. Durbin (D-Ill.), a frequent ephedra critic who worked for the ban, said the ruling underlined the need for "a mandatory and uniform system of reporting adverse health events that result from use of certain dietary supplements."
I'm happy to see that someone out there is making at least some attempt to mandate that the FDA stop galloping their own horse to the legal forefront.... Though I could care less about 'tweaking', I am surely glad that the FDA has been called on to follow Congress' lead, and not their own biased agenda............. senorsal
The FDA is crooked as any federal agency comes, almost as bad as those asses at the DEA trying to make salvia look like some kind of problem so that they have more things to control.
I am glad this was posted because I was just now NOW thinking of asking a few questions about ephedra. I live in Southern California and just about every herbals/supplements store here has COMPLETELY tossed anything in their stock which contained ephedrine, ephedra, or ma huang. All the popular weight loss crap (like hydroxycut and xenedrine, etc) which were selling so well here have also decided to turn over a new leaf and offer ONLY newer ephedra free alternatives.
Back when I used to play online video games, work at night, and go to classes in the morning, I utilized a wide variety of stimulants to get by. Back then, ephedra/ephedrine was one of the best and one of the worst. Used once in a while, the stuff was ideal for studying, staying up, or becoming alert on the fly. Taken regularly however, it would all turn sour real quick (well, in every aspect except weight loss). The tolerance would kill me. At one point, taking a whitecross without any caffeine would actually put me right to sleep in about half an hour. At that point it wasn't long before I stopped utilizing it completely.
What I want to know is, how dangerous is this stuff really...? There is a craze here in SoCal to denounce it as pure evil and I even sometimes see commercials on television at night offering legal assistance for people who have been harmed by use of ephedrine who wish to prosecute. Numerous websites too abound on the net sharing the same sentiment that this substance is not only dangerous (heart failure, hypertension, stroke) but potentially deadly.
Are these claims in terms of USE or ABUSE? Say I take an ephedra extract in an ECA stack once or twice a week before I go do cardio, that would be relatively safe right? I am thinking that the majority of these nightmare cases are from ignorant children who do stupid things like taking 8+ whitecross tablets to achieve a buzz or using it several times a day over a long period of time in order to lose weight. Would this assumption be fairly accurate, or is this substance really as potentially dangerous as the media and FDA seem to want everyone to believe?
Thanks.
-caul
Yeah well; senor is certainly no doctor, but my take on the whole thing is that ephedra products have been used for literally thousands of years with a pretty good safety record.... I'll grant that when an ephedra product is reconstituted down into something darn near meth like, then, sure there may be a problem for those with an underlying health condition/genetic predisposition... That said, I wouldn't put much faith in those that continue to cry from the rooftops that any trace of ephedra is something from the devils own stash....... Personally, I can't stand the stuff myself. (makes me stagger around semi-conscious on just one pill, but that's just me, never could handle any type of upper) 'course, there are some 'out there' that like it just fine----------- senorsal
Ephedra sure is a wierd one if you ask me. I find that their is a plateau of usefullness as in a favorite pair of socks......... they only wear so well so long. But it's been litterally 15 years since I last went on a solid ephedra binge.
Orrin Hatch had a lot to do with this, and he holds stock in the company
Nutraceutical International. This had to do with greed, it is not as good as it seems.
I'm grew up in Illinois. Think I'll send 'ole Durbin an e-mail asking him to back down on his own personal agenda, and let freedom ring!! That ought to trash his day pretty well, as he no doubt, is feeling the sting of this ruling, as we speak :wink: ~~~~~~~ senorsal