U.S. to ban dietary supplement ephedra
Health risks to be cited by government officials
The Associated Press
The Bush administration has decided to ban the herbal weight-loss supplement ephedra from the marketplace because of concerns about its effects on health, government officials said Tuesday.
Health and Human Services Secretary Tommy Thompson and Food and Drug Administration chief Mark McClellan were to announce the ban at a midday news conference, the officials said, speaking only on condition of anonymity.
Critics called the federal crackdown too late. Sales nationwide already have plummeted because of publicity about roughly 155 deaths blamed on the amphetamine-like stimulant, including Baltimore Orioles pitcher Steve Bechler in February. Ephedra is linked to heart attacks and strokes, even when used by outwardly healthy people at recommended doses, because it speeds heart rate and constricts blood vessels.
Asked about Tuesday's ban, Orioles vice president Jim Beattie said: "I don't think at this point it's appropriate to comment on that, unfortunately, because of outstanding" lawsuits.
Three states -- New York, Illinois and California -- have passed their own ephedra bans; use has been banned in the NFL, college sports and minor league baseball. Several retail chains, including supplement giant General Nutrition Centers, recently quit selling it, too.
"It's a dead product and unfortunately it has become a dead product over the backs of a lot of dead people when the FDA could have acted before," said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen, which petitioned the government for a ban in 2001.
Wolfe urged remaining manufacturers to recall all ephedra-containing products still on store shelves. For any future ephedra-linked injuries, "there's going to be hell to pay in terms of increased liability on the part of the companies that are allowing it to be sold," he said.
The supplement industry's Council for Responsible Nutrition said it didn't oppose a ban, noting that very few companies still make the stimulant -- its members who once did no longer do so.
"We think the reputable players have found so much controversy and difficulty in this marketplace that they've decided to get out of it," CRN's John Hathcock said. "We recognize the controversy is a cloud over our whole industry."
Remaining ephedra manufacturers didn't immediately comment Tuesday, but have insisted that studies prove their products safe when used properly.
"Anyone who has read our label knows that we go to great lengths to inform our customers about the proper use of our products," Metabolife International chief executive Russell Schreck said over the summer. "We make it quite clear on our label that the ephedra products are not to be sold or used by minors and that customers with certain pre-existing medical conditions should 'consult a physician before product use."'
But several scientists said that it was impossible to prove whether ephedra was safe because studies screen out participants who have health problems -- the people most likely to be hurt by the product.
The General Accounting Office, Congress' investigative arm, looked into the issue and found many people who reported problems had followed the label's instructions.
The government ban, one of the first involving a dietary supplement, comes after Thompson this summer urged Congress to rewrite a law that rolled back dietary-supplement regulations and to require manufacturers to acknowledge potential side effects.
Because ephedra is an herb, U.S. law let it sell over-the-counter with little oversight unless the FDA could prove a clear danger to public health. Manufacturers blocked a 1997 FDA attempt to restrict sales of certain dosages and to put warning labels on the herb by arguing the agency lacked enough proof of danger.
In March, FDA again proposed those warnings and said it would re-examine a ban.
Some free country we live in.
Took reccomended dosage of stuff with ephedra in it and it made me mean as hell. hated it.
BajaBryan: I don't think so. A lot of MMA athletes use various supplements with Ephedra to train and or cut weight.
What about Ephedrine? Will that be banned also?
I don't agree with the law. But it is bad shit when abused...
The End of Dietary Supplements
An Interview with Attorney Rick Collins
by Chris Shugart
Imagine walking into your local GNC or logging on to your favorite online supplement store and finding it virtually empty. The shelves are bare except for the few remaining legally available supplements: vitamins and protein powder. Even creatine is available only by prescription and at five times what you used to pay for it when it was "legal." Prohormones and effective fat burners? Not even produced any more. Legislated out of existence. Banned in the U.S.A.
Is this just a bad dream? No. The truth is that the situation described above could be a reality in just a few short years. No, this is not a scare tactic used to make you buy more supplements, but I'd be lying if I didn't tell you that many insiders are stocking up on their favorites already. The threat is that real.
This nightmare began not with dietary supplements but with steroids. Now, most average people on the street couldn't care less that steroids were criminalized and put on the DEA's list of Schedule III controlled substances. A person who's not interested in steroids probably wouldn't have much sympathy for a juicer who gets carted off to jail for illegally importing D-bol. But remember, using steroids didn't used to be a crime and it's still not a crime in many countries. However, misinformed media and politicians with hidden agendas succeeded in convincing most people that steroids were pure evil and those who used them were dangerous drug addicts.
Still don't care? Well, today, the exact same tactics are being used to get rid of something you may care about: your right to use dietary supplements. Right now, there are politicians and special interests groups whose main goal is to keep you from purchasing muscle building and fat burning supplements. Maybe one day you'll be carted off to jail for importing ephedrine or prohormones when those same politicians turn you into a felon by banning those safe and effective supplements. It could happen. Correction: It is happening.
Luckily, many supplement manufacturers are banding together to fight this trend. The movement was started by Rick Collins, the man once known as the "steroid lawyer" and author of the book Legal Muscle: Anabolics in America. Rick's a New York lawyer and former competitive bodybuilder who's built his reputation bridging the gap between the legal community and the bodybuilding world. He's been recognized as America's foremost legal expert on muscle-building substances and is the founder of steroidlaw.com.
Rick is also General Counsel for the United Supplement Freedom Association, Inc. (USFA), a coalition dedicated to the preservation of over-the-counter dietary supplements, including prohormones. T-mag's Tim Patterson is a trustee of the USFA and Biotest is a major contributor.
Rick is fighting the good fight to keep your favorite dietary supplements legally available. Testosterone sat down to talk with Rick recently and here's what he had to say.
T-mag: Rick, give us a synopsis of what's going on right now in Washington concerning sports supplements.
Rick Collins: It's a bad scene. Negative press reports about ephedra are having a spillover effect on all sports supplements. Congress is buzzing. They're now talking about holding more hearings on supplements in sports. The Chair of the House Committee on Energy and Commerce has sent letters to both the FDA and the DEA questioning the "drug classification of designer steroids," so-called pro-steroids.
T-mag: What bills are pending at this time?
RC: Bills have been introduced in both the House and the Senate that would take a variety of products off the market. One bill would permit the Attorney General to turn "steroid precursor" products into controlled substances -- a class that's supposed to be reserved only for dangerous, addictive drugs of abuse.
T-mag: Sounds like MAG-10, 4-AD-EC would go bye-bye if that bill was passed, not to mention DHEA and any other "andro" type supplement. What's the other bill?
RC: The other would re-define "anabolic steroid" to make certain products fit the definition based on advertising claims, regardless of their actual anabolic properties. Meanwhile, someone else in the Senate is working on his own bill to outlaw prohormones and pro-steroids. There's plenty going on.
T-mag: Besides not having access to effective supplements, why should the average bodybuilder be concerned?
RC: Because our freedom is at stake. At the Attorney General's discretion, millions of health-conscious bodybuilders could be dragged into the federal criminal justice system for the mere possession of popular dietary supplements re-labeled "anabolic steroids." People interested in optimizing their health and appearance could face arrest and prosecution as drug offenders. In some cases, they could even have their assets seized and forfeited!
Even if these products are banned by a mechanism other than the Controlled Substances Act, they would no longer be available unless and until the FDA approved them as drugs. It's scary because the attack on these products isn't going to go away. A law is most likely going to be passed. The issue is its scope.
T-mag: Who's behind this push to ban prohormones/pro-steroids? What's the real story?
RC: Bills have been introduced in both the House and the Senate that would take a variety of products off the market. One bill would permit the Attorney General to turn "steroid precursor" products into controlled substances -- a class that's supposed to be reserved only for dangerous, addictive drugs of abuse.
T-mag: Sounds like MAG-10, 4-AD-EC would go bye-bye if that bill was passed, not to mention DHEA and any other "andro" type supplement. What's the other bill?
RC: The other would re-define "anabolic steroid" to make certain products fit the definition based on advertising claims, regardless of their actual anabolic properties. Meanwhile, someone else in the Senate is working on his own bill to outlaw prohormones and pro-steroids. There's plenty going on.
T-mag: Besides not having access to effective supplements, why should the average bodybuilder be concerned?
RC: Because our freedom is at stake. At the Attorney General's discretion, millions of health-conscious bodybuilders could be dragged into the federal criminal justice system for the mere possession of popular dietary supplements re-labeled "anabolic steroids." People interested in optimizing their health and appearance could face arrest and prosecution as drug offenders. In some cases, they could even have their assets seized and forfeited!
Even if these products are banned by a mechanism other than the Controlled Substances Act, they would no longer be available unless and until the FDA approved them as drugs. It's scary because the attack on these products isn't going to go away. A law is most likely going to be passed. The issue is its scope.
T-mag: Who's behind this push to ban prohormones/pro-steroids? What's the real story?
RC: As usual, special-interest groups seem to be the prime culprits. In this case, it's the group that protects against doping in competitive sports. They're dedicated to banishing all performance-enhancing substances (drugs and dietary supplements) from collegiate, professional, and other organized athletics. But they're overstepping their bounds and trying to dictate what the rest of us can and can't do. What gives them that right?
T-mag: Well, they certainly haven't decreased the use of steroids in top level sports, that's for sure. Now, in your book, Legal Muscle, you write about how anabolic steroids were criminalized. I was amazed at the ignorance of those behind this measure. They didn't know a thing about steroids, just myths and misconceptions. I can't help but see similarities with the possible prohormone/pro-steroid measures.
RC: It's déjà vu! You've got tons of bad press, some of it based on speculation or completely unfounded. You've got regulatory bodies -- the FDA and DEA -- that have done little, if anything, to address the situation. You've got an aggressive anti-doping lobby provoking Congress to do something. As a result, you've got some Capitol Hill lawmakers feeling compelled to act. That's exactly what happened with steroids. The Ben Johnson scandal was the last straw before the axe fell. Now, it's ephedra horror stories.
T-mag: Rick, most of these horror stories seem really convoluted and unfounded. Usually they involve many extraneous factors besides the fact that the athlete had used a fat burner. Many who've had problems had preexisting medical conditions and didn't read the label, which clearly said not to take then product if you have those conditions. Others take five times the recommended dosage, then go out and train in the heat without water. These people may have been on ephedra, but that clearly wasn't what killed them.
I mean, we can't legislate common sense. Remember when creatine was under the microscope because of the two wrestlers who put on rubber suits and then exercised in a sauna in an attempt to make weight? Some tried to blame creatine for their deaths. Stuff like this makes anyone with a lick of common sense want to pull his hair out!
RC: We've become an extremely litigious society. When something bad happens, the immediate response is to blame others and sue. Some idiot holds a cup of hot coffee between his knees, then looks for somebody else to blame when it spills and burns him. Of course, the press is also to blame. They love to expose "unsafe" products and stir up a little public hysteria. It's a terrific ratings booster, and sells papers.
T-mag: A person can die from misusing a variety of OTC products, aspirin for example. So why do sports supplements get picked on?
RC: Because sports performance supplements have a sworn enemy that is very skilled at manipulating the media: the sports anti-doping establishment. To them, sports supplements are evil by their very definition. They are substances which, when consumed, give one competitor a significant athletic edge over another. So it's the combination of potentially being bad for you if abused with potentially being "too good" for you on the field that's the problem.
T-mag: It seems that a politician can't say the word "andro" without bring up ephedra, which, of course, isn't a prohormone. What's up with that?
RC: Those looking to outlaw prohormones want to confuse the issues. Dirty one with the other. Muddy the waters. Myths and misconceptions, Chris.
T-mag: Do they have any valid claims against prohormones/pro-steroids?
RC: Only in certain regards. The anti-doping folks have every right to ban prohormones in their own sports events. And when it comes to teenagers, most everyone agrees that prohormone products are inappropriate. But many of these products are very beneficial for adults. Many of these products fall under DSHEA, the federal law protecting dietary supplements, and it's just plain wrong to ban them.
T-mag: Are all prohormone/pro-steroid products protected by DSHEA?
RC: The government isn't sure which ones are and which ones aren't, so they just want to ban them all. That's the objective of some folks.
T-mag: If unchecked, where could this lead? Are we going to be back to desiccated liver tablets? Is something as safe and benign as creatine going to be next?
RC: I'm worried, and you should be too. They're on a crusade.
T-mag: If safe and effective supplements are pulled from the market, do you think more people will turn to the black market and steroids?
RC: Of course. That's exactly what happened when steroids were criminalized. The black market exploded, and so did the potential health risks of using steroids. That's one of the central themes of Legal Muscle.
T-mag: Would a compromise help at all? Since many claim they're wanting to ban supplements "for the children," how about carding for prohormones so no one under a certain age can buy them?
RC: Given the current climate, negotiating a fair compromise will be crucial if the healthful prohormone market is to be saved. Yes, prohibiting sales to minors has got to be part of that compromise. And it ought to be. The USFA is fully behind that idea. Getting rid of specific products that are unsafe or are not properly and legally protected by DSHEA is also important, as is demonstrating responsible self-regulation as an industry.
T-mag: Give us some more info on the USFA.
RC: The United Supplement Freedom Association is a non-profit coalition. It's made up of supplement companies, scientists, researchers, and consumers. Our goal is to ensure that safe and appropriate dietary supplements remain available for adults. We want to make sure that any law that Congress passes isn't overly broad and doesn't deprive adult Americans from healthful products.
T-mag: Assuming the politicians will listen, can we convince them that this is a bad idea that will lead to more illegal steroid use?
RC: I hope so. A team of lawyers and scientists from within the industry is conducting a review to determine which products are safe, legal, and protected by DSHEA -- and which are not. The review has to be absolutely honest. Some people in Washington have a very negative view of the dietary supplements industry. The USFA is aiming to restore public confidence in this industry and its products. For example, we're also drafting advertising guidelines to make sure that prohormones products are responsibly marketed. Some companies in this business need to clean up their acts.
T-mag: Who's involved in the USFA? Who's putting his money where his mouth is and who isn't?
RC: For starters, Biotest, Sci-Fit, ErgoPharm, Nutrex, Avant Labs, Molecular Nutrition, 1-FAST-400, S.A.N., and Impact Nutrition have contributed to the cause. These companies are devoting time and money to protect the rights of consumers to enjoy safe nutritional products. They have pledged to develop and adhere to responsible industry guidelines. Once these guidelines are set, all members will have to abide by them.
T-mag: Are the rival supplement companies of the USFA working well together?
RC: Better than I would have thought. As General Counsel, I had to smooth out a few minor rough spots in the beginning, but then the shared goals really brought them all together. Many of the individuals in these particular companies are really good and honest people. I think the members of the USFA really care about their products and their customers.
T-mag: You're missing a few "big names" on that list of USFA supporters. What about the other large supplement companies?
RC: Nothing. Some of them are just sitting on the fence, watching others do the fighting.
T-mag: Why are they being so lame?
RC: Greed, maybe, or shortsightedness. Some may think there's no chance of saving prohormones. Others claim to think they're not really in danger at all. They are in danger -- big time! And the more ads that boast "steroid-like gains" and talk about "legal loopholes," the more likely this market will meet a fast end. But until a law is actually passed, there's still hope.
T-mag: What can the average gym rat do to help out?
RC: Spread the word about this issue! Tell your friends and neighbors! Go to the USFA web site. It's at USFA.biz. There, you can follow the directions on how to petition your Congressional representatives and demand that they oppose any overbroad bills outlawing all prohormones for adults. A form letter and list of legislators is available on the site. Get involved! Support the USFA! Or it could be back to desiccated liver for all of us.
T-mag: Thanks for the scary interview, Rick. Let's hope supplement users out there read this and take action.
I feel I should have the freedom to put any supplement in my body that I choose as long as I do not compete in professional sports where my pay is based on my performance.
If I want to take ephedra/ma huang/ephedrine, why is it not my choice? There is a bill being voted on in the near future that if one idiot has an adverse reaction from say "creatine", regardless if they took the bottle, it can be pulled off the shelves. It likely won't be, but it is possible.
Supplement Group Found to Reduce Cancer Risk
At a time when the US Senate is considering making large-dose vitamins unavailable to the American public except with prescriptions at drug prices, an extensive study has revealed that a specific mega-dose supplement group can dramatically reduce cancer risk.
A total of 13,000 men and women aged 30 to 65 took part in the study, which found that regular use of a particular supplement group reduced cancer risk 37% in men and 31% in women. The supplement group is: 6mg of beta-carotene, 120mg of vitamin C, 90mg of vitamin E, 100 micrograms of selenium, and 20 milligrams of zinc.
Under SB 722, supplements at these dosages would be available only as prescription drugs. To read more about the study click here: http://news.bbc.co.uk/2/hi/health/3122033.stm
I was addicted to it for one reason:
I noticed that while I was taking it, I never got sore from working out, despite how psycho i got with my workouts.
help me lose 80+ pounds. I dont see them banning cigarettes.
I think the stuff's great if used correctly.
It helped me lose a lot of weight a few years ago. Compared to all of those "weight loss pills" you find now, it actually WORKED. I don't care what those newer ones claim, none of them gave me more energy, reduced my appretite, or actually made me lose weight like Xenedrine and Ripped Fuel did. In fact, I've never had any success at ALL with any of them.
It's actually been pretty tough to find it for the last 6 months anyway, but you can still find it online.
Lots of places still sell the old Xenedrine and Ripped Fuel, but I'd be willing to bet the prices will skyrocket as of today.
"Some people died from this stuff and it causes other problems like heart problems. No reason to shit on the government for trying to protect your dumbass. "
THe fact is that it helped a lot of people lose weight and is a great bronchio dilater. THere are far worse prescriptions out there that should be taken off the market, but we all know how that goes.
"I'm sure you feel you should be able to do whatever you want. Unfortunately, that's not the world we live in."
I am by no means trying to make this an argument, but... I do not feel I should be able to do whatever I want. I do feel that I should be able to put whatever I want in my body without the government telling me that it is bad. I feel I should be able to do whatever I want as long as it does not adversely affect others. You are right though, that is not the world we live in. In this world, I have someone telling me I can go to jail if I inhale/ingest a plant with medicinal benefits (ma huang,mushrooms,marijuana, etc. ), but I can drink myself jaundiced . (I don't do "illegal" narcotics, btw )
So weird, two days ago I found a vitamin store in cali that still had some bottles of stacker2 so I bought what they had. In cali its been pretty hard to find anything with ephedra for about 4 or 5 months now, at least for me.
Another bad idea that only serves to limit freedom of choice and lacks in any logic what so ever. More laws that serve only to protect stupid people (which the world needs fewer of).
"I used to be a Bush supporter, but like his Dad everyday he is pandering to liberal agendas as the election draws near."
This is too funny. Like yeah, I'm sure it has NOTHING to do with our creepy attorney general who thinks dancing is a sin, holds bible study every morning in a government office, thinks ritually speaking gibberish is divine, and put terrorism on the back burner in favor of porn and drugs when he took over.
Really though, if there's anything Bush would want to keep legal, it's over the counter speed. :)