quote: WASHINGTON (Reuters) - The U.S. Food and Drug Administration said on Tuesday it will ban the weight-loss aid ephedra, saying it is unsafe and can cause heart attacks and stroke.
It is the first time the FDA has banned a supplement.
The agency said dieters were likely to do more harm than good by taking ephedra, which raises metabolism.
The ban will become effective 60 days after the new rule is published, but the FDA gave no immediate date for publication.
"Consumers should stop buying and using ephedra products right away and FDA will make sure consumers are protected by removing these products from the market as soon as the rule becomes effective," Dr. Mark McClellan, an FDA commissioner, said in a statement.
It's about time! How many people have to die to get this stuff banned?
Posted by Dan_raven (Member # 3383) on :
I see a law suit pending, stating that Ephedra is a food Supplement, and not under FDA jurisdiction, so it can-not be banned.
(but Yes, I am for Banning Ephedra, and slapping silly all their spokesmen)
Posted by rivka (Member # 4859) on :
The day they overturn the stupid law that exempted "food supplements" from FDA regulation, I will REALLY cheer!
Posted by fugu13 (Member # 2859) on :
Its not how many, its who. When sports stars die, stuff gets banned.
Posted by aspectre (Member # 2222) on :
If folks wanna risk their own lives, it is their business, not the government's. Might as well ban ice cream sales.
Posted by fugu13 (Member # 2859) on :
Yes, Ephedra was a clear example of how the invisible hand of consumerism magically chooses the best outcome.
Posted by Farmgirl (Member # 5567) on :
quote: it was associated with higher risks of heart palpitations, tremors and insomnia. -- from the CNN story about the same topic
I get the same reaction if I'm stupid enough to drink too much coffee. You get this reaction from any stimulant if you take TOO MUCH. It is too bad the government always has to step in and protect people from themselves just because they don't know how to use anything in moderation....
FG
Posted by Dan_raven (Member # 3383) on :
Actually, moderation is not the problem. Ephedra is a drug that has different results on different body types and metabolism rates and yes, even heart conditions.
One women in my office had a minor stroke, and spent 3 days in the hospital, because she was using an Ephedra laced product, and using it in accordance with the directions.
She is young (in her 20's) and in good shape as well.
The only way you can use common sense and moderation on any products intake is to know 1) How much of the product is in what you are taking and 2) What is considered a moderate amount.
Since food supplements are overseen by NO government agency, such listings are few and far between.
Posted by BYuCnslr (Member # 1857) on :
aspectre: You make a very poinent case, but in the case of foods and drugs and other things that people intake, the FDA is very important because without it there would be no quality control over things that people consume, ephedra not only would be allowed, but the ephedra that is sold would also be able to contain quite a large percentage of trash just to lower production costs, as an example something that is out of the FDA's control...Esctacy (well it is regulated, but they cannot completely remove it from the black market), because the FDA has no control over it, those that do sell it put other things into it that make it even more dangerous, or any other drug that is on the street, it's not even close to pure, there's always salt, or sugar, or any number of unknown substances in there...can you imagine your flour with 50% landfill mass in it? Or perhaps your Advil made with 20% sand? That's why things are regulated, for the safety and quality of things we consume. And fugu, even though I agree with you wholeheartedly, the government can only be a reactionary force, and alas, it's all we have. Personally, I've taken to a friend's mantra and I'm saying that the Earth is crampin' my style, sign me up for the first ship to colonize Mars. Satyagraha
Posted by rivka (Member # 4859) on :
The other huge problem with unregulated "food supplements" is the HUGE variance in the actual levels of the active ingredient(s) compared to claims made on the label.
There have been a number of studies showing levels as variable as 1/10 to 5x the supposed dosage within samples from the same brand's batches.
And there are MANY brands with this problem, and many are large well-known companies.
If the FDA doesn't require (because they cannot) them to randomly test samples, why should they?
It is sheer insanity that "food supplements" are exempt from FDA regulation and supervision.
[Edit: Ooops, too many prepositions.]
[ December 30, 2003, 01:45 PM: Message edited by: rivka ]
Posted by fugu13 (Member # 2859) on :
I'm assuming everyone knew I was being highly sarcastic.
Posted by Sopwith (Member # 4640) on :
One of the big worries from the ban, is the impact it will have on asthmatics.
For those who don't know, ephedrine (from ephedra) is the main ingredient in Primatine Mist and other over the counter inhalers for asthmatics.
Last year, Primatine and other medications like it completely disappeared from store shelves as it was scooted away from the market.
The sad thing is, the ephedrine inhalers are very effective as rescue inhalers for asthmatics, and as an over-the-counter drug, they are an inexpensive medication for asthmatics who don't have medical insurance. Being that there has been no move to make ventolin or its ilk OTC, what are uninsured asthmatics to do? Shell out $26-$35 for Ventolin or $12 for Primatine?
I just hope they are going to check and see if the baby is still in the bathwater before they give it the old heave ho.
Posted by Ryuko (Member # 5125) on :
Yeesh. That is a bad thing. But I think that they may take that into account when they make the decision. At least I hope they will....
Posted by rivka (Member # 4859) on :
Kinda makes you wish the law allowed the FDA to regulate "food supplements" instead of only banning them after they've been shown to be harmful, neh?
Write your congresscritters!
Posted by aspectre (Member # 2222) on :
Look guys, I assume that anyone using the 'invisible hand of the marketplace' argument in favor of deregulation either hasn't read Adam Smith, is functionally illiterate, is brainwashed past the point of contact with reality, and/or is a deliberate liar. With millions of sellers pushing billions of products, it is impossible for any individual to know of the efficacy&safety of all products. So a free market intrinsicly must rely on externally-guaranteed trustability and enlightened self-interest.
Therefore, a collective enlightener -- a government, whether or not the collective uses that label -- is necessary to ensure that correct information is easily&readily available. And since sellers have the same free will to lie or to voice ignorant opinions as the rest of us, a collective enforcer -- a government, whether or not the collective uses that label - is necessary to make sure that the product is what the seller says it is. For skeptics, the strength of the LosAngeles/NorthRidge earthquake and the recent Iran/Bam earthquake was comparable. The NorthRidge region has about 50times the population of the Bam region. The NorthRidge earthquake killed about 40people. The Bam earthquake killed about a 1000times that number. The difference in results is due to difference in building regulations between the two regions.
In other words, the Congressmen who legislated a "food supplements" exemption from regulation were hypocritical IDIOTs, at best. Especially because there had been a recent near catastrophe due to a food supplement.
Nonetheless, we aren't talking about ensuring the purity of the product; nor about ensuring that information about the product is inescapable except by a deliberate choice to remain ignorant. Instead we are discussing a total ban based on the possible bad incidents experienced by a miniscule minority of users.
[ December 30, 2003, 08:40 PM: Message edited by: aspectre ]
Posted by The Rabbit (Member # 671) on :
Food supplements are not exempt from FDA regulation, they simply fall under a different set of regulations than drugs.
quote: But in choosing whether to use dietary supplements, FDA answers consumers' questions by noting that under DSHEA, FDA's requirement for premarket review of dietary supplements is less than that over other products it regulates, such as drugs and many additives used in conventional foods.
Why are they less regulated? Strong lobbying by interested parties. And criminal stupidity by Congress.