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FDA investigating Bitter Orange
- Thread starter aznurse
- Start date
Boulder257
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ridiculous...my family thinks that if you take Ephedra you will die thanks to the FDA...
NYBodyguard
New member
More people die from smoking but I guess that industry has better connections.
FDA Set to Step Up Its Scrutiny
Of Effects of Herbal Supplements
By ANNA WILDE MATHEWS
Staff Reporter of THE WALL STREET JOURNAL
WASHINGTON -- In the wake of its decision to ban the weight-loss treatment ephedra, the Food and Drug Administration is planning to step up its scrutiny of the health effects of a number of other herbal supplements.
In a speech Tuesday, FDA Commissioner Mark McClellan is expected to highlight herbal products that the agency wants to examine more closely.
Among them are bitter orange, or citrus aurantium, which is being marketed as a substitute for ephedra. Others include usnic acid, which is derived from lichens and has been used in weight-loss aids, and aristolochic acid, which is sold for weight loss and to alleviate gastrointestinal problems and other health issues.
The FDA is expected to unveil the rule formally for its ephedra ban in the next few weeks. Ephedra will be the first herbal ingredient banned by the agency under a 1994 law that set a high bar for restrictions. The move is likely to draw legal challenges. If upheld, it is expected to serve as a precedent for the kind of evidence needed for action.
Unlike drugs, herbal supplements don't have to be approved by the FDA before going on the market, so manufacturers typically don't have to do the large clinical studies that drug makers perform. The agency must prove that the supplements pose a "significant or unreasonable risk" before blocking their sale. Supplement makers also aren't required to report adverse events to the FDA.
In the speech Tuesday, Dr. McClellan is expected to say that the agency will move more aggressively to proactively gather data it needs in order to measure if a supplement poses serious health risks. Because scattered reports of adverse events haven't been considered adequate evidence, the agency is expected to look for other sources of scientific proof, including pharmacological evidence, clinical evidence from small controlled studies, and long and short-term studies without strict scientific controls.
A spokeswoman for the Council for Responsible Nutrition, which represents supplement makers, said the industry encourages more research but "it is important that people not overreact to all supplements based on concerns about ephedra."
A council official said that bitter orange has a weaker effect than ephedrine alkaloids, the active ingredients in ephedra supplements, and appears safer. In the case of aristolochic acid, the group agrees with the agency's concerns and "doesn't see it as being part of the spectrum of appropriate supplement ingredients," the official said. The group hasn't taken a position on usnic acid.
In 2001, FDA warned of the risk of serious liver injuries from a dietary supplement containing a form of usnic acid.
The agency has also warned of the effects of aristolochic acid, which it has said can cause cancer and kidney damage. Though a number of companies stopped selling products that contained the ingredient, two researchers at the University of California at Berkeley wrote in a letter last year to the New England Journal of Medicine that they had found online 19 products listing ingredients known to contain aristolochic acid and 95 products suspected to contain aristolochic acid.
Write to Anna Wilde Mathews at [email protected]
Updated January 20, 2004
Of Effects of Herbal Supplements
By ANNA WILDE MATHEWS
Staff Reporter of THE WALL STREET JOURNAL
WASHINGTON -- In the wake of its decision to ban the weight-loss treatment ephedra, the Food and Drug Administration is planning to step up its scrutiny of the health effects of a number of other herbal supplements.
In a speech Tuesday, FDA Commissioner Mark McClellan is expected to highlight herbal products that the agency wants to examine more closely.
Among them are bitter orange, or citrus aurantium, which is being marketed as a substitute for ephedra. Others include usnic acid, which is derived from lichens and has been used in weight-loss aids, and aristolochic acid, which is sold for weight loss and to alleviate gastrointestinal problems and other health issues.
The FDA is expected to unveil the rule formally for its ephedra ban in the next few weeks. Ephedra will be the first herbal ingredient banned by the agency under a 1994 law that set a high bar for restrictions. The move is likely to draw legal challenges. If upheld, it is expected to serve as a precedent for the kind of evidence needed for action.
Unlike drugs, herbal supplements don't have to be approved by the FDA before going on the market, so manufacturers typically don't have to do the large clinical studies that drug makers perform. The agency must prove that the supplements pose a "significant or unreasonable risk" before blocking their sale. Supplement makers also aren't required to report adverse events to the FDA.
In the speech Tuesday, Dr. McClellan is expected to say that the agency will move more aggressively to proactively gather data it needs in order to measure if a supplement poses serious health risks. Because scattered reports of adverse events haven't been considered adequate evidence, the agency is expected to look for other sources of scientific proof, including pharmacological evidence, clinical evidence from small controlled studies, and long and short-term studies without strict scientific controls.
A spokeswoman for the Council for Responsible Nutrition, which represents supplement makers, said the industry encourages more research but "it is important that people not overreact to all supplements based on concerns about ephedra."
A council official said that bitter orange has a weaker effect than ephedrine alkaloids, the active ingredients in ephedra supplements, and appears safer. In the case of aristolochic acid, the group agrees with the agency's concerns and "doesn't see it as being part of the spectrum of appropriate supplement ingredients," the official said. The group hasn't taken a position on usnic acid.
In 2001, FDA warned of the risk of serious liver injuries from a dietary supplement containing a form of usnic acid.
The agency has also warned of the effects of aristolochic acid, which it has said can cause cancer and kidney damage. Though a number of companies stopped selling products that contained the ingredient, two researchers at the University of California at Berkeley wrote in a letter last year to the New England Journal of Medicine that they had found online 19 products listing ingredients known to contain aristolochic acid and 95 products suspected to contain aristolochic acid.
Write to Anna Wilde Mathews at [email protected]
Updated January 20, 2004
The problem is that the FDA could give a rat's ass about people's health. Ephedrine/caffeine has been proven clinically to be better than any weight loss medication that doctors can prescribe. That's the problem with it. No pharmaceutical company is getting rich off of ephedrine nor is any doctor.
I just read an article in CNN about how the FDA is warning people not to go to Canada to fill their prescriptions because 'they have no idea what they are going to actually get'. Like going to a pharmacy in Canada is the same as getting your prescription filled by Vinny on the streetcorner. They then go on to 'explain' how it really isn't cheaper to buy your drugs in Canada. Why, you ask? They then compare namebrand drugs in Canada vs. generic equivalents in U.S. How much b.s. is that?
Ridiculous. And they do this because they want you to be safe. Remember that.
I just read an article in CNN about how the FDA is warning people not to go to Canada to fill their prescriptions because 'they have no idea what they are going to actually get'. Like going to a pharmacy in Canada is the same as getting your prescription filled by Vinny on the streetcorner. They then go on to 'explain' how it really isn't cheaper to buy your drugs in Canada. Why, you ask? They then compare namebrand drugs in Canada vs. generic equivalents in U.S. How much b.s. is that?
Ridiculous. And they do this because they want you to be safe. Remember that.
NYBodyguard
New member
TxLonghorn said:
Exactly, its amazing how much power these companies have!
jonny jacked
New member
god i'm glad i live in canada. just picked up a bottle of 300 tabs for 10 bucks
TheRide
New member
aznurse said:
Yeah, it was in Tues. edition... what next... Whey Protein!!
What they are accomplishing is simply the creation of a underground/black market for ephedra... When in actuality they should be educating the public on supplements and their "possible" side-effects when taking not as directed.
A
Animal
Guest
parkerjones said:
Where did you see that more people eat PB than take/took ephedrine?
As for Bitter Orange, that will just give the fedthugs a reason to kick down anybody's door. .......... an informant saw you buying oranges at the store by the bagful and the peels are illegal.............so we came to make sure you are safe.........................
wellbilt
New member
its rediculous cigarettes are probably hte most unhealthyest shit you could buy but there still available at the deli and gas station to just about anybody and only because the govt taxes the crap out of the i would not be suprised in the future to see ephedra available by perscription through some pharmacutical company i also would not be surprised to see the govt go ad\fter lots of other supps that work so that pharmacutical companies and docs could make money off of these products just my 2 cents
drveejay11
New member
Animal said:
yup..........
wellbilt
New member
i just saw on the nw\ews last night they showed the comercial like 3 times that the fda is going to go after the ephedra free products now becaused they are also dangerous man this shit pisses my off weres our freedom going.i do remember the supp ban a few months back and sent a letter to my congressman although i dont believe that he would even acknowledge it,i think we have to try i honestly dont believe that the govt is going after these products for saftey issues but to eventually make money on these products in the future just my 2 cents
