FDA bans Ephedra: deaths may be Aspartame related
The FDA has announced a ban on Ephedra, a herb that has been used in different remedies for millennia and that more recently has been sold as an energy booster and slimming aid.
While it is quite correct that a dangerous product should be banned if the risk posed by it is - let's use the FDA's own term - "unreasonably high", I am afraid that the evaluation of the deaths may be fatally flawed. In fact, many of the deaths may be due less to ephedra ingestion than to an overuse of 'sugar free' soft drinks, including popular sports drinks, containing ASPARTAME. The artificial sweetener has been implicated in a series of deaths and has more recently been said to be the cause of cardiac arrests, much the same as the ephedra herb.
Aspartame was approved by the FDA over the express opinion of its own expert panel, in a perfect exercise of the "revolving door" game between the FDA and big industry, in this case G. D. Searle corporation, under its then CEO Donald Rumsfeld, who brought political clout to bear where scientific information could not do the trick.
Unfortunately, even today no one at the FDA seems to be allowed to look at a possible causation of death by Aspartame, or look at the figures of Aspartame disease, although there are certainly enough indications to warrant immediate attention. But no, we can relax, the culprit has been identified and we can go on drinking Coke or Pepsy light or Gatorade, aspartame included. And what's one less herb - aren't there several thousand of them?
Coming back to Ephedra, it appears that the FDA considers it dangerous if sold as a dietary supplement, but is quite prepared to leave numerous cough medicines on the market, which contain comparable amounts of the active ingredient, pseudoephedrine. See what Rob McCaleb, a natural product consultant with the international law firm of Greenberg Traurig LLP and founder and president of the Herb Research Foundation says in a recent article.
Newsday: Questions About Ephedra, Drug Ban by FDA
(not available on NewsDay Web site)Alternative:
questions_about_ephedra_drug_ban_by_fdaU.S. Bans Ephedra, Drug Linked to Deaths
By Associated PressDecember 30, 2003, 2:00 PM EST
WASHINGTON -- The Food and Drug Administration has announced a new rule that in 60 days will ban the manufacture and sale of ephedra, an herbal dietary supplement that has been sold as a weight-loss aid, but also has been linked to serious health problems and even deaths.Q: What is ephedra?
A: Ephedra is a plant with varieties growing in Asia, Australia, Europe and North America. It is called Ma Huang in China where it has been used for 4,000 years to treat respiratory infections. A wild variety in the U.S. Southwest was used medicinally by early settlers to brew "Mormon tea" or "Squaw tea." Typically, the whole plant is powdered and used in pills or other preparations.
Q: What is the medical action of ephedra?
A: Ephedra contains two alkaloids, ephedrine and pseudoephedrine. These compounds can combat congestion and ease breathing in some conditions. But the chemicals in ephedra also affect the heart and can cause a serious rise in blood pressure. A synthetic ephedrine is used in a very limited way in a small number of drugs prescribed for respiratory infections.
Q: What is the most common use of ephedra?
A: Ephedra has been found in about 200 dietary supplements sold over the counter. Ephedra has been promoted at health food stores. Manufacturers and retailers have claimed the herb is good for weight control, building muscle and boosting energy. FDA's power to regulate the dietary supplements is more limited than for prescription drugs. The agency can ban risky supplements only after gathering evidence of injury.
Q: Why is ephedra now being banned by the FDA?
A: After years of studying, the FDA has concluded that continued sale and use of products containing ephedra "pose an unreasonable health risk." There have been about 1,000 reports of serious health complications from the use of ephedra and at least 100 deaths. The herb has already been banned in three states. Most organized athletic groups either outright ban use of ephedra and ephedrine, or severely discourage their use. A 23-year-old pitcher for the Baltimore Orioles who died suddenly was taking ephedra.
Q: Do companies making or selling ephedra products have a right of appeal to the FDA order?
A: Yes, they can sue. FDA officials said they are ready for the new ephedra rule to be challenged in court.
Q: Is the FDA evaluating other dietary supplements?
A: Yes. Officials said that other products are being looked at, but no immediate action is expected. An FDA publication lists a number of herb supplement ingredients with "possible health hazards," including chaparral, comfrey, willow bark and wormwood.
Here a recent article on the site of Jon RappoportEPHEDRA AND THE FDA
DECEMBER 31, 2003. The FDA ban this week of the herb ephedra is the forward wedge in a new round of attacks on herbs and other nutritional supplements.
The gist of the attack is: all these supplements are actually drugs because they create “biological activity.” Of course, what nutrient would not initiate biological activity? Something inert? A piece of plastic? FOOD CAUSES BIOLOGICAL ACTIVITY.
If the FDA can convince the public and the press and the beltway pols that nutrients are harming people and are drugs, then it can try to insist that all supplements undergo the multi-million-dollar testing that is required for new drug approvals. This would bankrupt most nutritional companies and allow the drug companies to accelerate their process of buying out these outfits.
Ephedra deaths have not been covered in detail. For example, what amounts were the people taking? The Chinese have been using ephedra (ma huang) for 5000 years.
And then we have the fact, which I’ve documented over and over, that FDA-approved pharmaceuticals correctly prescribed to patients in hospitals kill 100,000 people in the US every year. Where is the outcry about that?
Oh, that’s right. All outcries are supposed to come from…the FDA, the very agency that approves the drugs that are killing so many people.
For some reason, the mainstream press does not get up on its hind legs about THAT. Even though it would obviously make a sensational story that could be pounded on day in and day out.
Can you imagine what would happen if ephedra were killing 100,000 people like clockwork every year? People would burn down the buildings of the companies that sell it. The CEOs would be hung in public squares.
JON RAPPOPORT www.nomorefakenews.com
And here another view on the FDA's action from HSI Baltimore:Circle The Wagons
Health Sciences Institute e-Alert
January 8, 2004
**************************************************************
Dear Reader,If you've never used a supplement that contains ephedra, you might not be concerned about the recent announcement that ephedra has been banned by the FDA. But this drastic measure goes way beyond the outlawing of just one herb. An Associated Press headline made that clear on the last day of 2003: "Ephedra Ban Puts Industry On Notice - Move Shows Government Will Crack Down On Supplements."
If you value your freedom to make your own choices about what dietary supplements you take, brace yourself. We are now officially under fire.
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The real deal
--------------------------------------------------------------Every day people die due to reckless driving. Should we ban the sale of cars? That would be absurd, of course, but that's exactly what's happening with ephedra. A handful of people have blatantly misused products that contain a hyped-up, synthetic version of the active ingredient in ephedra, and now ALL ephedra products will be banned, even though thousands of people use ephedra responsibly every day with no problems.
So exactly what are we losing?
In the e-Alert "Jekyll and Hyde" (1/16/03), HSI Panelist Linda Page, N.D., Ph.D., gave us an insider's perspective on the value of ephedra. Dr. Page has been a Classical Herbalist for almost 30 years and has formulated over 250 effective whole herb combinations, many of them containing ephedra. Dr. Page writes:
"I am continually distressed about ephedra's misuse and abuse, most importantly the isolated component of ephedra, ephedrine. If herbalists and formulators lose the ability to use ephedra,
we are losing one of the best broncho-dilators from the plant kingdom that is extremely valuable when used for asthma and allergies. What then would people have to choose from to alleviate their symptoms? Drugs of course."Ephedra also has thermogenic qualities so it is very effective for weight loss. Weight loss product manufacturers know this, and in most cases, the ephedrine is isolated and boosted so that the end result is people are taking a dangerously high amount. Further, when ephedrine is isolated and boosted, it becomes an herbal 'drug.'
So what's the difference between ephedra and ephedrine? Dr. Page explains that in a whole herb formulation containing ephedra, there may be up to 50 mg of ephedra, containing only half a milligram of ephedrine. But the products that isolate ephedrine may deliver up to 20 mg of ephedrine - a full 40 times as much as ephedra!
Is it any wonder that people experience grave side effects when they exceed the recommended doses of this altered natural drug?
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In a Jiffy
--------------------------------------------------------------"If there ever were an indication that the drug companies control what agents we can and cannot acquire, the ephedra scandal is it."
That was the opening line of an e-mail I received last week from HSI Panelist Allan Spreen, M.D., who added: "The simple proof of drug company influence is that far higher doses of the (concentrated) synthetic analog of ephedra herb are still available, and in far higher doses per pill than the herbal form. Ever heard of Sudafed? It stands for 'pseudo-ephedrine,' and is available in any drugstore, 7/11, or Jiffy Mart you choose to enter, with no limit on the dose you might want to
take."Dr. Spreen also makes the point (which you've heard here before) that hundreds of people die every year due to complications associated with aspirin and acetaminophen. That's more people every year than have died in ephedra-related deaths total. Yet, last summer, Congress held an emotional, high-profile hearing about ephedra side effects. Have you ever heard of any such hearings about aspirin? No. And as long as giant drug companies continue their very aggressive and well funded lobbying efforts you never will.
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Smear job
--------------------------------------------------------------One of the worst aspects of the campaign to ban ephedra is the way the dietary supplement industry has been portrayed as reckless. But just the opposite is true. In fact, supplement manufacturers have provided perfectly adequate self-regulation of their industry. For instance, without any laws being passed, and without any FDA directives, guidelines for ephedra dosage and label warnings were drafted in 1994 by the American Herbal Products Association, in collaboration with the National Nutritional Food Association. The draft was revised and adopted in 2000 by the Consumer Health Products Association.
What NO ONE can regulate is the way people use supplements. You simply can't protect customers who ignore warning labels or use products at dosages much higher than recommended.
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T's and i's
--------------------------------------------------------------The FDA will soon publish a final rule that will ban the sale of all ephedra products, making it impossible to attain them even with a prescription. The ban will take effect 60 days after publication, probably sometime in March. But supplement manufacturers may challenge the ban, leading to a showdown in court. When Health and Human Services Secretary Tommy Thompson made the announcement about the FDA decision, he told reporters, "we crossed the t's and dotted the i's" to make sure the case for banning ephedra will stand up in court.
Hopefully the t's and i's of this rule WILL be challenged and severely tested. Because behind the familiar accusations about this "dangerous" herb is the lesser-known truth about its altered forms and the way those forms have been seriously misused.
So in spite of the fact that the ban sounds like it's signed, sealed and delivered, there may still be one more hurdle. If that hurdle is easily jumped, I think we can fully expect FDA officials to press even harder to increase the agency's regulatory powers over the supplement industry.
And you can be sure that nothing would please the drug companies more.
Sources:
"FDA Announces Plans to Prohibit Sales of Dietary Supplements Containing Ephedra" Food and Drug Administration press release, 12/30/03, fda.gov"Ephedra Ban Puts Industry On Notice - Move Shows Government Will Crack Down On Supplements" The Associated Press, 12/31/03, msnbc.msn.com
"U.S. Moves to Ban Ephedra Diet Supplement" Reuters, 12/30/03, reuters.com
See also:Despite Ban, Ephedra Will Remain In Common Cold-Flu Medications
Ephedra ban may not end danger - Other diet herbs likely to replace it
Nutritional Health Alliance Comments on FDA Ephedra Ban:
The Ephedra Battle Moves To The Courts
Nutraceutical Sues FDA Over Ephedra
Court battles challenge dietary supplements
Tim Bolen: FDA Ephedra Ban REVERSED by US Court...
San Diego Union Tribune: Utah judge strikes down FDA ban on ephedra
More mystery deaths than thought
The rate of sudden unexplained deaths in England is around eight times higher than previously thought, warn experts.
The assumption in the article is that the cause could be genetic because in a fifth of the cases, other family members died of similar unexpected deaths. Could it also be a question of a family consuming the same (aspartame containing) "light" beverages?Court Reviews Ephedra Ban, OK's FDA's Decision
SALT LAKE CITY—Nutraceutical Corp.'s latest move in its battle against the Food and Drug Administration's (FDA) ban on ephedra dietary supplements met with an unfavorable decision. The company requested, and won, a summary review of the case, specifically alleging FDA failed procedural rules in not issuing a proposed rule accompanying a public comment period on the use of risk-benefit analysis in the ban, in addition to "arbitrarily and capriciously" excluding ephedrine-containing foods and traditional Asian medicines from the ban. On March 16, the Central Utah court—which had originally ruled in Nutraceutical's favor, before the Tenth Circuit Court of Appeals sided with FDA—concluded Nutraceutical failed to show FDA violated procedures or acted unfairly in its ban of ephedra supplements.
posted by Sepp Hasslberger on Tuesday December 30 2003
updated on Tuesday December 7 2010URL of this article:
http://www.newmediaexplorer.org/sepp/2003/12/30/fda_bans_ephedra_deaths_may_be_aspartame_related.htm
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