Circle The Wagons

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
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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
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"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
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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
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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

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