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Headline News

Ephedra Controversy - part 3
18 September 2000
by Wyn Snow, Managing Editor

Solving these problems

One solution to the ephedra problems is to regulate dietary supplements in the same way as drugs. This would eliminate the problems of potential contamination and inconsistent potency -- and would also require products to demonstrate absolute proof of both safety and efficacy before they could be marketed. The FDA, American Medical Association, and the Center for Science in the Public Interest support this proposal.

However, other groups believe this approach tosses out the baby with the bathwater. All major supplement industry trade organizations predict that regulating dietary supplements in the same way as drugs would eliminate huge sections of the dietary supplement industry. These groups include the American Preventive Medical Association, the National Nutritional Foods Association, the Council for Responsible Nutrition, the American Herbal Products Association, the American Botanical Council, and the American Herbal Pharmacopoeia as well as such consumer groups as Citizens for Health.

Drawbacks to regulating supplements like drugs

Under such a plan, all dietary supplements would be removed from the marketplace until having passed through an approval process.

The FDA's approval process for pharmaceutical drugs costs hundreds of millions of dollars, usually takes 8-10 years, and requires enough documentation to (literally) fill a railroad car. The only companies that can afford this kind of outlay are large multinational pharmaceutical giants. Since a plant cannot be patented except for a "new use", there is no incentive for private companies to undertake this research for herbal products. The income from the resulting product would not recoup the costs of the approval process.

It's possible that the approval process for vitamins might be streamlined, since much independent research has been done on them. But all other supplements, including minerals and amino acids, would have a more difficult time -- perhaps insurmountably difficult, in which case they could disappear permanently from the American marketplace.

A better solution

All of these problems -- overdosage, potential side effects, interactions, contaminants, and inconsistent potency levels -- are not limited to ephedra. They are the biggest quality-control challenges facing the supplement industry. Solutions for these problems do exist. What's needed is a working group to meet the challenge and eventually an implementation plan.

Overdosage, side effects and interactions

The Supreme Court has said that when problems are caused by inadequate information, the better solution is to provide more information rather than less. It would be easy to add information to dietary supplement labels that can eliminate accidental overdosage problems.

Call for action:

The Dietary Supplement Quality Initiative (DSQI) calls for supplement producers to add a bottle/packaging labeling item showing the "side effect threshold" for each active ingredient in a dietary supplement. This would indicate where the danger zone actually lies and would give consumers more control over their health rather than less.

 

Also, there is a vast difference between benign side effects (such as niacin flushing) that cause no serious harm and that disappear when one reduces dosage or stops taking a product -- and dangerous side effects (such as cardiac arrhythmia) that are potentially life-threatening or can cause permanent injuries. Dangerous side effects can be listed on a label with a warning to seek medical attention in the event of occurrence.

Warnings about interactions are already being added to supplement labels. However, this field of knowledge is both complex and expanding rapidly. A central data bank with an 800-number and a website (referenced on a supplement package, insert or label) is another way to provide accurate, up-to-date information for the public.

Contamination and inconsistent potency levels

Concerns over possible contamination and inconsistent potency levels are most easily solved through uniform testing. Other industries have faced similar consumer safety issues -- and solved them by creating independent testing-and-certification structures. The consumer electrical industry, for instance, represents its safety standards through the UL seal in the US, with equivalents in Canada and Europe.

Call for action:

The Dietary Supplement Quality Initiative (DSQI) calls for supplement producers and trade organizations to convene a "National Dietary Supplement Congress" for the express purpose of creating standing committees tasked with setting quality testing standards. The product of these committees should be formalized as a "National Dietary Supplements Quality Institute," for the express purpose of establishing standard testing protocols for independent laboratories. Collaborators in the creation of such a "quality seal" program might include representatives of academia, the insurance industry and national standards organizations.

 

Solving the quality puzzle

The Underwriter's Laboratory (UL) symbol has become so ubiquitous as to pass almost unnoticed before the consumer's eye. But consumers do recognize the name -- and its role in promoting product safety represents a time-proven, highly productive relationship between standards organizations, independent testing laboratories and the insurance industry.

What role can the insurance industry play in promoting dietary supplement quality? Insurers are the "payers of last resort" in instances of product liability -- which gives them a compelling reason to make sure their clients (supplement manufacturers) produce the safest products possible.

In practice, this means insurers would ally with standard-setting organizations and independent testing labs in order to create an orderly process for product testing. As a method of ensuring supplement quality, this model is a low-cost, reliable alternative to increased government regulation.

Relevant fact:

According to MarketResearch.com, approximately 56 percent of Americans use vitamins, minerals, or other dietary supplements. Researchers at the Centers for Disease Control in Atlanta report that approximately 40 percent use supplements.

 

Sources:

JM Betz et al. "Chiral gas chromatographic determination of ephedrine-type alkaloids in dietary supplements containing Ma huang." J AOAC International, 1997:80.

ConsumerLab.com. Reports on ginseng testing on website www.ConsumerLab.com.

BJ Gurley et al. "Content versus label claims in ephedra-containing dietary supplements." Amer J Health Syst Pharm, 15 May 2000.

BJ Gurley et al. "Ephedrine pharmacokinetics after the ingestion of nutritional supplements containing Ephedra sinica (ma huang)." Ther Drug Monit, August 1998.

Ted Koppel. "Dangers of dietary supplements: Should they be regulated by government." Nightline, ABC News, 5 July 2000.

Allison Sarubin. The Health Professional's Guide to Popular Dietary Supplements. The American Dietetic Association, 2000; section on ma huang.

LM White et al. "Pharmacokinetics and cardiovascular effects of ma-huang (Ephedra sinica) in normotensive adults." J Clin Pharmacol, February 1997.

Williams, Dailey & O'Leary. "FDA Launches Hearings Today." AOL news & PRNewswire, 8 August 2000.

SM Zaacks et al. "Hypersensitivity myocarditis associated with ephedra use." J Toxicol Clin Toxicol, 1999, Vol 37, No 4.

Dulce Zamora. "FDA Takes Close Look at Popular Weight-Loss Herb." CBSHealthWatch, 9 August 2000.end-of-story

 

What is causing these adverse events?
Some of the reports of adverse events contain details that are biologically impossible, strongly suggesting that they are false reports, but it's unlikely that all of them are. Given that some of these reports probably reflect real problems, what kind of fire is causing all this smoke?

 

 

   
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