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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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