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ACSM Recommends That
FDA Revisit "Dietary Supplements"
Sports Medicine Experts Identify Need to Look
Closer at Androstenedione.
With continuing news surrounding both professional
and amateur athletes' use of "dietary supplements" such as androstenedione, creatine, DHEA, and HMB, sports medicine experts
from the American College of Sports Medicine (ACSM) have called for
the Federal Food and Drug Administration (FDA) to revisit the
Dietary Supplements Health and Education Act of 1994 (DSHEA).
"ACSM understands that Congress's intent in
enacting the DSHEA was to meet the concerns of consumers and
manufacturers to help ensure that safe and appropriately labeled
products can remain on the shelf. However, many physicians feel that
some supplements' should be considered drugs' because they contain
known active ingredients, whereas dietary supplements' have little
or no physiologic effects," indicated president of ACSM Paul D.
Thompson, M.D., FACSM. "Unfortunately, most supplements have not
been evaluated for either their potential risks or benefits promoted
via advertising."
While an issue of semantics for some, critical
evaluation and possible reclassification would allow professional
and amateur sports teams to take a firm stance regarding
performance-enhancing substances.
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Gary I. Wadler, M.D., FACSM, is a recent winner of
the IOC's President's Award for excellence in the field of drugs in
sports, and serves as Associate Professor of Clinical Medicine at
New York University. "Certainly, there are positive effects to the
supplements being questioned. Our concern is that many of the newer
substances have not yet been tested for their long-term
physiological and potentially adverse effects," stated Wadler. "Even
more of a concern is the use of these products by adolescents. As a
physician and a father, I would recommend that adults and children
consult with their physician before ever taking
performance-enhancing supplements."
The DSHEA established a formal definition of
"dietary supplement" using several criteria. A dietary supplement:
- is a product (other than tobacco) that is
intended to supplement the diet that bears or contains one or more
of the following ingredients: a vitamin, a mineral, an herb or
other botanical, an amino acid, a dietary substance for use by man
to supplement the diet by increasing the total daily intake, or a
concentrate, metabolite, constituent, extract, or combination of
these ingredients.
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- is intended for ingestion in pill, capsule,
tablet, or liquid form.
- is not represented for use as a conventional
food or as the sole item of a meal or diet.
- is labeled as a "dietary supplement."
- includes products such as an approved new drug,
certified antibiotic, or licensed biologic that was marketed as a
dietary supplement or food before approval, certification, or
license.
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Wadler, who is
attending the ACSM Annual Meeting in St. Louis this week, said that
the subject of steroid use in baseball peaked in 1998, when Mark
McGwire admitted to the use of the testosterone precursor, androstenedione.
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