HEALTH & SCIENCE
More oversight recommended for dietary supplements
An advisory committee report calls for scientifically based assessments
and even more attention from the FDA in evaluating supplement safety.
By
Susan J. Landers, AMNews staff. April 26, 2004.
Washington -- Additional scrutiny by the Food and Drug Administration of the vast dietary supplement market was recommended in a new federal report which also provided a scientific framework for use in analyzing the safety of supplements.
A science-based assessment process could include checking results of animal tests or information derived from tests on similar substances when human data are unavailable, advised the report, written by members of the Institute of Medicine and the National Research Council.
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"Approximately 29,000 dietary supplements are currently available to the
American consumer, and while most are safe, questions have been raised about
FDA's resources to identify and address the occasional problem products," said
Committee Chair Barbara Schneeman, PhD, a professor of nutrition at the
University of California, Davis.
The report, "Dietary Supplements: A Framework for Evaluating Safety,"
also recommended that Congress require supplement manufacturers and
distributors to report adverse events to the FDA and that the agency be
given more money to oversee the huge industry. Under the 1994 Dietary
Supplements Health and Education Act, which covers herbal remedies,
botanicals, vitamins and minerals, supplements were to be regulated
like foods instead of drugs and to be considered safe unless proven
otherwise. They were also not required to be clinically tested before
they reached the market.
Although the FDA recently took action to remove the supplements ephedra
and androstenedione from the market and has warned dietary supplement
manufacturers against making false and misleading claims for weight-loss
products, groups, including the AMA, had been seeking such action for
several years and believe more may be required.
The report also recommended that physicians and other health care
professionals be educated on ways to report health concerns and that
supplement labels include the phone number of MedWatch, the FDA's safety
information and adverse event reporting program.
ADDITIONAL INFORMATION:
Weblink
Information on the Institute of Medicine and National Research Council report,
"Dietary Supplements: A Framework for Evaluating Safety"
(
www4.nationalacademies.org/news.nsf/isbn/0309091101?opendocument)
Federal government resources on dietary supplements (www.foodsafety.gov/~fsg/dietsupp.html)
www.ama-assn.org/amednews/2004/04/26/hlse0426.htm
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