Criteria
Tested for Supplement Study
Excerpt
By Randolph E. Schmid, AP
WASHINGTON (AP) - The Institute of Medicine has picked six controversial
dietary supplements for a new evaluation program it developed
for the Food and Drug Administration.
The six, which may pose health hazards, will serve to test the
framework for determining the safety of supplements, which have
become a major industry in recent years but face only limited
government regulation.
The institute, a branch of the National Academy of Sciences,
said in a preliminary report Wednesday that it had selected the
supplements chaparral, chromium picolinate, glucosamine, melatonin,
saw palmetto and shark cartilage for reviews.
The final version of the report is expected to go to the FDA
in the fall, IOM committee chairman Barbara O. Schneeman said.
At that time, the FDA will make the final decision on doing
the six studies, said Schneeman, of the University of California,
Davis.
The FDA could do the evaluation internally or contract it out,
she said, adding that it would also be appropriate to ask manufacturers
for data, although it would be voluntary for them to provide it.
The FDA estimates that as many as 29,000 different dietary supplements
are available and that Americans spend an estimated $700 million
per year on supplements.
However, a 1994 law specifically exempted supplement makers
from having to prove their products are safe before selling them.
The FDA has to prove that a supplement is unsafe before it can
be removed from the market.
The herb ephedra is a prime example of the agency's problems
in dealing with supplements.
At least 54 deaths and about 1,000 reports of complications
have been linked to the popular supplement since the mid-1990s,
according to an analysis in the New England Journal of Medicine
two years ago.
But, after two years of FDA work developing rules seeking to
bar certain ephedra doses, industry protests killed the move.
The agency then began working on warning labels, but last month
the Bush administration ordered a new safety review of the stimulant
before any action can be taken. Supplement makers praised the
step.
Schneeman said the committee did not include ephedra in its
list because "there is a lot of activity going on around ephedra
and I'm not sure we would help the process by putting it into
a prototype evaluation."
Frustrated in its efforts to regulate supplements, the FDA asked
the Institute to develop a method for evaluating their safety.
In its report, the institute established guiding principles
in reviewing supplements, including a credible report of a serious
adverse event in humans associated with the supplement; evidence
of harm in laboratory animal studies and the presence of constituents
similar to known toxic or harmful compounds.
The supplements chosen for the first safety evaluations cover
a variety of types and uses, the institute noted. The selected
supplements and the reason they were chosen, are:
_Chaparral, because of concerns about liver toxicity. Used in
an herbal tea.
_Chromium picolinate, because of reports of kidney toxicity
and effects on insulin regulation in diabetics. Promoted to reduce
body fat.
_Glucosamine, because of concerns about its use by diabetics.
Sold as an arthritis treatment.
_Melatonin, because of reports of complications. Used to treat
sleep disorders and jet lag.
_Saw palmetto, because of reports of heart problems. Sold as
a prostate treatment.
_Shark cartilage, because of a report of hepatitis following
ingestion. Promoted as a treatment for cancer and other health
conditions.
___
On the Net:
Institute of Medicine:
http://www.iom.edu
Reference
Source 102
For more information on how to prevent other diseases, use
PreventDisease.com's "Quick
Prevention Resources".
|