Institute of Medicine to evaluate supplements

July 24, 2002 Posted: 3:24 PM EDT (1924 GMT)
 

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:

Shark cartilage, because of a report of hepatitis following ingestion. Promoted as a treatment for cancer and other health conditions.

 

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