IOM picks supplements for evaluation programme
of Medicine programme designed to help the FDA decide whether
further saftey tests are needed.
A new programme created by the Institute of Medicine for the US Food & Drug Administration and designed to help evaluate the safety of certain dietary supplements was unveiled at a meeting yesterday.
The IOM has focused on six controversial supplements which are currently subject to only limited regulation for the programme. They are chaparral, chromium picolinate, glucosamine, melatonin, saw palmetto and shark cartilage.
The IOM was commissioned by the FDA to assess whether a full-scale investigation into the safety of the supplements was necessary, and will publish its final report later in the year. Depending on the results of that report, the FDA may then decide whether to proceed with an in depth investigation of the supplements.
Barbara O. Schneeman of the University of California at Davis, who is chairing the IOM's investigation committee, said that if the FDA decided to carry out an investigation, it would be likely that companies would be asked to supply information on the products, although this would be on a voluntary basis.
The DSHEA legislation passed in 1994 means that supplement manufacturers are not obliged to prove that their products are safe before they are sold, and instead obliges the FDA to prove that it is unsafe before it can be banned.
The IOM said it had chosen to look at chaparral, commonly found in herbal teas, because of concerns about its effect on liver toxicity, while chromium picolinate, a popular ingredient in weight loss products, was selected because of reports that it might be linked to kidney toxicity. It is also thought to affect insulin regulation in diabetics. Shark cartilage, used to treat cancer and a range of other conditions, has allegedly been the cause of hepatitis.
Glucosamine, a popular arthritis treatment, was selected because of concerns about its use by diabetics, while melatonin has been linked to a number of adverse side effects. It is used as a treatment for sleep disorders. The last product on the list, saw palmetto, is worthy of investigation because of a potential link with heart problems, the IOM said. The botanical is sold as a treatment for prostate cancer.
