The Institute of Medicine (IOM) has selected six dietary supplements for a new evaluation program it developed for the FDA. The safety determination of these supplements will test the framework it developed. Supplements selected for review by IOM are chaparral, chromium picolinate, glucosamine, melatonin, saw palmetto and shark cartilage. The final version of the report is expected to go to the FDA in the fall.
The Dietary Supplement Health and Education Act (DSHEA) of 1994 acknowledges that millions of consumers believe dietary supplements may help to augment daily diets and provide health benefits. As per FDA estimates, there are approximately 29,000 different dietary supplements available in the market. Americans spend an estimated $700 million per year on supplements. Interestingly, the DSHEA specifically exempted supplement makers from most of the regulatory hurdles faced by over-the counter medications, allowing better consumer access. As for safety, the burden is on the supplier to make a safe product. However, the FDA must prove that a supplement is unsafe before it can be removed from the market.
Surprisingly, ephedra is not on the list of IOM. Ephedra is a good example of the type of challenges FDA faces to prove a dietary supplement is unsafe. According to an analysis in the New England Journal of Medicine, since 1990 at least 54 deaths and about 1,000 reports of complications have been linked to ephedra. In order to better regulate the supplements, FDA asked IOM to develop a method for evaluating the safety of dietary supplements.
The supplements selected by IOM for the first safety evaluations cover a variety of types and uses. The selected supplements and the reason they were chosen, are:
Chaparral, because of concerns about liver toxicity. Used in an herbal tea.
2. 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.
The dietary supplement industry and scientists for and against increased regulations of dietary supplements by FDA will be eagerly awaiting IOM reports on these substances.