A recent federal report, issued this past March by the Government Accountability Office (GAO) has called on the Food and Drug Administration (FDA) to become more active in monitoring side effects and assuring truth in advertising, so to speak, when it comes to the use of supplements in this country.
Currently, we the public only learn of the severe side effects of herbs and other dietary supplements, but the GAO reports wants all types of adverse events to be tracked by the FDA, similar to the rigorous scrutiny that drugs must undergo. Unfortunately, the report also acknowledges that the FDA lacks the most elementary ability to monitor the quality of dietary supplements.
Currently, companies that manufacture such products are not required by law to identify themselves as supplement manufacturers, nor are they required to provide the FDA with information about products or the ingredients in those products. More disturbing is the fact that even when a product is thought to be dangerous, the FDA is by law only able to request a voluntary recall. (Such a voluntary recall occurred in December with the product "Star Caps", a weight loss supplement which was found to contain prescription-strength levels of the diuretic bumetanide.)
The history of the FDA's impotency in dealing with the supplement industry dates back to 1994, with the introduction of the Dietary Supplement Health and Education Act of 1994. Prior to this, the ingredients of dietary supplements were regulated under FDA food additive amendments in 1958.
Dietary supplements are considered complementary and alternative medicine (CAM), and as a rheumatologist I see quite a few patients using supplements and herbal preparations which are thought by many to improve joint health and relieve pain. Obviously, these are quite popular, almost as popular as "natural" weight-loss products. And some of these products may be beneficial, but the problem is how to identify the good from the not-so-good: A recent study of ten different glucosamine products found that four of them did not even contain glucosamine!
But there are signs of more activity when it comes to protecting the consumer: In late 2007, the FDA began requiring manufacturers of dietary supplements and herbal preparations to report serious adverse events. However, activists would like ALL adverse events, serious or not, to be reported by those in the CAM business. Some experts estimate the number of adverse events may well total over 50,000 per year.
Still, it is strongly suggested that the FDA take an active role in clarifying what must be done to establish a particular ingredient's safety. The FDA also should assist in educating the public about what is and what is not know about a particular dietary supplement or herb. Manufacturing must be monitored, to insure purity of product. And this monitoring must extend beyond our borders, as many products are manufactured in other countries, and then re-labeled here.
While things are improving regarding consumer protection and CAM, it is still buyer beware, and be aware.
