April 12, 2004
Since 1994 liberal legislation in the United States has secured the American population full access to safe dietary supplements. 2½ year ago FDA asked the Institute of Medicine (IoM) to investigate the extent of harmful effects of supplements. The FDA received this report from IoM last week.
The conclusion is, among other things, that there are very few safety data for the 29,000 different dietary supplements sold in the United States, and the concern seems to be that this market grows by 25% a year, and today amounts to about 18 billion. dollars annually.
When the IoM was asked to do a safety assessment of the market, it was because there was growing concern about one supplement in particular, namely “Ephedra”, which was sold as a popular slimming and energy aid. The effect is somewhat reminiscent of the Danish, now banned drug, Letigen.
Ephedra does not exist in Denmark, and if it did, it would have to be registered as medicine, just as Letigen was in its time.
The FDA has now banned Ephedra as a dietary supplement after it caused 155 deaths and 16,000 cases of side effects. By comparison, over-the-counter arthritis medications (NSAIDs) cause 16,000 deaths in the United States each year.
The IoM also found products with wide variation in content, and products, particularly Chinese herbal preparations, which were contaminated with heavy metals and medicines. In some of the Chinese supplements, the medicine was actually added to promote the effect.
The IoM therefore proposes a “whistleblower” system with a central registration of side effects, similar to the Danish Side Effects Board, which is a fine idea. However, the IoM also writes that many side effects could be avoided if the consumer was sufficiently well informed.
This is a memento to the Danish system, where the Danish Food and Drug Administration prohibits information to both consumers and retailers of dietary supplements. Yes, not even doctors and pharmacists must be taught even the most factual information regarding dietary supplements.
This should be changed so that we increase security for the Danish consumer.
By: Vitality Council
Special report: A health fad that’s hard to swallow, New Scientist Special Report, 12. April 2004.