How big a risk are adverse reactions?
The 2006 Dietary Supplement and Non-prescription Drug Consumer Protection Act added more rigorous oversight of dietary supplements and mandated reporting of serious adverse events associated with dietary supplements and over-the-counter products. But this is not to say that there have been large problems with botanical safety. While serious adverse reactions to botanicals have been reported from time to time, botanicals typically possess an inherently wide margin of safety (Farnsworth, 1993). Most adverse reactions are produced by a small number of botanicals. Data from the American Association of Poison Control Centers Toxic Event Surveillance Database supports this. A study compared the adverse events due to one botanical, ephedra, to that for all other botanical medicines. Ephedra products were responsible for 64 percent of adverse reactions but accounted for only 0.82 percent of total sales (Bent, 2003). In April 2004, the FDA issued a ban on all dietary supplements containing ephe
