Letter to the Editor regarding: Botanical Medicines -- The need for new regulations, DM Marcus, AP Grollman, New England Journal of Medicine, 2002; 31(25):2073-6.
ABC has sent a letter to the editor about an article that calls for more FDA involvement in the regulation of herbal dietary supplements. ABC proposes the establishment of an expert committee comprised of appropriate herb and related scientific and medical experts to evaluate the safety and efficacy of herbs sold in the U.S.
The article's call for "premarketing approval from FDA" to demonstrate herbs' safety ignores the current federal law that requires pre-market submission of safety data to FDA of herbs introduced into the US after October 1994. FDA has rejected numerous submissions for safety approval. In addition, during the past 7-8 years the Agency has not responded to petitions for approval for over-the-counter drug status of valerian as a sleep aid and ginger for motion sickness and nausea.