Ephedra Dietary Supplements: Consume According to Label Directions

Washington, D.C., March 30, 2000—The Council for Responsible Nutrition (CRN) has conducted a preliminary analysis of adverse event reports (AERs) dating from 1997, on ephedra dietary supplements. John Hathcock, Ph.D., former U.S. Food and Drug Administration scientist and CRN vice president for nutrition and regulatory science, said, "This latest group of AERs does not change the earlier scientific assessment that ephedra supplements are safe when appropriately consumed in accordance with label instructions, and in compliance with label warnings."

FDA has announced its intention to release the approximately 140 AERs on ephedra containing dietary supplements on Friday, March 31. CRN recently obtained copies of these reports and completed its preliminary analysis in anticipation of the FDA release. AERS are reports filed with FDA by consumers and healthcare professionals, describing alleged side effects that have occurred in conjunction with the consumption of products such as dietary supplements, over-the-counter drugs and prescription drugs.

John Cordaro, president and chief executive officer of CRN said, "All AERS need to be placed into proper context when they are reviewed for regulatory or policy-making purposes. AERS are only one part of a broad database for risk managements decisions." He also noted, "The AERs on dietary supplements must be further scrutinized because of the extensive criticism by the General Accounting Office (GAO) report on ephedra." The GAO report, released in 1999, detailed the inconsistency of FDA's AERs, their inappropriate reliance on unsubstantiated anecdotal information and FDA's lack of thorough scientific analysis. Even FDA Commissioner Jane Henney, in recent congressional testimony, acknowledged the weakness in the current AER system on dietary supplements and has requested funds from Congress to correct these deficiencies. Mr. Cordaro said, "CRN agrees with Commissioner Henney's assessment of the deficiencies in the system and we strongly support FDA's request for appropriate funds to make this system work effective and efficiently."

CRN has worked with FDA, other dietary supplement associations, and noted scientists to help address questions about ephedra dietary supplements in order to provide a scientific base for resolving questions about the appropriate role of this dietary supplements. As part of this effort, CRN has contracted with an internationally known toxicology firm to make a thorough risk assessment of ephedra containing dietary supplements. The assessment will be conducted in accordance with U.S. National Academy of Sciences (NAS) standards designed to establish a recommended safe upper limit for ephedra. This risk assessment will be unique, since it will include an assessment of both AERs as well as all available scientific research, including clinical trials. Dr. Hathcock said, "It is appropriate for all consumers to continue to use these products during this assessment in accordance with label directions, and comply with label instructions and warnings about health conditions that could affect the safe use of ephedra supplements. Indeed, millions of consumers have used billions of servings safely and appropriately."

The Council for Responsible Nutrition (CRN) is a science-based, trade association founded in 1973 and represents more than 100 companies in the dietary supplement industry, including ingredient suppliers and manufacturers. CRN members adhere to a strong code of ethics, comply with dosage limits and manufacture dietary supplements to high quality standards under good manufacturing practices.