WASHINGTON, D.C., March 7, 2003 – The Council for Responsible Nutrition (CRN), one of the dietary supplement industry’s leading trade associations, today praised the Food and Drug Administration’s (FDA) analysis of the regulatory challenges presented by ephedra-containing supplements and made a commitment to work closely with the Agency to resolve these issues.
On Feb. 28, FDA released a white paper analyzing both the scientific evidence and the policy implications of those findings. In the white paper, FDA recognized that there is no “smoking gun” that proves a causal relationship between ephedra and serious adverse events. FDA then goes on to the key question, which is whether the available evidence indicates “a significant or unreasonable risk of injury” that justifies further regulatory action. The Agency suggests that the Dietary Supplement Health and Education Act (DSHEA) should be read in a way that “helps give DSHEA the meaning in practice that many of its supporters say it should have, by clarifying that public health authorities can take actions to protect the public from unreasonable but uncertain safety risks associated with ephedra.” CRN President Annette Dickinson, Ph.D. said, “We welcome FDA’s clear and insightful analysis of the issue, and we look forward to working with FDA and the Department of Health and Human Services (HHS) to bring about a resolution to this complex matter.”
FDA based its white paper analysis in part on a scientific report prepared by the Rand
Corporation under contract to the National Institute of Health’s (NIH) Office of Dietary Supplements (ODS). CRN had earlier contracted with Cantox Health Sciences International for a quantitative risk assessment of ephedra-containing supplements, and those results were considered as part of the Rand report. “CRN welcomes the opportunity to join with FDA in a science-based analysis of the evidence,” said John Hathcock, Ph.D., vice president, scientific and international affairs, CRN.
At the same time, Dr. Dickinson dismissed as “nonsense” an article released early by the Annals of Internal Medicine, and referenced in the white paper, purporting to show that ephedra-containing supplements account for less than 1% of the market for herbal supplements and yet are associated with a high percent of adverse events reported to poison control centers. “The authors of this article start with a false premise regarding the volume of sales of ephedra-containing products,” said Dr. Dickinson. “It is nothing short of ridiculous to assign ephedra products a market share of less than 1% of herbal sales. More comprehensive data obtained from Nutrition Business Journal indicates that the true ephedra sales volume in 2001 was approximately 35% of total sales of herbal products. Using the 35% rather than less than 1% as the denominator for the relative risk calculation would drastically change the estimated relative risk from 78-fold to less than 2-fold,” according to Dr. Dickinson. CRN has written to the editor of the Annals of Internal Medicine pointing out this error and recommending that the article be withdrawn by the authors or the journal, prior to the scheduled March 18 publication date. “It is important as FDA moves forward on this issue that their conclusions are based on sound science, accurate statistics and good public policy,” said Dr. Dickinson.
CRN intends to submit comments on this issue to FDA as requested in the Federal Register notice.