WASHINGTON, D.C., January 12, 2005 – The Council for Responsible Nutrition (CRN), one of the dietary supplement industry’s leading trade associations, had the following response to a report on complementary and alternative medicine issued today from the Institute of Medicine (IOM). CRN noted that the 30-page chapter on dietary supplements in a 300-page report drew a disproportionate amount of attention due to the predictably controversial recommendation to amend the Dietary Supplement Health and Education Act of 1994 (DSHEA).
"The dietary supplement chapter is an unwarranted hatchet job," said CRN President Annette Dickinson, Ph.D. "It focuses almost entirely on repeating a few shopworn criticisms with little attention to the positive science underlying the safety and benefits of a wide variety of products and no attention at all to the outstanding quality assurance and manufacturing controls that are typical of leading companies in the industry."
Supplements generally have a strong safety record, and the Food and Drug Administration (FDA) has recently demonstrated a new commitment to take enforcement action under DSHEA when the agency believes it is warranted, as in the case of ephedra and androstenedione. CRN and its members are committed to working with FDA on a variety of safety issues, including better defining the requirements for demonstrating the safety of new ingredients. The IOM report on a framework for evaluating dietary supplement safety, published in 2004, provides useful guidance in this area.
According to Dr. Dickinson, the report exhibits a lack of understanding of the law, pretending that DSHEA is responsible for classifying dietary supplements as foods, when in fact supplements have been considered a category of foods ever since the 1938 Food, Drug and Cosmetic Act was enacted. "Dietary supplements are not drugs, have never been drugs, and will never rightly be considered drugs. Congress has carefully reviewed the food/drug issue on three separate occasions in the last 65 years and has come down on the food side every time," she said.
Today’s report complains about the fact that new Good Manufacturing Practices (GMPs) for dietary supplements have not yet been finalized, but fails to recognize that in the meanwhile companies must comply with GMPs for foods, which are not insignificant and which have proven sufficient to protect the food supply for many decades. The dietary supplement industry fully supports stronger GMPs and has been a key player in pushing for the new regulations, which FDA is fully committed to finalizing in the near future.
The report calls for amendment to DSHEA and the current regulatory scheme for dietary supplements to accomplish goals that are already being vigorously pursued, such as active enforcement against inaccurate and misleading claims. Finally the report calls for changes to the law in order to protect consumers "against all potential hazards," a goal that while philosophically laudable is simply not achievable for any product category.
Dr. Dickinson called for continued attention to implementing and enforcing the law, saying, "DSHEA works when its full power is properly recognized and utilized, as FDA has demonstrated in the past few years."
The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing dietary supplement industry 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. For more information on CRN, visit http://www.crnusa.org.
Contact:
Judy Blatman
202-204-7962