CRN Submits Written Testimony to Senate Subcommittee Hearing on Dietary Supplements and Weight Loss

WASHINGTON, D.C., July 31, 2002 — The Council for Responsible Nutrition (CRN), one of the dietary supplement industry’s leading trade associations, today submitted written testimony to the Senate Subcommittee on Oversight of Government Management, Restructuring, and the District of Columbia.

John Hathcock, Ph.D., vice president, nutritional and regulatory science, Council for Responsible Nutrition, provided the following written statement:

Thank you for allowing us to submit our comments for the record with regard to the Senate Subcommittee on Oversight of Government Management, Restructuring, and the District of Columbia’s hearing on "When Diets Turn Deadly: Consumer Safety and Weight-Loss Supplements." CRN supports the committee’s concerns over the importance of this issue.

The Council for Responsible Nutrition commissioned Cantox Health Sciences International to perform a comprehensive science-based risk assessment on ephedra, and received the Cantox Report in December 2000. The Cantox risk assessment concluded that the dietary supplement ephedra is safe, under the recommended conditions of use, that specify a total daily dosage of 90 mg, divided into smaller doses of up to 30 mg, a six-month continuous use limit, use only by persons 18 years or older, and certain exclusions and contraindications.

The Cantox Report on ephedra evaluated all the available data utilizing a risk assessment method developed by the U.S. National Academies’ Food and Nutrition Board. The evidence reviewed included 19 relevant clinical trials, including the data from the now peer-reviewed study conducted by Columbia and Harvard University (Boozer et al.) and published in the International Journal of Obesity that found ephedra both safe and beneficial for weight loss.

In reviewing data on both ephedra and ephedrine, Cantox analyzed in detail clinical trials, adverse event reports (AERs) from the Food and Drug Administration (FDA), case reports and published articles, including data on both human and animal studies. Its exhaustive study revealed no serious concerns dealing with toxicity or other potentially harmful effects. This comprehensive database was analyzed in the context of the U.S. National Academies’ Food and Nutrition Board Upper Limit methodology, which is well established, broadly accepted, and generally applicable to dietary ingredients.

Since the release of the Cantox Report, there have been four additional studies released that provided further evidence that ephedra can be safely and effectively used for weight loss under recommended conditions of use, and have reaffirmed the findings of the Cantox Report.

CRN welcomes the recent announcement by the Department of Health and Human Services of its new efforts to expand scientific research on the safety of ephedrine alkaloids and to aggressively pursue the illegal marketing of non-herbal synthetic ephedrine alkaloid products. CRN has worked with Senators Harkin and Hatch to provide more money in the appropriations process for FDA to increase its enforcement activity with regard to dietary supplements, and for more money to improve FDA’s adverse event reporting (AER) system.

CRN believes that it is important that industry and government work together in partnership to continue to examine the relevant science available, and ensure that policies and regulations be based on sound, responsible science.

In addition to complying with all legal requirements, CRN’s members adhere to a strict code of ethics, comply with dosage limits and manufacture dietary supplements to high quality standards under good manufacturing practices.

CRN has advocated on behalf of dietary supplements for the last 29 years. We have been the primary association behind the passage of all major dietary supplement legislation since 1976, including the Dietary Supplement Health and Education Act of 1994. We have worked closely and effectively with the Food and Drug Administration, Congress and other governmental organizations over the years. CRN supports the authority of, and encourages action by, FDA to remove from the marketplace any product found to be misbranded, adulterated or contaminated.

Consumers use dietary supplements for a variety of reasons — to complement a specific restricted diet, offset deficiencies in normal diet, aid in disease prevention, and for general health maintenance. Our members are dedicated to providing safe and beneficial products to consumers.

I thank you for your time and consideration.

Note to Editor: The Council for Responsible Nutrition (CRN) is one of the dietary supplement industry’s leading trade associations representing ingredient suppliers and manufacturers. CRN Vice President, Nutritional & Regulatory Science, John Hathcock, Ph.D., is a nutritional toxicologist with 35 years of professional experience, including having served as a senior scientist at FDA and as a tenured professor. He is the author of the CRN report, Vitamin and Mineral Safety.

To arrange an interview with Dr. Hathcock, call Judy Blatman at 202-263-1005.