Sports Supplements:
Common Sense and Responsible Regulation

WASHINGTON, D.C., May 16, 2001—It is human nature to seek an "edge" to support and improve performance, and sports supplements are one tool millions of people have found helpful. As with all efforts to improve health and increase performance, common sense needs to be applied. Performance-enhancing products should not be promoted to children, and parents and coaches bear a responsibility for monitoring and guiding children’s behavior in this respect. The Council for Responsible Nutrition (CRN) believes responsible regulation by the Food and Drug Administration (FDA) and by the states is needed to support consumer confidence in dietary supplements, including sports nutrition products. FDA has the necessary authority, and needs only to exercise it constructively.

Creatine is probably the best-studied performance-enhancing supplement mentioned in a recent Consumer Reports article. Creatine has been shown to improve performance measurably, when a quick burst of energy is required, and it is for this reason that it is widely used by collegiate and weekend athletes. While more study can always be done, there is no evidence that creatine use is unsafe in otherwise healthy people. It should not be used by people with kidney problems.

Ephedra is an herbal supplement containing naturally-occurring ephedrine alkaloids. It provides an energy boost and has been widely used to provide the extra "oomph" that some people need to pursue a regular exercise program. It also contributes to weight loss, and two recent studies conducted jointly by researchers at Columbia and Harvard demonstrated that ephedra can be used safely and effectively for weight loss, at levels up to 90 mg of ephedra alkaloids per day. A recent comprehensive safety evaluation supported by CRN and conducted by Cantox, one of the leading firms in toxicological analysis. The Cantox study concluded that ephedra is safe at levels such as those used in the Harvard/Columbia study, using a risk assessment method developed by the National Academy of Sciences. The study evaluated all the available safety evidence, including FDA’s adverse event reports. CRN has submitted the Cantox study to FDA, to help the agency complete its effort to establish new regulations for ephedra-containing supplements.

The industry supports most of the existing state regulations on ephedra product formulation and labeling. The state regulations require an extensive warning label, cautioning against use by people with risk factors such as hypertension or heart disease, and the industry voluntarily adopted such labeling as early as 1995. The state regulations that impose a dosage limit generally select a maximum of 100 mg per day –a level very similar to that supported by the Harvard/Columbia studies and the Cantox report. If FDA’s regulatory proposal had followed this model, the regulation would be in place by now. The basis for the agency’s more restrictive approach has been criticized not only by industry but by a General Accounting Office report issued in 1999. "CRN urges FDA to revise its approach to the regulation of ephedra and move forward promptly to conclude the rulemaking based on sound and unbiased scientific analysis, including the Cantox report," said Dr. John Hathcock, CRN’s vice president for nutritional science and regulatory affairs.

Androstenedione is a hormone precursor and therefore may present more potential concerns, simply because there needs to be more research on all its effects. In the studies done so far, its conversion to hormones and the body’s own production of those same hormones seem to be controlled by feedback mechanisms which help protect against excess. A comprehensive safety assessment would be helpful.

Consumer Reports, like many other media, falsely asserts that dietary supplements, including sports nutrition products are "unregulated" and says they are readily available in all kinds of stores because of the Dietary Supplement Health and Education Act of 1994 (DSHEA). "In fact, FDA has as much authority over the safety and labeling of dietary supplements as it does over any other food product, and all foods and supplements have been freely sold in all types of stores forever, not just since 1994," said Dr. Annette Dickinson, CRN's vice president for scientific and regulatory affairs. She added, "The critics’ rants against DSHEA are so sweeping they have become ludicrous. The truth is that dietary supplements are used by more than half of Americans, are beneficial in a variety of ways, and have a safety record comparable to that of any other food category."