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Thursday, February 6, 2003

Dietary supplements hold perils as well as promises

Scientific Exhibit No. SE513

Dietary supplements are widely used, particularly among athletes, the elderly and the chronically ill. But the consumer may not anticipate the effects these supplements may have on the body. Under federal law, the U.S. Food and Drug Administration (FDA) is restricted in its ability to regulate both herbal and dietary supplements, which are not subject to the same stringent regulations that are applied to foods and drugs.

The AAOS Complementary and Alternative Medicine (CAM) Committee addresses the issues surrounding the limited regulation of supplements in Scientific Exhibit SE513. Under the 1994 Dietary Supplement Health and Education Act (DSHEA), the manufacturer is responsible for ensuring the safety of the supplement and for substantiating any nutritional statements or representations about the supplement that appear on the product's label.

Dietary supplements do not need to obtain pre-market approval from the FDA before being sold to the public. However, manufacturers must notify the FDA of nutritional label statements no later than 30 days after the product is first marketed. Under DSHEA, manufacturers are not presently required to record, investigate or forward to the FDA any reports they receive of injuries or illnesses that may be related to the use of their products.

Clinical problems have evolved from the relatively loose regulation of dietary supplements. Dangerous interactions with prescription medicines may result in serious side effects, including excessive bleeding following surgery, cardiac events, and even death. Once a supplement is marketed, the FDA must show it to be "unsafe" before action can be taken to restrict the product's use or remove it from the marketplace.

The labeling of dietary supplements is perhaps the most important regulatory function of DSHEA. FDA regulations require that certain information appear on dietary supplement labels, including a descriptive name of the product, specific mention that the product is a "supplement" and its nutritional information, including the name and quantity of each dietary ingredient. If the ingredient is botanical in nature, the label must state the part of the plan from which that ingredient is derived. The name and place of business of the manufacturer, packer or distributor, a complete list of ingredients and the net contents of the product must also be clearly indicated on the product label.

Although a dietary supplement cannot make any claims to prevent, treat or cure a specific disease (unless approved by the FDA), a product's label may describe the supplement's effect on the general well-being or structure and function of the body, so long as the statement is truthful and the label contains the statement: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

The FDA has already undertaken initial steps toward stricter guidelines for the manufacture of nutritional and dietary supplements. The FDA guidelines on good manufacturing processes for supplement manufacturers is eagerly anticipated by industry, the medical community, and consumers.

However, until the guidelines are released, external third-party laboratories are verifying quality control practices of manufacturers. Both the U.S. Pharmacopeia (USP) and Consumer Labs (CL) are independent, nonregulatory bodies that serve to verify that a product is free from contaminants, accurate in its ingredient labeling and manufactured using sound practices. The "USP Verified Dietary Supplement" or "CL Seal of Approval" mark on a product's label will provide some indication of the supplement's quality, potency and purity. Neither seal, however, provides any indication of the supplement's safety or efficacy.

In their exhibit, members of the AAOS CAM Committee will present a drug-herb interaction chart, which details interactions of popular herbs/supplements with prescription medicines; evidence-based information about orthopaedically relevant supplements; and clinically pertinent information to enhance management of orthopaedic patients who are also using herbs and supplements.

The CAM Committee is chaired by John W. Wickenden, MD, of Camden, Maine; members include William Cabot, MD, of Easton, Md., Charles W. Kennedy, MD, of Corpus Christi, Texas; Julie Dodds, MD, of East Lansing, Mich.; Harris Gellman, MD, of Miami, Fla.; Andrew Hutter, MD, of West Orange, N.J., and consultant rheumatologist William J. Arnold, MD, of Wilmette, Ill.

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Last modified 20/January/2003