March 11, 2005

Oversight of supplements crucial to public safety: panel

Featured Image

Jason Morrow, M.D.

Oversight of supplements crucial to public safety: panel

A panel organized by the American Society for Clinical Pharmacology and Therapeutics recently released a position statement recommending increased oversight of dietary supplements by the Food and Drug Administration.

Jason Morrow, M.D., F. Tremaine Billings Professor of Medicine and Chief of the Division of Clinical Pharmacology at Vanderbilt University Medical Center, presented the panel's conclusions on March 4 at the society's annual meeting in Orlando, Fla.

The panel's report stated “enhanced oversight of dietary supplements is essential to increase the safety of these products for the American consumer.” In his presentation, Morrow outlined the panel's specific recommendations to help achieve this goal:

• Improve the detection, reporting and monitoring of adverse events by the FDA.

• Implement FDA's proposed current good manufacturing practices to improve product quality and safety of supplements.

• Expand the labeling system to include contact information for reporting adverse events.

• Provide enhanced educational opportunities on dietary supplements to healthcare professionals and consumers.

• Enhance research opportunities on adverse events and efficacy of dietary supplements.

Dietary supplements are currently regulated under the Dietary Supplement Health and Education Act (DSHEA) of 1994, which regards supplements as more like foods rather than drugs.

Therefore, supplements are not required to undergo the extensive safety and efficacy testing as is required for prescription and over-the-counter drugs.

The realization that dietary supplements may not be as innocuous as once thought came to light during the controversy surrounding products containing Ephedra.

These products, which were marketed for weight loss and performance enhancement, were banned by the FDA following the report of several serious adverse events (high blood pressure, stroke, seizures and fatalities).

According to the ASCPT panel's report, sales of dietary supplements in 2002 exceeded $18 billion. With more than 30,000 products currently available and approximately 1,000 new products introduced annually, several agencies have recognized the growing need for increased oversight of dietary supplements.

The ASCPT panel's report echoed the conclusions of the Institute of Medicine report, “Complementary and Alternative Medicine in the United States,” released in January. The IOM report suggested that complementary and alternative therapies be held to the same standards as conventional therapies, with increased regulation of dietary supplements as a cornerstone.

“ASCPT believes that enhanced oversight of dietary supplements and research to better determine dietary supplement safety and efficacy will help to identify their potential for harm, as well as their benefits,” the authors wrote.

The panel's full report appears in the March 2005 issue of Clinical Pharmacology and Therapeutics, available online now.