Dietary Supplements and the Playing Field

Article excerpt

Writing in the April newsletter of the Drug, Device and Biotech Committee, Steven M. Kohn and Courtney E. Quinn of the Oakland, California, office of Crosby, Heafey, Roach & May discuss the alleged dangers emanating from dietary supplements:

Athletes and fitness buffs alike take ephedrine supplements to enhance performance, bulk up or slim down. Yet in the past few years, the alleged dangers posed by dietary supplements containing ephedrine have engendered world-wide media scrutiny. Numerous stories about adverse health impacts related to the supplements may force the U.S. Food and Drug Administration to finalize regulations currently under consideration or to use existing mechanisms to further monitor dietary supplements.

Armed with knowledge of current federal regulations and the FDA's proposed regulations regarding ephedrine alkaloid-- containing supplements, members of the dietary supplement industry can be proactive to prevent potential lawsuits and/or government enforcement actions.

Background on ephedrine

Ephedrine and related alkaloids are the primary ingredients in many dietary supplements sold in drug stores, pharmacies and supermarkets. These products are marketed for a variety of purposes: weight loss, body building, increased energy and as an aid to asthma sufferers. Ephedra, the botanical source of ephedrine alkaloids, has been used in Chinese medicine for more than 5,000 years. Ephedra is sometimes referred to as Ma Huang, Bishop's Tea or Chi Powder. See "Products That Consumers Inquire About," www.cfsan. fda.gov/dms/ds-prod.html.

Ephedra and ephedrine alkaloid-containing products, according to the FDA, stimulate the nervous system or heart in a manner similar to amphetamines. Of the 800 reports of adverse events received by the FDA involving more than a hundred dietary supplement products, the most common and consistent finding is the presence of ephedrine alkaloids. To date, the FDA has investigated and reported 140 adverse event reports associated with ephedrine alkaloids, ranging from high blood pressure, heart rate irregularities, insomnia, nervousness, tremors and headaches, to seizures, heart attacks, strokes and death. 62 Fed.Reg. 30677-79, 30690 (June 4, 1997).

Nevertheless, even critics of ephedrine alkaloid-containing products concede that these adverse event reports do not provide scientific proof that ephedrine-containing dietary supplements cause these reactions. See Ephedra Education Council, "The Facts About Ephedra," www.ephedra facts.com/thefacts.html.

According to the Nutrition Business Journal (November/December 2001), the dietary supplement industry made $16.8 billion dollars in sales profits in 2000. In the same year, sales of herbal supplements exceeded $4.1 billion. Dietary supplements containing ephedrine alkaloids alone constitute a billion dollar industry. The ephedrine alkaloid-containing supplements reach a wide audience-from high school athletes looking to gain a competitive edge, to women looking to lose unwanted pounds. The volume of sales, the wide audience and the recent press coverage regarding ephedrine may leave members of the dietary supplement industry vulnerable to potential lawsuits and possible regulatory enforcement.

Supplements and sports

In 1999, dietary supplements first made headlines in the arena of alleged sports-related injuries when Anne Marie Capati, a New York woman, died after suffering a stroke at Crunch Fitness in Manhattan. Capati's husband sued the fitness club, alleging his wife's trainer encouraged her to buy supplements containing ephedrine. For months following Capati's death, articles and press coverage questioned the safety of the dietary supplements. See Marilyn Chase, "Workout Fatality Puts Focus on Gyms and Supplements," Wall Street Journal, June 28, 1999, at BI; Terry Prison, "Health Club and Trainer Are Sued in Death, New York Times Abstracts, June 29, 1999.

While the debate over the safety of ephedrine alkaloid-containing supplements continues, media coverage of dietary supplements has resurfaced in the past year. …