Conning the IADC Newsletters.

• Position: Conning

Recognizing that a wide range of practical and helpful material appears in the newsletters prepared by committees of the International Association of Defense Counsel, this department highlights interesting topics covered in recent newsletters and presents excerpts from them.

Dietary Supplements and the Playing Field

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 B1; Terry Pristin, "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. The new wave of discussion began on September 27, 2001, when the National Football League became the first professional sports organization to ban products containing ephedrine alkaloids. Although the National Collegiate Athletic Association and the International Olympic Committee already had banned these products, no professional organization had done so.

Under the NFL ban, players are prohibited from taking, distributing or having ephedrine alkaloids on club premises. The ban additionally prohibits players from endorsing companies that make or sell the prohibited substances, and an NFL player cannot endorse a non-ephedrine product if the manufacturer also produces a product that contains ephedrine alkaloids.

Following the NFL ban, an association of responsible manufacturers and distributors, the Ephedra Education Council (EEC), reiterated that scientific and medical evidence has found that ephedra-containing supplements are safe and effective when used properly. See Ephedra Education Council, "Use of Ephedra Dietary Supplements by Athletes," www.ephedra facts.com/oct2.htm

Many NFL players believe the league's ban is a knee-jerk reaction to recent football-related deaths. In 2001, 16 football players died nationwide, ranging from the middle school level to professional. The death of Minnesota Vikings' lineman Korey Stringer especially intensified concerns about ephedrine-related supplements. While many believe Stringer's death to be heat related, rumors of his ephedrine use have surrounded his death. See Stefan Fatsis, "On Sports: Muscling Out Supplemental Income," Wall Street Journal, November 30, 2001.

While the NCAA banned ephedrine use in 1997, a USA Today survey shows that collegians still are using ephedrine-related products. College level football players' deaths brought additional attention. In August 2001, Rashidi Wheeler, a Northwestern University player died after collapsing during a team running drill. A medical examiner found ephedrine in his blood. In February 2001, Devaughn Darling, a Florida State football player, died after a football workout. Darling's autopsy report revealed ephedrine in his system, possibly from cold medicine. See Gary Mihoces, "Ephedrine: Safe or lethal? Debate intensifies as supplement becomes the energy booster of choice for athletes," USA Today, November 8, 2001, at CO 1.

Given this recent media attention, an analysis of federal regulations relating to these products is necessary for manufacturers to remain vigilant and proactive in the industry.

Federal regulation

While lawmakers and plaintiffs' lawyers complain that the FDA is powerless against the manufacturers of these products, the FDA does have a wide variety of enforcement mechanisms already in place. These are (1) the Federal Food, Drug and Cosmetic Act (FD&C Act); (2) the Dietary Supplement and Health Education Act of 1984 (DSHEA); (3) the FDA's proposed rule; and (4) the FDA's and FTC's joint regulation of advertising and marketing.

FD&C Act

Before 1994 and DSHEA, the FD&C Act regulated dietary supplements in the same way as food additives. It required a dietary supplement manufacturer to obtain pre-market approval for food additives or demonstrate that such ingredients were "generally recognized as safe" before marketing the product. 21 U.S.C. [section] 321. If the product was not generally recognized as safe, or if the FDA challenged the determination that the product was generally recognized as safe, then the manufacturer was required to file a food additive petition establishing the product's safety. 21 U.S.C. [section] 348.

Because of the costly petition process under the FD&C Act, dietary supplement manufacturers and distributors pressed Congress to deregulate. This effort was successful, resulting in DSHEA. See Ilene Ringel Heller, "Functional Foods: Regulatory and Marketing Developments," 56 Food Drug Cosmetic Law Journal 197, 198 (2001).

DSHEA

The sentiment that the dietary supplement industry is unregulated began in 1994 when Congress passed the DSHEA. It created an entirely new regulatory scheme for dietary supplements. Under it, dietary supplements are categorized within "foods," not drugs. Therefore, many members of the public perceive no regulation at all. See Jim Lassiter, "Cooperative Enforcement: A New Approach to Dietary Supplement Regulation and Enforcement," Update, eds. FDLI, Issue 6 (November/December 2001).

Definitions. A product must meet the definition of a dietary supplement to full under the DSHEA. A "dietary supplement" is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. 21 U.S.C. [section] 321(ff). If the product meets this definition, it will be regulated as food.

In order for an ingredient of a dietary supplement to be a "dietary ingredient," it must be one or any combination of these substances: (1) a vitamin, (2) mineral, (3) an herb or other botanical, (4) an amino acid, (5) a dietary substance used to supplement the diet by increasing the total dietary intake, or (6) a concentrate, metabolite, constituent or extract.

A dietary supplement must be intended for ingestion in pill, capsule, tablet or liquid form. Additionally, a dietary supplement may not be represented for use as a conventional food or as a sole item of a meal or diet. 21 U.S.C. [subsection] 321(ff)(2)(A)(i), 411(c)(1)(B)(ii), and 321 (ff)(2)(B).

A "new dietary ingredient" is an ingredient that meets the definition for a "dietary ingredient" but was not sold in the United States in a dietary supplement before October 15, 1994. See "Overview of...