FDA to Probe Herbal Stimulant — Meeting Could Affect Supplement Industry

By Alex Wong
Staff Writer

The herbal stimulant has been blamed for health complications ranging from heart palpitations to death.

The deaths attributed to ephedra include that of John Lesemann, 22, who died of cardiac arrest a year ago while training at the New Jersey State Police Academy.

Lesemann died while running. A police investigation said his death may have been triggered by two ephedrine pills a fellow recruit gave him before the run to boost his performance.

Of the 2,621 dietary supplement complaints in the FDA's database of adverse effects, which tracks more than 3,000 supplements, ephedra accounts for 534.

Dr. Wanda K. Jones, a deputy assistant secretary of health for the U.S. Department of Health and Human Services and chairwoman of the forum, said the meeting will have an effect on the supplement industry and may lead to new FDA regulations.

"We are dealing with problems here that are not unique to ephedra," she said. "The regulatory process piece of the puzzle has not fallen into place for dietary supplements. Some manufacturers have established [safety standards] on their own, but not everyone is able or willing to comply."

Much of the concern about the barely regulated dietary supplements is over how they interact with other medicines, said Dr. Steven Reichert, the director of medical clinics at Englewood Hospital and a clinical assistant professor at Mount Sinai School of Medicine.

For example, ginkgo, a supplement said to enhance concentration, can be life-threatening if taken with certain medications, Reichert said.

"For the most part, supplements don't do any good or bad," he said. "But a popular supplement, ginkgo, is a blood thinner and we had a patient here who had a bleeding problem and was hospitalized because she was taking it with Coumadin, a prescription blood thinner."

Coumadin lowers the risk of blood clots, especially for patients prone to strokes.

Reichert added that there is no proof that gingko has "any use in a normal, healthy person."

Reichert cited two other popular supplements, St. John's wort and kava kava, as effective as anti-depressants, but dangerous if taken in concert with a long list of prescribed drugs and other anti-depressants.

The medical community's concerns go beyond the possibly fatal interaction of substances taken together.

"There's a lot of consumer fraud going on," Reichert said. "These products are not regulated as to who manufacturers it, proper dosage, or purity."

Dr. Louis Evan Teichholz, the chief of cardiology and director of complementary alternative medicine at Hackensack University Medical Center, said that in addition to consumer savvy, doctors must be trained to account for the effects of supplements on their patients.

"There have been many problems with supplement agents reacting with conventional medicine," he said. "Patients usually don't tell doctors they're taking this herb or this supplement."

Teichholz believes that supplements have potential in the medical field if regulated properly.

"Optimal medicine is the highest-quality conventional medicine coupled with the highest-quality complementary medicine," he said. "But I do believe there have to be changes in current regulations."

Though cognizant of the regulatory problems and the possible dangers of supplements, many users feel safe.

"I always read up on [the supplements] and my doctor's cool with it," said Mark Dock, a West Milford resident who was shopping at the Basic Health Center in Paramus.

Dock said he takes echinacea, an herb used to build the immune system, and St. John's wort. "There are a lot of good books out there, and as long as I read up I'm not scared," he said.

Present regulations grew out of the Dietary Supplement Health Education Act of 1994 (DSHEA), which covers all substances from vitamins to botanical and animal extracts. The law does not call for the FDA to test supplements for safety and efficacy before they go to market as the FDA does with pharmaceuticals.

As long as manufacturers do not claim that their products cure or treat disease, the onus is on the FDA to identify dangerous supplements and take them off the market, said Dr. Stephen L. DeFelice, chairman of the Foundation for Innovation in Medicine.

This setup, he said, presents a problem.

"The problem is that we have a new self-care movement where products are being sold without any research to show if they're safe or effective," he said. DeFelice is working with Rep. Frank Pallone Jr., D-Long Branch, to push new supplement regulations through Congress.

"DSHEA says manufacturers can make a health claim versus a disease claim, which is illogical. Health is the prevention of disease," DeFelice said. "It's become a language game, and it doesn't require clinical research to back up a claim."

DeFelice gave the example that a company cannot say a supplement lowers cholesterol, but it can claim that it helps maintain a healthy cholesterol level.

The passing of DSHEA opened the door to a boom in the supplement industry. Supplements are a $16 billion-a-year industry -- double 1994's sales -- and will grow to $21 billion in 2005, according to the Nutrition Business Journal. The journal estimates that 70 percent of U.S. adults have taken supplements in the past year.

"The self-care movement began because people felt that with their HMOs, doctors weren't paying enough attention to them," DeFelice said.

"That is coupled with the fact that people believe anything natural is safe and wonderful. Also, baby boomers are getting older and they want to stay healthy without taking pharmaceuticals," he said.

But the financial promise of supplements and the lax regulation has attracted irresponsible manufacturers to enter the business, said David Schardt, an associate nutritionist at the Center for Science in the Public Interest, a non-profit consumer group.

"There are more and more companies getting in on the act that don't have track records or experience," he said. "These companies are looking to distinguish themselves from the competition and are tempted to introduce products that haven't been tested adequately."

Schardt cited ephedra as one of those products. "People are suffering some serious side effects from ephedra, such as high blood pressure and stroke. More than three dozen deaths have been attributed to ephedra," he said. "If it weren't for the easy entry into the business, we would not see so many ephedra products sold."

But industry officials say the lack of manufacturing and safety standards is the fault of the FDA. "The FDA fails to take advantage of the authority that they have to develop good manufacturing practices," said Dr. John Hathcock of the Council for Responsible Nutrition, a supplement trade association.

Hathcock said his organization and other industry groups petitioned the FDA to set up industry standards four years ago and that the FDA has "moved like a glacier" and "has not reached the stage of regulation."

"We've also encouraged them to exercise fully their authority against bogus, renegade supplement companies," he said.

Those companies give the other, more responsible companies a bad name, said Lisa Schofield, managing editor of Vitamin Retailer magazine.

"So many little fly-by-night Internet and by-mail sellers really prey on excessive hype and people's desperation to lose 100 pounds, or gain more energy, or their desperation in a cancer situation," she said, adding that the FDA has dragged its feet on "cracking down" on those rogue manufacturers.

"It comes down to the consumer to be smart about their supplements," she said.

Dr. Yank D. Coble, a trustee of the American Medical Association, believes that the American public is too trusting in the belief that the products they use for self-medication are safe.

"People have such confidence in the American food system and they think supplements are regulated in the same fashion [as food and] with the same kinds of studies," Coble said. "But it's important they know that the claims of these supplement companies are not science but personal opinion, and they are two very different things."

Coble said that even though studies are under way to determine the effects of supplements, all the effects may not be seen for a few years. That leaves people with "a false sense of security" about supplements.

"The fact that a person taking supplements doesn't have any [side effects] doesn't mean [the supplements] are safe," he said. "Symptoms may not show up for a long time."