If the benefits of dietary supplements were backed by scientific proof — enough to outweigh any health risks — how much would you be willing to pay for them?
It's a question some Americans may soon ponder.
The 1994 Dietary Supplements Health and Education Act, authored by Sen. Orrin Hatch, R-Utah, exempts supplement companies from testing products before putting them on the market.
As a result, there is little incentive to conduct clinical research. But a recent court ruling out of Denver has the potential to cause changes.
The Aug. 17 decision not only upheld the federal ban on the diet aid ephedra, it also sanctioned a new standard for evaluating the safety of supplements — a risk-benefit analysis Hatch insists was never contemplated by Congress.
The dietary supplements act (DSHEA) was meant to force the U.S. Food and Drug Administration to acknowledge the benefits of supplements, not question them, Hatch says.
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If the ephedra decision is allowed to stand, manufacturers will have little choice but to fund expensive studies — and pass those costs on to consumers — in hopes of convincing the FDA their products are worth the risk.
And that, says Hatch, is why the ruling is wrong and must be appealed to U.S. Supreme Court if necessary.
"I can live with ephedra being off the market," Hatch says. "But if you give bureaucrats the right to determine the risks and benefits of supplements, the same standard used to evaluate drugs, (supplements) will be priced out of the marketplace just like drugs are now."
Some scientists say small companies unable to fund experiments will simply fold, lessening competition and further driving up prices. But they also say any decision that encourages additional and better research is a good thing.
"This ruling could have a huge impact on industry," says Mary Ann Lila, professor of biological sciences at the University of Illinois-Champaign-Urbana, one of six institutions that make up the National Institutes on Health Botanical Center for Age Related Diseases.
"It will increase costs, yes. But it also could change things for the better."
Most studies on supplements are funded by NIH grants and conducted at academic research centers, such as the one Lila directs.
The Office of Dietary Supplements, for example, supports six dedicated Dietary Supplement Research Centers with five-year grants.
Current studies include the use of black cohosh and red clover in menopausal therapies, treatment of bronchial asthma with borage seed oil, the role of echinacea and turmeric in cancer treatment and the use of antioxidants to promote eye health.
Stephen Coates, head of the dietary supplements office, says funding for his office has increased from $1 million in 1995 to $27 million this year. For every dollar his office spends on research, other NIH centers, led by the National Center for Complementary and Alternative Medicine, spend $10, Coates says.
The lack of dietary supplement research was a major factor in the ephedra debate.
Supplements "will be priced out of the marketplace just like drugs are now."
Sen. Orrin Hatch
Supplement-testing opponent
