Ephedra, a once-popular herbal, was banned by the FDA's final rule in 2004 on the grounds that it does not present a significant health benefit to outweigh the reported increased risk of heart attack, stroke and death. A year later the ban was successfully challenged by Nutraceutical in a Utah court since the 1994 Dietary Supplements Health and Education Act (DSHEA) does not make mention of risk-benefit balance in establishing whether a supplement presents an unreasonable risk. Rather, the FDA drew on the medical devices provisions of the Food Drug and Cosmetics Act, which does state that this is a determining factor. Since then the pendulum has swung back and forth on appeal, and the latest twist in the regulatory tale is that Nutraceutical the Supreme Court to take up the matter. However David Seckman, president of the NPA, said that the situation is not just about ephedra, but rather the precedent that the latest ruling sets for the industry as a whole. With the amicus curiae ('friend of the court') the association asks the court to give it and other interested parties the opportunity to prove, on merits, that the FDA overreached and exceeded the bounds of Congress' regulatory scheme. Seckman told NutraIngredients-USA.com the NPA filed the amicus since it believes the Supreme Court should get involved. "We filed the amicus because there is a statutory distinction between food and drugs. We think the risk-benefit standard could cause a problem with that distinction," said Seckman. Crucially, risk-benefit is an analysis method that is applied to drugs, and forms part of the pre-market clinical testing procedures. Dietary supplements are regulated as foods, however, under the 1994 Dietary Supplement Health and Education Act (DSHEA). "We are not arguing about the case itself - whether ephedra should or should not be banned - but we argue that FDA should follow what is in DSHEA," said Seckman. He maintains that FDA has the ability to remove a product from the market under DSHEA, and that there is no need for risk-benefit to enter into the process. In NPA's eyes the FDA, in relying on a risk-benefit analysis in its ephedra decision, "chose not to rely on its lawful powers and instead took the opportunity to re-write DSHEA". It sees the present scenario creates a dangerous precedent that could impact on other supplements in the category. To illustrate its point, it uses fiber as an example. Fiber is recognised for its role in lowering cholesterol, control diabetes, and prevent colon cancer, and the benefits are dose dependent. Yet there can be risks associated with high doses, since fiber binds to other nutrients like calcium, magnesium, phosphorus and iron, and could potentially lead to mineral depletion. NPA says that that if a risk-benefit analysis were applied to fiber it may be deemed adulterated at high doses unless a rigorous scientific process were to prove that the health and disease benefits were sufficient to counterbalance those risks.
The most recent court ruling on ephedra blurs the distinction between supplements and drugs and could force the industry to conduct clinical tests, says the Natural Products Association, which has filed an amicus curiae with the Supreme Court.