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NPA Takes Ephedra Case to Supreme Court
May 7, 2007
2 Min Read
WASHINGTONThe Natural Products Association (NPA) filed an amicus (friend of the court) brief with the U.S. Supreme Court in April, challenging a lower court ruling on the standard used by the Food and Drug Administration (FDA) to impose a 2004 ban on ephedrine alkaloids in dietary supplements. The ban was successfully challenged and overturned in 2005 in a Utah district court, but was subsequently reversed in a circuit appeals court in 2006. In March 2007, U.S. District Court Judge Paul Cassell rejected Nutraceutical Corp.s challenge and effectively closed the case.
According to NPAs brief, if the most recent court ruling is allowed to stand, the distinction between dietary supplements and drugs will effectively evaporate; dietary supplement makers will be forced to conduct the same rigorous clinical tests that are required for drugs, and as a result, consumer choicecurrently protected under the Dietary Supplement Health and Education Act (DSHEA)will be eroded.
Were taking this strong stand for the millions of Americans who use dietary supplements to live healthier, more fulfilling lives, and the people in our industry who make, sell and deliver those products, said David Taylor, president of NPA (www.naturalproductsassoc.org). Some critics may try to twist this into a debate about one product, which it clearly is not. It is instead a critical decision about the proper enforcement of DSHEA, which will have a far-reaching effect on consumers and the industry for years to come.
Among the key arguments presented in NPAs brief include:
With DSHEA, Congress gave the FDA ample powers to protect public health and safety from adulterated foods, including dietary supplements. But in banning ephedrine alkaloids in dietary supplements, the FDA chose not to rely on its lawful powers and instead took the opportunity to rewrite DSHEA.
In determining that ephedrine alkaloids in dietary supplements pose an unreasonable risk and should be banned, the FDA relied upon a risk-benefit analysis not authorized by DSHEA.
The FDAs ruling, upheld by the appeals court, essentially requires that dietary supplements be governed by the same standard that governs premarket approval of drugs; foods, including dietary supplements, are not subject to any such standard.
Were not arguing with the decision, were arguing that FDA used the wrong legal route to get there, said David Seckman, executive director and chief executive officer (CEO) of NPA. And unless the court gets this right, there could be huge consequences for consumers, retailers and manufacturers of dietary supplements.
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