Nutraceutical Corporation is not giving up its fight for banned herbal, ephedrine, and has filed a petition for rehearing in front of the entire tenth circuit of the US Court of Appeals, following a federal appeals court decision in August.
The decision pendulum has been swinging back and forth over the controversial sports performance and weight loss herbal. A Utah judge blocked FDA action against Nutraceutical in April 2005, which a federal appeals court then overturned in August.
Nutraceutical's latest petition specifically faults the three-judge federal appeals panel for using "the same risk-benefit comparison standard in post-market review of dietary supplements that is reserved for pre-market review of drugs."
The ongoing controversy over ephedra, stemming from case reports linking the herbal with serious adverse events, has given critics of the supplements industry ammunition. Unlike pharmaceuticals, which must go through a series of pre-market approvals, finished dietary supplements need no pre-market approval. Under the Dietary Supplement Health and Education Act (DSHEA), which is part of the Food and Cosmetics Act, only ingredients not marketed in the US before October 1994 must be approved by the FDA before use in consumer products.
The industry has indicated that supports measures to protect consumers within the existing framework, and most major players have expressed their support of a recently introduced bill that would make serious adverse events reporting to the FDA by companies mandatory.
In her judgement in April 2006, Judge Tena Campbell sided with Utah-based Nutraceutical that the FDA did not prove a daily dosage of 10mg or less of ephedra results in an unreasonable risk of illness or injury.
But the FDA appealed this decision and, in August, the US Circuit Court of Appeals in Denver came down on the FDA's side.
In its new appeal, Nutraceutical argues the FDA's assessment of "unreasonable risk" is too rigid and gives the agency license to declare any dietary ingredient adulterated.
The company also challenges the court's interpretation of food adulteration. "FDA's rule produces the absurd result of causing raw, crushed ephedra sinica herb to be unlawful when placed in a gelatin capsule, but legal when placed in a tea bag," it wrote in the appeal.
It calls such risk analysis subjective, and claims that they set a negative precedent for the federal agency's jurisdiction over the entire herbal and supplement industry.