Utah-based Nutraceutical Corporation has lost its fight for banned herbal, ephedrine, after filing a petition for a rehearing in front of the entire tenth circuit of the US Court of Appeals.
On Monday, the Supreme Court issued a "certiorari denied" without comment in the case of Nutraceutical Corp vs. Eschenbach, meaning it is refusing to consider an appeal.
The decision, which came on the heels of a federal appeals court decision, represents a nail in the coffin for ephedra and the series of court rulings that played out its fate.
Ephedra, which was marketed for weight loss and sports performance, came into the spotlight after being linked with serious adverse events. The US Food & Drug Administration banned the herbal and the case gave critics of the dietary supplements industry more ammunition in the regulatory debate.
In April 2005, a Utah judge countered and blocked FDA's action against Nutraceutical Corporation and the banned herbal. This was then overturned by the federal appeals court decision in August of the same year.
Judge Tena Campbell had sided with Nutraceutical and stated that the FDA did not prove a daily dosage of 10mg or less of ephedra results in an unreasonable risk of illness or injury.
Nutraceutical's appeal argued that FDA's assessment of "unreasonable risk" and ephedra was too rigid and gave the agency license to declare any dietary ingredient adulterated.
The company also challenged the federal 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 called 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.
A number of recent studies linked ephedrine alkaloids with adverse effects on the cardiovascular and central nervous systems.
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.