Nutraceutical International Corporation has announced a court decision that has granted the company's motion for summary judgement against the Food and Drug Administration (FDA) in the company's lawsuit involving FDA's Final Rule on Ephedra.
The motion put forth by Nuraceutical International Corporation asked the court whether the Final Rule banning ephedra containing supplements was allowable, forcing the court to determine whether FDA's use of risk-based analysis is appoprriate and whether FDA had sufficient evidence to support the conclusion that products containing 10mg or less per day of ephedrine alkaloids "pose a significant or unreasonable risk of illness or injury."
The court determined that DSHEA, unlike in the case of medical device provisions, contains no provision for risk-benefit analysis, noting that Congress intended to harmonize treatment of dietary supplements with that of foods and not drugs or medical devices, further noting that by imposing a risk-benefit anlysis, FDA demanded each producer of an ephedra containing supplement to demonstrate a benefit as a precondition of sale, which "alleviates the burden congress placed squarely on the givernment to demonstrate the existence of a significant or unreasonable risk.".
The court, in evaluating whether products containing 10mg or less of ephedrine alkaloids pose a signficant or unreasonable risk, noted that the government's responsibility to produce evidence to support this can be met only if it has demonstrated risk at "conditions of use recommended or suggested in labelling" - a dose specific analysis. Yet in declaring all ephedrine alkaloid containing supplements illegal, FDA included low dose products, and in that category, relied on only one reference in the administrative record, which actually extrapolates from intravenous injection of epinephrine, not ephedrine alkaloids, and does not involve oral ingestion. The court determined that by failing to "prove by a preponderance of the evidence that a dosage of 10mg or less of ephedrine alkaloids presents a significant or unreasonable risk of illness or injury", FDA has failed to give effect to the dose-specific language of the rule.
The court ruling can be found at: http://www.nutraceutical.com/courtruling.pdf