In an ephedrine manufacturer’s challenge to the Food and Drug Administration’s decision to ban the substance, a federal appeals court has ruled that the litigation must be strictly limited to a review of the FDA’s administrative record, and that the manufacturer therefore is not entitled to present its own expert witnesses nor to gather and present additional evidence.
The decision in NVE Inc. v. Department of Health and Human Services could have an immediate impact on similar cases around the country. Several court battles are under way to challenge the FDA’s ban on sales of popular dietary supplements and weight loss aids after the active ingredient was linked to deaths among athletes.
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