Issue of the Case
The FDA banned interstate sale of products containing ephedra, and that decision was challenged by a manufacturer of products containing that ingredient. At issue was the interpretation of the Dietary Supplement Health and Education Act (DSHEA) of 1994 and its relationship to the Federal Food, Drug, and Cosmetic (FDC) Act. The firm alleged that the decision by the FDA was inconsistent with the statute and should be overturned by the courts.
Facts of the Case
The FDA conducted a risk-benefit analysis to determine whether products containing ephedra and other ephedrine-alkaloid dietary supplements (EDS) should be viewed as posing an unreasonable risk to public health.
A firm based in a western state challenged that decision in federal court with arguments that the federal agency had acted outside its authority conferred by Congress when it applied a risk-benefit analysis in the process of deciding whether products containing the compounds in question should be considered adulterated under the FDC Act. The manufacturer also said that the ban was not supported by a preponderance of scientific evidence. This second argument was specifically directed at an earlier decision by the FDA that products containing less than 10 mg EDS could continue to be marketed while the FDA studied the issue in full. The firm had not taken that option, declining to market any such products at any dosage level while the agency conducted its review.
The federal trial court agreed with the manufacturer and issued an injunction prohibiting the FDA from implementing its ban on the sale of EDS-containing products in the United States. The FDA appealed that judge's decision.
The Court's Ruling
The US Court of Appeals reversed the injunction ordered by the trial court and reinstated the ban that the FDA had attempted to implement on sales of such products.
The Court's Reasoning
In the view of the appellate court, the primary issue in the case was whether the FDA's authority to act in this area was based on an unambiguous manifestation of congressional intent. Had Congress given the agency authority, through both the DSHEA and the FDC Act, to weigh both benefit and risk in assessing whether products such as these should be sold or withdrawn from the market?
The DSHEA assigned to the FDA the responsibility of keeping adulterated dietary supplements off the market. A dietary supplement is considered adulterated under the statute if "it presents a significant or unreasonable risk of illness or injury." In the view of the FDA, the agency has authority to compare the level of risk with potential benefits in order to assess "unreasonableness."
The court acknowledged that the DSHEA had been put into law by Congress in order to improve access to dietary supplements by the public. That statute must be read in concert with the FDC Act, however. Both statutes are designed to protect the public health and, consequently, should not be interpreted too restrictively. Traditionally, courts have given rather broad deference to laws designed to protect public health, safety, and welfare, based on the inherent legal authority of government known as "police power."
On reviewing the appeal, the court concluded that, when Congress used words such as "significant" and "unreasonable" when enacting the statute, it had expected the agency to assess the risk in concert with the circumstances (ie, to weigh one against the other). Moreover, the FDA's enforcement of the DSHEA did not require the manufacturer to submit the product for premarketing clearance with regard to conferring a documented benefit. Rather, the agency took on the role of assessing postmarketing benefit versus risk. The trial court had ruled that this action of balancing risk versus benefit by the agency was improper; the appellate court reached the opposite conclusion.
The appeals court also examined whether the postmarketing review by the FDA was sufficiently extensive and complete to support a total ban on the sale of products containing EDS. The agency had concluded that the potential health benefits of these products were "dwarfed" by the potential for long-term serious cardiovascular complications. The FDA had taken 7 years to collect and review scientific data and peer-reviewed literature about the effects of EDS-containing products. Concluding that the majority of the data compiled supported the FDA action, the appellate court lifted the injunction entered by the lower court and reinstated the agency's ban on the sale of EDS-containing products.
Dr. Fink is professor of pharmacy law and policy at the University of Kentucky College of Pharmacy, Lexington.
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