Reconsidering the Ban on Ephedra Products

Pharmacy Times, Volume 0, 0

Issue of the Case

The FDA banned interstate sale ofproducts containing ephedra, and thatdecision was challenged by a manufacturerof products containing that ingredient.At issue was the interpretationof the Dietary Supplement Health andEducation Act (DSHEA) of 1994 and itsrelationship to the Federal Food, Drug,and Cosmetic (FDC) Act. The firmalleged that the decision by the FDAwas inconsistent with the statute andshould be overturned by the courts.

Facts of the Case

The FDA conducted a risk-benefitanalysis to determine whether productscontaining ephedra and otherephedrine-alkaloid dietary supplements(EDS) should be viewed as posing anunreasonable risk to public health.

A firm based in a western state challengedthat decision in federal courtwith arguments that the federalagency had acted outside its authorityconferred by Congress when it applieda risk-benefit analysis in the process ofdeciding whether products containingthe compounds in question should beconsidered adulterated under the FDCAct. The manufacturer also said thatthe ban was not supported by a preponderanceof scientific evidence. Thissecond argument was specificallydirected at an earlier decision by theFDA that products containing less than10 mg EDS could continue to be marketedwhile the FDA studied the issuein full. The firm had not taken thatoption, declining to market any suchproducts at any dosage level while theagency conducted its review.

The federal trial court agreed with themanufacturer and issued an injunctionprohibiting the FDA from implementingits ban on the sale of EDS-containingproducts in the United States. The FDAappealed that judge's decision.

The Court's Ruling

The US Court of Appeals reversedthe injunction ordered by the trial courtand reinstated the ban that the FDAhad attempted to implement on salesof such products.

The Court's Reasoning

In the view of the appellate court,the primary issue in the case waswhether the FDA's authority to act inthis area was based on an unambiguousmanifestation of congressionalintent. Had Congress given the agencyauthority, through both the DSHEA andthe FDC Act, to weigh both benefit andrisk in assessing whether productssuch as these should be sold or withdrawnfrom the market?

The DSHEA assigned to the FDA theresponsibility of keeping adulterateddietary supplements off the market. Adietary supplement is considered adulteratedunder the statute if "it presentsa significant or unreasonable risk of illnessor injury." In the view of the FDA,the agency has authority to comparethe level of risk with potential benefitsin order to assess "unreasonableness."

The court acknowledged that theDSHEA had been put into law byCongress in order to improve access todietary supplements by the public. Thatstatute must be read in concert withthe FDC Act, however. Both statutesare designed to protect the publichealth and, consequently, should notbe interpreted too restrictively. Traditionally,courts have given ratherbroad deference to laws designed toprotect public health, safety, and welfare,based on the inherent legalauthority of government known as"police power."

On reviewing the appeal, the courtconcluded that, when Congress usedwords such as "significant" and "unreasonable"when enacting the statute, ithad expected the agency to assess therisk in concert with the circumstances(ie, to weigh one against the other).Moreover, the FDA's enforcement ofthe DSHEA did not require the manufacturerto submit the product for premarketingclearance with regard toconferring a documented benefit.Rather, the agency took on the role ofassessing postmarketing benefit versusrisk. The trial court had ruled thatthis action of balancing risk versusbenefit by the agency was improper;the appellate court reached the oppositeconclusion.

The appeals court also examinedwhether the postmarketing review bythe FDA was sufficiently extensive andcomplete to support a total ban on thesale of products containing EDS. Theagency had concluded that the potentialhealth benefits of these productswere "dwarfed" by the potential forlong-term serious cardiovascular complications.The FDA had taken 7 yearsto collect and review scientific dataand peer-reviewed literature about theeffects of EDS-containing products.Concluding that the majority of thedata compiled supported the FDAaction, the appellate court lifted theinjunction entered by the lower courtand reinstated the agency's ban on thesale of EDS-containing products.

Dr. Fink is professor of pharmacy law and policy atthe University of Kentucky College of Pharmacy, Lexington.