Court Reviews Ephedra Ban, OK’s FDA’s Decision

extracted by Peter Ou Court Reviews Ephedra Ban, OK’s FDA’s Decision

Posted on: 03/19/2007

by Steve Myers
SALT LAKE CITY—Nutraceutical Corp.’s latest move in its battle against the Food and Drug Administration’s (FDA) ban on ephedra dietary supplements met with an unfavorable decision. The company requested, and won, a summary review of the case, specifically alleging FDA failed procedural rules in not issuing a proposed rule accompanying a public comment period on the use of risk-benefit analysis in the ban, in addition to “arbitrarily and capriciously” excluding ephedrine-containing foods and traditional Asian medicines from the ban.

The U.S. District Court, Central Utah, agreed to the request for review, instead clarifying it as a cross appeal after the defendants successfully argued a summary review of a government agency in district court must be treated as an appeal. On March 16, the Central Utah court—which had originally ruled in Nutraceutical’s favor, before the Tenth Circuit Court of Appeals sided with FDA—concluded Nutraceutical failed to show FDA violated procedures or acted unfairly in its ban of ephedra supplements.

Specifically, the court stated FDA did not violate requirements of the Administrative Procedures Act (APA), because it began the notification and comment series on ephedra in 1997. The decision further stated a March 2003 proposed rule publication from FDA mentioned the possible use of risk-benefit analysis relative to ephedra safety. It further decided FDA did not err in publishing a final rule (without comment period) that differed from the previously published proposed rule because the final rule was a logical outcome from the original 1997 proposal, including the more than 48,000 comments submitted. “In light of the Federal Register notices, the final rule was foreseeable,” the court wrote. “Nutraceutical’s own participation in the rulemaking process belies its claims that the FDA provided statutorily inadequate notice in the process—from 1997 to the time FDA promulgated the final rule—submitting detailed comments.” It further concluded FDA never established a standard for deciding which products to ban (using “significant” and “unreasonable” risk), so it could not have unfairly departed from a standard that didn’t exist.

On the matter of “arbitrary or capricious” exclusion of other ephedrine-containing products (beyond dietary supplements), the court ruled, “FDA’s separate regulation of [ephedrine-containing dietary supplements]…is consistent with the regulatory scheme of DSHEA [the Dietary Supplement Health and Education Act].” It explained DSHEA requires FDA to regulate dietary supplements separately from conventional foods and other drug products. Also, outside of DSHEA, the scope of regulation in this case would still be left up to FDA to decide, under direction from Congress, to “take swift action against products that are unsafe or adulterated.”

By this decision, U.S. District Judge Paul G. Cassell ordered the judgment final and the case closed

(Published: Natural database )

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