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October 9, 2008

Eleventh Circuit Issues First Impression of Ephedrine Statute

With a tip of the hat to Ted McClure at Phoenix School of Law, and the FDA Law Blog, the Eleventh Circuit in Hi-Tech Pharmaceuticals, Inc. v. Crawford, __ F.3d __ (11th Cir. Oct. 7, 2008), issued an opinion of first impression concerning 21 USC 342(f)(1). Basically, after exhaustive hearings, the FDA declared in a final rule that dietary supplements with ephedrine alkaloids in them were "adulterated because they present an unreasonable risk."  When the FDA went to enforce this rule against Hi-Tech, it did not present any independent evidence that, in fact, ephedrine was unreasonably risky; instead, it simply relied on its final rule.

The defendant appealed the seizure of its products, and argued that summary judgment in favor of the FDA had been improperly granted -- no evidence supported its position -- and the final rule could not substitute for evidence because 21 USC 342(f)(1) stated that the US had the burden of proof to show that a supplement was adulterated by a preponderance of the evidence and "the court shall decide any issue... on a de novo basis."  Thus, argued the defendant, the de novo basis required evidence, not just the final rule.

The Eleventh Circuit disagreed.  It spent almost no time on the text, instead turning to the legislative history.  (The bridge to the legislative history wasn't ambiguity, but instead the lack of appellate construction!) Ultimately, the court stated:

The statute does not say that the applicability of a regulation promulgated by an executive agency, through an extensive administrative procedure cannot be sufficient proof of adulteration. And the legislative history does not so indicate. Indeed, that history suggests the opposite: that the statute empowers the FDA to settle the issue of adulteration through rulemaking and that additional proof to a court will not be necessary.


S. Rep. No. 103-410, at 35.

October 9, 2008 in Current Affairs | Permalink


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