U.S. v. 5 Unlabeled Boxes

Decision Date14 July 2009
Docket NumberNo. 07-4352.,07-4352.
Citation572 F.3d 169
PartiesUNITED STATES of America v. 5 UNLABELED BOXES, more or less, of an article of food, each box containing various quantities of 100 tablet bottles, labeled in part: "Lipodrene Dietary Supplement 100ct. 25 mg ephedrine group alkaloids Manufactured for: Hi-Tech Pharmaceuticals, Inc. Norcoss, GA 05121004EXP09/08" v. Hi-Tech Pharmaceuticals, Inc., Third Party Plaintiff v. Andrew C. Von Eschenbach, M.D., Commissioner of the U.S. Food and Drug Admimistration; Food and Drug Administration; Michael O. Leavitt, Secretary of the Department of Health and Human Services; Department of Health & Human Services, Third Party Defendants. Hi-Tech Pharmaceuticals, Inc., Appellant.
CourtU.S. Court of Appeals — Third Circuit
572 F.3d 169
UNITED STATES of America
v.
5 UNLABELED BOXES, more or less, of an article of food, each box containing various quantities of 100 tablet bottles, labeled in part: "Lipodrene Dietary Supplement 100ct. 25 mg ephedrine group alkaloids Manufactured for: Hi-Tech Pharmaceuticals, Inc. Norcoss, GA 05121004EXP09/08"
v.
Hi-Tech Pharmaceuticals, Inc., Third Party Plaintiff
v.
Andrew C. Von Eschenbach, M.D., Commissioner of the U.S. Food and Drug Admimistration; Food and Drug Administration; Michael O. Leavitt, Secretary of the Department of Health and Human Services; Department of Health & Human Services, Third Party Defendants.
Hi-Tech Pharmaceuticals, Inc., Appellant.
No. 07-4352.
United States Court of Appeals, Third Circuit.
Argued October 23, 2008.
Filed July 14, 2009.

[572 F.3d 170]

Kathryn L. Clark, Esq., Eckert, Seamans, Cherin & Mellott, Pittsburgh, PA, Joseph P. Schilleci, Jr., Esq., [Argued], Timothy M. Fulmer, Esq., Natter & Fulmer, P.C., Esq., Birmingham, AL, Edmund J. Novotny, [Argued], Baker, Donelson, Bearman, Caldwell, & Berkowitz, P.C., Atlanta, GA, for Appellant Hi-Tech Pharmaceuticals, Inc.

[572 F.3d 171]

Christine N. Kohl, Esq., [Argued], Douglas N. Letter, Esq., United States Department of Justice, Civil Division, Washington, DC, for Appellees United States of America; Andrew C. Von Eschenbach, M.D., Commissioner of the U.S. Food and Drug Administration; Food and Drug Administration; Michael O. Leavitt, Secretary of the Department of Health and Human Services; Department of Health & Human Services.

Before: RENDELL, SMITH, Circuit Judges, and POLLAK,* District Judge.

OPINION OF THE COURT

POLLAK, District Judge.


This case concerns ephedrine alkaloids ("EDS"), substances that were marketed beginning in the early 1990s as dietary supplements to reduce weight and boost energy. In 2004, the Food and Drug Administration ("FDA") banned all supplements containing EDS after concluding that they present an "unreasonable risk of illness or injury" at all dose levels. Hi-Tech Pharmaceuticals, Inc., a maker of products containing EDS, challenges that determination.1 As discussed below, we conclude that Hi-Tech's challenge is precluded.

I.

A. Rulemaking Background

The Food, Drug, and Cosmetic Act ("FDCA") prohibits the "introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded." 21 U.S.C. § 331(a). In 1994, Congress amended the FDCA through the Dietary Supplement Health and Education Act, Pub.L. No. 103-417 (2000) ("DSHEA"), which sets guidelines for how FDA may regulate dietary supplements. FDA may declare that a dietary supplement is "adulterated" if it "presents a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use." 21 U.S.C. § 342(f)(1)(a). The DSHEA also makes clear that the FDA bears the burden of proof in seeking to have a dietary supplement declared adulterated, as the section provides: "In any proceeding under this subparagraph, the United States shall bear the burden of proof on each element to show that a dietary supplement is adulterated. The court shall decide any issue under this paragraph on a de novo basis." 21 U.S.C. § 342(f).2

In 1995, FDA began examining EDS and in 1997 began to consider regulating dietary supplements containing EDS. 62 Fed.Reg. 30,678 (June 4, 1997). FDA sought comment on a proposed finding that a dietary supplement is adulterated if it contains 8 mg or more of EDS per serving, or if its labeling suggests usage resulting in a total daily intake of 24 mg or more of EDS. FDA received negative feedback on this proposal and in 2000 withdrew

572 F.3d 172

part of the proposed rule. 65 Fed.Reg. 17,474 (Apr. 3, 2000). Between 2000 and 2003, FDA released information on EDS and solicited other comments through notices to the public. In 2003, FDA published another notice, informing the public that FDA intended to consider whether EDS "present a `significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use.'" 68 Fed.Reg. 10,417 (Mar. 5, 2003).

FDA issued a final rule in 2004, declaring all EDS to be "adulterated" and therefore banned. FDA explained that it was acting based on "the well-known pharmacology of ephedrine alkaloids, the peer-reviewed scientific literature on the effects of ephedrine alkaloids, and the adverse events reported to have occurred in individuals following consumption of dietary supplements containing ephedrine alkaloids." Final Rule Declaring Dietary Supplements Containing Ephedrine...

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