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U.S. v. 5 UNLABELED BOXES

No. 07-4352.

572 F.3d 169 (2009)

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.

United States Court of Appeals, Third Circuit.

Filed July 14, 2009.

Attorney(s) appearing for the Case

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.

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...

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