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HI-TECH PHARMACEUTICALS, INC. v. CRAWFORD

Nos. 07-14309, 07-14312.

544 F.3d 1187 (2008)

HI-TECH PHARMACEUTICALS, INC., Plaintiff-Appellant, v. Lester M. CRAWFORD, D.V.M., Ph.D., as Commissioner of the United States Food and Drug Administration, United States Food and Drug Administration, Michael O. Leavitt, as Secretary of the Department of Health and Human Services, United States Department of Health and Human Services, Acting Commissioner Andrew C. Von Eschenbach, M.D., Defendants-Appellees. United States of America, Plaintiff-Third Party Defendant-Appellee, v. 18 Cases, More or Less, of an Article of Food, Each Case Containing 120/100 Tablet Bottles Labeled in Part Lipodrene Dietary Supplement 100 ct. Sida Cordifolia (leaves) (25 mg ephedrine group alkaloids) Lot 05121004 Manufactured for Hi-Tech Pharmaceuticals, Inc., Norcross, GA, et al., Defendants, Hi-Tech Pharmaceuticals, Inc., Claimant-Third Party Plaintiff-Appellant.

United States Court of Appeals, Eleventh Circuit.

October 7, 2008.

Attorney(s) appearing for the Case

Edmund J. Novotney, Jr., Baker, Donelson, Beraman, Caldwell & Berkowitz, P.C., Atlanta, Ga, Joseph P. Schilleci, Jr., Natter & Fulmer, P.C., Birmingham, AL, for plaintiff-appellant.

Christine N. Kohl, Dept. of Justice, Appellate Staff, Civ. Div., Gerald Cooper Kell, Douglas N. Letter, U.S. Dept. of Justice, Washington, DC, Stephen H. McClain, U.S. Atty's Office, Atlanta, GA, Marci B. Norton, U.S. Dept. of Health and Human Services, Rockville, MD, for defendants-appellees.

Before WILSON, PRYOR and COX, Circuit Judges.

PER CURIAM:

We consider in this appeal whether 21 U.S.C. § 342(f)(1)'s de novo provision impacts the evidentiary weight to be given to Food and Drug Administration (FDA) regulations. Section 342(f)(1)'s de novo provision provides that a reviewing court shall decide any issue in an adulterated dietary supplement proceeding de novo. The issue is whether a FDA regulation which declares that dietary supplements containing ephedrine alkaloids are adulterated is sufficient...

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