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NVE, INC. v. DEPARTMENT OF HEALTH AND HUMAN SERV.

No. 04-4481.

436 F.3d 182 (2006)

NVE INC., Appellant v. DEPARTMENT OF HEALTH AND HUMAN SERVICES; Tommy G. Thompson, Secretary Department of Health and Human Services; Food and Drug Administration; Lester M. Crawford, Jr., Acting Commissioner, Food and Drug Administration; John Does, 1-10 fictitious individuals and ABC Agencies 1-10 fictitious agencies and/or entities.

United States Court of Appeals, Third Circuit.

February 7, 2006.

Attorney(s) appearing for the Case

Walter F. Timpone [Argued], McElroy, Deutsch, Mulvaney & Carpenter, Morristown, NJ, for Appellant.

Douglas N. Letter, Christine N. Kohl [Argued], U.S. Department of Justice, Civil Division, Washington, DC, for Appellees.

Before RENDELL, FUENTES and GARTH, Circuit Judges.

OPINION OF THE COURT

RENDELL, Circuit Judge.

In 1994, Congress passed the Dietary Supplement Health and Education Act ("DSHEA"), declaring dietary supplements that "present[] a significant or unreasonable risk of illness or injury" to be "adulterated food" under the Food, Drug, and Cosmetic Act ("FDCA"). DSHEA § 4, 21 U.S.C. § 342(f)(1) (2000). In 2004, the Food and Drug Administration ("FDA") promulgated a final regulation stating that dietary...

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