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United States v. 5 Unlabeled Boxes

July 14, 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



Appeal from the United States District Court for the Western District of Pennsylvania (D.C. Civil No. 06-cv-0027) District Judge: The Honorable Nora Barry Fischer.

The opinion of the court was delivered by: Pollak, District Judge.

PRECEDENTIAL

Argued: October 23, 2008

Before: RENDELL, SMITH, Circuit Judges, and POLLAK,*fn1 District Judge.

OPINION OF THE COURT

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.*fn2 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).*fn3

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 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 Alkaloids Adulterated Because They Present an Unreasonable Risk, 69 Fed. Reg. 6788-6854 (Feb. 11, 2004) (hereinafter "Final Rule").*fn4 The Final Rule represented the first time FDA banned an entire class of dietary supplements under the DSHEA.

FDA determined in the Final Rule that its burden to show unreasonable risk is met "when a product's risks outweigh its benefits in light of the claims and directions for use in the product's labeling, or if the labeling is silent, under ordinary conditions of use." FDA defined unreasonable risk to "represent[ ] a relative weighing of the product's known and reasonably likely risks against its known and reasonably likely benefits." In conducting this weighing, FDA evaluated the claimed benefits of EDS, including weight loss, enhanced athletic performance, and increased energy, against the known risks, including increased blood pressure and heart rate, and their consequences, such as increased risk of stroke and heart attack. FDA found that the "best clinical evidence for a benefit is for weight loss, but even there the evidence supports only a modest short-term weight loss, insufficient to positively affect cardiovascular risk factors associated with being overweight or obese." FDA concluded that the potential benefits of EDS did not outweigh the risks and therefore determined that EDS products were adulterated and must be banned.

B. The Two Litigation Proceedings

Hi-Tech filed a complaint challenging the Final Rule in the Northern District of Georgia on August 15, 2005.*fn5 Hi-Tech claimed that the Final Rule was issued in violation of the Administrative Procedures Act and that FDA failed to meet its burden to prove that supplements containing EDS present an unreasonable risk. Hi-Tech's main claim was that FDA could not meet its burden of proving adulteration with a generally applicable rule for an entire class of substances, but was, instead, required to proceed on a product-by-product basis. On February 22, 2006, FDA sought forfeiture of EDS products, made by Hi-Tech, in the ...


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