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United States Second Circuit

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NRDC v. US FDA, 12-2106

In an action seeking to force the defendant Food and Drug Administration (FDA) to prohibit the use of certain antibiotics in animal feed, summary judgment in favor of plaintiffs is reversed and remanded, where: 1) Congress has not required the FDA to hold hearings whenever FDA officials have scientific concerns about the safety of animal drug usage; 2) the FDA retains the discretion to institute or terminate proceedings to withdraw approval of animal drugs; 3) the statutory mandate contained in 21 U.S.C. section 360b(e)(1) applies to limit the FDA's remedial discretion by requiring withdrawal of approval of animal drugs or particular uses of such drugs only when the FDA has made a final determination, after notice and hearing, that the drug could pose a threat to human health and safety; and 4) the decision whether to institute or terminate a hearing process that may lead to a finding requiring withdrawal of approval for an animal drug is a discretionary determination left to the prudent choice of the FDA.

Appellate Information

  • Decided 07/24/2014
  • Published 07/24/2014




  • United States Second Circuit


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