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In 1977, the Food and Drug Administration initiated a process to withdraw approval of the subtherapeutic use of antibiotics in food producing animals out of concern the use was not shown to be safe. Over thirty years later, the FDA still had not completed the process, prompting several nonprofit advocacy groups to seek a court order compelling action. In Natural Resources Defense Council, Inc. v. U.S. Food & Drug Administration, a federal district court considered whether the FDA unlawfully withheld or unreasonably delayed agency action in violation of the Food, Drug, and Cosmetic Act and the Administrative Procedure Act. The district court applied the APA’s “unlawfully withheld” test, considered the plain meaning of the statute, and rendered a swift decision in favor of the plaintiffs. This Comment argues that applying the APA’s “arbitrary and capricious” test instead of the more deferential “unlawfully withheld” test would have encouraged greater transparency in agency decision-making.


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7 Sep 2022
152 kB



  • Subject
    • Administrative Law

    • Civil Procedure

    • Consumer Protection Law

    • Food and Drug Law

    • Health Law and Policy

  • Journal title
    • Boston College Environmental Affairs Law Review

  • Volume
    • 40

  • Issue
    • 3

  • Pagination
    • E. Supp. 1

  • Date submitted

    7 September 2022