Is the Incorporation of the United States Pharmacopeia into the Food, Drug, and Cosmetic Act an Unconstitutional Delegation of Legislative Power?

Anne Stark

ABSTRACT

When Congress incorporated the United States Pharmacopeia (USP) into key provisions of the 1906 Pure Food and Drug Law (and subsequently, the 1938 Food, Drug, and Cosmetic Act), it impermissibly conferred legislative authority on a private trade organization in two different ways. First, Congress defined “drug” for the purposes of the statute as any article listed in the USP. In doing this, Congress enabled the United States Pharmacopeial Convention (USPC) to shape the reach of the Food, Drug, and Cosmetic Act (FDCA) and the jurisdiction of the Food and Drug Administration (FDA). Secondly, it defined “adulteration” and “misbranding” in the statute by incorporating drug standards published in the USP. This empowered the USPC to create legally binding requirements, the violation of which is punishable by criminal penalty. Although this broad delegation of authority to a private organization has been defended on the grounds of practical necessity and legal precedent, these arguments fail to justify its constitutionality. Even if legislative delegations to private parties like the USPC are permissible, this delegation is impermissible because Congress failed to provide any intelligible principle to guide or constrain the discretion of the USPC. This paper outlines how the FDCA’s incorporation of the USP violates the nondelegation doctrine and analyzes how this invalid statutory arrangement has survived for more than one hundred and ten years.

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