The Interchangeable-Part Structure of Food and Drug Law

Congress and regulatory agencies frequently engage in interchangeable-part lawmaking (IPL). IPL occurs when a government takes a portion of its law in one subject area and uses it as a model for its own law in another subject area. One notable example is the set of statutes and regulations administered by the U.S. Food and Drug Administration (FDA).
Nested tiers of interchangeable parts serve as the foundation for the regulatory programs administered by the FDA. Core interchangeable parts used in FDA-administered programs include product categories, prohibitions on adulteration and misbranding, agency-registration requirements, current good manufacturing practice, product standards, marketing authorization requirements, postmarket requirements, claims authorization requirements, and user fees. Some combination of these interchangeable parts can be found in the regulatory program for each product category regulated by the FDA. This includes food and food-adjacent products (food, food additives, and dietary supplements); medical products (drugs, animal drugs, medical devices, combination products, biologics, and human cells, tissues, and cellular and tissue-based products); and other products (cosmetics, electronic products, and tobacco products). This interchangeable-part structure provides a unifying perspective on the wide array of disparate regulatory programs administered by the FDA.
The Article then briefly addresses two implications and two research questions that arise from this analysis. The two implications relate to (1) the structure of change to FDA-administered statutes and (2) the potential use of IPL by other lawmakers and in other institutional fields. The two research questions relate to (1) the institutional actors that have developed and maintained the interchangeable-part structure of food and drug law and (2) the normative value of IPL.