The Interchangeable-Part Structure of Food and Drug Law

This Article demonstrates that nested tiers of interchangeable parts serve as the foundation for the regulatory programs administered by the U.S. Food and Drug Administration. Core interchangeable parts used in FDA-administered programs include product categories, prohibitions on adulteration and misbranding, agency-registration requirements, current good manufacturing practices, product standards, marketing authorization requirements, postmarket requirements, and user fees. In each of these areas, Congress or the FDA has engaged 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. 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, biologics, combination products, 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 concludes with three brief observations about the analytical value of the interchangeable-part framework presented here. First, it suggests that IPL both explains the structure of recent changes to the statutes administered by the FDA and provides insight into the likely form of future changes to those statutes. Second, it suggests that IPL may provide a useful perspective on statutes administered by other federal agencies, such as the Environmental Protection Agency and the United States Department of Agriculture. Third, it suggests that IPL may provide similar insights into the regulatory programs of U.S. states and of foreign countries