crs_reports: R48915

Congressional Research Service reports with summaries, authors, and topic classifications.

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R48915 Preemption and the Federal Food, Drug, and Cosmetic Act (FD&C Act) 2026-04-23T04:00:00Z 2026-04-24T11:09:05Z Active Reports Wen W. Shen, Dorothy C. Kafka Federal Preemption, Federal Food, Drug & Cosmetic Act (FFDCA) First enacted in 1938, the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, empowers the Food and Drug Administration (FDA) to regulate various products affecting public health, including food, drugs, medical devices, cosmetics, and tobacco products. By FDA’s estimate, the products it oversees in 2025 were valued at $4.1 trillion and accounted for about 21 cents of every dollar spent by U.S. consumers. In general, the FD&C Act prohibits the distribution of a covered product in interstate commerce that is “adulterated” or “misbranded,” and defines, for each product type, the circumstances and standards under which that product is “adulterated” or “misbranded.” Additional statutory or regulatory provisions often further refine the specific federal requirements that apply to specific subsets or components of a product type. Some subsets of drugs, devices, and tobacco products, for instance, must be reviewed by FDA before they can be lawfully marketed, while food and cosmetic products (with the exception of certain ingredients) generally are not subject to premarket review. States have historically regulated many products covered by the FD&C Act based on their general police power to provide for the public health and safety of their residents. State regulation of such products might include statutes specific to certain products, along with more general consumer protection and products liability laws. State consumer protection and products liability laws provide mechanisms by which consumers allegedly injured by a relevant product may challenge the product’s promotion, manufacture, design, and/or warning, on the grounds that the defendant manufacturers should have taken a different course of action with respect to those activities—some of which may be regulated by the FD&C Act and its implementing regulations. Under the U.S. Constitution’s Supremacy Clause, federal law supersedes (preempts) conflicting state law and can do so expressly—through explicit preemption provisions specifying the scope of preempted state law—or impliedly—where a state law is displaced because it conflicts with federal law or because federal law so thoroughly occupies the regulatory field as to leave no room for state activity. Over the FD&C Act’s nearly 90-year history, Congress has amended the law to include provisions that expressly preempt certain state laws that address areas specifically regulated by the FD&C Act, such as state laws imposing requirements on the safety and efficacy of medical devices, labeling requirements for food and cosmetic products, and requirements on certain standards for tobacco products. In other instances, Congress has not spoken specifically to preemption, as is the case for FD&C Act provisions governing prescription drugs. Courts—including the Supreme Court—have frequently considered the preemptive scope of the FD&C Act on state statutes and causes of action—an inquiry the Court has sometimes described as focused on discerning the intent of Congress. In practice, courts often look to the text, structure, and contextual background of the relevant FD&C Act provisions to determine their preemptive scope. This report provides an overview of the courts’ FD&C Act preemption jurisprudence, focusing on the following FDA-regulated products: food products, prescription drugs, medical devices, cosmetics, and tobacco products. Generally speaking, these cases illustrate that while the FD&C Act’s enforcement scheme impliedly preempts a particular type of state fraud claim (i.e., one alleging that an applicant made misrepresentations to FDA during a premarket review process), context-specific analyses are usually required to assess whether other state laws or claims are preempted. In these analyses, courts typically undertake a case-specific, often granular, comparative analysis of what an applicable federal law requires or permits and whether and to what extent the relevant state requirements conflict with federal requirements. The courts’ nuanced approach often results in the preservation of at least some state claims or requirements—a result that arguably reflects the courts’ recognition of states’ long-standing, concurrent role in the regulation of these products. State requirements are most likely to survive preemption where Congress is silent on the interaction of federal and state law, but courts have sometimes understood the FD&C Act’s express preemption provisions as leaving room for certain state requirements. At the same time, courts may be more likely to construe relevant FD&C Act provisions to have broader preemptive effect on certain aspects of product regulation that are not historically regulated by states. These considerations may inform Congress’s decision on whether to modify existing express preemption provisions, add additional express preemption provisions, and consider the appropriate degree of specificity of any such provisions. https://www.congress.gov/crs_external_products/R/PDF/R48915/R48915.1.pdf https://www.congress.gov/crs_external_products/R/HTML/R48915.html

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