Eugenics and the Development of U.S. Food and Drug Law

Daniel A. Kracov


The Food and Drug Administration (FDA) and its core statutory authorities have a complex and storied history. Historians and lawyers recounting the agency’s early development—which roughly spanned from the debates culminating in the Pure Food and Drug Act of 1906 to the enactment of the Federal Food, Drug, and Cosmetic Act of 1938—typically cite a long list of influences, including coalitions and clashes among various business and consumer interests in an emerging national market for foods and medicines, product safety tragedies, “muckraking” journalists and the publication of Upton Sinclair’s The Jungle, and a shift from a laissez-faire era to federal regulatory power in a growing nation. Yet, as in other fields, another influential factor in that critical period typically goes unnamed or unexamined: eugenics.

Eugenics is the now-discredited notion that scientists and policy makers could rank human beings by race and eventually engineer what they believed was an optimal population by controlling heredity and eliminating what they called “degeneracy”— the proliferation of those considered “unfit.” While there were many areas of focus, the eugenicists’ beliefs and activities had two primary tracks: so-called “positive” eugenics—in which the focus was on increasing reproduction in favored races and improving hygiene—and “negative” eugenics—meaning, reducing the reproduction, such as through involuntary sterilization of the “unfit.” Ultimately, the goal of the eugenics movement was “a biologically superior race, which would gradually wipe
away the existence of all inferior strains.”

Today, issues relating to race and diversity are certainly an FDA focus in terms of clinical trial populations, regulatory science that may address disparities, vaccine hesitancy, and tobacco product use, among other areas. And other race-related issues and controversies have periodically emerged as an explicit issue in FDA regulation, such as in the initial scrutiny of the agency’s approval of the drug BiDil® (isosorbide dinitrate/hydralazine), a heart failure drug that was approved in 2005 for the treatment of “self-identified black patients.” However, as detailed herein, history suggests that we should dig deeper to better understand the potential role of eugenics as a formative and early ideological influence on FDA.