The Food and Drug Administration and Drug Legalization: A Brief Model of Regulation

Abstract

This paper offers a brief model of FDA regulation of currently illegal narcotics in the United States. Given that nearly three out of four Americans believe that the drug war has failed, recent calls from prominent liberal and conservative thinkers to legalize drugs, and state “compassionate use†ballot initiatives, future drug legalization is at least conceivable in the United States. Yet, how would the FDA regulate NLD’s under its current statutory mandate and agency discretion. To answer this question, this paper applies current FDA regulation procedures, derived from the Food, Drugs, and Cosmetic Act (FDCA) to the regulation of NLD’s. Part One of this paper considers the trend toward drug legalization in the United States: the apparent failure of the drug war, calls for legalization from prominent Americans, state medical marijuana referenda, and the historical analogies cited by proponents of drug legalization to America’s failed alcohol prohibition regime (1920-33). Secondly, it describes a hypothetical drug legalization regime, using the marketing of recreational and medicinal marijuana as hypothetical NLD’s. Thirdly, it considers the threshold question of whether the FDA indeed has statutory authority to regulate NLD’s without statutory amendment to the FDCA.