Closing the Regulatory Gap for Synthetic Nicotine

In July 2017 the U.S. Food and Drug Administration (FDA) announced a new “comprehensive plan for tobacco and nicotine regulation.” This plan is focused on making cigarettes less addictive while facilitating the development of alternative nicotine-containing products that are far less harmful. This approach holds promise, and the public health stakes could not be higher—smoking is the leading cause of preventable death in the United States, causing roughly 480,000 deaths per year. But a new product is emerging that could upset the FDA’s plans for a well-balanced regulatory scheme: synthetic nicotine. These products currently fall into a regulatory gap because they fall outside the Federal Food, Drug, and Cosmetic Act’s (FDCA) definition of a tobacco product. If this gap remains in place, it is likely that more companies will exploit it in order to evade regulation, undoing the potential benefits of the FDA’s plan for tobacco and nicotine regulation. This Article argues that the FDA can, and should, address this problem by regulating synthetic nicotine products as drugs. After reviewing the science of nicotine addiction and the FDA’s past and present regulatory schemes for nicotine, it explains how the FDA could establish that synthetic nicotine satisfies the FDCA’s definition of a drug. It concludes with a discussion of the policy benefits of categorizing synthetic nicotine as a drug.Citation: Patricia J. Zettler, Natalie Hemmerich, & Micah L. Berman, Closing the Regulatory Gap for Synthetic Nicotine, 59 B.C. L. Rev. ___ (forthcoming 2018).