Closing the Regulatory Gap for Synthetic Nicotine Products

In July 2017 the U.S. Food and Drug Administration announced a new “comprehensive plan for tobacco and nicotine regulation.” This plan focuses on making cigarettes less addictive while facilitating the development of alternative, and less-harmful, nicotine-containing products. 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, resulting in roughly 480,000 deaths per year. But a new consumer product is emerging that could upset the FDA’s plans for a well-balanced regulatory scheme: synthetic nicotine. Synthetic nicotine products currently fall into a regulatory gap because they do not appear to meet the Federal Food, Drug, and Cosmetic Act’s definition of a tobacco product. If this gap remains in place, it is likely that more companies will choose to market synthetic nicotine products 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, this Article explains how the FDA could establish that synthetic nicotine products are drugs under the FDCA’s definition. This Article then concludes with a discussion of the policy benefits of categorizing synthetic nicotine products as drugs.