Lessons for cannabinoid regulation from electronic nicotine delivery system product regulation.

Abstract

Cannabis legalization continues to spread, with 38 states permitting the use of medical marijuana, 22 states permitting recreational use, and growing political momentum for federal legalization. The last time the Food and Drug Administration (FDA) was tasked with regulating a new product occurred with 2009's Family Smoking Prevention and Tobacco Control Act, which created the Center for Tobacco Products (CTP). Thus, the time is ripe to review the history of CTP with particular attention to difficulties the nascent center faced in regulating novel products such as e-cigarettes or electronic nicotine delivery systems (ENDS). Specifically, FDA has struggled with defining its scope of authority, determining which review pathway(s) to utilize, and promulgating timely and transparent product standards for marketing authorization-all of which offer lessons for improving cannabis product oversight and enforcement.