For nearly 25 years, states across the U.S. have passed laws legalizing the use of cannabis as medicine. As of the November 2020 elections in the United States, 36 States plus the District of Columbia, Guam, Puerto Rico and the U.S. Virgin Islands allow the use of cannabis-based products for medical purposes, despite the drug’s continued status as a Schedule I substance under the Federal Controlled Substances Act (CSA).¹ State cannabis laws are protected, due in part to an amendment known as the Rohrabacher-Farr amendment, which Congress has passed each year since 2014. The amendment dictates that the Department of Justice (DOJ) cannot use federal funds to prevent states from implementing their own medical cannabis laws.² However, at times the DOJ must assist the U.S. Food & Drug Administration (FDA) in enforcing the Food, Drug & Cosmetics Act as it relates to cannabis-based products. Therefore, confusion and tension remain surrounding the FDA’s role in protecting public health as it relates to cannabis- and hemp-derived products.

A review of individual state regulatory approaches to the manufacturing and sale of cannabis for medical use reveals a myriad of differences surrounding who enforces the laws, who is responsible for product testing and oversight, as well as the standards and methods required for such testing. This patchwork approach ultimately impacts products that end up in the hands of patients ‒ a major concern when you consider the serious health conditions for which people use cannabis-based products. Without federal oversight by the FDA of the production, testing and labeling of cannabis-derived products, the impact on patients’ health could be detrimental.

More high-quality, controlled human clinical trials of cannabis-based products ‒ required of the FDA for all medicines ‒ is crucial. Without rigorous research, there will continue to be incomplete information about how cannabis-based therapies both help and harm patients. Legislators must support policies that will incentivize the development of cannabis-based medicines that have been subject to rigorous clinical research, demonstrated safety and efficacy, and obtained regulatory approval. Along with other necessary legal and regulatory changes, de-scheduling or rescheduling cannabis could be a useful step to bolster access and support research. Such action ultimately protects the health and safety of Americans.