[co-author: Hanna Barker Mullin]

The U.S. Food and Drug Administration (FDA) recently released new guidance on sourcing and product quality to companies conducting clinical research related to the development of human drugs involving cannabis or cannabis-derived compounds. The agency’s nonbinding recommendations highlight potential opportunities for clinical researchers and sponsors of investigational new drugs after the 2018 Farm Bill significantly altered the regulatory landscape applicable to cannabis products.

The 2018 Farm Bill reclassified cannabis and cannabis-derived products with a tetrahydrocannabinol (THC) content lower than 0.3% as “hemp” (rather than “marihuana”), which removed them from the list of Schedule I substances regulated by the Drug Enforcement Agency (DEA) under the Controlled Substances Act (CSA). The DEA still regulates cannabis products with more than 0.3% THC, and the FDA retained the authority to regulate human drugs containing cannabis under the bill.

The National Institute on Drug Abuse (NIDA) Drug Supply Program (DSP) was the only domestic, federally legal source of cannabis for clinical research until 2020, when the DEA adopted new procedures to allow the registration of new cannabis manufacturers. The FDA is now clarifying that clinical studies may use these new manufacturers and advising companies. The agency further clarified that (1) cannabis sources with any delta-9 THC amount may be used for clinical research if “deemed to be of adequate quality by FDA” when reviewed as part of an investigational new drug (IND) application and (2) cannabis may be sourced from a broader list of DEA-authorized suppliers.

With respect to quality standards, the agency announced that it would hold cannabis and cannabis-derived compounds to the same regulatory standards as other botanical materials and drugs.

Cannabis with a delta-9 THC concentration higher than 0.3% is still considered a Schedule I controlled substance and regulated under the CSA. The guidance recommends that sponsors and investigators proposing drug development activities involving controlled substances consult DEA regarding applicable requirements. The guidance further suggests that delta-9 THC content in proposed cannabis or cannabis-derived investigational drugs be calculated early in the development process to gain additional clarity regarding the products’ controlled status.

While not legally binding, the FDA’s recent guidance provides additional clarity about the regulatory landscape applicable to FDA-regulated drug products derived from cannabis and related investigations. This guidance is timely in light of Congress recently passing the Medical Marijuana and Cannabidiol Research Expansion Act, as we have written about previously (here and here).

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