FDA, NIH Regulators Recommend Amending Regulations to Facilitate Clinical Cannabis Testing

Thursday, 19 September 2019

Washington, DC: The Director of the US National Institutes of Health (NIH) and the Acting Commissioner of the US Food and Drug Administration (FDA) have acknowledged that existing federal regulations hinder clinical cannabis research, and are suggesting that scientists be able to legally access cannabis products from sources other than the University of Mississippi – the only federally licensed supply source of marijuana for research purposes.

In a letter to Sen. Brian Schatz (D-HI), first obtained by Politico, the officials acknowledge that the existing monopoly on federally authorized cannabis production limits "the diversity of [cannabis] products and formulations available to researchers, [thus] slowing the development of cannabis-based medications." The letter's authors suggest both "licensing additional entities to supply cannabis," as well as "enabling researchers holding Schedule I licenses for marijuana to obtain products from state authorized dispensaries" – changes NORML has long argued for.

They conclude that the current regulations governing the clinical study of cannabis, along with the Schedule I status of marijuana under federal law, create "significant administrative cost challenges that slow this research and may deter scientists from pursuing cannabis research altogether."

Since 2016, officials at the US Drug Enforcement Administration have promised to license additional, private producers of research-grade cannabis. As of yet however, the DEA has failed to take action on more than 30 applications pending before it, and the agency has yet to provide a timeline as to when they intend to do so.

Since 1968, only the University of Mississippi has been federally licensed to engage in the growing of cannabis for FDA-approved clinical research. Scientists familiar with the product have consistently said that it is of inferior quality and fails to accurately reflect the types of marijuana varieties commercially available in legal states. Further, the University only provides scientists with the option to access herbal cigarette formulations of the plant, not concentrates, edibles, or extracts. Strains high in the compound cannabidiol (CBD) – a chemical of particular interest to many scientists – are also not currently available from the University.

Earlier this year, Maryland became the first state to enact explicit legislation authorizing academic institutions and researchers seeking to study the "medical use, properties, or composition of cannabis" to obtain source materials from state-licensed cannabis dispensaries.

On Wednesday, members of the United States Senate Appropriations Committee expressed similar concerns that existing regulatory barriers unduly inhibit the clinical study of cannabis.

For more information, contact Paul Armentano, NORML Deputy Director.