WASHINGTON, D.C. – The Food and Drug Administration (FDA) this week released draft guidelines for the creation of cannabis research regulations. The guidance titled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry,” describes the agency’s “current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds.”
Official guidelines have been anticipated by cannabis industry members and legislators for some time, especially as the legal CBD market has expanded. Reputable hemp and CBD makers have led the call for more regulatory guidance from the FDA as the market has been flooded with unregulated, and often unsafe products. The Agriculture Improvement Act of 2018, which first outlined how hemp and its derivatives including CBD could be used, was passed in December of 2018, but did not include a great deal of specificity.
“A range of stakeholders have expressed interest in development of drugs that contain cannabis and compounds found in cannabis,” FDA Principal Deputy Commissioner Amy Abernethy M.D., Ph.D said. “Recent legislative changes have also opened new opportunities for cannabis clinical research. As that body of research progresses and grows, the FDA is working to support drug development in this area.”
One of the key changes proposed by the FDA would greatly expand research opportunities, making research of hemp and CBD products a bit easier for scientists to conduct. Previously, researchers could only analyze cannabinoids sourced from the National Institute on Drug Abuse Drug Supply Program grown under contract by the University of Mississippi at the National Center for Natural Products Research. Under the draft guidance, scientists would be allowed to use hemp acquired from other sources as long as it contains no more than 0.3 percent THC.
“It is critical that the FDA continues to do what we can to support the science needed to develop new drugs from cannabis,” Abernethy said. “The FDA believes the drug approval process represents the best way to ensure that safe and effective new medicines, including any drugs that contain cannabis or cannabis-derived compounds, are available to patients in need of appropriate medical therapy.”
Paul Armentano, deputy director at NORML, does not believe the draft guidelines provide enough clarity for producers. “As best I can tell, these newly proposed guidelines provide little if anything in the way of substantive new guidance that will significantly address the existing untenable situation,” he said.
The FDA’s draft guidance currently is open for public comment. The comment period will close September 21, 2020.
“Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date,” the agency said.