FDA issues draft guidance on cannabis research
The Food and Drug Administration (FDA) on Tuesday issued a draft guidance that would establish a set of rules for researching cannabis.
The guidance, which is “limited to the development of human drugs and does not cover other FDA-regulated products,” largely informs researchers how to lawfully conduct cannabis research. The guidance has been long-awaited by lawmakers and cannabis advocates.
In March the FDA told the House and Senate Appropriations committees that it “is actively evaluating what and how much data would be sufficient to support a conclusion that CBD can be safely allowed in dietary supplements under certain conditions.”
The new guidance draws on a 2019 public hearing during which industry representatives expressed concern about inaccurate or misleading marketing for products with CBD. Those products are not regulated by the FDA.
“A range of stakeholders have expressed interest in development of drugs that contain cannabis and compounds found in cannabis. Recent legislative changes have also opened new opportunities for cannabis clinical research,” FDA Principal Deputy Commissioner Amy Abernethy said in a statement Tuesday. “As that body of research progresses and grows, the FDA is working to support drug development in this area.”
The 2018 Farm Bill federally legalized hemp and its derivatives such as CBD, distinguishing it from THC-containing marijuana. CBD is derived from the marijuana plant, but unlike THC, it does not give users a euphoric high.
Currently, cannabis with more than 0.3 percent THC is federally illegal, posing an obstacle for researchers to obtain the substance. The farm bill also gave researchers more avenues to obtain marijuana for research.
“This change gives sponsors and investigators of clinical studies new options that do not involve the [National Institute on Drug Abuse Drug Supply Program],” the FDA wrote, referring to the nation’s only federally-authorized marijuana manufacturer at the University of Mississippi.
The FDA said that researchers should work with them and the U.S. Drug Enforcement Agency to see if they are in violation of the law.
“Regardless of whether cannabis or a cannabis-derived compound meets the definition of hemp, sponsors and applicants should work with reliable laboratories for analytical testing,” the FDA wrote.
Paul Armentano, deputy director of the National Organization for the Reform of Marijuana Laws, told The Hill the new guidance falls short of substantive policy change.
“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.
As of now Epidiolex, a treatment from GW Pharmaceuticals to reduce epileptic seizures, is the only FDA-approved product using a cannabis extract.