FDA Issues Draft Guidance on Cannabis Research

WASHINGTON – The Food and Drug Administration issued a draft guidance establishing rules for lawfully researching cannabis.

The guidance is limited to the development of drugs and does not cover other FDA-regulated products.

Nevertheless, the release of the document and publication of a Federal Register notice seeking comments has been eagerly awaited by cannabis advocates.

The new guidance stems from 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.

Since then officials from the FDA have told the House and Senate Appropriations committees that the agency “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.” 

“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.

“It is critical that the FDA continues to do what we can to support the science needed to develop new drugs from cannabis,” Abernethy continued. “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.”

Hemp and its derivatives such as CBD were legalized in the 2018 Farm Bill. Though CBD is derived from the marijauna plant, it does not give users a high like another chemical in the plant, THC, does.

Currently, cannabis with more than 0.3 percent THC is federally illegal, posing an obstacle for researchers to obtain the substance. 

The agency is asking that comments and suggestions about the draft document be submitted within 60 days of publication in the Federal Register of the notice announcing its availability. That publication is scheduled for Wednesday.

Electronic comments can be submitted here.

Written comments can be submitted to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 

All comments should be identified with the docket number listed in the notice of availability that is in the Federal Register.

For questions regarding this draft document, contact Amy Muhlberg at 240-402-6901 or Cassandra Taylor at 240-402-5290.

“The agency is committed to supporting the development of these new drugs through the investigational new drug, drug review and drug approval processes — and one key element of this support involves development of guidance, like this one,” Abernethy said.