US FDA Draft Guidance for the Cannabis Industry Released
Many in the Industry Disappointed by Lack of Guidance in Key Areas – LPC
The much-anticipated US Food and Drug Administration (FDA) draft guidance for the cannabis industry was released on July 21. The nine-page document is officially titled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry”. It covers sources for clinical research, information on quality considerations, and other recommendations for both cannabis and hemp-derived compounds.
“A range of stakeholders have expressed interest in development of drugs that contain cannabis and compounds found in cannabis,” said FDA Principal Deputy Commissioner Dr. Amy Abernethy. “It is critical that the FDA continues to do what we can to support the science needed to develop new drugs from cannabis.”
But many say the FDA draft guidance for the cannabis industry doesn’t go far enough. That’s particularly true in terms of guidance for non-medical CBD use such as in dietary supplements.
“This is our latest disappointment,” said Jonathan Miller, general counsel of the US Hemp Roundtable. “Many of us were really hopeful this might be the long-awaited effort to regulate CBD as a dietary supplement. Unfortunately, this document—this public guidance—is exclusively focused on CBD as a drug.”
What many applaud though is the fact that it recommends a new, more accurate method for calculating THC. Researchers have called for a standard cannabis unit system.
Hopefully, these guidelines will encourage a loosening of cannabis research restrictions, which some call a danger to public health. But they will likely not do anything to change the fact that the US Drug Enforcement Agency (DEA) will review all cannabis research applications. This has also been seen as a major hurdle to cannabis research in the US.
Stakeholders have 60 days to comment on the FDA draft guidance for the cannabis industry. The FDA will write its final version after that.
This editorial content from the LPC News Team provides analysis, insight, and perspective on current news articles. To read the source article this commentary is based upon, please click on the link below.
