FDA Releases Guidance for Cannabis
This document is the final version of the 2020 guidance that went through a White House review. This reformed guidance is necessary, says the FDA, because hemp, now legal at the federal level due to the 2018 Farm Bill, has different drug development protocols than cannabis.
Cannabis is still a Schedule I controlled substance under the Controlled Substances Act (CSA).
“This guidance outlines FDA’s current thinking on several topics relevant to the development of cannabis and cannabis-derived human drugs, including the source of cannabis for clinical research,” the FDA said. Adding, “this guidance is being issued to support clinical research for development of cannabis and cannabis-derived human drugs.”
The FDA provided several suggestions for scientists seeking to create cannabis-based medications. These recommendations are not mandatory.
Details on FDA Guidance for Cannabis
Among the recommendations made by the FDA regarding cannabis is to “address the legal definitions and regulatory controls related to cannabis, and to address certain questions raised about drugs containing cannabis.”
The FDA considers cannabis hemp so long as it has a THC content of 0.3% or less by dry weight. It is not a controlled substance like cannabis, which is still under the DEA’s jurisdiction.
The guidance document has changed since the FDA first released it in draft form. It now includes more detailed information on where researchers can legally obtain cannabis for drug development.
As well the guidance document allows for more options for obtaining federally legal hemp for research purposes.
Researchers no longer need to rely on a limited number of National Institute on Drug Abuse (NIDA) contracted suppliers for cannabis as long as the FDA has deemed the hemp to be of adequate quality.
In the past, scientists could only obtain cannabis from one NIDA-approved farm at the University of Mississippi. However, the DEA has approved more manufacturers, providing researchers with new options for sourcing cannabis for research purposes.
Cannabis Vs. Hemp
While technically, cannabis and hemp are the same plant genus, the FDA’s new guidance defines how they’re separate. The guidance addresses how to distinguish hemp from cannabis based on THC content.
The FDA primarily defers to the DEA on this matter. But they advise researchers to calculate the delta-9 THC content in their proposed cannabis or cannabis-derived investigational drug product. Preferably, says the FDA, early in the development process.
The FDA notes that even if the starting materials meet the definition of hemp, intermediates or drug products that contain more than 0.3% THC may no longer meet that definition. And, therefore, may be considered Schedule I controlled substances.
Farmers and researchers have pointed out that this could be problematic. Environmental factors and manufacturing processes can affect THC levels and potentially make a legal crop into a controlled substance. They have called for more flexibility in the total THC concentration.
FDA & Cannabis: The Takeaway
Overall, the FDA’s guidance aims to provide an overview of its regulatory mechanisms and explain how investigational new drugs work. It covers basic standards for clinical studies, how combustible drug products differ from oral preparations, storage requirements for researchers and more.
However, everyone is still waiting for the FDA to take steps to approve the sale of hemp-based products such as CBD oil as food or dietary supplements.
FDA officials have said that they are evaluating whether CBD can be used safely over a long period. Also, what effects might it have during pregnancy? The recent increase in the popularity of delta-8 THC products, which the DEA says aren’t controlled substances, has added complexity to the regulation process, says the FDA.
All this is taking place as part of the Biden administration’s slow crawl to legalization. The FDA’s recommendation will not be mandatory. Officials anticipate that the DEA will soon provide a scheduling recommendation that aligns with the FDA’s guidance about cannabis.