The Food and Drug Administration (FDA) has issued guidance on the development of cannabis-based drugs, outlining the process and unique considerations for scientists when it comes to hemp and marijuana. The guidance, titled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research,” was announced in a notice set to be published in the Federal Register on Tuesday. The agency had previously released a draft version that underwent a White House review in 2020.
What is the FDA Guidance on Cannabis and Hemp?
The guidance is being issued to support clinical research for the development of cannabis and cannabis-derived human drugs. The FDA made several non-binding recommendations for researchers interested in developing cannabis drugs that could go to market. The advice is “intended to address the legal definitions and regulatory controls related to cannabis, and to address certain questions raised about drugs containing cannabis.”
This guidance comes as a result of the federal legalization of hemp in the 2018 Farm Bill, which makes the drug development protocol different for that version of the cannabis crop than it is for marijuana, which remains in Schedule I of the Controlled Substances Act (CSA).
As a general rule, cannabis containing no more than 0.3 percent THC by dry weight meets the federal definition of hemp and is not considered a controlled substance like marijuana, which continues to fall under the purview of the Drug Enforcement Administration (DEA). This means that there is more flexibility when it comes to sourcing federally legal hemp. These products don’t need to come from the limited number of National Institute on Drug Abuse- (NIDA) contracted suppliers for marijuana as long as they are “deemed to be of adequate quality by FDA.”
Research for Cannabis and Hemp Finally Expands
The agency also points out that for “many years,” scientists could only get marijuana from one NIDA-approved farm at the University of Mississippi. DEA has since accepted more manufacturers, giving researchers “new sourcing options” as they pursue cannabis research.
There is also a new section of the guidance that addresses calculating THC to distinguish hemp from marijuana. FDA largely defers to DEA on the matter, but it also advises researchers to “calculate the delta-9 THC content in their proposed cannabis or cannabis-derived investigational drug product early in the development process to gain insight into their product’s potential abuse liability and control status.”
This guidance is meant to walk researchers through FDA’s regulatory mechanisms and explain how investigational new drugs work. It also details basic standards for clinical studies, how combustible drug products differ from oral preparations, storage requirements for researchers, and more.
Meanwhile, advocates, lawmakers and stakeholders are still waiting to see what actions, if any, FDA will take to allow for the marketing of hemp-based products like CBD oil in the food supply or as dietary supplements.
