The FDA Issues Guidance For Cannabis Research
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Scientists researching cannabis in the US now, finally, have some guidance to go off.
On January 23, the US Food and Drug Administration (FDA) released its long-awaited guidance document on clinical cannabis research, “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry”.
This guidance outlines the FDA’s “current thinking” on topics relevant to clinical research related to the development of human drugs containing cannabis or cannabis-derived compounds.
The guidance is not currently "binding" and comments and feedback can be submitted at the FDA website.
A few words of advice from the FDA
The FDA is one of the most important US federal agencies when it comes to cannabis regulation. It oversees everything from pharmaceutical drug development to the health and wellness supplement market to veterinary products, and so can exert a tremendous amount of influence over the fast-diversifying cannabis industry.
The agency first issued some guidance to scientists in July 2020, although this document was deemed a draft. Now, the agency has clarified its guidance for those researching cannabis and its derivatives for clinical use. This guidance includes the following:
- Sources of cannabis with not more than 0.3% delta-9 THC and those over 0.3% delta-9 THC (on a dry-weight basis) may be used for clinical research if deemed to be of adequate quality by the FDA when reviewed as part of an investigational new drug (IND).
- Sponsors and investigators may use the National Institute on Drug Abuse’s (NIDA’s) approved sources of cannabis or they may use other sources authorized by the Drug Enforcement Agency (DEA) to provide Schedule I cannabis materials for research.
- As part of an IND for any drug, sponsors are expected to show that they can consistently manufacture a quality product.
- Highly purified substances of botanical origin are considered analogous to conventional synthetic single-chemical active pharmaceutical ingredients. However, a naturally occurring compound isolated from a botanical source would be expected to have a different impurity profile from the corresponding synthetically produced cannabis-related compound.
- If a device is to be used in combination with a drug (such as an inhaler), the product is considered to be a “combination product” and must comply with current good manufacturing practice requirements.
- Sponsors and applicants should consider their container closure system carefully. As drug development progresses, applicants pursuing FDA approval should generate adequate characterization information and safety assessment data for extractable and leachable compounds to support a marketing application.
- Assays to characterize the metabolic profile of major cannabinoids in humans and in toxicology species should be developed early to avoid delays in development.
- Sponsors and investigators may find it useful 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.
Further elements of the new guidance can be found here.
The FDA and cannabis
The FDA really began taking a closer look at cannabis regulations after December 2018, when the then-president passed the Farm Bill, a piece of legislation that legalized the production and sale of hemp (cannabis with less than 0.3% THC).
In more recent years, the agency changed leadership; the US Senate voted in February 2022 to confirm Robert M. Califf as the new commissioner of the FDA, a role he previously held under the Obama administration. The response to this confirmation from within the hemp and cannabis industry was generally positive, as Califf previously expressed support for medical cannabis research.
“I’m heartened to have heard in his testimony that Dr. Califf does also want to expand access to international research, which has been something that the FDA has been hard-pressed to do in the last few years,” Sarah Chase, executive director of the Council for Federal Cannabis Regulation told Analytical Cannabis last year.
“I think that the doors are opening here in a good and positive way. Again, they now have a leader who I think is going to take them forward effectively.”
Some of the agency’s more recent actions since that appointment have included issuing warning labels to makers of CBD and delta-8 THC products. The CBD products, according to the FDA, were marketed in a way that may have led consumers to purchase them without realizing they contained CBD. The delta-8 THC products were reportedly “illegally marketed” as unapproved treatments for various medical conditions.
*This article was updated on July 25, 2023, to include reference to the FDA's draft research guidance, which was issued in 2020.