FDA Releases Guidelines for Cannabis-Based Drug Development Research
On Tuesday, July 21st, the U.S. Food and Drug Administration published the preliminary guidelines regarding marijuana-related clinical research, drafting how businesses should go about looking to get federal approval for drugs containing cannabis or its derivatives. And even though the agency is still working out regulations for products containing CBD, we can already conclude that the pathway for federal legality will always include double-blind, peer-reviewed clinical trials.
The state of CBD in the US
Since the 2018 Farm Bill was signed into law, CBD has remained in a regulatory grey area because, although the bill legalized the hemp plant, it did not explicitly legalize CBD. It basically just handed it over from the DEA to the FDA. And since the FDA has approved Epidiolex, a drug that contains CBD, the organization’s stance is that, being a drug, it cannot be freely added to foods, drinks and lotions, nor can the companies marketing these products make health claims about their CBD-based goods. As we have seen, there are certain studies claiming CBD has potential to cause liver damage and, generally speaking, the FDA has been quite strict (and rightfully so, often times), when it comes to companies not following the ‘no health claims’ guidelines. The main concern of the organization, at this point, is to conduct the due diligence to be able to finally provide businesses and companies with clear guidelines, that would insure the compliant companies’ market presence and legitimacy once and for all. Currently, the FDA opened a 60-day period for stakeholders to comment and criticize the guidelines. A separate period is still open for CBD.
What do these guidelines introduce?
The guidelines published on Tuesday specifically outline the steps and procedures to conduct federally approved research for developing a drug development, mentioning aspects like where researchers can legally obtain marijuana, and stressing the vital importance of methodological and product consistency. The main change introduced by the 2018 Farm Bill is that the cannabis plant is federally legal as long it contains less than 0.3% THC. Researchers can now access hemp products from other manufacturers that meet that definition, rather than relying on the NIDA DSP, the only federally authorized cannabis supply, produced at the University of Mississippi.
The FDA is warning researchers that a concentration of THC above 0,3% could amount to breaking the DEA regulations, and advises to consult with the agency in regards to that aspect. Researchers applying to investigate a new cannabis-based drug are required to provide quantitative data on the THC contents of their product, along with thorough descriptions of the employed testing methodology.
