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What is the FDA’s stance on cannabis, and how has it evolved? Join Darshan Kulkarni as he discusses recent FDA guidance on cannabis, and the differences between hemp and marijuana under federal law. Plus, we’ll talk about the basics of the Controlled Substances Act and how federal regulation of cannabis products differs.

Narrator: This is the DarshanTalks Podcast, regulatory guy, irregular podcast, with host Darshan Kulkarni. You can find the show on Twitter at Darshan Talks or the show's website at

Darshan: A really important discussion to be had is about the role of cannabis and drug development in the context of cannabis. As we all know, there is already a product that uses naturally occurring cannabis, or at least components of it, which is Epidiolex by GW pharma, by Greenwich pharma. However, the fact is that there are more and more companies that are interested in doing this, and there's always been this overarching problem about the FDA and the federal government not encouraging research in the cannabis area. To change that, companies have always accused the FDA of hiding the ball if you will. The FDA took a long overdue step of putting out a guidance on how to actually do research in the context of cannabis. They put out a guidance called cannabis and cannabis derived compounds, quality considerations for clinical research guidance for industry.

Darshan: The key portion of this is the idea of how they start by defining a drug. According to the FDA, a drug is any product that is intended to diagnose, cure, mitigate, prevent or treat a disease, or any product other than food intended to affect the structure and any function of the body. Now, the key reason this is interesting is because the FDA takes this position and therefore renders a lot of the state approved or state eligible cannabis... So the products that are available because each state says that as long as you meet these criteria, we're going to allow you to make drug-like claims. Suddenly those are rendered drugs under the definition of the federal food, drugs, and cosmetics act. And it's not suddenly, it's always been the case, but the FDA is sort of putting it down again.

Darshan: In 2018, there was the farm bill, which changed how cannabis is treated on the controlled substances act. So essentially what they came up with, and they said, that there's a new definition of hemp, which includes cannabis and derivatives or extracts of cannabis with no more than 0.3% by dry weight of the compound of Delta-9-THC. So the bill removed hemp from the definition of marijuana provided in section 102 of the controlled substances act, which means that hemp is no longer a controlled substance under federal law.

Darshan: So essentially now you've got to think about hemp and you've got to think about marijuana. Marijuana is still technically a regulated under the controlled substances act, but hemp has been pulled out from under it. And you qualify for hemp only if you have no more than 0.3% by dry weight of THC in it. The key component and the key question that companies have asked over and over and over again is, "Where do we get the cannabis?" For the most part sponsors, including sponsored investigators are required to meet all FDA requirements to conduct human clinical trials, regardless of the source of cannabis or any other botanical product under studying the trial.

Darshan: NIDA, which is a National Institute of Drug Abuse, drug supply program provided the only domestic federally legal source of cannabis for clinical research. So cannabis for this drug supply program was grown under contract by the University of Mississippi at the National Center for Natural Products, natural products research. But the 2018 farm bill changes that, essentially saying that under the 2018 farm bill, hemp may be produced as a source of cannabis and cannabis derived compounds for drug development if they do not contain Delta-9-THC at more than 0.3% by dry weight. And this gives sponsors and investigators new options that do not involve NIDA.

Darshan: So the big question that kept coming up is, "How do we do research if we can't get the product?" Well, now you have a way of getting the research and NIDA is not the only source of product for it. Now the key important piece that the FDA has come out and emphasized is the idea that cannabis will be held to the same regulatory standards as any botanical raw material, botanical drug substance, or botanical drug product. So sponsors are expected to show that they can consistently manufacture a quality product. So saying that there is natural variability is not going to fly. Sponsors will be required to submit sufficient information to ensure the identity, quality, purity, potency, or strength of the investigational drug. Providing qualitative quantitative data regarding the phytochemicals that are present in this proposed product, not including cannabinoids, terpenes, and flavonoids will be essential.

Darshan: Now what's interesting here is that a lot of individuals have reached out to me and asked me about things like, "What if we want to use cannabis in the context of vaping?" If a device has to be used in combination with a drug, the product is considered to be a combination product and must comply with CGMP, which is Current Good Manufacturing Practices, including requirements for design controls. So suddenly your vaping mechanism would be deemed the device and you need to comply with the standards required under it. Also remember that if you are providing the cannabis, or the hemp to be more specific, you need to make sure you have the right container closure system. So you should adequately characterize and do appropriate safety assessment of extractables and leachable compounds.

Darshan: The guidance lastly gets into one more component, which is regardless of where the cannabis or cannabis derived compounds meet the definition of hemp, sponsors will be required to work with reliable labs for analytical testing. So phase one studies have a guidance. You need to use that. If you have phase two and phase three studies for NDA submissions, labs must use validated analytical methods and applicants must provide those methods in their application.

Darshan: They give very specific definitions of how they expect you to calculate the 0.3%, Delta-9-THC by dry weight and that's going to be important as you continue. So if you want to look at that, that might be important. If you have questions about how this applies to you and what the guidance means to your company, feel free to reach out to me. You can find me on Twitter at Darshan Talks. You can go to our website at darshantalks. And you can reach out to me via email at darshan[at] And I just look forward to hearing from you.

Narrator: This is the DarshanTalks Podcast, regulatory guy, irregular podcast, with host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website at

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