Regardless of the cannabis source utilized by drug developers, FDA advises that cannabis is held to the same regulatory standards as other botanical raw material, botanical drug substance or botanical drug products.
On July 21, 2020, the U.S. Food & Drug Administration (FDA) issued its draft guidance outlining the agency’s current thinking on the development of drugs containing cannabis or cannabis-derived compounds. Ever since the 2018 Farm Bill legalized hemp, industry participants have been waiting for FDA guidance addressing the marketing of nondrug, hemp-derived CBD products. However, the new guidance does not address those issues; it is expressly “limited to the development of human drugs and does not cover other FDA-regulated products” such as dietary supplements, foods and cosmetics.
In the guidance document, FDA attempts to clarify its current thinking on sources of cannabis used in clinical research in light of the changes brought about by the 2018 Farm Bill. Perhaps the most impactful change ushered in by the 2018 Farm Bill was the removal of hemp (with a THC concentration of no more than 0.3 percent on a dry weight basis) from the definition of marihuana under the Controlled Substances Act (CSA). Prior to this change, as FDA notes, the only federally legal source of cannabis for researchers to use in developing cannabis-related drugs came from the National Institute on Drug Abuse (NIDA) Drug Supply Program (DSP). Now, as FDA instructs in the draft guidance, hemp can be a source of cannabis and cannabis-derived drug compounds, provided it satisfies the THC concentration threshold established by federal law.
Regardless of the cannabis source utilized by drug developers, FDA advises that cannabis is held to the same regulatory standards as other botanical raw material, botanical drug substance or botanical drug products. As such, the recommendations contained in FDA’s Botanical Drug Development (December 2016) industry guidance likewise apply to conducting clinical trials of drugs containing cannabis compounds.
Further, the draft guidance addresses how to calculate the THC concentration in a given plant or compound—a critical metric, given that a slight deviation in concentration percentage can turn an otherwise lawful plant into a Schedule I controlled substance under the CSA. If the THC concentration is above 0.3 percent by dry weight, the researchers utilizing the cannabis must abide by CSA requirements as enforced by the Drug Enforcement Administration (DEA). FDA suggests different calculation steps based on the material being tested. For example, the draft guidance sets out the recommended steps to calculate THC concentration in both (i) a solution-based material, such as intermediate, in-process material or final drug product; and (ii) a solid, oral dosage form, such as a tablet or capsule.
Although the draft guidance provides valuable insight to those interested in developing and testing human drugs containing cannabis or cannabis derivatives, it does not contain any advice to manufacturers, distributors, retailers or consumers in the nondrug, hemp-derived CBD product market―the segment of the U.S. cannabis market fraught with perhaps the greatest lack of clarity. In this respect, the guidance does not change the status quo. FDA has still not issued regulations implementing the 2018 Farm Bill as it relates to hemp-derived CBD products, and thus the federal regulation of those products is still subject to FDA discretion.
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