The Food and Drug Administration Won't Budge on Cannabis and Hemp

• Jurisdiction: United States,Federal
• Citation: Vol. 1 No. 3
• Publication year: 2023

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Eric P. Berlin, Joanne Caceres, and Amy Rubenstein ^*

After discussing two recent announcements by the Food and Drug Administration relating to cannabis or cannabinoid compounds and products, the authors contend that Congress must take action to end the stalemate between federal and state laws and the "purgatory of FDA selective enforcement."

Two recent announcements by the Food and Drug Administration (FDA) affirm that the agency will not compromise—or create new standards—in evaluating or permitting cannabis or cannabinoid compounds and products, and particularly cannabidiol (CBD). Congress must take action to end the stalemate between federal and state laws and the purgatory of FDA selective enforcement.

Guidance on Cannabis Research: More of the Same

The FDA recently published its guidance entitled, "Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research." ¹ The guidance only minimally updated the FDA's 2020 version. Two takeaways from this guidance are (1) the guidance applies only to "products that meet the legal definition of a drug under the FD&C Act," and (2) except for clinical research products, hemp and cannabis are not distinct categories based on federal legality; generally, the FDA's concerns for both substances are the same.

The Federal Register Notice summarizes the guidance's purpose:

This guidance outlines FDA's current thinking on several topics relevant to the development of cannabis and cannabis-derived human drugs, including the source of cannabis for clinical research; general quality considerations for developing human drugs that contain cannabis and cannabis-derived compounds; and calculation of percent delta-9 tetrahydrocannabinol

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(THC) in botanical raw materials, intermediates, drug substances, and drug products to determine their control status. This guidance is being issued to support clinical research for development of cannabis and cannabis-derived human drugs. ²

The FDA Guidance Relates to Drug Products

Notably, the FDA made clear that the guidance applies only to drugs. Its website posting notes: "The recommendations in this guidance are intended for 'products that meet the legal definition of a drug under the FD&C Act,' i.e., '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 or any function of the body,' including 'any product (including one that contains cannabis or cannabis-derived compounds) marketed with a claim of therapeutic benefit, or with any other disease-related claim.'" ³

Understanding what qualifies as a "claim" is critical because many products sold in the current state cannabis markets or hemp...