FDA Launches Aggressive ‘Cannabis-Derived Products’ Study Protocol
If you can’t measure it, you can’t manage it.
With cannabis-derived products (CDPs) outpacing the existing science and imposing massive health concerns, in October 2021 the FDA issued a “Cannabis-derived products data acceleration plan” (DAP) to detect safety signals and accelerate research studies.
Comprised of hundreds of manufacturers selling products online, CDP’s fragmented and dynamic market requires greater clarity as to the supply chain’s quality and safety systems, which the CDP DAP addresses through:
Evaluating current data sources
Cultivating collaborative partnerships
Accelerating CDP scientific safety and toxicology research
Piloting CDP data acceleration initiatives
CDPs and the FDA
Budgeted at $6.1 billion, the FDA protects and promotes public health through controlling and supervising food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, cosmetics, animal foods and feed, and veterinary products.
Like all emerging substances, CDPs challenge the FDA’s ability to execute its mandate, and because marijuana-derived products cannot be sold across states lines (and, thereby, elude federal oversight), the FDA is focusing on hemp-derived products like cannabidiol (CBD).
Generating $4.6 billion in annual revenue and spanning thousands of FDA-approved and unapproved human and animal drug, food, beverage, cosmetic, and dietary supplement products, CBD is sold across diverse distribution channels not easily tracked by traditional third-party data providers or surveillance methods.
Further, while still nascent, emerging hemp-derived cannabinoids products (including delta-8-tetrahydrocannabinol, delta-10-tetrahydrocannabinol, cannabinol, tetrahydrocannabivarin, and cannabigerol) impose evolving public health concerns of known or potential safety problems, lack of labeling information, potentially misleading product claims, and product adulteration.
CDPs and the DAP
Focusing on advancing “data-driven safety signal detection” and building advanced technological capabilities, the FDA’s DAP leverages novel data sources and analytics to identify “CDP market safety and consumer vulnerabilities,” forges state data partnerships, champions evaluative scientific research, and launches CDP data acceleration initiatives.
First, to grasp the current CDP data landscape, available datasets, and collection method capabilities, the FDA evaluates data sources/providers, ranging from third-party purchase data and surveys to traceability systems and mobile apps enabling:
Proactively identifying CDP safety signals (including adverse events from online activity and content)
Monitoring and evaluating a digital-first market with thousands of companies across multiple product categories and forms
Understanding CDP usage motivations and patterns
Understanding how CDP safety misinformation impacts consumer behavior, and identifying education and outreach opportunities
Informing scientific, healthcare, and social-related CDP research
This analysis aims to generate healthcare opportunities like understanding human/animal healthcare providers’ role in promoting/preventing CDP consumption, determining if CDPs are replacing approved prescription and over-the-counter drug products, evaluating whether human/animal healthcare data can inform CDP safety gaps or identify consumer vulnerabilities, and understanding healthcare provider knowledge, practices, and needs related to improving/reporting CDP adverse events.
Second, the FDA is partnering with states to harness respective “CDP usage and adverse events insights,” developing an inter-agency scientific agenda for CDP through a National Toxicology Program pilot initiative, and collaborating with the Centers for Disease Control and Prevention to pursue CDP public health strategy and epidemiological intelligence.
Third, the FDA is conducting toxicology, safety, and quality initiative research including CBD’s impact on the male reproductive system, CBD’s transdermal penetration and pharmacokinetics, CBD’s impact on neurological development, risk of liver injury from CBD, characterization of chemical constituents for smoked hemp flower and vaped cannabis products, in vivo and in vitro toxicity studies, and ingredient labeling accuracy.
Fourth, DAP is launching “CDP data acceleration initiatives,” testing the feasibility of using advanced analytical tools and data sources to detect safety signals associated with CDPs. For example, one initiative regards analyzing Certificates of Analysis (“COA”) to evaluate whether a CDP’s actual ingredients match what manufacturer/seller is representing. COAs are used by product manufacturers to express both the product’s quality and that its THC levels are below the requisite threshold. To identify inconsistencies and quality issues, this initiative maps product COA data against data collected via FDA’s CBD product sampling project, which tests for cannabinoids, toxic elements, pesticides, residual solvents, and microbial pathogens. The initiative also seeks to ascertain how consumers access and use COA information, hurdles to accessing COA documents, and opportunities to improve COA access and communication to consumers.