About Effects Of CBD And ‘Emerging’ Cannabinoids Like Delta-8 THC
The Food and Drug Administration (FDA) announced that it plans to use Reddit and other “novel” data sources to gain a better understanding of public health issues surrounding the use of CBD and other “emerging” marijuana derivatives like delta-8 THC.
The agency published a report on its new Cannabis-Derived Products Data Acceleration Plan this week, explaining that the federal agency “needs robust information about potential safety problems or adverse events associated with FDA-regulated products, including [cannabis-derived products],” or CDPs.
“FDA also needs information about general patterns of product use and emerging trends—and it needs this information in close to real-time so that the FDA can deploy its limited resources quickly and effectively,” it said. “The FDA believes that new approaches to detecting safety signals and other insights using diverse data sources and rigorous analytical methods can contribute significantly to FDA’s ability to respond to emerging and rapidly evolving product areas, like the CDP market.”
To get the new initiative started, FDA first examined existing data collection and analysis methods, including “third party purchase data and surveys to traceability systems and mobile apps.” This initial step enabled the agency to identify data gaps and refine the process.
As it solicits partnerships to further advance data-based health research into cannabinoids, the agency said there are a series of projects that are in the “feasibility assessment phase.” One of those would involve looking at consumer-generated content such as posts on Reddit in order to “identify issues that may not be easily captured via traditional systems.”
Another potential project would involve comparing the FDA’s database of CBD product samples with Certificates of Analysis to identify “inconsistencies and quality issues.”
The agency also wants to develop a system of finding “safety signals and usage patterns associated with emerging CDPs in real-time.” That includes delta-8 THC, a cannabinoid that the agency recently warned consumers about, as it has not yet evaluated its safety or efficacy.
Other cannabis-derived compounds the agency is interested in learning about include delta-10 tetrahydrocannabinol (delta-10 THC), cannabinol (CBN), tetrahydrocannabivarin (THCV), and cannabigerol (CBG).
“Overall, the growth of the CDP market continues to outpace the growth in the science and our understanding of the public health implications of these products. The size and complexity of the CDP market—coupled with the public health concerns associated with CDPs—requires the efforts of diverse stakeholders, including FDA and other federal, state, local, territorial, and tribal government entities, academia, and industry, to identify new ways of detecting safety signals and accelerating appropriate research studies, including but not limited to rigorous toxicology studies.”
In January, FDA separately said that it would be taking steps to fill gaps in research about the safety and efficacy of CBD.
The agency said it would be working to improve CBD product identification, increase product sampling as it relates to reports of adverse effects, help develop a register of CBD consumers, look at market research data and evaluate “which strategies are best for safety and quality monitoring for different types of CBD products,” among other practices.
Last year, FDA released draft guidelines that are meant to streamline approvals for generic oral CBD medications. The agency also held a comment period on separate draft guidance on developing cannabis-derived medications. The agency was mandated under appropriations legislation enacted in 2019 to provide an update on its regulatory approach to CBD, and it did so in March 2020
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