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22. January 2021
CBD News North America Regulation Trends & Insight

Analysis: FDA Outlines Framework for Building a Robust Evidence Base for CBD

The U.S. Food and Drug Administration (FDA) released a new article last week which clarified the organisations current activities and work surrounding the CBD industry, as well as introducing a framework for building a more robust evidentiary foundation to inform public health decisions.

In the article, Stephen M. Hahn, M.D., Commissioner of Food and Drugs and Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner summarises the agency’s existing position on CBD.

We still don’t have clear answers to important questions such as what adverse reactions may be associated with CBD products and what risks are associated with the long-term use of CBD products. Better data in these areas are needed for the FDA and other public health agencies to make informed, science-based decisions that impact public health.” writes Hahn.

We see an important public health opportunity in using novel sources of data and rigorous analytical methods to build a more robust base of scientific evidence on the safety profile and use of CBD products. The FDA is uniquely situated to contribute its expertise in evaluating data from different sources to inform regulatory decision-making. We think that real-world data (RWD) on CBD use and safety has a crucial role alongside data from other types of studies to fill in the current gaps in our understanding.” Hahn continues.

The FDA is currently working extensively with industry participants to build a robust library of evidence that can help direct the agency’s CBD policy and form the basis for any future regulatory implementation.

In July 2020, the FDA gathered industry stakeholders regarding the challenges surrounding quality, safety, and monitoring of the current marketplace. Later in the year, a multidisciplinary scientific conference was held to provide further insight into the scientific evidence supporting the presence or absence of sex and gender differences in use and responses to CBD and other cannabinoids.

CBD product testing

Sampling and testing of marketed CBD products is another way that the FDA is gathering information about the safety profile of cannabinoid products. This is an important component of the FDA’s work because little is known about the amounts of CBD and various related cannabinoids, as well as the occurrence of toxic elements, pesticides, and other possible chemical contaminants that may be present in the CBD products marketed to consumers.

The FDA is currently involved in a variety of initiatives to sample and test products in a bid to improve the accuracy of labelling and product claims.

One such project has seen the agency conduct a two-phase marketplace sampling and testing study. The first phase involved a small sampling and analysis study of just 200 samples.

While the data collected so far are from a limited sample size and are insufficient to draw definitive conclusions regarding the prevalence of results in marketed products, general observations indicate fewer than half of the tested products which presented label claims contained CBD at concentrations within 20% of their claimed amount and some products contained the psychoactive, intoxicating cannabinoid THC.” comments Hahn.

The second phase of this research will involve a much larger sample set of some 1000-3000 CBD brands, from a variety of different product classes.

Framework for CBD data projects

Significantly this new article introduces a practical framework for future research and data projects that the FDA hopes can be used to inform public health decisions around CBD usage and safety.

According to the article, “this framework provides the basis for the FDA’s work in the development of research projects that lay the methodological groundwork for high quality RWD science on the safety and use of CBD products. These research projects would be aimed at building upon currently existing independent state and national quality and safety monitoring efforts, observational study data models, and novel data sources to develop more robust capabilities and methods for CBD data collection and analysis.”

We know from experience that collaborative projects with researchers across government, academia, and the private sector can stimulate rapid progress in the development of rigorous methods for collecting and analyzing RWD. Most recently, in the context of COVID-19, collaborative research projects between the FDA and outside data experts have focused on using RWD to improve analytical methods and inform the public health response to the pandemic.” the article continues.

We strongly believe that RWD, when collected and analyzed using rigorous methods, can be important for moving the science forward—including by aiding hypothesis generation and by refining the design of follow-up studies. For example, RWD may identify new potential adverse events or subpopulations of CBD users that should be the focus of follow-up studies.” the author concludes.

To this end the FDA has provided some guiding principles which will be used to help build this necessary evidentiary foundation upon which it plans to base its CBD decisions:

  • Research projects should contribute, where possible, to the development of more sophisticated data infrastructure for understanding the safety and quality of CBD products.
  • Research projects should yield information that helps us refine future studies—for example, by identifying potential adverse events or subpopulations that are most important to study further.
  • Research projects should be designed with the goal of complementing existing work by other public health agencies, such as NIH and SAMHSA, as well as other stakeholders. States provide an important laboratory for novel data collection and analysis. The FDA projects should build on existing efforts at the state and national level to incorporate data from poison control centers, emergency departments, and other potential sources of information about adverse events related to CBD products.

Challenges in current capabilities for collecting data regarding the use and safety of CBD

  • Much of the existing data on CBD use in the general population comes from spontaneously reported adverse events (e.g., from poison control centers), but more systematic data collection and analysis will be crucial for understanding relative safety risks.
  • Rates of CBD use, and rates of use of specific CBD products, are poorly understood. What is the denominator of risk for adverse events in the population taking CBD? What specific populations have the highest CBD exposures and what specific products are frequently used? What other products, such as over-the-counter or prescription drugs, are used alongside CBD products? Are there risks associated with interactions between CBD products and other products, beyond those that have already been identified and communicated by the FDA?
  • Data collection systems may not yet have specific codes that can precisely identify specific CBD products.
  • Longitudinal studies (i.e., studies that provide data about the health of subjects over an extended period of time) are needed to understand long-term health effects of CBD use.

Forthcoming FDA research on CBD

In the coming months, the FDA intends to develop and refine plans for research projects that use the following strategies, among others, to address the gaps in current CBD data research capabilities:

  • Work with existing and emerging data systems (e.g., poison control databases, electronic health records, opt-in consumer/patient registries) to enable precise identification of CBD products that may be associated with reported adverse events through appropriate coding, data curation, and other means.
  • Evaluate approaches to link adverse event data with CBD product sampling and testing data.
  • Collaborate on the development and evaluation of systems and methods, such as an open, opt-in registry for users of CBD, to gain a better understanding of safety outcomes of interest and incorporate data from other sources.
  • Evaluate the use of market-research data and other data sources that provide insights on the use of specific CBD products in different populations.
  • Evaluate use of data linkage approaches to provide insights about safety risks that may appear across time while protecting the privacy of patients and consumers.
  • Evaluate the value of combining multiple research and data approaches to synthesize an aggregate view of CBD safety and quality across the market and across time.
  • Evaluate which strategies are best for safety and quality monitoring for different types of CBD products.

 Source | U.S. Food & Drug Administration