How the FDA is Filling CBD Research Gaps with Real World Data

The market for cannabidiol (CBD) products continues to experience explosive growth since the passing of the 2018 Farm Bill, which legalized the production and sale of industrial hemp products containing less than 0.3% THC. As hemp manufacturers respond to rising consumer demand, the FDA is working to fill in data gaps about CBD, such as why it is effective and if there are any effects from long-term use.

In January of 2021, the FDA released an announcement titled, “Better Data for a Better Understanding of the Use and Safety Profile of Cannabidiol (CBD) Products.” With so many questions surrounding CBD use, the announcement went into extensive details on how the FDA would obtain answers.

In this article, we will cover how the FDA is filling the current gaps in CBD research and the real-world data being uncovered as we explore the following topics:

  • Data and input from stakeholders in the CBD market
  • CBD product sampling and testing activities
  • Real-world data and evidence

Data and Input from Stakeholders in the CBD Market

It is encouraging that the FDA is not only performing research on CBD itself but also gathering input from external sources. CBD stakeholders have access to a docket that was created in May of 2019 during a hearing following the passing of the 2018 Farm Bill. This is a public request for comments that opens the line of communication for these stakeholders to share data related to safety, medical research, and market industry trends and findings related to CBD. As of this writing, more than 4,500 comments have been submitted.

The FDA will also hold regular sessions to better understand scientific evidence and receive regular input from CBD stakeholders. Additionally, the FDA will keep these stakeholders informed of any drug reviews, potential changes to FDA regulations, documented approval processes and comments from industry experts.

CBD Product Sampling and Testing Activities

Product sampling and testing are key components to gathering the most relevant data related to the safety of CBD products. To gain this invaluable information, the FDA is currently testing CBD products to check for the presence of toxic or chemical contaminants and to confirm that the products contain the promised levels of cannabinoids.

The FDA created a two-phase CBD testing survey. The first phase involves a sampling of close to 200 products. The results confirmed that unwanted ingredients such as toxic lead or THC were below the level of reporting (the LOD), if they were present at all. In addition, of the CBD product samples tested, less than half contained within 20% of the cannabidiol concentrations they claimed to have on their label declarations.

The second phase is still rolling out and will be conducted by a third party that will involve a much larger sample set of between 1,000 and 3,000 products. As the findings for both phases become available, we will monitor the results and share updates here on our blog.

Real-World Data and Evidence

The FDA will also incorporate real-world data and evidence to better understand CBD use. Real-world data (RWD) is directly related to sources such as electronic health records, claims and billing activities, and mobile devices that track health status. Researchers at the FDA can analyze this type of data looking for patterns that support findings about how CBD is being used, among other conclusions.

To gather real-world evidence (RWE), the FDA can use study methods such as large sample trials, observational studies and randomized trials. With proper scientific safeguards such as double-blind tests and control groups, it is possible to more accurately determine the effectiveness of CBD products. (See our recent post about exciting CBD studies in 2021 for examples currently underway.)

produce the most accurate results and findings that will benefit CBD users, stakeholders and the industry as a whole.

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