Since the 2018 Farm Bill passed Cbd Products containing less that 0.3%THC have become legal on the open US market. The public’s interest in CBD products has grown dramatically in the last few years, although scientific studies on the effects and potential risks of CBD are still limited. The FDA sees itself as uniquely positioned help evaluate scientific data and inform regulatory decision making. The FDA is taking a strategic two-pronged approach to developing an understanding of CBD:
1) Engaging with stakeholders, such as the public, the government, CBD producers and retailers.
2) Testing CBD Products
Engaging with Stakeholders
The FDA has held numerous conferences and calls for stakeholder input, and has received input from thousands of members of the public, industry leaders, medical manufacturers and scientific researchers. The FDA is especially calling for stakeholders to developer sources of high-quality data regarding CBD – in order to drive data-based regulation. The FDA is also providing guidance to researchers with regards to which aspects of CBD use are most critical to study. They published a helpful guide for researchers here: “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research”
Testing CBD Products
The FDA is actively testing off-the-shelf CBD products. The tests are to determine if these products actually contain the levels of CBD they claim to contain, and also to test for the presence of other, unwanted compounds, such as THC and chemicals byproducts of cultivation and processing. So far the FDA has conducted a small sample study (~200 samples) and is now working on a larger scale study which will examine 1000 – 3000 different products. Results of these studies so far indicate that accurate labelling of CBD products is rare – over half of them had mislabelled CBD content and several products covertly contained the psychoactive cannabinoid THC.
Other Research Considerations: Real World Data
Beyond traditional studies, the FDA is relying heavily on Real World Data to provide insight into CBD’s characteristics. Stakeholders are asked to consider collecting data in a highly structured way, so that the scientific community can use real world data to advance our understanding of CBD. The FDA also encourages and invites collaboration, to ensure projects complement existing work.
Areas of specific interest include: What are the potential adverse effects of CBD use, both short term and long term? What are the rates of CBD product use, and which products are being used specifically? 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? Is there a presence or absence of sex and gender differences in use and responses to CBD and other cannabinoids?
The FDA strategy is to cultivate a culture of high quality data collection in the real world, accompanied with small targeted studies to improve data in specific areas. Researchers and other stakeholder can learn more about how to collaborate with the FDA’s ongoing research by visiting their public resource page for Clinical Cannabis Studies.
