FDA Reopens Public Docket Seeking Data on the Safety and Potential Benefits of CBD
On March 5, 2020, the U.S. Food and Drug Administration (FDA) announced an expansion of its effort to comprehensively evaluate cannabidiol (CBD) products, including an opportunity for stakeholders and other members of the public to continue submitting “high-quality data” for FDA review on the safety and potential benefits of CBD. FDA’s update – issued by FDA Commissioner Stephen M. Hahn M.D. – also describes several new steps FDA is taking in related areas of education, research and enforcement.
In May 2019, FDA held a full-day public hearing to obtain scientific information about issues associated with food and other products that contain cannabis and cannabis-derived compounds, such as CBD. Simultaneously, FDA opened a public docket to accept comments on the issue, which closed on July 16, 2019. FDA’s most recent update announces that FDA continues to seek high quality data on the safety and potential benefits of CBD, and thus FDA will reopen the public docket in the coming days – and keep it open indefinitely – as a conduit to accept data.
FDA restated in its update that only one prescription drug containing CBD has been approved by FDA to date. No other CBD products have been evaluated or approved by FDA, and thus FDA encourages members of the public to consult with their health care providers before using CBD products. Moreover, FDA emphasized that it continues to enforce against unlawful CBD products that pose a risk to public health.
FDA Seeks Data to Close the Knowledge Gaps in Both CBD’s Safety and Potential Benefits
The Agriculture Improvement Act of 2018 (known commonly as the “2018 Farm Bill”), legalized industrial hemp, resulting in increased interest in drug development from CBD and other compounds found in cannabis. To benefit from this increase in data development, FDA is re-opening its public docket.
FDA’s notice identifies several categories of data in which FDA is interested, including:
the sedative effects of CBD;
the impacts of long-term sustained or cumulative exposure to CBD;
transdermal penetration and pharmacokinetics of CBD;
the effect of different routes of CBD administration (e.g., oral, topical, inhaled) on its safety profile; the safety of CBD for use in pets and food-producing animals; and
the processes by which “full” and “broad spectrum” hemp extracts are derived, what the content of such extracts is, and how these products may compare to CBD isolate products.
Significantly, FDA also included in the docket a mechanism for a stakeholder to submit data or information that the stakeholder believes to be confidential. FDA noted that it is taking this approach to enable responsible industry participants, academic researchers, and other stakeholders to share relevant information with FDA – including information about specific products, which could help inform FDA’s next regulatory steps.
In addition to seeking data from stakeholders, FDA is working to generate data. For example, FDA’s Office of the Chief Scientist recently awarded a grant to FDA’s National Center for Toxicological Research to conduct a study to better understand the effects of CBD exposure during pregnancy. In addition, FDA has initiated a research study in partnership with the University of Mississippi to evaluate the levels of CBD and THC in a sample of cosmetic products to assess sensitization of THC and CBD topically, and dermal penetration.
Only One CBD Product Has Been Approved by FDA
FDA expressed concerns in the update that there are myriad CBD products on the market, which the public may wrongly perceive as having been evaluated and determined safe by FDA. FDA strongly reiterated that except for one prescription drug that FDA approved to treat two rare, severe pediatric epilepsy disorders, no CBD products have been evaluated or approved by FDA. Therefore, one of FDA’s priorities is educating the public and health care professionals regarding the number of questions that remain regarding CBD’s safety.
FDA recently updated the public on its concerns about potential harm from CBD products, which include potential liver injury, interactions with other drugs and male reproductive toxicity, as well as side effects such as drowsiness.
FDA is Monitoring the Marketplace for Unlawful CBD Products
FDA indicated that it is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions.
Simultaneously, FDA warned that it continues to monitor the marketplace and will take appropriate action against unlawful CBD products that pose a risk of harm to the public. In particular, FDA notes that it will continue to enforce against CBD products being marketed with claims of therapeutic benefit, such as treating or curing serious diseases such as cancer and Alzheimer’s disease, or other drug claims, which have not gone through FDA’s drug approval process and thus pose a risk to the public.
FDA has serious concerns about products that put the public at risk in other ways, such as products that contain contaminants such as “heavy metals, THC or other potentially harmful substances.” Moreover, FDA expressed significant concerns about products marketed with false claims or statements such as “omitted ingredients, incorrect statements about the amount of CBD, products marketed for use by vulnerable populations like children or infants, and products that otherwise put the public health at risk.”
FDA plans to continue to update its online resources on CBD as new information becomes available.
Update: Following publication of this news alert, on March 11, 2020, FDA published in the Federal Register a notice that it has reopened the public docket for high-quality data on the safety and potential benefits of CBD. The docket is available here.