Over the past year, the U.S. Food and Drug Administration has embarked on a comprehensive evaluation of cannabidiol (CBD) products, with a focus on educating the public about the risks and unknowns of these products, gathering the science needed to better understand both these safety concerns and potential benefits to inform their regulatory approach, as well as taking steps when necessary to address products that violate the law in ways that raise a variety of public health concerns.
The FDA is providing updates on efforts in this area, including several new steps in areas of education, research and enforcement with the ultimate goal of continuing to protect the public health and working to provide market clarity.
Educating the Public About Potential Risks of Using CBD
The FDA is seeing CBD being marketed in several different products, such as oil drops, capsules, syrups, food products, such as chocolate bars and teas, cosmetics and other topical lotions and creams, as well as products marketed for pets and other animals – and they understand consumers are seeking out these novel products for a variety of perceived health-related or other reasons.
But as the agency has stated before, they are concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by the FDA and determined to be safe, or that using CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two rare, severe pediatric epilepsy disorders, no other CBD products have been evaluated or approved by the FDA.
They remain focused on educating the public about the number of questions that remain regarding CBD’s safety. There may be risks that need to be considered before using CBD products outside of the monitored setting of a prescription from your health care provider.
In particular, the agency recently updated the public on concerns about potential harm from CBD products, including potential liver injury, interactions with other drugs and male reproductive toxicity, as well as side effects such as drowsiness. Also, there is still much the FDA does not know about other potential risks. For example, other than the approved prescription drug, they know little about the potential effects of sustained and/or cumulative use of CBD, co-administration with other medicines, or the risks to vulnerable populations like children, pregnant and lactating women, the elderly, unborn children and certain animal populations. This does not mean that they know CBD is unsafe to these populations or under these circumstances, but given the gaps in their current knowledge, and the known risks that have been identified, they also are not at a point where they can conclude that unapproved CBD products are safe for use. The FDA encourages Americans to consult with their health care providers before using CBD products.
The FDA will continue to expand its educational efforts on this front. This includes consumers broadly, specific populations where there are additional, important health considerations, as well as health care professionals who must understand these risks when talking to their patients. They will also continue to update their online resources for consumers, researchers and industry, as well as sustain multiple lines of communication with Congress, industry, researchers and our regulatory partners at the federal, state, local, territorial, tribal and international levels to share and collect needed information and hear a variety of perspectives.
Closing Knowledge Gaps in Both Safety and Potential Benefits
The marketplace for CBD-containing products is quickly evolving and they must work together with stakeholders and industry to develop high-quality data to close the knowledge gaps about the science, safety, and quality of many of these products, as well as further evaluate any potential benefits outside of the one FDA-approved drug product to treat two rare, severe pediatric epilepsy disorders.
To address the questions and concerns the FDA already raised, they’re seeking reliable and high-quality data. This includes data on, among other things: 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-spectrum” and “broad spectrum” hemp extracts are derived, what the content of such extracts is, and how these products may compare to CBD isolate products.
Given the importance of answering these questions, they’re exploring several ways to address the data gaps as quickly as possible. This includes encouraging, facilitating and initiating more research on CBD, providing venues for industry and researchers to share new data with the agency and identifying opportunities to further collaborate with their federal partners at Centers for Disease Control and Prevention, Substance Abuse and Mental Health Services Administration and National Institute on Drug Abuse on this important issue.
Importantly, the Agriculture Improvement Act of 2018 – which, among other things, changed federal law so that cannabis and cannabis derivatives with very low levels of the psychoactive intoxicating component of cannabis, delta-9 tetrahydrocannabinol (THC) are no longer controlled substances – has opened significant new opportunities for research, and as that body of research develops and grows, there will be considerably more information available. In particular, there’s been an increased interest in drug development from CBD and other compounds found in cannabis and the FDA are working to support drug development as much as possible.
First, given all the research and activity in this space, they are taking new steps to provide a public and transparent way for stakeholders to provide new and emerging information to them in real-time as it becomes available. To this end, in the coming days, the FDA is reopening the public docket they established for our May 2019 public hearing. The docket provides a valuable conduit for submission of scientific data on CBD to the agency, so they have decided to extend the comment period indefinitely to allow the public to comment and to share relevant data with the agency. As the agency continues to move forward to explore viable pathways for CBD products outside the drug context, this extension will allow stakeholders to continue to provide relevant data as research in this area evolves.
This docket also includes a mechanism for a stakeholder to submit data or information that the stakeholder believes to be confidential. They hope that this will enable responsible industry participants, academic researchers, and other stakeholders to share relevant information with the FDA – including information about specific products, which could help inform appropriate regulatory steps.
They also are working to generate data to help inform their work in this area. For example, the FDA’s Office of the Chief Scientist recently awarded a grant to the FDA’s National Center for Toxicological Research to conduct a study to better understand the effects of CBD exposure during pregnancy. Additionally, they’ve 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.
As data become available that are high-quality, reliable and relevant to their evaluation of CBD products that fall under the FDA’s purview, they will be able to refine – and, perhaps in some cases, revise – their thinking and approaches.
Monitoring the Marketplace with a Focus on Greatest Risk to Public Harm
As the FDA work to educate the public and close the knowledge gaps to further guide their approach to CBD products, they will continue to monitor the marketplace and take appropriate action against unlawful CBD products that pose a risk of harm to the public.
They have seen many CBD products being marketed with claims of therapeutic benefits, such as treating or curing serious diseases such as cancer and Alzheimer’s disease, or other drug claims, without having gone through the drug approval process. The proliferation of such products may deter consumers from seeking proven, safe medical therapies for serious illnesses – potentially endangering their health or life.
The FDA also has serious concerns about products that put the public at risk in other ways. For example, they are aware of the risks posed by product contaminants such as heavy metals, THC or other potentially harmful substances. They also have 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.
As the FDA moves forward, they are currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors the agency intends to take into account in prioritizing enforcement decisions. Any enforcement policy would need to further the goals of protecting the public and providing more clarity to industry and the public regarding the FDA’s enforcement priorities while they take potential steps to establish a clear regulatory pathway.
The FDA’s ongoing efforts related to CBD, including the steps they’re announcing, are in line with their mission to protect the public, foster innovation and promote consumer confidence. They recognize the significant public interest in CBD and they must work together with stakeholders and industry to develop high-quality data to close the substantial knowledge gaps about the science, safety, and quality of many of these products. They are committed to working efficiently to further clarify their regulatory approach to these products – as always, using science as their guide and upholding their rigorous public health standards.