Posted by Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner, and Lowell Schiller, J.D., Principal Associate Commissioner for Policy on Sep 17th 2019
By: Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner, and Lowell Schiller, J.D., Principal Associate Commissioner for Policy
Science forms the basis for decisions at the U.S. Food and Drug Administration (FDA) and is paramount when it comes to making decisions that will impact the health and safety of the American public. We apply this rigorous, science-based approach to matters large and small that come before the Agency — including with respect to products containing cannabis or cannabis-derived compounds, including cannabidiol (CBD).
We recognize that there is significant public interest in these products, for therapeutic purposes and otherwise. At the same time, there are many unanswered questions about the science, safety, and quality of many of these products. As we approach these questions, we do so as a science-based regulatory agency committed to our mission of protecting and promoting public health.
The FDA’s approach to cannabis and cannabis-derived compounds has been consistent. We treat substances derived from cannabis just like we do any other substances, and they are subject to the same authorities as any other substance. That said, some other relevant laws have changed, and so has the market.
On the state level, some jurisdictions have eliminated certain prohibitions on cannabis or cannabis-derived compounds. On the federal level, the Agriculture Improvement Act of 2018 (Farm Bill) removed cannabis and cannabis derivatives that are very low in THC from the definition of marijuana in the Controlled Substances Act (CSA). At the same time, that legislation specifically preserved the FDA’s responsibility over such products.
As these other laws have changed, and as more cannabis products come to the market (whether lawfully or otherwise), the FDA’s role is becoming more practically relevant to many affected stakeholders. We recognize the need to be clear and open about where things stand, and about the efficient and science-based way in which we are moving forward. This includes being transparent and up-front with the public and all of our stakeholders as we continue to collect information and data to deepen our understanding of CBD.
Under the statutory authorities that the FDA has the responsibility to administer, the relevant legal requirements vary depending on which type of product we’re talking about. For example, if a product is being marketed as a drug — meaning, for example, that it’s intended to have a therapeutic effect such as treating a disease — then it’s regulated as a drug, and it generally cannot be sold without FDA approval (or, in the case of an over-the-counter drug, an FDA monograph). Drugs have important therapeutic value, and it is critical that we continue to do what we can to support the science needed to develop new drugs from cannabis.
Food, including dietary supplements, is regulated differently, but with the same overarching goal of protecting consumers. Among other things, it is currently illegal to put into interstate commerce a food to which CBD has been added, or to market CBD as, or in, a dietary supplement. Essentially, the relevant statutory provisions prohibit these uses of CBD because CBD was the subject of substantial clinical investigations into its potential medical uses before it was added to foods (including dietary supplements), and, separately, because CBD is the active ingredient in Epidiolex, an FDA-approved prescription drug product to treat rare, severe forms of epilepsy.
At the same time, we recognize that there is substantial public interest in marketing and accessing CBD in food, including dietary supplements. The statutory provisions that currently prohibit marketing CBD in these forms also allow the FDA to issue a regulation creating an exception, and some stakeholders have asked that the FDA consider issuing such a regulation to allow for the marketing of CBD in conventional foods or as a dietary supplement, or both. This raises important and challenging questions of regulatory policy and public health.
When dealing with complex questions like those posed by CBD, the FDA’s top priority is always our mission of protecting and promoting public health. The Agency is committed to science-based decision making when it comes to CBD, while also taking steps to consider if there are appropriate regulatory pathways for the lawful marketing of CBD, outside of the drug setting.
While we recognize the potential benefits of CBD, questions remain regarding its safety. During our review of the marketing application for Epidiolex, we identified certain safety risks, including the potential for liver injury. Furthermore, unsubstantiated therapeutic claims — such as claims that CBD products can treat serious diseases — can lead consumers to put off getting important medical care. Over the past several years, the Agency has issued several warning letters to firms that were marketing unapproved new drugs claiming to contain CBD, including for uses such as treating cancer or Alzheimer’s disease. These products were not approved by the FDA for the diagnosis, cure, mitigation, treatment, or prevention of any disease. Consumers should beware of purchasing and using any such products. The FDA also tested the chemical content of cannabinoid compounds in some of the products, and many were found not to contain the levels of CBD they claimed to contain.
The Agency understands the importance of communicating clearly with the public about our approach to CBD and is taking an Agency-wide, integrated, and collaborative approach to addressing the regulation of products made from CBD that fall under our jurisdiction. Through this work, the FDA is exploring potential pathways for various types of CBD products to be lawfully marketed. An important component of this work is obtaining and evaluating information to address outstanding questions related to the safety of CBD products that will inform the Agency’s consideration of potential regulatory frameworks for CBD while maintaining the FDA’s rigorous public health standards.
The magnitude of the issue was center stage at the FDA’s recent public hearing, on May 31st, where the Agency provided stakeholders a platform to share feedback and experiences and to provide the Agency with scientific data and other information related to cannabis and cannabis-derived compounds, including CBD. Perspectives were shared from supporters of cannabis and cannabis-derived products, as well as commenters who are concerned about potentially harmful products being widely available.
In addition to the overall uncertainty about the safety of CBD, there were several significant takeaways from the hearing. Several commenters expressed a desire for a regulatory pathway to enable lawful marketing of cannabis-derived products (especially CBD) in food and dietary supplements, with appropriate regulatory oversight that includes: clear safety standards and strong enforcement; the need to support research evaluating the therapeutic effects of CBD; the need for consistent terminology related to these products; and, the need for industry standards to address the potentially dangerous manufacturing quality issues with some cannabis-derived products on the market today.
The Agency benefitted from the myriad of viewpoints expressed and information shared during the recent public hearing, including new scientific data, and we look forward to reviewing written comments submitted to the public docket, including comments on safety (including whether there is a threshold level that could appropriately be considered safe for foods and dietary supplements), manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.
Information collected through the public docket will assist our ongoing work in this area. Together, this will allow us to articulate what we reliably know and where new research is needed. Where data gaps are identified, we will be examining how additional research can be performed quickly and efficiently to address critical questions about the safety and effectiveness of CBD.
There are many unanswered questions about CBD products outside the approved drug context. For example, there are open questions such as:
These and other questions need to be considered if there is interest in exploring a framework under which CBD might be available more widely.
We take to heart concerns from stakeholders about the challenges in conducting research with cannabis and CBD. The FDA is committed to doing what we can to facilitate and preserve incentives for clinical research. We are also concerned that widespread availability in products like foods or dietary supplements could reduce commercial incentives to study CBD for potential drug uses, which would be a loss for patients.
To conduct clinical research that could potentially lead to an approved new drug, researchers need to submit an Investigational New Drug application to the FDA’s Center for Drug Evaluation and Research. For use as an animal drug product, researchers would establish an Investigational New Animal Drug (INAD) file with the FDA’s Center for Veterinary Medicine.
Because the 2018 Farm Bill removed hemp from the definition of marijuana in the CSA, this change may streamline the process for researchers to study hemp and certain cannabis derivatives, including CBD, which could speed the development of new drugs from those substances.
While the Agency continues to believe that the drug approval process is the best way to ensure the safety of new drugs, including those made with CBD, the Agency is committed to evaluating the regulatory frameworks for non-drug uses, including products marketed as foods and dietary supplements. We remain steadfast in our effort to obtain research, data, and other safety and public health input to inform our approach and to address consumer access in a way that protects public health, maintains incentives for cannabis drug development, and creates a robust administrative record needed to support the initiation of any rulemaking. As we learn more, we will continue to update the public about our path forward and provide information that is based on sound science and data.
Just signed #FarmBill18 Conference Committee Report. Consensus reached! Next stops: Full House➡️ Senate➡️ President pic.twitter.com/KxNuy1jUTi— James Comer (@KYComer) December 10, 2018
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