On March 5, FDA sent Congress an update on the agency’s regulatory efforts regarding hemp cannabidiol (CBD). CBD is currently an illegal ingredient in dietary supplement and food products; despite this, the CBD supplement and food/beverage markets have mushroomed, leaving FDA to grapple with how to control the quickly growing, illegal CBD products market. The 2020 spending bill, signed by President Donald Trump back in December, required FDA to update Congress within 60 days on the agency’s progress on collecting data to potentially create a policy of regulatory enforcement discretion for CBD, in order to police the growing CBD market. Unfortunately for those hoping that the spending bill directive would also force FDA to move more quickly on establishing a plan to make CBD a legal dietary ingredient, the March 5 report FDA sent to the U.S. House and Senate appropriations committees focused mainly on the agency’s progress in collecting data on CBD, but provided no new material information on whether the agency will make CBD a legal dietary ingredient.
FDA said in its report that it remains concerned that there could be potential safety risks to consumers of using CBD, given that clinical and toxicology research on CBD is currently limited. The agency also noted that there could be harmful CBD products on the market, such as those making unsubstantiated claims to consumers or those not produced up to legal Good Manufacturing Practices standards. Potential problems could include the presence of heavy metals, high levels of the psychoactive cannabinoid tetrahydrocannabinol (THC), or other potentially dangerous substances.
With research on CBD still in early stages, FDA said in its report that it “is working to understand the safety profile of CBD, especially for sustained and/or cumulative exposure, co-administration with other medicines, and vulnerable populations like children, pregnant and lactating women, the elderly, and unborn children.”
For dietary supplements specifically, FDA wrote, “The Agency is actively evaluating what and how much data would be sufficient to support a conclusion that CBD can safely be allowed in dietary supplements under certain conditions.”
FDA said that these are some of the questions the agency is trying to answer about CBD:
- What happens if you use CBD daily for sustained periods of time?
- What level of intake triggers the known risks associated with CBD?
- How do different methods of exposure affect intake (e.g., oral consumption, topical, smoking or vaping)?
- What is the effect of CBD on the developing brain (such as children who take CBD)?
- What are the effects of CBD on an unborn child or breastfed newborn?
- How does CBD interact with herbs and botanicals?
- Does CBD cause male reproductive toxicity in humans, as has been reported in studies of animals?
- Are there differing safety concerns for use in certain animal species, breeds, or classes?
In addition, the agency is also seeking more information from the dietary supplement industry on CBD products labeled as “full-spectrum” or “broad-spectrum” hemp extracts. Specifically, the agency said it is interested in learning the makeup of products labeled with those terms, what the CBD concentrations typically are in those products, and how these products compare to CBD isolate products.
In its report, FDA noted that, prior to the passage of the 2018 Farm Bill, “it was difficult to study CBD…because cannabis-derived CBD was a Schedule I controlled substance.” The passage of the 2018 Farm Bill legalized industrial hemp with a THC content below 0.3% as an agricultural crop and removed CBD from Schedule I of the Controlled Substances Act. Said FDA in its report: “We are aware that some studies may be ongoing, and that new studies have been initiated since the passage of the Farm Bill, which made it easier in certain respects for parties to conduct CBD-related research. The Agency encourages parties to share new data with us as they become available.”
The majority of FDA’s report focuses on the progress the agency has made in collecting more clinical and safety data on CBD. To encourage more stakeholders to submit data they have on CBD to FDA, the agency has extended, indefinitely, the deadline to submit comments via public docket following a public hearing on cannabis that FDA held last May. The comment period’s close date was extended to July 16, 2019, and in its March 5, 2020, letter to Congress, the agency explained:
“In addition to establishing a clear process for providing product-specific information, we also want to ensure there is a transparent way for FDA to receive new data and other information as they emerge. We recognize that decontrolling hemp in December 2018 opened significant new opportunities for research, and as that body of research develops and grows, there will be considerably more information available than there was shortly after the Farm Bill passed in December 2018. Researchers and other stakeholders should have a clear way to submit information to the Agency as it becomes available. To facilitate such information sharing, we are reopening the docket that we established as part of the May 2019 public meeting, in order to have a central, publicly accessible place to receive new information. The docket will remain open indefinitely.”
FDA said that its goal is to also create an environment in which companies can share data with FDA while also keeping that data confidential if they wish. Confidentiality assurances would make firms more willing to share information with FDA. Wrote the agency: “We are working to establish a clear process by which proprietary information regarding specific products could be submitted to the Agency, with appropriate protection against disclosure of trade secret or confidential commercial information. It is our hope that this process will enable responsible industry participants to share relevant information with FDA about specific products, which could help inform appropriate regulatory steps.”
Finally, the agency said it is looking to encourage, facilitate, and fund more research on CBD. Until more research data is available, FDA wrote, “In light of our role as a science-based, public health agency, obtaining information to address evidence gaps is essential and, to date, outside groups have not provided the robust data and information needed to fully inform potential paths forward.”
No Imminent Change in CBD's Legal Status
FDA’s report to Congress states, “we also are not at a point where we can conclude that unapproved CBD products are safe for use. We encourage Americans to consult with their health care providers before using CBD products.”
Although what FDA is doing—data gathering—is a key part of the regulatory process, dietary supplement stakeholders reacting to FDA’s March 5 report to Congress criticized the agency for not setting forth a more decisive, fast-acting plan on creating a legal pathway for CBD in supplements. (For food, the agency remains concerned about CBD’s usage in food and commented in its report that it is still seeking information on “whether there are conditions under which CBD could safely be added to food.”)
In its letter to Congress, FDA said what it has said in the past: that it continues to consider creating a policy of enforcement discretion for CBD products already on the market—that is, to only take enforcement action against certain CBD companies and not others.
At the same time it's evaluating enforcement discretion, the agency said it is also considering the big win for industry: a rulemaking change that would make CBD a legal dietary ingredient, period.
The agency said it’s taken a “highly proactive approach to analyzing relevant safety questions” about CBD, considering the “significant public interest” in CBD dietary supplements. It wrote: “Rather than waiting for data to be submitted, we have been actively working to identify and review all available data to understand the risk profile of CBD and the potential for CBD to be safely included in dietary supplements, under certain conditions of use.”
But for dietary supplement stakeholders, the lack of a fast-acting solution within FDA's report to make CBD a legal dietary ingredient is disappointing.
In response to FDA’s March 5 letter, Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN; Washington, DC), said in a public statement: “CRN is disheartened by today’s FDA report to Congress on CBD. The time for ‘active consideration and evaluation’ has long since passed. As we’ve said before, the time for action was more than a year ago, but we will settle for now. Today’s report amounts to more bureaucratic can-kicking, and Congress should recognize it as such and take action now to declare CBD a lawful dietary ingredient. That will direct FDA to allow CBD in dietary supplements and impose that significant regulatory framework on these products. Every day, more CBD products come to market, some from responsible manufacturers, and some from less reputable companies. By not enforcing the full range of dietary supplement regulations on this category, FDA is essentially an absentee regulator and the public is at risk. As several recent risk assessments have demonstrated, the safety of CBD as an ingredient itself is no longer an issue. However, as long as FDA ‘actively’ continues to drag its feet, the public is at risk from CBD products that may be poorly manufactured or illegally marketed. The best way to protect public health and promote market clarity is to give industry a clear pathway to market.”
Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA; Washington, DC), issued this comment: “This is more of the same from FDA: All words and no action. The longer FDA waits to regulate the CBD industry, the greater chance we have of risking another public health crisis. Setting a safe level of consumption for CBD products is the best way to move forward with this promising new product while protecting consumers.”