FDA Issues Update on CBD Research

FDA Commissioner Stephen M. Hahn MD yesterday released an update on the agency’s efforts to evaluate cannabidiol (CBD) products, outling new steps towards gathering more data and increasing research related to topical cosmetics and other areas, “with the ultimate goal of continuing to protect the public health and working to provide market clarity.” 
 
“We’re seeing CBD being marketed in a number of 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 we understand consumers are seeking out these novel products for a variety of perceived health-related or other reasons,” Hahn wrote in the statement.
 
Over the past year, the FDA has embarked on a comprehensive evaluation of cannabidiol (CBD) products, with what it calls 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 its 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.
 
Hahn said the agency is focused on closing knowledge gaps in both safety and potential benefits.
 
FDA says it is seeking reliable and high-quality data on: 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, we’re exploring a number of 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 our federal partners…,” Hahn wrote.
 
Among those efforts, FDA plans to re-open the public docket established for its May 2019 public hearing.
 
“The docket provides a valuable conduit for submission of scientific data on CBD to the agency, so we 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,” Hahn said.
 
“This docket also includes a mechanism for a stakeholder to submit data or information that the stakeholder believes to be confidential. We 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.” Hahn wrote.
 
FDA says it also working to generate data to help inform its work. For example, 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.
 
FDA’s Office of the Chief Scientist has also 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.
 
“As data become available that are high-quality, reliable and relevant to our evaluation of CBD products that fall under the FDA’s purview, we will be able to refine – and, perhaps in some cases, revise – our thinking and approaches,” Hahn wrote.
 
As the agency works educate the public and close the knowledge gaps to further guide our approach to CBD products, it says it will continue to “monitor the marketplace and take appropriate action against unlawful CBD products that pose a risk of harm to the public.”

Hahn also stated that FDA also have serious concerns about products that put the public at risk in other ways, including risks posed by product contaminants such as heavy metals, THC or other potentially harmful substances. 
 
The agency also has significant concerns about products marketed with false claims or statements such as omitted ingredients, incorrect statements about the amount of CBD.
 
“As we move forward, we 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 we take potential steps to establish a clear regulatory pathway.” Hahn wrote.
 
“We recognize the significant public interest in CBD and we 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. We are committed to working efficiently to further clarify our regulatory approach to these products – as always, using science as our guide and upholding our rigorous public health standards,” he stated.