The Food and Drug Administration (FDA) will hold a public hearing on regulating hemp-derived CBD on May 31, the agency announced in a notice scheduled to be published in the Federal Register on Wednesday.
The much-anticipated hearing will feature testimony from stakeholders and is aimed at informing FDA’s regulatory approach to CBD products. Outgoing FDA Commissioner Scott Gottlieb, who initially said the meeting would take place sometime in April, has repeatedly stressed that while the 2018 Farm Bill federally legalized hemp and hemp-derived products, CBD products remain under the agency’s purview.
Because CBD is an FDA-approved drug in the form of prescription medication Epidiolex and hasn’t been previously introduced into the food supply, regulating CBD products is especially complicated, Gottlieb has said. However, there are alternative pathways the agency can pursue, and the public hearing is one of the first steps in that rulemaking process.
“The goal of the hearing is to obtain additional scientific data and other information related to cannabis and cannabis-derived compounds, both from botanical and synthetic sources, to inform our regulatory oversight of these products,” the agency wrote. “FDA does not intend for this hearing to produce any decisions or new positions on specific regulatory questions, but this hearing is expected to be an important step in our continued evaluation of cannabis and cannabis-derived compounds in FDA-regulated products.”
FDA listed a number of “unanswered questions” that it hopes will be addressed at the hearing.
Are there any “particular safety concerns that FDA should consider” as far as regulating CBD products is concerned? Should any specific populations like pregnant women be taken into consideration when developing regulations for CBD? What’s the “maximal acceptable daily intake from all products?”
The notice also discusses why CBD’s status as an approved drug for the treatment of certain forms of epilepsy complicates its regulatory responsibility. If the ingredient is allowed in the food supply or as dietary supplements, there’s a risk that companies will have less of an incentive to conduct additional clinical trials investigating its therapeutic potential, FDA said.
Beyond the public safety issues, FDA listed more questions about the manufacturing and marketing of CBD products. It’s soliciting input on the safest practices for manufacturing CBD and how to properly notify consumers about health risks through labeling, among other topics.
FDA’s steps include a public hearing on May 31 for stakeholders to share experiences/challenges w/ these products, formation of a high-level internal agency working group to explore potential product pathways, web QA updates & new warning letters for unfounded marketing claims.
— Scott Gottlieb, M.D. (@SGottliebFDA) April 2, 2019
“The public hearing will give stakeholders an opportunity to provide the FDA with additional input relevant to the agency’s regulatory strategy related to existing products, as well as the lawful pathways by which appropriate products containing cannabis or cannabis-derived compounds can be marketed, and how we can make these legal pathways more predictable and efficient,” Gottlieb said in a new statement accompanying the Federal Register notice. “We hope to gain additional information and data for the FDA to consider with respect to products containing cannabis and cannabis-derived compounds, including CBD.”
He also provided new details about an FDA working group tasked with exploring “potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health.”
The agency also updated a cannabis products questions-and-answers page on its website with new information.
FDA said it’s aware that there are companies that are already marketing CBD products, including cases where the companies have been formally warned about making unauthorized medical claims about the products. Gottlieb hinted at the agency’s enforcement priorities at a congressional hearing last week.
Hemp cultivators and processors are eager to receive federal guidance on CBD, but the commissioner has tried to temper expectations about the timeline for that guidance. Without congressional action that specifically targets CBD, it may be years before the regulations are enacted, he said.
In the meantime, people interested in shaping the FDA’s CBD regulatory process can submit public comments through July 2. The agency says it will soon make information on how to register for the public hearing available online.
The U.S. Department of Agriculture held a lengthy public hearing last month to receive input from stakeholders about its efforts to implement the Farm Bill’s hemp legalization provisions more generally.
This story was updated to include comments from Gottlieb.