FDA Announces Details on CBD Public Hearing

The Food and Drug Administration (FDA) will hold a public hearing on CBD regulation of hemp on May 31, the agency said in a notice to be published in the Federal Register on Wednesday.

The long-awaited hearing will feature stakeholder testimony and inform the FDA's regulatory approach to CBD-based products. Outgoing FDA Commissioner Scott Gottlieb, who initially announced the meeting in April, has repeatedly pointed out that while the 2018 Farm Bill legalized hemp and by-products, CBD-based products remain the responsibility of the agency.

Since CBD is an FDA-approved drug in the form of an Epidiolex prescription drug and has not been previously introduced into the diet, the regulation of CBD-based products is particularly complicated. Gottlieb. However, the agency can borrow other ways and the public hearing is one of the first steps in this rule-making process.

"The purpose of the hearing is to obtain additional scientific data and other information on cannabis and cannabis-based compounds, from both botanical and synthetic sources, to inform our regulatory oversight of these products." writes the agency. "The FDA does not intend this hearing to produce decisions or new positions on specific regulatory issues, but this hearing should be an important step in our ongoing assessment of cannabis and its compounds." cannabis in products regulated by the FDA. "

The FDA has listed a number of "unanswered questions" that it hopes will be addressed at the hearing.

Are there any "specific safety concerns that the FDA should consider" with respect to the regulation of CBD products? Should specific populations such as pregnant women be taken into account when developing CBD regulations? What is the "maximum acceptable daily intake for all products?"

The opinion also explains why the status of the CBD as an approved drug for the treatment of certain forms of epilepsy complicates its regulatory responsibility. If the ingredient is allowed in food or in the form of dietary supplements, companies are less likely to want to conduct additional clinical trials to study its therapeutic potential, the FDA explained.

Beyond public safety issues, the FDA has listed more questions about the manufacture and marketing of CBD products. It seeks information on the safest practices for CBD manufacture and how to properly inform consumers of health risks, including through labeling.

The FDA milestones include a public hearing on May 31 to allow stakeholders to share their experiences / challenges with these products, forming a high-level internal working group to explore potential product lines, updates and updates. online QA day and new warning letters for unfounded marketing claims.

– Scott Gottlieb, M.D. (@SGottliebFDA) April 2, 2019

"The public hearing will provide stakeholders with the opportunity to provide the FDA with additional information regarding the agency's regulatory strategy for existing products, as well as the legal channels through which appropriate products containing cannabis or derived compounds Cannabis can be marketed, and how can we make these legal channels more predictable and effective, "Gottlieb said in a new statement accompanying the Federal Register's announcement. "We hope to obtain additional information and data that the FDA will be able to take into account with respect to products containing cannabis and compounds derived from cannabis, including CBD."

He also provided new details on an FDA task force to explore "potential pathways for legally marketed dietary supplements and / or conventional CBD-containing foods; taking into account the statutory or regulatory changes that may be necessary and the impact of this marketing on public health. "

The agency has also updated a question-and-answer page on cannabis-based products on its website with new information.

The FDA said it was aware that some companies were already marketing CBD-based products, particularly in cases where they had been formally cautioned to make unauthorized medical claims for these products. Gottlieb alluded to the agency's enforcement priorities during a congressional hearing last week.

Hemp growers and processors want the federal government's guidelines on BCD, but the commissioner has tried to moderate expectations about the timing of these guidelines. Without congressional action that specifically targets the CBD, it may be years before the regulations are adopted, he said.

In the meantime, those interested in the FDA regulatory regulation process of the CBD may submit their comments by July 2nd. The agency announced that it would soon make available online information on the registration process at the public hearing.

The US Department of Agriculture held a lengthy public hearing last month to gather stakeholder feedback on its efforts to implement the hemp legalization provisions of the Farm Bill more generally.

FDA Chief Clarifies Priorities for Application of CBD Products

This story has been updated to include Gottlieb's comments.