FDA CBD Hearing Leaves Questions Unanswered

On Friday, May 31, 2019 the U.S. Food and Drug Administration (“FDA” or “Agency”) held the widely anticipated hearing on scientific data and information about products containing cannabis or cannabis-derived compounds, including cannabidiol (“CBD”). This is the first public hearing since legalization of hemp in the 2018 Farm Bill. The Agency heard from approximately 140 speakers from diverse industries including, academia, agriculture, consumers, health professionals, and manufacturing companies who offered various perspectives on the safety of cannabis-derived compounds and CBD. Over 500 people registered to attend the meeting in-person, while more than 800 people registered to join remotely.

The 2018 Farm Bill’s removal of hemp as a controlled substance and the lack of research to support CBD’s broader medical and food use led FDA Acting Commissioner Ned Sharpless to emphasize the need to gather safety information as the Agency determines how to regulate cannabis-derived products. While drafting and implementing a regulation could take years, CBD-advocates urged the Agency to devise an efficient regulatory framework.

Summary of Public Comments:

Healthcare professionals and speakers from various academic institutions requested regulators to be more flexible in permitting research exemptions and working with state regulators in obtaining cannabis while relaxing the requirements for detailed pharmacology and toxicology for new cultivars.

Private industries and manufacturers were generally supportive of the cannabis market presenting general data supporting its safety and benefits. A few speakers pointed to CBD’s ability to reduce opioid and benzodiazepine dependency and protecting patients from complications of chemotherapy and radiation. With respect to dietary supplements and food, the presenters called on FDA to allow the addition of CBD to food products and dietary supplements. Specifically, speakers requested regulation permitting CBD to be a lawful dietary supplement ingredient through the new dietary ingredient (“NDI”) pathway.

While there were only a handful of consumer presenters at the hearing who highlighted the harmful effects of marijuana, a majority of them submitted individual comments to the docket. Out of the 1,128 comments submitted to the docket thus far, nearly 1,100 are from individual consumers.

There were no promises made at the conclusion of the hearing to determine how cannabis products would be regulated. It is possible that the Agency may utilize its newly-created Working Group to identify legislative authority to create a framework and then seek additional legislation that would authorize regulations specifically related to cannabis-derived compounds and CBD.

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