The USA’s Food and Drug Administration (FDA) is again inviting submissions on CBD and cannabis products generally to assist it in the preparation of regulations.
As we mentioned earlier this week, the FDA said it was to take new steps to provide a public and transparent way for new information to be submitted to it in real time as it becomes available.
Last year, the FDA kicked off a comment period in April to advance the agency’s continued evaluation of potential regulatory pathways for products that contain or are derived from cannabis.
As part of this effort, the agency is reopening the comment period for the notice that appeared in the Federal Register of April 3, 2019. That comment period ended on in July last year, but will now be extended “indefinitely”.
“In light of the continued interest and increased research activity in this space, as well as the need for additional scientific data on this topic, we have decided to reopen the comment period and extend it indefinitely to allow interested parties to continue to comment and to provide relevant data to the Agency on this subject,” says part of a statement from the agency.
By “indefinitely”, it doesn’t mean forever – but if in the future FDA decides to close the comment period, it will publish a Federal Register notice.
Comments can be submitted online here. The last feedback period resulted in 4,494 comments being received – so the FDA already had plenty of food for thought. It should be noted that comments submitted online will be made public, so care should be taken concerning confidential information.
The FDA says it’s particularly interested in information that may assist in addressing its uncertainties and data gaps in relation to the safety of cannabidiol (CBD) – and it still has plenty of those. In relation to CBD safety, it has nine key questions that are mentioned on pages 9 and 10 in its recent report to Congress.
This step of extended the public comment period could be seen as another step forward – or perhaps a signal the FDA is happy to continue kicking the cannabidiol can down the road for as long as possible.