The public comment period associated with an FDA hearing on cannabis that invited experiences and challenges with cannabis products to be shared with the Administration has now closed.
In May, the USA’s Food and Drug Administration held a public hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds. One of particular interest to the FDA is cannabidiol (CBD), which can be derived from hemp; marijuana’s non-intoxicating cousin.
More than 100 speakers presented at the hearing. The FDA also established a docket for public comment on this hearing, which was extended on June 20 to close at midnight on July 16, 2019. At the time of writing, more than 3,850 associated submissions had been received, all of which can be reviewed here.
Last week, Principal Deputy Commissioner and Acting CIO at the FDA, Dr. Amy Abernethy, stated the Administration was expediting its work to address the many questions about cannabidiol.
“This is an important national issue with public health impact, & an important topic for American hemp farmers and many other stakeholders,” said Dr. Abernethy. “We are enthusiastic about research into the therapeutic benefits of CBD products but also need to balance safety.”
Information collected through the public docket will assist the FDA’s work in this area. Dr. Abernethy says the FDA plans to report on its progress around end of summer/early fall this year.
“Where data gaps are identified, we will be examining how additional research can be performed quickly and efficiently to address critical questions about the safety and effectiveness of CBD,” said Dr. Abernethy in June.
The FDA is under a lot of pressure as the demand for CBD products in the USA continues to grow. Early this year, Senators. Ron Wyden and Jeff Merkley wrote to the FDA urging it to hurry up already and begin updating regulations related to hemp-derived CBD and other cannabinoids immediately.
A report published in May estimated the collective market for CBD sales is expected to exceed $20 billion in the United States by 2024; up on $1.9 billion in 2018.