The Food and Drug Administration has formally reopened the public comment window on cannabis and cannabinoid-products. The Agency, which is in the process of crafting regulations for these products, is “extending it indefinitely,” after the first window closed in July 2019. The FDA first said it would reopen the window in a report to Congress, about which Cannabis Wire published an analysis last week.
Federal regulators began collecting public comment on cannabis products after the passage of the 2018 Farm Bill legalized hemp. In addition to opening a comment window last year, the FDA held its first public meeting about regulating these products. A separate United States Department of Agriculture public comment window that opened in late 2019, after the Department published its interim final rule for hemp, drew statements from more than 4,600 individuals and entities by the time it closed in January. (Read Cannabis Wire’s coverage of what these groups and people had to say about how the USDA wants to regulate hemp production.)
The FDA continues to seek “scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds,” according to the notice posted on the Federal Register.
“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,” the notice continued.
The FDA added that the indefinite window will aim to “provide a public and transparent way for stakeholders to provide new and emerging information to us in real time as it becomes available.”
While the window is extended for comment on all cannabinoids, the FDA emphasized that “We are particularly interested in data that may help to address uncertainties and data gaps related to the safety of cannabidiol (CBD).”
The FDA wants to collect data related to, for example, the potential for liver damage, how cannabis use affects reproductivity, and possible interactions between cannabinoids and prescribed medications, alcohol, or dietary supplements.
If the FDA decides to close the public comment period at some point in the future, they will post another notice on the Federal Register.
As Cannabis Wire recently reported, FDA Commissioner Stephen Hahn, sworn in as FDA commissioner in December, addressed CBD products when talking to attendees of a Winter Policy Conference hosted by the National Association of State Departments of Agriculture.
Hahn asked the attendees how many people went through Reagan National Airport, and came upon a store that has a “huge stand for CBD products.”
“So, we know one thing from the American people: they’re using CBD products,” Hahn said. Hahn went on to tell a story about a patient who texted him to say that they were using CBD oil as part of a broader cancer treatment.
“We’re not going to be able to say ‘you can’t use these products,’” Hahn said. “Even if we did, it’s a fool’s game to even try to approach that. But what do we need to do? We need to fill the information gaps. We need to understand what it helps with, because we have some evidence on the drug side that it may be beneficial.”