The U.S. Food and Drug Administration has provided an update to Congress on where it’s at on evaluation of cannabidiol (CBD) products. It still has plenty of questions.
The agency says it is still concerned by the fact some Americans mistakenly believe CBD products generally have been evaluated to be safe by the FDA. As we’ve previously reported, a poll last year indicated 41% of Americans believe FDA had already developed safety standards for CBD. This is not the case and only one CBD product has been approved by the Administration to date.
The FDA says it still has many gaps in knowledge, including the effects of long term use, potential interactions with other drugs and a myriad other issues.
“This does not mean that we know CBD is unsafe to these populations or under these circumstances, but given the gaps in our current knowledge, and the known risks that have been identified, we also are not at a point where we can conclude that unapproved CBD products are safe for use.”
Some of what it says are the known risks outlined in a consumer update late last year.
On the issue of research, the FDA is taking new steps to provide a public and transparent way for stakeholders to provide new information to it in real time as it becomes available. Through this and other strategies, the FDA says it will be able to refine and revise its thinking and approaches.
Over the last year the FDA has also fired a number of warning shots across the bows of companies producing and selling CBD products that it feels are overstepping the mark as to claims made. The industry really needs some clarity on what is acceptable and what isn’t. On this point the FDA says it is mulling over issuing a risk-based enforcement policy that would provide greater transparency.
“Any enforcement policy would need to further the goals of protecting the public and providing more clarity to industry and the public regarding the FDA’s enforcement priorities while we take potential steps to establish a clear regulatory pathway,” it states.
So, in summary – while the FDA seems to have made some progress, it still appears to have a long way to go – and that’s frustrating for all parties involved.
The full report it provided to Congress can be viewed here.
