After initial publication, this post was updated to provide links to the three petitions that FDA denied as mentioned above.
The FDA has been struggling with the issue of CBD for quite a while. The use of CBD products in the marketplace has surged with CBD being claimed to be a dietary supplement and a food additive, as well being marketed in other forms such in creams, ointments, drinks, gummies and other oral and topical forms. We have written extensively about the CBD issue in other posts (here, here, here, here, and here) and now the FDA has taken another step towards the beginning of development of a regulatory framework to tame this beast.
In an FDA statement dated January 26, 2023, entitled “FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward” which can be found here, Principal Deputy Commissioner Janet Woodcock, M.D. said “Today we are announcing that after careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks. The agency is prepared to work with Congress on this matter.” This statement will likely rock the CBD world and the supporters of CBD’s use in a myriad of products as described above. But the Agency has seen enough and recognizes that, like the vaping fiasco, they need to reel in the CBD white whale and get it under control before it swallows up more of the Agency’s resources and gets further out of control.
Among the risks associated with the unknown issues surrounding CBD, Woodcock noted that “[G]iven the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives. For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods.” In waiting for Congressional action of FDA comment and rulemaking, the Agency will continue to take enforcement action by identifying CBD and other cannabis derived products that pose risks while acting under its authority. This notice was posted concurrently with the Agency’s denial of three citizen petitions “that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.”
Now that the needle is moving towards regulation of CBD to protect the public health, we will stay on top of the developments and keep you informed along the way.