The Food and Drug Administration (FDA) has submitted draft CBD enforcement guidance to the White House Office of Management and Budget (OMB) for review.
The contents or even basic scope of the document—titled, “Cannabidiol Enforcement Policy; Draft Guidance for Industry”—are not yet publicly known.
The agency was mandated under appropriations legislation passed late last year to provide an update on its regulatory approach to CBD, and it did so in March. The update stated that “FDA is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions.”
FDA Commissioner Stephen Hahn said when that report was submitted to Congress that “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.”
This latest development comes in the same week that FDA released separate guidance on conducting research into cannabis for drug development purposes. That document also went through the process of being reviewed by OMB before it could be published.
An FDA spokesperson told Marijuana Moment that, like that guidance, it’s not clear when or even if the agency will ultimately release this CBD enforcement document that’s now being reviewed by White House officials.
While it remains to be seen what the draft guidance contains, FDA has been using enforcement discretion for CBD in the years since hemp and its derivatives were federally legalized under the 2018 Farm Bill.
The agency has continued to issue warnings to cannabis businesses in certain cases—such as instances in which companies claimed CBD could treat or cure coronavirus—and provide public notices about recalls.
FDA also recently submitted a report to Congress on the state of the CBD marketplace, and the document outlines studies the agency has performed on the contents and quality of cannabis-derived products that it has tested over the past six years.
Also this month, a spending bill for FDA was released that includes a provision providing “funding to develop a framework for regulating CBD products.”
Photo by Kimzy Nanney.