Federal food and drug officials submitted a CBD enforcement policy document for approval on Wednesday, Hemp Industry Daily has learned.
The U.S. Food and Drug Administration submitted its “Cannabidiol Enforcement Policy” draft guidance for industry to the White House Office of Management and Budget. With approval from the OMB, which must sign off on new regulations from any federal agency, the public release of the enforcement policy could take months, or come any day.
The action may mean long-awaited clarity could finally be coming to the CBD space, said cannabis attorney Jonathan Havens, a Washington DC-based partner with Saul Ewing Arnstein & Lehr. Havens said in a LinkedIn post on Thursday that the enforcement policy could be claims-focused, meant to control the illegal unsubstantiated claims that companies have been making regarding their CBD products, and that the FDA is less likely to “lay out specific serving size limits.”
The move comes on the heels of the FDA releasing its draft guidance for clinical research related to developing cannabis and cannabis-derived drug products on Tuesday.
Havens told Hemp Industry Daily that the new guidance for research and development for cannabis-based drug products could provide a glimpse of what the process could look like when the agency drafts guidance for ingestible products such as dietary supplements.
“In the normal course of how the FDA generally goes about things in the food and beverage docket,” Havens said, “you’re going to have multiple steps: an advanced notice of proposal rule-making, a proposed rule, comments, FDA considers the comments, the final rule and implementation.”
