(This story has been updated to include the industry reaction.)
Federal food and drug officials submitted a CBD enforcement policy document for approval Wednesday, Daily hemp industry You’ve learned, which means the long-awaited industry guide to CBD is coming.
The United States Food and Drug Administration submitted its draft cannabidiol application policy guide for the industry to the White House Office of Administration and Budget.
With OMB approval, which must approve new regulations from any federal agency, the public release of the compliance policy could arrive in a matter of weeks.
The action could mean clarity could finally come to the CBD space, said cannabis attorney Jonathan Havens, a Washington, DC-based partner with Saul Ewing Arnstein & Lehr.
Havens wrote in a LinkedIn post on Thursday that compliance policy could focus on claims, with the aim of controlling the illegal and unsubstantiated claims that companies have been making regarding their CBD products.
“It is hard to believe that the agency completely backslides from its ‘not allowed ingestible’ stance,” he said.
Havens wrote in an email to Daily hemp industry that it is not clear which direction the FDA is going and it is difficult to say what will happen, according to the enforcement policy.
“It could be based on claims, on portions, (which is) less likely, based on product standards, some combination of all three, or something else,” Havens wrote.
“On the standards front, the FDA may be able to begin to require ingestible CBD marketers the agency’s dietary supplement regulations, for example, good manufacturing practice requirements.”
Such a standard is what supplement industry trade associations have been pushing for, Havens said.
“It would raise the bar for the industry, drive out the nasty companies that are producing unsafe products, and allow vendors to say they are compliant with FDA requirements, which would hopefully soften the true patchwork of state requirements, among other benefits.”
The move comes immediately after the FDA released a draft guidance for clinical research related to the development of cannabis and cannabis-derived products.
Paradises Daily hemp industry The new guide for research and development of cannabis-based pharmaceuticals could provide insight into what the process might look like when the agency develops guidelines for ingestible products like dietary supplements.
“In the normal course of how the FDA generally addresses things on the food and beverage list,” Havens said, “it’s going to have several steps: advanced notice of proposed rulemaking, a proposed rule, comments. , FDA considers comments, final rule and implementation. “
Laura Drotleff can be contacted at [email protected]
