The Food and Drug Administration plans on expediting CBD rules and regulations, potentially by the end of summer or early fall, according to Dr. Amy Abernathy, the principal deputy commissioner and acting chief information officer.
“We are enthusiastic about research into the therapeutic benefits of CBD products but also need to balance safety. To understand the breadth of issues and gather data on safety we have conducted a public hearing, reviewed the medical literature, and have an open public docket.” – Abernathy, via Twitter
Abernathy notes that the agency heard testimony from more than 100 speakers at the May 31 public hearing on CBD policy and the public docket on the issue has more than 3,400 comments.
The previous update provided by the agency last month offered no insight into the FDA’s plans to regulate the cannabinoid but said they would apply a “rigorous and science-based approach” in crafting the rules and regulations.
The authors – Abernathy and Lowell Schiller, principal associate commissioner for policy – did express concern that “widespread availability in products like foods or dietary supplements could reduce commercial incentives to study CBD for potential drug uses.”
The FDA approved GW Pharmaceuticals’ CBD-based medicine Epidiolex last year. During the May hearing, a representative from Greenwich Biosciences testified that at least one study found that CBD is potentially toxic to the liver; however, in that study, mice were given doses that far exceed any reasonable amount – the human equivalent of 42,050 milligrams, according to the CED foundation.
The public comment period on CBD closes today.
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