FDA ISO Data On CBD Safety In Supplements, Sees Potential As Well As Risks
There's a reason the FDA continues accepting comments on questions about using hemp- and cannabis-derived ingredients in products other than drugs months after the comment period closed. "It's safe to say say that in 4,500 comments, we did not receive a lot of hard data around the issues that we specifically requested comments on," says Sharon Mayl, senior advisor for policy in the commissioner's office.
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Two months after submitting CBD enforcement draft guidance for OMB review, FDA published separate draft guidance on studies for bioequivalents of an approved cannabidiol-based drug. But the draft guidance that the supplement industry awaits in pitched anticipation remains under review.
The trade group’s petition is second on a regulation for CBD’s use in non-drug products submitted to FDA and largely tracks with CHPA’s November 2019 petition. Comments continue to reach the FDA after in March it reopened its docket about establishing a CBD regulation, but with little data the agency says is needed for its decision.
Leading discussions on CBD safety as a dietary ingredient and developing best-practices guidance were natural steps for AHPA. "We were viewing it as another botanical product, another one of the type of products that we’ve been dealing with throughout our history," said program development director Jane Wilson.