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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New York proposal for packaging and testing hemp-derived cannabinoids could be ‘de facto’ standard for other stat, say attorneys tracking the patchwork of state laws. The proposal sets per-product concentration limits and includes licensing fees for processors and retailers.
CFSAN regulatory affairs chief Douglas Stearn says a regulatory pathway wouldn’t be an open door for CBD-containing food and supplements due to concerns about the ingredients’ safety. Legislation from Congress might "do something with CBD that’s different than the rest of the Food, Drug and Cosmetic Act," he says.
Two months after submitting CBD enforcement draft guidance for OMB review, FDA published separate draft guidance on studies for bioequivalents of an approved cannabidiol-based drug. But the draft guidance that the supplement industry awaits in pitched anticipation remains under review.