If Safety Data Open Door In US, Cannabinoids’ Lawful Use In Supplements At Least A Year Off
At FDLI annual meeting, attorneys cast doubt on CBD rules outlook. Paul Joseph says regulations are at least a year away while Jonathan Havens doubts FDA is even working on regulations, including GMPs, because it is still asking industry for specific safety details.
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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.
Senate on 29 September was expected to a pass a CR the House passed a week earlier to fund FDA and other federal departments and agencies through 11 December.
Two months after submitting CBD enforcement draft guidance for OMB review, FDA published separate draft guidance on studies for bioequivalents of an approved cannabidiol-based drug. But the draft guidance that the supplement industry awaits in pitched anticipation remains under review.