As Quantity Of Cannabis IND Applications Grows, US FDA Has ‘Quality Considerations’ Guidance
Research targeting botanicals generally, as well as cannabis, as potential APIs is increasing, a factor in CDER’s publication of cannabis trials guidance, the FDA’s Norman Birenbaum says in an interview.
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Industry trade groups say FDA decision against starting rulemaking for lawful use of hemp ingredients is not only overdue but failed to clear the air for businesses making or using the ingredients.
Industry reps are glad that Birenbaum, who was the chief cannabis policy advisor to the governors of New York and Rhode Island, was given a prominent role at FDA that could spur regulatory action.
Announcement and warnings, in addition to noting firms’ violative drug and disease claims, explain differences between delta-8 THC and other hemp-derived cannabinoids intended for de-scheduling as controlled substances in 2018 farm bill.