US FDA Heightens Focus On Cannabis With Hiring Of Norman Birenbaum As Public Health Advisor
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.
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Rise in state-legalized marijuana helped pushed FDA to recommend more lenient regulation of the substance, easing pathway to prescription drug approval, but those same state markets may pose a challenge for commercialization of an Rx botanical if DEA follows through on rescheduling.
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.
Hemp Roundtable says Cannabis Administration and Opportunity Act’s limit of 0.001% THC per 100 g by dry weight for ingredients derived from cannabis to qualify as hemp “would impose a devastating setback to a thriving industry, and further limit opportunities for already struggling hemp farmers.”