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The US Food and Drug Administration (FDA) recently appointed Norman Birenbaum to a top post as a senior public health adviser at the FDA’s Center for Drug Evaluation and Research (CDER), signalling a seismic shift at the agency.
In a public meeting earlier this year, FDA commissioner Robert Califf admitted that the agency had not progressed further along the path to CBD or cannabis regulation from when he last held the reins under president Barack Obama, and emphasised that he intended to change that during his second tenure. This appointment seems to be one of his efforts toward that goal.
Birenbaum (pictured) previously led cannabis regulation and legalisation efforts for New York and Rhode Island. Before his work in those states, Birenbaum worked for Massachusetts Democratic senator Elizabeth Warren, and former Democratic governor of Massachusetts Deval Patrick. While New York’s director of cannabis programs, Birenbaum served as the inaugural president of the Cannabis Regulators Association.
At the time of the organisation’s founding, Birenbaum said: “The Cannabis Regulators Association will provide a much-needed forum for regulators to engage with each other to identify and develop best practices, create model policies that safeguard public health and safety, and promote regulatory certainty for industry participants.”
‘Failed policy of prohibition’ leads to focus on public health
Birenbaum entered into politics without the intention of becoming a cannabis policy wonk. In an interview with New York City news and culture website Gothamist when he took the position under former New York governor Andrew Cuomo, Birenbaum said: “I was working for [Rhode Island Democratic] Governor [Gina] Raimondo, and her former chief of staff asked me what I knew about cannabis. I told him I could identify it by smell, but other than that, really nothing.
“It’s been a wonderful and exciting and challenging ride ever since, and I’m very grateful to be here. But I never had this as an aspiration or as part of my career plans.”
In his past work, Birenbaum has emphasised public health. In the same interview, he said: “The intent is to make sure that we’re capturing the illicit market and that it’s as safe as possible from a public-health standpoint. But there’s only so much we can do with consumer behavior. That’s been demonstrated through the failed policy of prohibition. Banning products does not work.
“So, if people are going to use products like smoking [cannabis] flowers, what can we do to make sure that flower is tested for mold and microbials and heavy metals and pesticides? It’s providing the safest environment possible, to make sure that this doesn’t contribute to other public-health events.”
Tackling the issue of cannabis scheduling from the top
US president Joe Biden recently directed the secretary of health and human services and the US attorney general to initiate the administrative process to review expeditiously how cannabis is scheduled under federal law.
“Finally, even as federal and state regulation of marijuana changes, important limitations on trafficking, marketing, and underage sales should stay in place,” Biden said. “Too many lives have been upended because of our failed approach to cannabis. It’s time that we right these wrongs.”
Janet Woodcock, the FDA’s principal deputy commissioner, has been looking at CBD and cannabis regulations. Woodcock said at a webinar organised by the Council for Federal Cannabis Regulation: “We are working diligently on looking at the scheduling of marijuana under the Controlled Substance Act and what flexibilities we might have here.”
When asked what role Birenbaum might have in the cannabis scheduling review, the FDA told CannIntelligence that he “will be the center lead and advisor responsible for advancing our efforts related to research and regulation of cannabis as a part of CDER’s work in controlled substances”.
It looks like the stars are aligning in favour of meaningful regulatory change under the current administration and that Birenbaum’s new post is more of the same advocacy work – just with a broader scope and more authority.
– James DeLise CBD-Intel contributing writer
