The U.S. Food and Drug Administration made a headline-grabbing announcement last week: after years of work, the agency concluded that “existing regulatory frameworks” are insufficient for allowing CBD in foods and supplements, and that it aims to work with Congress on a “new regulatory pathway for CBD.”
So, what does this mean for the agency’s first cannabis-focused advisor, just a handful of months into the job?
The FDA’s Center for Drug Evaluation and Research (CDER) announced in September that Norman Birenbaum, a former cannabis regulator in New York and Rhode Island, was hired as a senior public health advisor “responsible for advancing our efforts related to research and regulation of cannabis.” Birenbaum is also the founding president of the Cannabis Regulators Association (CANNRA).
“With his expertise in policy analysis and legislative outreach related to cannabis and cannabis-derived products, Norman is excited about creating the high-value partnerships needed for FDA’s outreach throughout the health care community, including with patients and patient advocacy groups,” FDA’s Deputy Director for Regulatory Programs, Douglas Throckmorton, wrote in the email to colleagues regarding Birenbaum’s hiring.
The FDA was tasked with developing rules for cannabis-derived compounds like CBD once the 2018 Farm Bill legalized cannabis plants with .3% THC or less, known as hemp. While a wide range of CBD products began to line shelves, one rub emerged back in 2018: the FDA approved Epidiolex, a CBD drug that’s prescribed most often to children with severe forms of epilepsy, and under the Federal Food, Drug & Cosmetic Act, an active ingredient in an approved drug can’t be added to foods or supplements.
The agency’s work kicked off in May 2019, when the FDA hosted a public meeting on CBD, during which more than 100 stakeholders spoke, and opened a public comment period indefinitely. Then, in 2021, noting that the thriving-but-unregulated market for these products “continues to outpace the growth in the science and our understanding of the public health implications of these products,” the FDA announced a Cannabis-Derived Products Data Acceleration Plan, which, as the name suggests, is an effort to speed up its data collection efforts.
Last year, the agency formed a Cannabis Products Committee, and FDA Principal Deputy Commissioner Janet Woodcock serves as its chair. Soon after, the FDA hired Birenbaum. And then came last week’s announcement.
Cannabis Wire sat down with Birenbaum via Zoom for his first in-depth interview to discuss his new role and the FDA’s work on cannabis-derived products.
(This conversation has been very lightly edited for space and clarity.)
Alyson Martin, Cannabis Wire: Can you lay out your role at the FDA and what your cannabis priorities will be this year?
Norman Birenbaum, FDA: I’m a senior public health advisor within CDER, which is the Center for Drug Evaluation and Research. In that role, I’m helping CDER with all things cannabis-related in terms of their existing portfolio for drug development and evaluation of new drugs, which may or may not be cannabis-derived. I’m also really fortunate to be part of the agency’s Cannabis Products Committee, which is the cross-cutting vehicle used for all things cannabis-related across all the different agency centers. So whether that’s consumer updates, enforcement actions, policy development—which we saw a little bit of news there in the past week. So that’s another opportunity for me to weigh in. And my role is really making sure that my experience can be of use to everyone at FDA in terms of what has happened at the state level, what has happened across the country in terms of all these different markets and regulatory structures which have cropped up.
Martin: What are the Cannabis Product Committee’s priorities for this year?
Birenbaum: I think the largest priority is: what is the appropriate regulatory framework for CBD and hemp-derived products as a whole. We had the 2018 Farm Bill and we are all living in the consequences of that. And it’s FDA’s charge to safeguard consumer safety and to make sure that the proper protections are in place there, as much as possible. And so one of the things that we’ve been working on is: what is the appropriate regulatory structure for CBD and hemp-derived products? Can any of the existing pathways be utilized? Are they suitable for CBD and hemp-derived products? What you saw last week was the announcement of years of work and findings that, no, the food pathways and the dietary supplement pathways are not suitable for CBD products. So now, as we announced last week, FDA is eager to work with Congress, understanding that these products are out there and consumers desire them, but also understanding that there’s not standardization, there’s not the safeguards and consumer safety mechanisms that consumers expect. So, you know, looking forward to engaging in that work as well.
Martin: Right, this conversation is coming on the heels of the FDA’s announcement that it would seek to work with Congress on a regulatory framework for CBD. What prompted that decision?
Birenbaum: Well, I’ll say that, you know, we have these citizen petitions. That’s been some time in the making. But in responding to those petitions and in doing the evaluation of the work of the CPC—which previously was the CBD Working Group, and then before that had a different name—it became very clear that the safety profile of CBD products and, you know, the hemp-derived market as a whole, they do not satisfy the safety requirements, are very unlikely to satisfy the safety requirements for food and dietary supplements. And I think that no one wants to erode or undermine the safety structures and profiles and the frameworks that are there, for really good reason. And when consumers are purchasing products that they think are dietary supplements or think are foods, then they should meet those safety standards. It’s very, very unlikely that these products can meet those standards. And we’ve seen a whole rash of things over the last year and a half, particularly with the hemp-derived market, showing that other hemp-derived products have an even riskier safety profile, especially looking at intoxicants and synthetics. So this is something that the agency is committed to finding a suitable pathway for, but the food and dietary supplement pathways are not suitable.
Martin: What does the FDA’s decision to turn to Congress specifically mean for you in your role in the next six months?
Birenbaum: I’ll tell you first and foremost that I’ll go wherever I can give the most help and be of the most value, whether that’s specifically within CDER, or whether that’s within the agency or whether that’s elsewhere, to help with this task. And it’s a large one. Fortunately, I have a bit of experience with the state experiments of setting up their own regulatory structures over CBD and hemp-derived products. During my time in Rhode Island, I established the first state-level regulatory agency that had authority over both medical marijuana and CBD and hemp-derived products. And then in New York, as you know, spearheaded the promulgation of rules and regulations for an entirely new licensing structure and market for cannabinoid hemp products, as the state refers to them there. So, understanding what states are doing and have been doing and the lessons learned, I think, is going to be really, really important here. And so wherever I can provide value in this process—developing policies, or working with Congress and providing them feedback—is certainly what I’ll be doing.
Martin: I’m already hearing from sources what they’re hoping for with regard to the 2023 Farm Bill. Does the FDA have any cannabis or cannabinoid-related priorities that they’re aiming for with regard to the 2023 Farm Bill?
Birenbaum: The one area we’ve seen at the state level with the most uniform kind of changes over the last 18 months have been state approaches to their definitions of THC or marijuana under their Controlled Substances Act and extending those also to other isomers of THC, whether they’re derived from hemp or not. We’ve seen this all over the place in terms of Delta-8 bans or, expanding the definition of THC to include Delta-10 or HHC, these other intoxicating isomers. So it’s not unusual that people would be thinking about what’s the federal equivalent there in terms of the definition, and could it be augmented?
I’ll say one thing about that. If you’re looking at the Farm Bill loophole, whether that gets shrunk or closed or what have you, it doesn’t address the fact that we need a regulatory structure for CBD and hemp-derived products. The Farm Bill definition right now relates to how these substances are classified under the Controlled Substances Act and whether they’re legal or not under the CSA. But what that doesn’t do is provide a comprehensive regulatory framework for these products and one that can distinguish between the nuances of: is this being sold in something that’s an edible, something that’s a beverage, something that is a smokable product or something that’s vaporized and inhaled? Right? And those are two very different product categories with very different public health concerns.
So, I understand why people might be gravitating towards the Farm Bill because of state experiences and their approach, and also because it’s just going to be up this year and it’s going to be reauthorized. So, you know, there’s a little bit of driving force there. It will come up. But I would not think that making changes to the Farm Bill definition would necessarily provide a regulatory structure that’s appropriate for these products in all their various forms and what that means for public health and safety.
Martin: So, it sounds to me like: if the FDA and other agencies are sort of in the building phase of a CBD regulatory structure, that’s going to have to be outside the purview of the Farm Bill. So would a standalone bill be the target?
Birenbaum: I don’t want to say anything that makes anyone think that we’re taking anything off the table. We’re going to work with Congress and make sure that we can evaluate all options. But one thing I do want to highlight is, right now we have the Farm Bill, but we don’t have a corresponding regulatory structure for the products and substances that it allows. And so we can’t repeat that mistake again. So, we will need to make sure that there’s a comprehensive regulatory framework. And if that’s possible, through the Farm Bill, that’s something, you know, for folks to explore. But, you know, it didn’t do it the first time around.
Martin: Can you characterize the status of the FDA’s work on the research review related to the scheduling review?
Birenbaum: In talking about, kind of, my role and my priorities, this is also one of them. In the process where [President Joe Biden] on October 6 initiated a, or called for, a reevaluation of how marijuana is classified under the CSA, obviously, that goes to the [Department of Justice] and the [Department of Health and Human Services (HHS)]. HHS gives that to FDA. Within FDA, it’s CDER’s Controlled Substances group that actually does what is called the eight factor analysis to try to determine and make a recommendation as to whether marijuana has an accepted medical use and also its abuse potential and abuse liability and then the corresponding recommendation. So, the president called for this to be done in an expedited fashion. And that is certainly something that we are working on. And, we’re going to do everything we can to make sure there’s an exhaustive evaluation. We heard Secretary Becerra talk a little bit about this, saying that it’s very important to make sure that we’re using all relevant real world data we can, given how rapidly evolving this space is. And so, we’re certainly engaged in that and that’s a priority.
Martin: What are the other specific cannabis policy areas that you hope that Congress will tackle?
Birenbaum: One is what is the proper regulatory structure for CBD and hemp-derived products in general. And that is certainly the most pressing thing we see out there. These products are readily available. Gas stations, corner stores, convenience stores, online. And there’s very, very little standardization there.
Unfortunately, we’ve seen a whole host of adverse events pop up over the last three or four months, particularly with the intoxicating products and particularly among young users and minors. And so, I think making sure that we can take a comprehensive approach forward, so that consumers can have consistency and as much safety as possible with these products, is really going to be important. And that isn’t just a regulatory structure for these products, but it’s also public education, which the FDA has been very engaged in with various consumer updates and announcements. It’s also making sure the proper resources are in place for adverse event reporting and other epidemiological programs for monitoring and surveillance so that we can respond when there are issues. So, you know, these are kind of the tools that relate to the larger issue, but those are the things that are certainly front and center in my mind.
Martin: I want to drill down a bit on the Cannabis Products Committee. Are there any public meetings scheduled? Any hearings?
Birenbaum: There was a meeting a little while ago in front of the Science Board that was convened by the CPC. The CPC is also engaged in listening sessions with various stakeholders, whether that’s researchers, trade coalitions, industry members. That is an ongoing activity. And anyone who’s interested can submit a request to hold a listening session with the CPC. And, with the announcement of last week, looking to work with Congress on a new regulatory pathway and new authorities for CBD, there’s also going to be a pretty robust stakeholder outreach initiative. And stakeholders were emailed and should stay tuned for some instructions on how they can interact with us.
Martin: When it comes to your work at FDA, what are your biggest challenges and opportunities?
Birenbaum: The universal challenge is probably just the constant change and innovation that we see out there in the industry, in the products, in consumer behaviors, in being able to track that and monitor that to properly inform our policy development. So, luckily we have the Cannabis Products Committee, we have other resources that are here. We have great partners over at the [Centers for Disease Control and Prevention] and the [National Institute on Drug Abuse], within HHS. And so, there certainly is the infrastructure that’s required to try to keep tabs on the changing nature of this. But, as you’re aware, it changes not just every year, but every six months or every quarter. So that’s something that certainly is constantly changing. But with that comes opportunities. We recently put out guidance to provide some clarification for the development of new cannabis-derived drugs. And so, with the constantly changing market that’s out there and additional scientific research, we want to make sure that we’re encouraging the drug development and drug approval pathway. And so that’s something that goes hand-in-hand, and we’ve seen the approval of a handful of cannabis drug products which have been very effective in terms of therapeutic outcomes. And so, not losing sight of that aspect of it, because it’s easy to with everything that’s happening on the hemp-derived side of things or with state markets. Understanding that there is an established process for drug development and approval and that that’s also going to increase, I think is very important.
Martin: What has been the biggest surprise about your role?
Birenbaum: I think the biggest surprise has been the extent of work that has already been done on this issue by FDA and partners at HHS. And, the intent and drive to move this issue forward and get real progress and results. Coming from the state perspective, sometimes, you think that there’s maybe a data gap there or potentially even a lack of interest just because states are forced into this right into the breach. And historically, the federal government hasn’t been shoved into this issue by ballot initiatives or comprehensive legislation. There’s been almost none from Congress. And to get here and to be able to work with colleagues who really have done their due diligence, have kept up to speed with state developments and industry developments and scientific developments, and to see the motivation here to move things forward in the interests of public safety and consumer protection and also to provide regulatory certainty is really, really wonderful.
Martin: What keeps you up at night when it comes to cannabis policy?
Birenbaum: The thing that really keeps me up at night is that we’re going to wake up the next morning and be faced with another [e-cigarette, or vaping, product use-associated lung injury or EVALI]. You know, that the state of the industry right now—at least on the non-state regulated side for hemp-derived products, whether it’s CBD or intoxicants—it only takes one bad actor with national distribution to see a real public health crisis. And, from the period of about October, around Halloween, to late November, Thanksgiving, I think we saw a whole host of adverse events with groups of teenagers in Virginia, and in Iowa being hospitalized, and infants in Texas getting their hands on their teacher’s delta-8 gummies. And so there’s really, there’s a possibility for another real public health emergency just because of the size and scale of the industry and the fact that there aren’t safeguards in place right now. So, it’s also a motivating factor. Right? What can we do to make sure that there is a regulatory structure in place so that we’re educating consumers and so that these products are as safe as possible. That’s kind of the thing that keeps me up at night, but also that’s the motivating factor.
Martin: Is there anything else cannabis-related that I haven’t asked you about that you’d like to add?
Birenbaum: I don’t think so. You know, the one thing that I think is important to note, particularly in the wake of the announcement last week, is a new regulatory framework really is needed considering the wide variety of products that we see out there. Certainly there were parties that were interested in pursuing either foods or dietary supplements. But when you think of the large sectors within the industry and the market of products that are vaped, products that are smoked, products that are applied to the skin in transdermal patches or lotions, those are not products that would be regulated under those other pathways, regardless of the safety profile. So, I’m really encouraged by the path that’s been charted here by the CPC, and FDA’s leadership. It certainly is appropriate and I’m looking forward to working with my colleagues in Congress to make some progress on this issue.