The list of cannabis-related issues that the U.S. Food and Drug Administration is working on continues to grow.
On Thursday, the FDA’s Principal Deputy Commissioner Janet Woodcock spoke during a virtual event hosted by the Council for Federal Cannabis Regulation. Woodcock is also the executive lead for the FDA’s Cannabis Product Committee, chaired by Patrick Cournoyer, who also spoke during the event.
Woodcock immediately acknowledged President Joe Biden’s historic announcements earlier in October that initiated a review of the federal scheduling of cannabis and pardoned those with federal cannabis possession records.
“We are working diligently on looking at the scheduling of marijuana under the Controlled Substance Act,” Woodcock said, and “what flexibilities we might have there. So that is a very high priority that the secretary of [Health and Human Services] is very interested in. We’re working closely with our partners at [the National Institute on Drug Abuse] and also with the assistant secretary for health.”
Cannabis has been in Schedule I of the Controlled Substances Act, a category reserved for substances with the highest potential for misuse and no medical value, since the 1970s. Following Biden’s announcement, the FDA is undertaking a scientific review of cannabis, and it will then hand off its scheduling recommendation to the Drug Enforcement Administration.
Woodcock also gave an overview of the pathway to FDA approval for cannabis-derived drugs, a “well-defined role where we do drug development.”
But what about all of the other non-FDA-approved cannabis products that are on shelves from coast to coast, which are technically unregulated?
“We’re agnostic, in general, about cannabis,” Woodcock said. “But,” she added, “products that are contaminated with heavy metals or pesticides, products that are mislabeled as far as their content or overdoses, and so forth, these are products where we need to take action.”
A quick refresher on why the cannabis industry is so laser-focused on the FDA. In 2018, the Farm Bill legalized cannabis plants that contain .3% THC or less (also known as hemp). This includes hemp-derived cannabinoids, like CBD. And now the FDA is in charge of creating regulations for CBD products—for humans and animals, for food and cosmetics, and for the myriad uses in between.
Meanwhile, and importantly, it needs to be noted that the Administration approved Epidiolex in 2018, a cannabis plant-derived medication containing CBD that is prescribed for severe epilepsy. Because pharmaceutical compounds—in this case, CBD—cannot be food additives or supplements, the approval of Epidiolex complicates the FDA’s work toward regulating products like foods and supplements that contain CBD, which, as Cournoyer noted, have grown in popularity across the U.S.
“This was identified right away as a barrier for the whole CBD market in so far as these products are marketed as dietary supplements,” Cournoyer said. “It raises the question, what do we do about this? What does the industry do about this since they’re facing an immediate legal barrier?”
To put it mildly, many cannabis industry stakeholders have become impatient with what they view as delays in the regulation of CBD.
Since 2018, many of the updates about CBD from the FDA have been focused on the need for more data. Back in 2018, former FDA Commissioner Scott Gottlieb established a CBD working group, which has since evolved into the new Cannabis Products Committee. In May 2019, the FDA held a public meeting during which more than 100 stakeholders spoke. The FDA also opened a public docket that remains open today. In October 2021, the FDA announced their Cannabis-Derived Products Data Acceleration Plan because the sprawling cannabinoid market “continues to outpace the growth in the science and our understanding of the public health implications of these products.” The FDA has also identified a handful of scientific questions and posted those to the Federal Register. Most recently, the FDA’s Center for Drug Evaluation and Research (CDER), announced that Norman Birenbaum, a former cannabis regulator for New York and Rhode Island, had been hired as a senior public health advisor “responsible for advancing our efforts related to research and regulation of cannabis.”
“I think people view us as not having been very active since that time,” Cournoyer said. “But internally we’ve been very active.”
Cournoyer and Woodcock addressed an elephant in the room: the FDA wants more data, but research has long been inhibited due to cannabis’ Schedule I status. While research has picked up considerably in the past few years, Cournoyer said, the FDA still needs more, particularly targeted, data.
“When we’ve looked at the toxicology profile and the scientific information, we’ve identified a lot of red flags. This is a very bioactive compound, which is not surprising for an approved drug that has the effect that we know it has. And that raises a lot of questions,” Cournoyer said, adding that CBD, for example, can cause liver damage, can interact with drugs, and could pose reproductive issues, particularly in men.
The FDA is poring over the literature that does exist, and is working with research firms to better understand the existing cannabinoid marketplace, which is vast.
In the meantime, the FDA’s enforcement has come in the form of warning letters, including to food producers that made products that contain CBD.
“From the information we’ve seen, we cannot conclude that CBD is generally recognized as safe. And that’s what we’ve included in certain warning letters,” Cournoyer said.
That bar for CBD in food is “very, very strict,” Cournoyer said, meaning that officials have to have a “reasonable certainty of no harm.”
“If there’s reason to believe that an ingredient in food might harm somebody, then it really shouldn’t be there in the first place. And we don’t have a lot of options,” Cournoyer said.
Warning letters have also been sent to producers of intoxicating products made from hemp, such as those containing delta-8 THC, and the FDA has posted a public health alert on its site.
“This is something that’s really exploded and there’s not much we know about these. We know that they’re intoxicating,” Cournoyer said, adding that the FDA is concerned about adverse events. “These are naturally a very large concern for us. And this has been evolving extremely quickly. So we’re doing what we can in the short amount of time that we have that this has unfolded.”
The FDA is also monitoring how other jurisdictions across the world are regulating CBD. For example, the European Union and the United Kingdom were considering how to regulate CBD as a potential new food ingredient, but put those evaluations on pause “because they found that there are too many safety questions and not enough data to address them,” Cournoyer said.
Meanwhile, there’s a global patchwork of regulations emerging with regard to how other countries treat CBD. In Australia and New Zealand, consumers have access to CBD products through their Medicines Authority and in Canada, consumers have access through the adult use cannabis pathway, Cournoyer said.
“In terms of the pathways for CBD, it’s not just us that’s struggling with this question,” Cournoyer said.
