The U.S. Food and Drug Administration reiterated its hope this week for a “harm reduction approach” to products containing cannabidiol (CBD), rather than a “harm elimination” approach.
On Thursday, the FDA held a virtual panel for stakeholders titled “A New Way Forward for Cannabidiol and Other Hemp Products.” The main speaker was Patrick Cournoyer, senior science advisor who leads the Administration’s Cannabis Product Committee. Norman Birenbaum, senior public health advisor, also fielded questions during a Q&A section.
The meeting was focused on what led the FDA to its January 26 statement that existing pathways for regulation at the FDA were “not appropriate” for cannabidiol (CBD), and on how the FDA has evolved to focus on what Cournoyer described as a “harm reduction approach rather than what is essentially a harm elimination approach.”
During the conversation, the FDA officials emphasized that the ball is in Congress’ court, but signaled a more-than-openness to work with members of Congress on everything from CBD gummies to pet products to delta-8 products.
“We’re not talking about marijuana here or changing the federal status of marijuana through this work. We’re simply talking about the products that were descheduled and were descheduled in a way that left them lacking an appropriate regulatory framework,” Cournoyer said.
The “story began,” as Cournoyer said, with the 2018 Farm Bill, which legalized low-THC cannabis, which is known as hemp. This catalyzed the market for CBD products and other hemp-derived cannabinoid products, such as those that contain cannabigerol (CBG), cannabinol (CBN), and cannabichromene (CBC).
Also in 2018, the FDA approved Epidiolex, a CBD formulation most often prescribed for children with seizure disorders. This approval created a statutory barrier for CBD products because, under the Food, Drug, and Cosmetic Act, it’s not lawful to sell and market foods or dietary supplements that contain a drug approved for a medical indication, in this case, CBD.
But that, of course, hasn’t stopped CBD products from being sold on shelves at gas stations, beauty shops, grocery stores, and online.
“It’s essentially a form of self-medication that is motivating a lot of people to use CBD,” Cournoyer said.
While the FDA collected data as it considered crafting rules for some of these products, Cournoyer reiterated that the FDA was clear that such rulemaking was conditional: only if CBD met the safety standards for ingredients in foods and supplements.
The FDA kicked off its “fact-finding” mission in May 2019 with a large public meeting, and subsequently collected information on the market, monitored adverse events, and led toxicological studies on CBD.
“We found some important safety concerns,” Cournoyer said, referencing potential for harm to the liver, potential for drug interactions, and potential harm to the male reproductive system.
“These types of safety red flags are quite concerning and they’re not things that we normally see for typical food ingredients like, let’s say, sweeteners or preservatives or emulsifiers,” Cournoyer said. “This is quite distinct in terms of the safety concerns that we’re seeing that set CBD apart from some of the more run-of-the-mill types of food ingredients. And this checks out because we know that CBD is highly biologically active, which could explain why the market is large and people are using them as what we can see for the context of self-medication.”
Given the available evidence, the FDA concluded that because of CBD’s “risk profile,” the “highly protective safety standards” for food ingredients and dietary supplements “don’t allow for any risk at all.”
So, what could a “new pathway” look like? Cournoyer and Birenbaum provided more insight into what the FDA imagines than ever before, while flagging that some states have implemented regulations similar to what they laid out.
“It’s really in Congress’ hands,” Cournoyer said, but a framework could include a “basic” degree of regulatory oversight, including clear labeling that mitigates risk of contaminants. It could also include CBD content limits and measures to prevent accidental ingestion.
There are heightened concerns around some foods, particularly those that include caffeine and lookalike products that can be extra-appealing to kids.
Still, there are options for edibles, if Congress chooses that path, Cournoyer said.
“What a new pathway could allow is for these types of products to be removed from, let’s say, the food regulatory category. So, they wouldn’t be regulated as foods, per se, and held to the same standards. They’d be subjected to a more permissive pathway, let’s say, that would allow them to be in formats that might to a regular user look something like regular food,” Cournoyer said.
What about animals? CBD can pose a risk to animals and people who eat meat, milk, and eggs from animals that consumed CBD could also be unknowingly exposed to CBD.
“A new pathway could provide access for certain CBD containing products for animals. But noting that for the livestock pathway for food producing animals, that there are special concerns there and that’s not necessarily something that we’re proposing here,” Cournoyer said. “But, I did want to note that there is a special consideration there for that.”
One participant asked about the “potential stance” that the FDA might take on synthetic cannabinoids being sold in the marketplace.
Birenbaum answered by saying that the FDA has noticed that this market has “rapidly emerged” over the past couple of years and that the FDA has fielded reports of adverse events tied to these types of products.
“This is a serious public health issue and a solution is urgently needed. We are prepared to work with Congress on possible solutions,” Birenbaum said.
The FDA will continue to take action on CBD manufacturers that pose an “immediate risk.” In the past, the Administration has sent warning letters to companies making unverified health claims.
Despite the FDA collecting substantial amounts of data, gaps remain. Cournoyer laid out a scenario in which, even if the FDA was able to collect a “full data package” related to CBD, a “likely outcome” could be that the acceptable daily intake would be so low as to “not be useful to the marketplace as it now stands.”
“So, what our announcement was doing,” Cournoyer said, was “seeking to solve this problem now, because we can’t wait five more years to do a lot of studies and then have the outcome not really solve the initial problem.”