The U.S. Food and Drug Administration will hold a day-long meeting on Tuesday to consider “challenges in evaluating the safety of dietary supplement and food ingredients with predicted pharmacological activity, utilizing cannabinoids as a case study.”
Robert Califf, the Commissioner of the FDA, is scheduled to provide an update on data and science efforts. The following officials are also scheduled to speak: FDA Principal Deputy Commissioner Janet Woodcock, who the FDA also confirmed to Cannabis Wire is the chair of the Administration’s newly-formed Cannabis Products Council; David Strauss, director of the Division of Applied Regulatory Science for the Center for Drug Evaluation and Research within the FDA; and Jacqueline O’Shaughnessy, the FDA’s acting Chief Scientist.
Officials are prompted in meeting materials to consider “potential scenarios.” One of those scenarios is: “How might a public health agency assess the unique toxicological safety questions raised by a substance (e.g., cannabinoids), likely used for pharmacological (e.g., psychoactive) effects, outside the context of an approved drug?”
These officials will cover topics like the “Safety of CBD in Humans” through the lens of a literature review, the “Use and Perceptions of Cannabidiol Products in Canada and in the United States,” and the “Safety and Regulation of Natural Products Used as Foods and Food Ingredients.”
Cannabidiol (CBD) is a particularly complex cannabis-derived compound, or cannabinoid, for the FDA because, in 2018, the FDA approved GW Pharmaceuticals’ Epidiolex, a cannabis plant-derived CBD product prescribed to children with severe forms of epilepsy. This is the first and only pharmaceutical derived from cannabis plants to obtain FDA approval. Because pharmaceutical compounds—in this case, CBD—cannot be added to foods or supplements, this complicates the FDA’s efforts to regulate these popular products, which have already proliferated across the country.
At a May hearing on the FDA’s FY 2023 budget hosted by the House Appropriations subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, Califf said that he was “committed” to figuring out a path for CBD, as Cannabis Wire reported.
Califf first responded to Washington Rep. Dan Newhouse’s request for an update on the FDA’s work by commenting on the “amazing plethora of derivatives of the cannabis plant,” calling it “quite profound and astounding.” He then noted that much of the FDA’s work so far has been centered around research to assess risks.
“I am very committed to taking a path on this,” he said. “And just to put a marker down, I don’t think the current authorities we have on the food side or the drug side necessarily give us what we need to have to get the right pathways forward. We’re going to have to come up with something new.”
Wisconsin Rep. Mark Pocan then asked, “What is FDA’s plan to clarify that CBD could possibly be regulated as a food or a food additive? And is there any timeline?”
“The research so far has shown that there are some risks with CBD and so we’re going to need a different pathway than just the standard food pathway,” Califf said. “I’ve told you and I really mean it, I’m committed to do something about this and it’s going to take some work. I hope that you’ll work with me on that because it’s going to take some creativity.”
Among other “potential scenarios” that attendees of Tuesday’s FDA meeting are asked to consider, with cannabinoids as the example: potential “known or predicted pharmacological activity that raises toxicological concerns,”the “lack of substantial history of safe use directly relevant to the context of use,” “variability in product quality and composition, particularly variability in the concentration of active constituents,” and “consumer ability to self-administer without practical limitations to dosage.”
And, if “consumers have broad access to a substance (e.g., cannabinoids), likely used for its known or predicted pharmacological (e.g., psychoactive) effects, outside of the context of an approved drug, what approaches might a public health agency use to manage, mitigate, or communicate potential harm?”
The FDA has been increasingly collecting data on cannabinoids since the 2018 Farm Bill legalized hemp, which is defined as cannabis plants containing .3% THC or less. The passage of the Farm Bill sparked a CBD production and sales frenzy, leading to CBD products for sale from online sites, grocery shops and gas stations to home goods and pet stores. Meanwhile, the FDA has reiterated, over and over again, that it needs more research and data before it can approve any products, as Cannabis Wire has reported.
One of those efforts is the “Cannabis-Derived Products Data Acceleration Plan,” which the Administration announced in October. This plan laid out a handful of pilot initiatives that centered on how the FDA could leverage data and technology as it seeks to regulate CBD.
