The Council for Federal Cannabis Regulation (CFCR) has launched a new monthly webinar series in which regulators and industry professionals will participate in moderated conversations regarding responsible cannabis regulation.
The first session, “Understanding the Regulatory Impact of Groundbreaking New CBD Study” featured Vicki Seyfert-Margolis, chairwoman of the Science & Regulatory Affairs Committee, Council for Federal Cannabis Regulation, and former senior advisor at the Food and Drug Administration (FDA).
Seyfert-Margolis spoke about a recently released study drawing from a volunteer program among frontline healthcare workers in Brazil, which sought to answer a question: “Is cannabidiol (CBD) therapy capable of reducing emotional exhaustion and burnout symptoms among frontline health care professionals working with patients with COVID-19?”
A 22-item survey known as the Maslach Burnout Inventory enabled researchers to gauge emotional exhaustion, depersonalization and a low sense of personal accomplishment. At multiple points throughout the survey, respondents were asked to rate the frequency of various mental states ranging from “a few times a year or less” to “every day.”
In the end, the study’s findings suggest that CBD may act as an effective agent for the reduction of emotional exhaustion and burnout symptoms among frontline health care professionals, though it is necessary to balance the benefits with potential undesired effects when making decisions regarding the use of CBD.
These are the first steps that allow us to begin to understand more about the safety and efficacy components of CBD, said said Seyfert-Margolis. “This study is a blueprint for the kind of work that needs to be done.”
It’s extremely important to establish credibility for the research that is being done in this field, she said — actually being able to qualitatively and quantitatively put data around it, rather than anecdotal evidence.
“We’re in the world of building a body of evidence right now. … Right now, my sense is the FDA is interested in data, data, data,” she said.
The category’s in a regulatory limbo, and it’s been enforced in a very limited way. But that could change.
“They have the option to do (enforce limitations) if they so choose or if a problem arises,” Seyfert-Margolis warned. “Everybody’s kind of in this holding pattern waiting to see what the FDA is going to do on what I would call the medical or health side of it.”
So, who will fund future studies? Seyfert-Margolis said the burden will be in part on the companies that make the products — though some of the costs can be deferred through grants.
“We want to try to be in front of this, not behind it,” she said. “It’s always good to be a willing participant. … It’s in every company’s interest to show benefit and risk of these products.”
