With thousands of CBD products on the market, from infused enemas to espresso, the US Food and Drug Administration (FDA) is preparing to craft regulations around the cannabinoid.
At a public hearing that kicks off Friday morning, the agency will hear from dozens of experts and interested citizens. That testimony will help shape FDA policies that could govern everything from CBD quality and labeling standards to infused food and beverages.
Leafly news editors Bruce Barcott, Ben Adlin, and David Downs will liveblog the meeting all day, with the most recent notes at top.
Importance of the WHO Report
8:27 a.m.—A speaker from the US Hemp Roundtable references the World Health Organization’s 2018 review of CBD, which found it safe and non-addictive. I wouldn’t be surprised to hear that report referenced as a touchstone throughout the day today. It’s a big one—the clearest endorsement of CBD’s safety (if not efficacy) by the UN’s globally known and trusted health agency.
It’s Not Just About CBD Patients
8:25 a.m.—We here at Leafly tend to focus on the importance of CBD to medical patients, but there are a lot of stakeholders here representing other aspects of the product, from hemp farmers to veterinarians. Early on here we’ve got a run of speakers advocating for Virginia hemp farmers, who see their colleagues over in Kentucky prospering with their hemp fields and want a piece of that action. Somebody from the Hemp Feed Coalition talks about the growing use of hemp as forage for stock animals. It’s fascinating to see who this hearing brings out of the woodwork.
Tough to Dose
8:19 a.m.—Tory Spindle, a Johns Hopkins University researcher who’s done a lot of work on tobacco vaping, cannabinoid compounds, and various drug delivery systems, tells the FDA panel that dosing cannabis-derived products will be extremely difficult. He notes the differences in delayed onset between smoking, vaping, and edible ingestion. This is fairly well known, but seems like a good bit of foundational information early in the session.
‘Maelstrom of Claims’
8:17 a.m.—Peter Pitts, president of the Center for Medicine in the Public Interest, starts the public comment period with a full two-minute blast against what he calls the “aggressive and misleading marketing campaigns” around CBD, with its “maelstrom of claims and shoddy standards.” There’s no dosing data, no production quality standards, nothing known about harm or help regarding chronic long-term use of CBD, he adds. “We know nearly nothing,” he says.
FDA Commissioner: FDA Will Act
8:00 a.m. EDT — And we’re off! The meeting opens with remarks from acting FDA Commissioner Ned Sharpless. Sharpless stepped into the job recently, after Commissioner Scott Gottlieb stepped down earlier this year. (Gottlieb’s interest in CBD actually led to this hearing; previous FDA commissioners had ignored it, but Gottlieb recognized both the potential benefits and risks, and spurred the agency to action, so honestly it’s a shame he couldn’t be here for this.)
Sharpless, former director of the National Cancer Institute, delivers some smart, sharp notes. He opens by correctly and easily pronouncing both delta-9 tetrahydrocannabinol and cannabidiol, which is something 99% of most lawmakers fail to do. So that inspires confidence.
“Hemp is no longer a controlled substance under federal law” due to the passage of the 2018 farm bill, he notes. And the farm bill specifically called out the FDA’s regulatory authority over hemp and hemp-derived products, specifically drugs and food products.
Sharpless makes clear this is not a mere curiosity for the FDA. The agency has a number of senior officials working on this, and looks to be on a path to create significant, long-lasting federal regulations on CBD.
No Drugs in Food
Sharpless brings up what could be a really important point: “Federal law prohibits drugs from being added to food.” CBD is clearly a drug, he says. The FDA last year approved Epidiolex, which is essentially pure CBD, as a prescribed drug. What that means, he says: “CBD and THC cannot lawfully be added to food or marketed as a dietary supplement.”
This seems important.
Sharpless also has a number of questions he’d like answered. How much CBD is safe to consume in a day? How does it interact with other drugs? What if a pregnant woman takes it? What if a child consumes it? “These questions represent significant gaps in our knowledge,” he says.
The FDA has an internal working group looking at these and other issues, he says. Members of that working group are here today on the 10-member FDA panel hearing comments.