FDA doesn’t envision pre-market approval for new CBD pathway

ESTES PARK, Colo. — In imagining a new pathway for CBD, the Food and Drug Administration does not envision premarket approval on a product-by-product basis.

That was one of the messages conveyed Thursday by an FDA official at an industry conference in Estes Park, Colorado, a gateway community to Rocky Mountain National Park.

Speaking at the NoCo Hemp Expo, Patrick Cournoyer said “Congress really gets to decide” a new pathway for CBD, though he mentioned some general ideas for a new framework, including truth-in-labeling. Cournoyer is FDA’s senior science advisor and cannabis product committee lead with the Office of the Commissioner.

“We’re also imagining a list of rules to follow, not premarket approval on a product-by-product basis,” he said in a fireside chat with cannabis attorney Garrett Graff. “We know that is resource-intensive on both sides.”

For instance, he mentioned rules to ensure a product is manufactured safely.

In January 2023, FDA announced its conclusion that the existing pathways for foods and dietary supplements are not appropriate for CBD, and that the agency was prepared to work with Congress on a new pathway. FDA found CBD presented safety concerns, especially with long-term use.

The safety standards for food and supplements are “very protective” and, unlike FDA-approved drugs, they don’t allow for a risk-benefit analysis, according to Cournoyer.

With things like sweeteners and preservatives, “the assumption is that you’re going to be eating those your whole life and all kinds of people will be eating them, so there needs to be a really high assurance that you won’t get harmed even in the long term,” he said. “That’s one characteristic of the safety standard. It’s a high bar.”

Through its review of CBD, FDA has identified “concerning red flags from a safety perspective,” including liver toxicity and the potential for interactions with other drugs, Cournoyer said. He cited “pretty convincing evidence that … one of the drug interactions is actually caffeine, and that it can interfere with [metabolizing],” resulting in additional caffeine in the body. Such a result could pose risks to consumers who are caffeine-sensitive.

FDA also has expressed concern that CBD could cause harm to the male reproductive system.

“There’s a lot of unknowns there, but we’ve seen effects on animals’ testicles,” Cournoyer shared, noting the male offspring of pregnant mice administered CBD have fewer babies.

“This isn’t typical for food ingredients or dietary supplements,” and FDA would be expected to not allow such an ingredient in a sweetener or preservative, for example, the FDA official said.

FDA has determined CBD cannot not be lawfully marketed in food or dietary supplements because essentially it was first researched or approved as a drug. Although the agency has rulemaking authority to lift that hurdle, Cournoyer said “it wouldn’t make sense to go through the work of lifting the drug preclusion if that wasn’t going to be helpful in providing … a lawful pathway for these products.”

On the issue of enforcement, Cournoyer noted FDA takes a risk-based approach “in collaboration with state regulators when appropriate, and we’ll communicate about public health issues as soon as we can.”

He said FDA doesn’t have the resources to shut down the CBD sector or the burgeoning market for intoxicating hemp products.

“In the intoxicating space, things are very new, but they’re also very large and … we lack the resources to flip a switch and get rid of these products overnight,” Cournoyer said.

He rejected the notion that other countries are allowing CBD in products like food and supplements while FDA has charted a disparate course.

“I’ve heard that other countries are fine with CBD. What’s wrong with FDA? And that’s really not true,” Cournoyer asserted. “We’re really on the same page. We’re looking at the same science. CBD is not allowed in the food pathways in Canada, for instance. CBD is available but through separate special pathways. Australia is the same.”

Finally, Cournoyer cited “strong bipartisan support” to create a CBD solution in the U.S.

Following a fireside chat on April 11 at the NoCo Hemp Expo in Estes Park, Colo., FDA's Patrick Cournoyer (center) is surrounded by people waiting to speak with him.

“This can be done. New pathways can be formed. Pathways can be overhauled and changed,” he said. “It’s not insurmountable.”

Cournoyer spoke in Colorado the same day FDA Commissioner Robert Califf, M.D., appeared in the nation's capital before the House Committee on Oversight and Accountability.

Among the various topics addressed by the congressional committee: CBD.

"The FDA’s refusal to regulate hemp products is creating significant confusion in the market and resulting in products with intoxicants that may be dangerous to Americans who use these products," House Oversight Committee Chairman James Comer (R-Ky.) said in prepared remarks. "It has also halted businesses trying—in good faith—to enter the market, while bad actors continue to thrive."

In spite of FDA's conclusions that existing pathways for food and supplements are not appropriate for CBD, FDA recognizes "consumers want access to these products," Califf said in prepared remarks for the hearing. "That is why FDA announced that the agency is prepared to work with Congress on a new regulatory pathway that would provide access, safeguards, and oversight over products containing CBD in ways that existing pathways cannot."