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

On April 11, at an industry conference in Colorado, FDA’s Patrick Cournoyer discussed a pathway forward for CBD and explained why existing pathways are not appropriate.

Josh Long, Associate editorial director, Natural Products Insider

April 12, 2024

4 Min Read

At a Glance

  • It's up to Congress to decide a new pathway for CBD, FDA official said.
  • FDA's review of CBD revealed "concerning red flags."
  • FDA official addressed enforcement against CBD and intoxicating hemp products.

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.

Patrick Cournoyer

“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."

About the Author(s)

Josh Long

Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition

Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Education and previous experience

Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.

Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.

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