FDA official outlines ‘harm-reduction’ framework for CBD

FDA envisions a pathway for CBD in food and dietary supplements that reduces harm while helping consumers make informed decisions regarding their health, an FDA official said last week during a call with industry stakeholders.

But ultimately, a new regulatory framework “is really in Congress’s hands,” Patrick Cournoyer, Ph.D., who leads FDA’s Cannabis Product Committee, said.

In general terms, Cournoyer outlined such basic consumer protections for CBD as truth in labeling, disclosure of certain ingredients and ensuring products contain no contaminants. He also identified hazard-mitigation safeguards such as content limits on CBD or other cannabinoids, and measures to mitigate accidental risk of ingestion by children.

FDA, he said, is “looking forward to working with Congress on a new way forward that would embrace a harm-reduction approach rather than what is essentially … a harm-elimination approach in the previous pathways that a lot of interest was focused on.”

A new regulatory pathway would “provide some form of consumer access but still give some basic regulatory oversight that we know people are seeking,” Cournoyer said during a May 25 stakeholder call, where he was joined by cannabis expert Norman Birenbaum, a senior public health advisor at FDA. “People don’t want a complete free-for-all.”

Related:FDA denies CBD dietary supplement petitions, looks to Congress for new pathway

Instead, consumers are seeking “responsible actors” in the market and want to “have some degree of trust in the product that they’re buying,” Cournoyer added.

Cournoyer shared many consumers are using CBD for anxiety, insomnia and pain, based on what they have reported to FDA.

“It’s essentially a form of self-medication that is motivating a lot of people to use CBD,” he said.

FDA is aware that hemp contains some other non-intoxicating cannabinoids that are subject to a growing market, though Cournoyer cautioned “in the case of these different chemicals, these different molecules, there is less actually known about them. The situation about their risk profile is largely unknown.”

FDA in January denied requests in citizen petitions to create a lawful market for CBD in dietary supplements through a rulemaking. At the time, the agency said it was prepared to work with Congress on a new regulatory pathway.

FDA has safety concerns about CBD, especially its long-term use, citing the potential for possible harm to the liver, adverse interactions with certain medications and possible harm to the reproductive system. FDA also is concerned about the effects of CBD exposure on vulnerable populations like children and pregnant women.

During the stakeholder call, Cournoyer elaborated on FDA’s view that the current frameworks for food and supplements are not appropriate for CBD.

“This is really about safety,” he explained. He cited “CBD’s inherent risk profile” as well as the “highly protective safety standards of the food ingredient and dietary supplement pathways.”

“So, it’s a combination,” Cournoyer added. “It is the red flags that we see in the science, and the way that these highly protective safety standards are written in statute really don’t allow for … any risk at all.”

He distinguished the regulatory pathway for drugs from supplements and food.

With FDA-approved drugs, “There may be risks but as long as they’re outweighed by a benefit … then a drug can be approved,” Cournoyer said. FDA in 2018 approved a CBD medicine called Epidiolex as a drug to treat seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. 

He added risks can be managed by such tools as precise labeling and warnings, and by restricting consumer access to drugs through prescriptions and putting products behind the counter.

By comparison, the safety standard for dietary supplements does not consider benefits, he said. If the supplement poses “reasonable risks,” Cournoyer added, “there’s no way to really offset those with the benefit that the product might provide.”