As the Food and Drug Administration (FDA) carries out a scientific review into marijuana that will inform its federal scheduling status, top officials at the agency say they are months away from releasing a regulatory assessment for hemp-based products like CBD.
FDA has faced significant criticism in recent years over the lack of rules allowing for the marketing of cannabis in the food supply or as dietary supplements. Hemp and its derivatives were legalized under the 2018 Farm Bill, but the agency has long maintained that more research must be done, or Congress should step in again, before regulations for consumable cannabinoid products are finalized.
In interviews with the Wall Street Journal that was published on Tuesday, FDA Principal Deputy Commissioner Janet Woodcock and two other officials steering the agency’s cannabis policy, Patrick Cournoyer and Norman Birenbaum, discussed next steps.
“Given what we know about the safety of CBD so far, it raises concerns for FDA about whether these existing regulatory pathways for food and dietary supplements are appropriate for this substance,” Woodcock said.
It’s possible that FDA may ultimately punt to Congress, as officials have previously said could be necessary in order to forge a regulatory pathway for the plant.
Meanwhile, the market for hemp, CBD and more novel intoxicating cannabinoids like delta-8 THC is already widespread across the country. As such, FDA officials seem to increasingly recognize the urgency of rulemaking.
“I don’t think that we can have the perfect be the enemy of the good when we’re looking at such a vast market that is so available and utilized,” Birenbaum, a former state marijuana regulator in New York and Rhode Island, told the Journal. “You’ve got a widely unregulated market.”
U.S. Hemp Roundtable said in a statement that FDA’s comments signal that “the new year may offer some promise for the long-awaited regulation of hemp-derived extracts such as CBD.”
The industry organization said that it would be “meeting with the FDA in early January as part of our continuing dialogue on what a regulatory scheme should entail” and that it would also continue its advocacy on Capitol Hill in case the agency does need new legislative authority from Congress in order to set cannabinoid regulations.
The FDA officials said that a couple of points they are assessing concern whether CBD can be used safely in the long-term, and what impacts consumption might have during pregnancy. The rise in popularity of delta-8 THC products, which the Drug Enforcement Administration (DEA) says are not controlled substances, has further complicated rulemaking.
Birenbaum said officials have “growing and more intensifying short-term concerns” about the effects of cannabinoid products.
“Over the last year and a half, we have seen a whole host and cadre of intoxicating hemp derived cannabinoids come up,” he said. “There are very, very different regulatory considerations for products that are going to intoxicate you.”
Birenbaum also said that the “safety profiles around these products are not what they are generally accustomed to and not the same as what they get from other products when they walk into a wellness store or grocery store or even a gas station.”
FDA recently touted its role helping a state agency crack down on a company selling delta-8 THC gummies that they said are linked to “serious adverse events.”
Last month, FDA sent warning letters to five companies that sell foods and beverages containing CBD.
The agency didn’t specify why it targeted those particular five companies out of the many more that market similar cannabidiol-infused consumables, but it said that they sell products “that people may confuse for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD.”
Bipartisan lawmakers have repeatedly pressed FDA to create that marketing pathway for CBD in the food supply and as dietary supplements.
Reps. Morgan Griffith (R-VA) and Brett Guthrie (R-KY) sent a letter to FDA Commissioner Robert Califf in September, demanding answers over the continued lack of regulations for CBD for those purposes.
Griffith and other bipartisan lawmakers sent a separate, related letter to the FDA commissioner in August. They expressed frustration over the “completely insufficient response” the agency provided in response to their bill calling for hemp-derived CBD to be permitted and regulated as a food additive.
After the CBD Product Safety and Standardization Act was filed in December 2021, the sponsors sought technical assistance from FDA to advise on key provisions. But four months after they sent the inquiry, FDA returned a “one-page” response that was “simply a reformatting of a document provided to Congress over two years ago,” the lawmakers said
At a House Appropriations subcommittee hearing in May, FDA’s Califf recognized that the agency had moved slowly with rulemaking for CBD in the food supply, stating that the situation “looks pretty much the same in terms of where we are now” as compared to when he first worked on the issue in 2016.
He said the FDA has taken steps to research the safety profile of cannabinoids to inform future rules, but he also punted the criticism about inaction to Congress, saying he doesn’t feel that “the current authorities we have on the food side or the drug side necessarily give us what we need to have to get the right pathways forward.”
“We’re going to have to come up with something new,” Califf said. “I’m very committed to doing that.”
Stakeholders have strongly encouraged FDA to live up to its authority and provide guidelines and clarity for the industry. But the agency has largely limited its regulatory enforcement authority to sending warning letters to certain CBD businesses and denying cannabinoid marketing applications.
In May, for example, the agency simply sent warning letters to four cannabis companies for allegedly making unsanctioned claims about the medical benefits of CBD products they’ve marketed for animals.
FDA also warned consumers about marijuana-infused copycat food products that resemble popular brands and the risks of accidentally ingesting THC, particularly for children.
The agency separately issued its first set of warnings to companies over the allegedly illegal sale of products containing the increasingly popular cannabinoid delta-8 THC.
It sent five warning letters to companies that are marketing products with the intoxicating compound and making what the agency says are unsanctioned claims about their therapeutic potential.
In May, a top Republican on a key congressional committee also called on leadership to schedule a hearing to hold FDA accountable for its lack of action to set regulations for CBD and delta-8 THC products.
All of this comes in the background of a major task for FDA: Conducting a scientific review into marijuana, at the direction of President Joe Biden, to aid in an assessment of its federal scheduling. FDA’s recommendation won’t be binding, but officials say they expect DEA to product a scheduling recommendation that’s consistent with their findings about its risks and benefits.
Photo courtesy of Brendan Cleak.