WASHINGTON — The FDA is giving up on trying to figure out a way to regulate CBD on its own. The agency announced Thursday that it is formally calling on Congress for help — and, according to one official, looking for guidance on other hemp products like Delta 8 THC, too.
For nearly four years, the Food and Drug Administration has been laboring to craft a solution that would allow CBD to be legally sold in capsules, gummy vitamins, and various foods, even though the agency also considers the product a prescription drug, which would traditionally bar companies from selling it except at pharmacies. Then-FDA Commissioner Scott Gottlieb stood up a working group in April 2019 aimed at figuring out whether they could stand up a pathway for supplement makers or food companies to sell CBD products legally.
On Thursday, regulators came to the conclusion they can’t do so without help from Congress.
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“The FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks,” said Janet Woodcock, the FDA’s principal deputy commissioner, in a statement.
Thursday’s announcement was light on specifics about the FDA’s preferred approach for regulating CBD. It did not outline a suggested regulatory framework that the agency might pitch to Congress, as officials have done for other tricky regulatory issues, like regulating certain medical tests. Instead, Thursday’s statement simply implied that the legislation could include restrictions like CBD serving size limits and minimum purchase ages.
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During an interview Thursday, an FDA official told STAT they also hoped the eventual framework lawmakers devise will address other hemp-derived products, including smokable hemp products and intoxicating products like Delta 8 THC, as well as CBD creams and patches.
“The focus has been on ingestible CBD products … but this issue is bigger than that and other products need an appropriate regulatory framework,” the official said. “A pathway just for ingestible CBD wouldn’t be enough to address what’s out there.”
The announcement prompted frustration from the dietary supplement industry, which complained that the FDA had done nothing to move toward regulation of the industry after nearly four years of deliberation. The supplement industry has argued the FDA can regulate CBD as a traditional dietary supplement, and has petitioned the FDA to do so; the agency formally denied three of those requests Thursday.
“They clearly have done absolutely nothing,” said Daniel Fabricant, the CEO and president of the Natural Products Association, an industry group that filed one of the three petitions. “The FDA does not care, they want to do what they want to do … and they don’t care what any of their stakeholders think.”
Jonathan Havens, an attorney at Saul Ewing that represents CBD companies, expressed similar frustrations.
“It would have been nice if [the] FDA moved the ball down the field,” he said. “How are we here and how has so little gotten accomplished in [roughly four years]?”
The FDA official defended the agency, arguing that it has spent several years reviewing research to determine if such products could be safely added to supplements and foods.
“We’ve been working at collecting data for quite some time, and the information that we have before us now is substantially greater than it was in 2019,” the FDA official said. “We’ve given it a lot of thought.”
The FDA’s announcement Thursday names liver toxicity and male reproductive harm as two potential risks of CBD.
The Hemp Roundtable, a group representing hemp farmers and CBD makers, argued in a statement that the FDA’s safety concerns are overblown.
“When it comes to the safety of CBD, the FDA gets it wrong,” said Jonathan Miller, the group’s general counsel. “Contrary to the FDA’s continued assertions regarding the safety of CBD, there is clear, established evidence of safety over the years. CBD products have been sold at retail for nearly a decade with no significant safety issues.”
It’s not clear yet whether Congress wants to work with the FDA to create such a framework, or how long such a process would take.
“How do we deal with this in a way that’s not gonna take eight years?” asked Havens, the attorney, who noted that the FDA may also need to issue regulations enacting whatever framework Congress creates.
Lawmakers have introduced legislation directing the FDA to regulate CBD, but a number of those bills simply directed the agency to regulate the product as a dietary supplement.
When asked how long it may take this problem to be solved, the FDA official said: “That’s really not something we can speak to now.”
Thursday’s announcement is unlikely to change the FDA’s enforcement approach toward CBD companies. While the FDA has said all CBD-laden dietary supplements and foods are illegal, the agency has previously only targeted companies making egregious health claims, like suggestions the products can cure cancer. The FDA official implied Thursday that it would continue to take that approach.
“We’ve focused our enforcement resources on products that pose the most immediate risks, and we will continue to do that,” the FDA official said. “That continues to be our position.”
STAT’s coverage of the commercial determinants of health is supported by a grant from Bloomberg Philanthropies. Our financial supporters are not involved in any decisions about our journalism.
