As the market for products containing cannabidiol, or CBD, grows, the U.S. Food and Drug Administration is asking Congress to figure out how to regulate and oversee it.
The agency has declined requests to let the products be marketed as dietary supplements.
“CBD is part of the cannabis plant that does not cause the high associated with marijuana use. Some research has found that it can ease pain, and the FDA has approved one drug with CBD to treat rare, severe forms of epilepsy,” CNN reported.
In a statement issued Thursday, an FDA deputy commissioner, Dr. Janet Woodcock, said an internal working group studied where CBD fits into the regulatory framework and concluded that it really doesn’t.
“After careful review, 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,” she said. “The agency is prepared to work with Congress on this matter.”
As the Deseret News reported back in 2019, CBD has been booming in products — “sold online and prominently displayed in mainstream stores and specialty boutiques alike across America — touted as a key ingredient in everything from tinctures and lotions to gummy chews, taffy, bath bombs and coffee additives. You can take CBD by pill or capsule, suck a lozenge, put a drop under your tongue, vape it, rub it on or soak in it.”
That article noted that “right now even those rooting for CBD to live up to its hype say the rules governing product sales are complicated and caution that use is buyer beware. Medicinal claims are illegal. Studies in humans are scarce. And product oversight is challenging and sometimes lacking.”
Little has changed in the intervening years.
Woodcock said there are still safety concerns around use of CBD, “especially with long-term use.” She said studies suggest the potential to harm the liver, to interact with some medications and “possible harm to the male reproductive system.” She also said there are worries concerning CBD exposure by children and pregnant women, among others.
The goal, she said, is to create a new regulatory pathway that would offer both safeguards and oversight, while minimizing risks. The existing FDA regulatory foods and dietary supplements regulatory pathway only provides “limited tools for managing many of the risks associated with CBD products,” she said.
She questioned how, within the current framework, CBD products could meet safety standards for dietary supplements or food additives, including how much is safe to consume.
Another concern, she said, is risk to animals and how that could impact people who consume animal products like meat and milk. “Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food. A new regulatory pathway could provide access and oversight for certain CBD-containing products for animals.”
CNN quoted Christopher McCurdy, president of the American Association of Pharmaceutical Scientists, as saying that CBD poses a real challenge for the FDA because there are so many products — and they are so popular — that “there’s much more anecdotal evidence than scientific evidence about how they work.”
The issue was also highlighted by The New York Times. “Unlike tetrahydrocannabinol, or THC, the cannabis component that gets users high, CBD is not psychoactive. But there is little data to back up marketing claims that CBD can prevent diabetes, soothe anxiety or ease menstrual cramps.”
“I think you’re always going to have the FDA being on the more conservative side because it’s always better to err on the safety side than not,” McCurdy, who is also a pharmacy professor at the University of Florida, told CNN.
Woodcock said the FDA will prioritize protecting the public and will continue to take action against CBD by monitoring the market and acting when products pose risk.
“The FDA looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products to protect the public’s health and safety,” Woodcock said.
Those within the CBD industry have been frustrated by the FDA for some time, according to The New York Times. Jonathan Havens, who was once legal counsel for the FDA but now represents companies in the CBD industry, told the Times that the agency’s “inaction” has contributed to a chaotic marketplace and confusion, the TImes reported.
“The FDA has never wanted to deal with this issue,” Havens said. “And although that’s regrettable, it would be less regrettable if we knew that in 2019 and Congress could have dealt with it, particularly at a time when Congress wasn’t so sharply divided and bills more regularly emerged from both houses and reached the president’s desk.”