Canadian scientists are applauding efforts by the U.S. Food and Drug Administration to put tighter regulations on cannabidiol (CBD), saying more research is needed into the long-term effects of the cannabis product, given its popularity as a supposed cure for a variety of maladies.
The FDA last week asked Congress to let it create a regulatory framework for CBD, which is currently bound by few if any rules under the U.S. Farm Act. The regulator says CBD-infused products — from gummies to sodas — generally fail to meet its food safety standards.
"We have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm," said Janet Woodcock, the FDA's principal deputy commissioner, in a statement.
Her concerns echoed those of Canadian researchers, some of whom say CBD ended up in consumer hands before enough study, for the wrong reasons. Ottawa legalized cannabis for medical use in 2001, and for recreational use in 2018.
"I think science should come before politics and social pressure. The safety of patients should go first," said Dr. Gabriella Gobbi, a psychiatrist and neuroscientist, who researches mental health disorders at McGill University's department of psychiatry.
The FDA cited evidence of CBD's potential risks to the liver, to the male reproductive system and of possible drug interactions. There's also scant long-term data to predict how use affects people over time.
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For example, some children developed liver problems after using Epidiolex, the first FDA-approved medication to treat seizures that contains CBD, according to a 2020 study that analyzed clinical trials.
CBD is a compound found in cannabis, that can also be derived from hemp or parts of the cannabis plant with very low levels of the mind-altering THC.
Gobbi says the FDA's move highlights the potential risks and lack of knowledge of a substance infused in everything from body oils to pain relievers, and seen by many as harmless.
She also hopes the FDA's stance drives demand for better clinical data to determine what CBD is effective for, at what dose and with what risk. She also hopes one day to see Epidiolex available in Canada.
"Canada always looks to the U.S. and follows, so probably this will put pressure on Health Canada to … look better at the pharmacological properties of CBD and go through better regulatory standards," said Gobbi.
Hance Clarke, medical director of the Pain Research Unit at Toronto General Hospital, says he also hopes Canada takes note of the U.S. direction. He says this country lacks regulation around the $13-billion cannabis industry and could use stricter rules to "keep Canadians safe" given emerging research.
Strictly regulated
Health Canada says CBD is already under strict regulations. The packaging must include health warnings and they are prohibited from making unproven health or cosmetic claims.
Health Canada declined an interview request but in an email said the Cannabis Act regulates production, distribution, sale and possession of cannabis, including CBD.
Other than a few natural health and veterinary products, all health products containing cannabis or CBD fall under the Food and Drugs Act and undergo extensive testing.
Toronto retiree Mike Parish got interested in CBD after a nasty spill on his bike left him with a metal pin in his arm. A friend recommended a CBD-infused topical for the pain. Parish says the product — labelled a "relief stick" — seems to work.
"I don't know if it's just because I believe so much I want it to work — so it works? I can sleep. So it works," said Parish.
He is one of many Canadians turning to CBD to solve myriad ills, despite a lack of clinical proof of its effectiveness, and high prices that insurance won't cover.
James MacKillop, director of the Michael G. DeGroote Centre for Medicinal Cannabis Research at McMaster University in Hamilton, says while CBD is low risk at low doses, it's not risk free.
"There is, unfortunately, a myth that CBD is harmless," he said.
An expert review at the World Health Organization suggested CBD is "non-addictive, not associated with potential human abuse" and low-risk enough to legalize.
But the July 2022 report also noted concerns about dosing, liver damage and drug interactions.
It also noted that over-consumption "could lead to unpleasant but minor side effects such as diarrhea."
MacKillop says studies from years ago on rats and sea urchins showed harmful effects on sperm counts — but says the only human study showed no effects.
While he's not overly concerned about the dangers of CBD, MacKillop says more research is needed and clinical trials are prohibitively difficult to mount in this country.
"If something is strong enough to treat a condition, it's probably strong enough to have some unwanted side effects and be risky also," he said.
MacKillop is currently developing a study of the effects of CBD-infused drinks. He says it's unknown how they interact with alcohol and other drugs.
He says Canada's current regulations make it "less of a 'wild west' environment" than in the U.S.
"And that's probably for the good of consumers."
MacKillop concedes CBD is not intoxicating or addictive and it's anecdotally credited to help with a "laundry list" of ills — from poor sleep and anxiety, to pain, addiction and even PTSD. But he says there's still not enough high-quality research on its effects.
"CBD — and really all of the available cannabis products — exist in a fairly murky and grey area when it comes to evidence. There's a lot more lore…than there is good evidence," said MacKillop.