Canadian researchers cheer U.S. regulator's push for tighter rules on CBD
Canadian scientists are ap‐ plauding efforts by the U.S. Food and Drug Administra‐ tion to put tighter regula‐ tions on cannabidiol (CBD), saying more research is needed into the long-term effects of the cannabis product, given its populari‐ ty as a supposed cure for a variety of maladies.
The FDA last week asked Congress to let it create a reg‐ ulatory 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 — general‐ ly fail to meet its food safety standards.
"We have not found ade‐ quate evidence to determine how much CBD can be con‐ sumed, and for how long, be‐ fore causing harm," said Janet Woodcock, the FDA's principal deputy commissioner, in a statement.
Her concerns echoed those of Canadian re‐ searchers, some of whom say CBD ended up in consumer hands before enough study, for the wrong reasons. Ot‐ tawa legalized cannabis for medical use in 2001, and for recreational use in 2018.
"I think science should come before politics and so‐ cial pressure. The safety of pa‐ tients should go first," said Dr. Gabriella Gobbi, a psychia‐ trist and neuroscientist, who researches mental health dis‐ orders 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 pre‐ dict how use affects people over time.
WATCH | Everywhere, and not always legal:
For example, some chil‐ dren developed liver prob‐ lems after using Epidiolex, the first FDA-approved medica‐ tion to treat seizures that contains CBD, according to a 2020 study that analyzed clini‐ cal 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-al‐ tering THC.
Gobbi says the FDA's move highlights the potential risks and lack of knowledge of a substance infused in every‐ thing from body oils to pain relievers, and seen by many as harmless.
She also hopes the FDA's stance drives demand for bet‐ ter 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 proba‐ bly this will put pressure on Health Canada to … look bet‐ ter at the pharmacological properties of CBD and go through better regulatory standards," said Gobbi.
Hance Clarke, medical di‐ rector of the Pain Research Unit at Toronto General Hos‐ pital, says he also hopes Canada takes note of the U.S. direction. He says this coun‐ try lacks regulation around the $13-billion cannabis in‐ dustry and could use stricter rules to "keep Canadians safe" given emerging re‐ search.
Strictly regulated
Health Canada says CBD is already under strict regula‐ tions. The packaging must in‐ clude health warnings and they are prohibited from mak‐ ing unproven health or cos‐ metic claims.
Health Canada declined an interview request but in an email said the Cannabis Act regulates production, distrib‐ ution, sale and possession of cannabis, including CBD.
Other than a few natural health and veterinary prod‐ ucts, all health products con‐ taining cannabis or CBD fall under the Food and Drugs Act and undergo extensive test‐ ing.
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 recom‐ mended 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 be‐ cause 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 Canadi‐ ans turning to CBD to solve myriad ills, despite a lack of clinical proof of its effective‐ ness, and high prices that in‐ surance won't cover.
James MacKillop, director of the Michael G. DeGroote Centre for Medicinal Cannabis Research at McMaster Univer‐ sity 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 Organiza‐ tion suggested CBD is "nonaddictive, not associated with potential human abuse" and low-risk enough to legalize.
But the July 2022 report al‐ so noted concerns about dos‐ ing, liver damage and drug in‐ teractions.
It also noted that overconsumption "could lead to unpleasant but minor side ef‐ fects such as diarrhea."
MacKillop says studies from years ago on rats and sea urchins showed harm‐ ful effects on sperm counts — but says the only human study showed no effects.
While he's not overly con‐ cerned about the dangers of CBD, MacKillop says more re‐ search 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 de‐ veloping a study of the effects of CBD-infused drinks. He says it's unknown how they interact with alcohol and oth‐ er 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 ef‐ fects.
"CBD — and really all of the available cannabis prod‐ ucts — 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.