When discussing the potential risks of natural health products, family doctor Chris Koo shares an anecdote he heard from a colleague.
Doctors were stumped as to why a patient had developed liver failure, and eventually landed on a green tea supplement as the culprit. A lab analysis of the supplement revealed toxic ingredients not disclosed on the label, says Koo, who practises at Misericordia Community Hospital in Edmonton.
“All you see on the label is green tea extract, but there’s all this other stuff, some of which is safe and some of which is not … we need to regulate all those other things that go into the medication,” said Koo, who is also an assistant clinical professor at the University of Alberta.
Not everyone agrees with him.
A private member’s bill, currently being considered in Parliament, proposes relaxing rules introduced last year that regulate natural health products such as vitamins, herbal products and homeopathic medicines.
Industry representatives argue natural health products — which are used by more than 70 per cent of Canadians — are lower risk than pharmaceutical drugs and should be subject to fewer rules. Ottawa’s stricter regulations have burdened the industry and raised the cost of these products, they say.
“Our members have seen an increase in the cost of products” and “loss of some products” since the regulations changed, says Shawn O’Reilly, executive director at the Canadian Association of Naturopathic Doctors. Naturopathic doctors favour natural health products and lifestyle changes over prescription medications.
But medical experts — who supported more stringent regulation of natural health products — say the rules were changed for good reason and should be maintained.
“Given the potential seriousness of adverse health reactions of many health products, whether natural or not, it is critical that these products are subject to proper oversight for quality and safety purposes,” said Joss Reimer, president of the Canadian Medical Association in a Sept. 16 brief delivered to a parliamentary standing committee on health.
What is safe?
A 2021 government audit of Health Canada’s oversight of natural health products identified serious shortcomings with the agency’s practices. It recommended improved oversight, monitoring and labelling of natural health products.
Following the audit, Health Canada ran a pilot program inspecting 36 companies that produce natural health products. The program notified 15 of them — 42 per cent — about “potential or immediate suspensions of site or product licences.”
While the suspensions were all ultimately reversed after the companies addressed compliance issues, some discontinued products following further testing.
In June 2023, Ottawa went a step further by bringing natural health products under the same set of rules as pharmaceutical drugs and medical devices.
Healthcare institutions are now required to report all serious adverse reactions from natural health products. And Health Canada has the power to recall unsafe products and compel better product labelling.
But in December, Conservative MP Blaine Calkins introduced a a private member’s bill, Bill C-368, which proposes regulating natural health products under their own category — as they used to be regulated.
“We do feel that the [former] regulations are sufficient to ensure that the products are safe and effective,” said O’Reilly.
O’Reilly says Ottawa’s rules have made it more expensive to get natural health products approved. Companies now face product application fees in the range of $1,600 to $400,000 — up from no fees previously. For some companies, it is a barrier to producing natural health products at all.
“If [naturopathic doctors] have a product that is used for a particular illness … [and the company] doesn’t manufacture a large number of them, those products may disappear from the market because … the companies won’t be able to afford to produce them,” said O’Reilly.
“You can imagine the negative impact that will have on patients and naturopathic doctors,” he said.
At the parliamentary committee’s latest meeting on Oct. 31, Jules Gorham, director of regulatory affairs and policy at the Canadian Health Food Association, a natural health trade organization, asked members of Parliament to consider the effect of heavy-handed oversight on the natural health industry.
The industry has been subject to six legislative and regulatory changes over the last three years, Gorham said. “Catching an entire industry off-guard … has left us with a mess that has severe ramifications for business, trade and public health,” he said.
But oversight of the production of natural health products is necessary to ensure public safety, says Koo.
Ottawa agrees. “The Government opposes Bill C-368 because repealing [it] would be detrimental to consumer health and safety,” Health Canada told Canadian Affairs in an emailed statement.
The proposed bill assumes there is less risk in natural health products, says Koo. “That’s putting a lot of blind faith into the industry, and saying, ‘Oh no, I’m sure they’re going to be fine. I’m sure nobody wants to do harm. I’m sure nobody’s going to take advantage and put false claims on these labels.’
“For me that makes me really, really nervous, I don’t think I have that level of faith that everybody’s just going to do everything properly — and if there is an issue then there’s no way to recall, there’s no way to alert other people, like, ‘Hey, we should take a second look’.”
Bill C-368 is under study by the standing committee on health, which will produce a report before sending the bill for third reading in the House of Commons.
