Natural health products are not being safely or effectively monitored by Health Canada which is leaving Canadians at risk, according to a scathing report from a federal watchdog.
Environment and Sustainable Development Commissioner Jerry DeMarco said Thursday that products like vitamins, mineral supplements, homeopathic medicines, and even certain kinds of toothpaste are not being closely monitored during production.
The “gaps in the oversight” at manufacturing sites mean that products are hitting store shelves and leaving consumers open to severe health and safety risks.
“There have been cases of people experiencing serious and unexpected adverse reactions to authorized and unauthorized natural health products,” DeMarco’s report said. “Overall, Health Canada’s oversight of natural health products available for sale in Canada fell short of ensuring that products were safe.”
“Reactions have included septic shock, jaundice, and disruption of liver function; some adverse reactions required hospitalization.”
The report found that federal inspectors are failing to ensure these health products are accurately labelled or advertised.
DeMarco’s team reviewed samples from 25 active manufacturing plants in Canada and foreign sites of Canadian importers that Health Canada approved between 2017 and 2019.
At 13 sites, the report found Health Canada relied on inspectors from other countries to license them and 10 of those 13 sites showed the department lacked evidence that inspectors had even reviewed the natural health product lines.
At the other 12 sites, Health Canada did not verify key types of evidence showing the sites followed good manufacturing practices, like quality assurance or adequate sanitation.
“Health Canada could not verify that natural health products sold to Canadian consumers were manufactured in sites that complied with good manufacturing practices before they went on the market,” the report found.
A review of 75 licensed products for sale in Canada — which included probiotics or certain kinds of sunscreen or shampoo — found 88 per cent were advertised using misleading information and 56 per cent had misleading label information.
Some of the unproven claims included products that relieved fatigue, enhanced endurance or burned fat.
“We found that Health Canada did little to prevent poor information from being given to consumers about licensed natural health products,” DeMarco said.
COVID-19 claims
The audit also found dozens of instances in which Health Canada inspectors found false or misleading claims during the course of the COVID-19 pandemic.
Between April and May 2020, Health Canada found 80 instances of natural health products claiming to prevent, treat, diagnose, or cure COVID-19.
One false claim included that some mushrooms would prevent COVID-19 and boost the immune system and that oil of oregano stopped the growth of multiple bacteria, the report said.
“We looked at a sample of 25 of these advertisements and found that three of them were still online at the time of the audit despite Health Canada’s efforts,” the report said.
DeMarco’s audit also searched Canadian websites to determine whether products were making claims to prevent COVID-19 or protect against it. His team examined 30 websites that advertised such products and found that 25 of them made unauthorized claims.
“Although the department actively monitored the COVID-19 market, we found that many licensed and unlicensed natural health products were still making unauthorized claims at the time of the audit,” the report said.
Health Canada was, however, generally successful at regulating products, such as hand sanitizers, during the pandemic, according to the report.
READ MORE: Canada opens door to some unregulated sanitizer, health products to fight coronavirus
One of the major stumbling blocks, according to the report, is that unlike Australia or Europe, Canada doesn’t conduct routine on-site inspections of manufacturing plants.
And when they do, inspectors generally find a “high level of industry non-compliance.”
Between 2017 and 2019, all 46 sites visited by inspectors found problems with product quality and nearly half the sites required departmental action. Seven companies had their licences cancelled.
In one case, DeMarco’s audit found that one of the companies was still selling products online in October 2020 despite not having its licence renewed by Health Canada.
The report noted a lack of funding, limited regulatory power and rapid issuing of licences for products has contributed to the widespread oversight problems.
READ MORE: Counterfeit Chinese-made face masks pulled offline after Global News probe
While Health Canada can suspend or cancel manufacturing licences, issue public warnings, or stop products from being sold, it can’t force a mandatory recall.
Since 2004, Health Canada has issued more than 91,000 licences for natural health products.
The report also found Health Canada to be more reactive, “and not always successful in having all products pulled from the shelves. The agency generally responds to complaints, rather than first checking advertising and label information.
According to DeMarco’s team, the department needs to take a “risk-based approach” to better monitor product label and advertisement information, consistent with their licence conditions
Health Canada said in a statement it was already working to follow the recommendation from DeMarco’s report.
“Our department is already working to address all of the recommendations and is taking steps to accelerate its efforts to strengthen the natural health products program, including increased oversight of quality, advertising and labelling,” the department said.
“This includes strengthening the oversight of online advertising to ensure that Canadians have accurate and reliable information to inform their choices, launching an inspection pilot program intended to inform the development of a permanent inspection program.”
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