Natural health products are not being monitored safely or effectively by Health Canada which is putting Canadians at risk, according to a scathing report by a federal observer.
Environment and Sustainable Development Commissioner Jerry DeMarco said Thursday that products like vitamins, mineral supplements, homeopathic medicines and even some types of toothpastes are not being closely monitored during production.
“Surveillance gaps” at production sites mean products are hitting store shelves and leaving consumers open to serious health and safety risks.
“There have been cases of people experiencing serious and unexpected adverse reactions to authorized and unauthorized natural health products,” the DeMarco report said. “Overall, Health Canada oversight of natural health products available for sale in Canada failed to ensure that the products were safe.”
“Reactions have included septic shock, jaundice, and impaired liver function; some side reactions required hospitalization. ”
The report found that federal inspectors are failing to ensure that these health products are accurately labeled or advertised.
The DeMarco team reviewed samples from 25 active manufacturing plants in Canada and foreign Canadian importer sites that Health Canada approved between 2017 and 2019.
At 13 sites, the report found that Health Canada relied on inspectors from other countries to license them, and 10 of those 13 sites indicated that the department had no evidence that inspectors had even reviewed natural health product lines.
In the other 12 countries, Health Canada has not verified the main types of evidence showing that countries have followed good manufacturing practices, such as quality assurance or proper sanitation.
“Health Canada could not verify that natural health products sold to Canadian consumers were produced on sites that complied with good manufacturing practices before they hit the market,” the report found.
A review of 75 licensed products for sale in Canada – which included probiotics or certain types of sunscreen or shampoo – found that 88 percent had advertised using misleading information and 56 percent had misleading labeling information.
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Some of the unproven claims included products that relieved fatigue, increased resistance, or fat burning.
“We found that Health Canada did little to prevent poor customer information about licensed natural health products,” DeMarco said.
The audit also found dozens of cases 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 cases of natural health products claiming to prevent, treat, diagnose, or cure COVID-19.
A false claim included that some mushrooms would prevent COVID-19 and boost the immune system, and that oregano oil stopped the growth of numerous bacteria, the report said.
“We saw a sample of 25 of these ads and found that three of them were still online at the time of the audit, despite Health Canada efforts,” the report said.
The DeMarco audit also searched Canadian websites to determine if the products were making claims to prevent or protect against COVID-19. His team reviewed 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 health products were still making unauthorized claims at the time of the audit,” the report said.
Health Canada was, however, generally successful in fixing products, such as hand cleaners, during the pandemic, according to the report.
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One of the main obstacles, according to the report, is that unlike Australia or Europe, Canada does not conduct routine inspections instead of production facilities.
And when they do, inspectors usually find a “high level of industry mismatch.”
Between 2017 and 2019, all 46 countries visited by inspectors found problems with product quality and almost half of the countries requested departmental action. Seven companies have had their licenses revoked.
In one case, DeMarco’s audit found that one of the companies was still selling products online in October 2020 despite not renewing its license from Health Canada.
The report noted the lack of funding, limited regulatory power and the rapid issuance of product licenses have contributed to widespread surveillance problems.
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While Health Canada may suspend or revoke manufacturing licenses, issue public warnings, or prohibit the sale of products, it may not enforce a mandatory withdrawal.
Since 2004, Health Canada has issued more than 91,000 licenses for natural health products.
The report also found that Health Canada was more responsive, “and not always successful in getting all products off the shelves. The agency generally responds to complaints, rather than checking advertising and label information first.”
According to the DeMarco team, the department should take a “risk-based approach” to better monitor product label and advertising information, in accordance with the terms of their license
Health Canada said in a statement that it was already working to follow the recommendation from the DeMarco report.
“Our department is already working to address all recommendations and is taking steps to accelerate its efforts to strengthen the natural health products program, including increasing quality oversight, advertising and labeling,” the department said.
“This includes strengthening the oversight of online advertising to ensure Canadians have accurate and reliable information to inform their choices, by launching a pilot inspection program that aims to inform the development of a permanent inspection program.”
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