2021 Reports 1 and 2 of the Commissioner of the Environment and Sustainable Development to the Parliament of Canada—Health Canada’s oversight fell short of ensuring that natural health products were safe and effective

2021 Reports 1 and 2 of the Commissioner of the Environment and Sustainable Development to the Parliament of CanadaHealth Canada’s oversight fell short of ensuring that natural health products were safe and effective

Ottawa, 22 April 2021—A report from Commissioner of the Environment and Sustainable Development Jerry V. DeMarco concludes that Health Canada is unable to ensure that natural health products available in the Canadian marketplace are safe, effective, and accurately represented to consumers. Natural health products include certain sunscreens, toothpastes and shampoos, vitamins and minerals, probiotics, homeopathic and traditional medicines, and alcohol-based hand sanitizers.

The audit found that though Health Canada relied on evidence of safety and effectiveness to approve products, gaps in the oversight of manufacturing sites and in the monitoring of products available for purchase left consumers exposed to potential health and safety risks. For example, Health Canada did not conduct routine inspections to ensure that manufacturing sites followed good manufacturing practices before products were released on the market.

The audit also found that once products were on the market, Health Canada did not sufficiently monitor to ensure that products were licensed for sale or were as described on the label. Auditors found that 88% of the products they reviewed were advertised with potentially misleading information, including health claims not authorized by Health Canada because they might not have been proven. These included claims of products that relieved fatigue, enhanced endurance or burn fat; an erroneous statement that the product was recommended for children of ages 3 and older when it was authorized only for adolescents and adults; and the wrong dosage of medicinal ingredients.

“We found that Health Canada investigated products that were suspected of causing serious health risks and took immediate action to address them,” said Mr. DeMarco. “However, the department’s approach was reactive and not always successful in having products pulled from the shelves.”

Finally, the audit found that during the COVID‑19 pandemic, Health Canada responded to the urgent need for COVID‑19 products such as alcohol-based hand sanitizers. The department provided flexibility to Canadian manufacturers by temporarily waiving compliance with specific regulatory requirements without increasing the risk of serious safety concerns. It also increased its oversight of the products marketed for COVID‑19.

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The 2021 Reports of the Commissioner of the Environment and Sustainable Development, Report 2—Natural Health Products—Health Canada is available on the Office of the Auditor General of Canada website.

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