Over 5,000 serious adverse reactions to natural health products not reported by Health Canada before publication of correction

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According to Health Canada, thousands of Canadians may have experienced serious adverse effects from the use of natural health products, but the numbers were not detailed until a correction of the “mistake be made a month later.

On August 15, a erratum was released to correct a July 6 legal notice on the new labeling rules for natural health products (NHPs), in which the number of “serious” incidents in the section on reporting adverse reactions related to the use of NHPs was not included.

“Since the introduction of the RPSN [Natural Health Products Regulations] from 2004 to December 2021, Health Canada received reports of over 8,000 adverse reactions in which the use of NHPs had a suspected role, of which over 5,000 were serious, the erratum notice states.

According to Blacklock’s Reporter, the figures follow a 2021 audit that found the federal health ministry failed to enforce regulations, rarely randomly check wholesalers and failed to ensure products of health are not contaminated.

“Overall, Health Canada’s oversight of natural health products available for sale in Canada failed to ensure that the products were safe and effective,” said the audit report by Environment and Sustainable Development Commissioner Jerry V. DeMarco.

DeMarco’s report, released on behalf of the Office of the Auditor General of Canada last year Aprilsaid products audited include: vitamins, minerals, probiotics, homeopathic and traditional medicines, alcohol-based hand sanitizers, some sunscreens, toothpastes and shampoos that make health claims.

“This finding is important because Health Canada is responsible,” the report said.

‘Leave unchecked’

More than 91,000 natural health products have been licensed by the Department of Health since 2004, auditors noted, but the regulator has not performed “routine inspections” on manufacturers.

“The lack of routine inspections made it difficult for Health Canada to ensure that manufacturing sites were following good manufacturing practices,” the auditors wrote in the report.

“The department also did not monitor product label information to ensure that products were as described on the label or authorized for sale.”

To better understand the scope of the problem, auditors said they examined a sample of 75 licensed products for sale on Canadian websites.

“We found that 88 [percent] of these products were advertised with misleading product information. Also, 56 [percent] of the products we reviewed were marketed with misleading label information.

These claims included products not authorized by Health Canada because they may not be proven, including products claimed to relieve fatigue, improve endurance or burn fat; an erroneous statement that the product was recommended for children aged 3 and over when it was only authorized for adolescents and adults; and the wrong dosage of medicinal ingredients.

Additionally, the report states that Health Canada “has left natural health products unchecked after they enter the market” and “has failed to always respond to serious concerns.”

“We found that Health Canada has done little to prevent misinformation from being provided to consumers about licensed natural health products.

In a Press release on April 22, 2021, DeMarco said that although Health Canada investigated products suspected of causing serious health risks and acted immediately to address them, the department’s approach was “reactive” and did “not always successful in having products removed from the shelves. ”

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Isaac Teo is an Epoch Times reporter based in Toronto.

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