Over 5,000 Serious Adverse Reactions to Natural Health Products Unreported By Health Canada Before Correction Issued

The Emergency Department entrance at the Ottawa Hospital Civic Campus in Ottawa is shown on May 16, 2022. (The Canadian Press/Justin Tang)

Thousands of Canadians may have suffered serious adverse reactions from using natural health products, says Health Canada, but the figures were not detailed until a correction to the “error” was made a month later.

On Aug. 15, an erratum was published to correct a July 6 legal notice on new labelling rules for natural health products (NHP), in which the number of “serious” incidents under the section on adverse event reporting related to NHP use were not included.

“From the introduction of the NHPR [Natural Health Products Regulations] in 2004 until December 2021, Health Canada has received reports of over 8,000 adverse reactions in which NHP use had a suspected role, of which over 5,000 were serious,” the erratum notice said.

According to Blacklock’s Reporter, the figures follow a 2021 audit that found the federal health department failed to enforce regulations, seldom conducted random checks on wholesalers, and failed to ensure the health products were not contaminated.

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

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

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

‘Left Unchecked’

Over 91,000 natural health products were licensed by the Department of Health since 2004, the auditors noted, but the regulator did not conduct “routine inspections” on manufacturers.

“The absence of routine inspections did not allow 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 licensed for sale.”

To gain an understanding of the scale of the problem, the 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 examined were marketed with misleading label information.”

These included claims of products not authorized by Health Canada because they might not have been proven, including products said to relieve fatigue, enhance 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.

In addition, the report said Health Canada “left natural health products unchecked after they entered the market” and “was not always successful in responding to serious problems.”

“We found Health Canada did little to prevent poor information from being given to consumers about licensed natural health products.”

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