Federal oversight of natural health products full of holes: commissioner
Health Canada does not guarantee that natural health products are safe, effective and accurately represented to consumers, a federal watchdog warned Thursday.
Due to a lack of monitoring of manufacturing facilities and inadequate monitoring of products on store shelves, the department has left consumers exposed to health and safety risks, according to a damning audit by the Commissioner of environment and sustainable development Jerry DeMarco.
Although Health Canada appropriately authorizes natural products health products, it is not verify that production facilities follow good manufacturing practices before products are sold in store or online, instead of relying on manufacturers to self-report, the audit found.
Once products are on the market, federal inspectors don’t do enough to make sure they are properly labeled and advertised.
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While Health Canada is investigating products suspected of causing serious health risks, such as side effects, and acting quickly in response, the ministry’s approach is reactive and does not always result in products being taken off shelves.
Certain sunscreens, toothpastes, shampoos, vitamins and minerals, probiotics, homeopathic and traditional medicines, and alcohol-based hand sanitizers are considered natural health products.
About 70 percent of Canadians regularly use natural health products, which are regulated differently from over-the-counter drugs or cosmetics.
Since 2004, Health Canada has issued more than 91,000 licenses for natural health products.
The ministry can suspend or cancel manufacturing licenses, issue public notices, stop selling products, or grabbing them outright. However, it cannot force a mandatory recall, including when a product poses a serious or imminent risk of causing damage.
To determine if good manufacturing practices were followed before products were released to market, DeMarco’s office examined a sample of 25 active manufacturing plants in Canada and abroad that the Department of Health had authorized. between 2017 and 2019.
At 13 of these sites, Health Canada relied on inspectors from other countries to authorize them. In 10 of the 13 cases, the ministry lacked evidence to show that inspectors had specifically examined natural health product lines.
For the other 12 sites, Health Canada obtained information from the site before issuing a license, but did not verify that all good manufacturing practice criteria were met.
Unlike natural health products, the ministry inspects the facilities where drugs are manufactured before they are marketed. He is also informed when drugs appear on store shelves, but does not know when natural products do.
Once products are available to consumers, Health Canada responds to complaints, rather than first verifying that advertising and label information meet the product’s license conditions.
DeMarco’s office examined a sample of 75 licensed products for sale on Canadian websites, 88 percent of which were advertised using misleading information. Fifty-six percent of the products had misleading information on the label.
The label information includes health claims not authorized by Health Canada because they may not have been proven, such as relieving fatigue, improving endurance or burning fat. In other cases, the labeling includes an incomplete list of risks and ingredients, or incorrect amounts of medicinal ingredients.
A quarter of the 75 products reviewed did not have a natural product number issued by Health Canada, indicating that a product has been evaluated for safety and efficacy.
Unlike Europe, Health Canada does not perform periodic on-site inspections of manufacturing facilities.
When it did, in a pilot program, many companies failed to meet manufacturing and quality standards.
The 46 sites inspected between 2017 and 2019 revealed product quality issues. Almost half of the sites required ministerial action, including seven whose licenses were canceled.
While performing the audit, DeMarco’s office discovered that one of the companies, whose license Health Canada had refused to renew, was still selling products online as of October 2020.
Health Canada also does not have a program to actively monitor high-risk unauthorized products on the market.
Despite limited regulatory authority, from 2017 to 2019, the department managed to withdraw from the market 36 of the 40 products suspected of presenting a serious risk to health.
Health Canada has generally been successful in regulating products, such as hand sanitizers, during the pandemic, the audit added.
During the audit, the ministry also said that, as part of its product licensing process, it has limited regulatory power to compel companies to produce information and lacks stable funding to regulate. these products.
Health Canada has agreed to follow DeMarco’s recommendations and said it will try to strengthen surveillance, including adopting risk-based approaches to authorization and surveillance.
A ministry statement released Thursday said “Canada has one of the best regulatory systems in the world for health some products.”