Health Canada is failing to provide natural health products are safe, effective and accurately represented for consumers, a federal observer warned on Thursday.
Due to a lack of oversight of production facilities and inadequate product monitoring on store shelves, the department has left consumers exposed to health and safety risks, according to a damn check by Environment and Sustainable Development Commissioner Jerry DeMarco.
While Health Canada licenses appropriately naturally health products, does not verify that manufacturing facilities follow good manufacturing practices before products are sold in stores or online, instead of relying on manufacturers to self-report, found control.
Once products come on the market, federal inspectors do not do enough to make sure they are properly labeled and advertised.
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While Health Canada investigates products suspected of causing serious health hazards, such as side effects, and acts quickly in response, the department’s approach is responsive and does not always result in products being removed from the shelves.
Some sun creams, toothpastes, shampoos, vitamins and minerals, probiotics, homeopathic and traditional medicines and alcohol-based hand cleansers are considered natural health products.
About 70 percent of Canadians regularly use natural health products, which are regulated differently from over-the-counter medicines or cosmetics.
Since 2004, Health Canada has issued more than 91,000 licenses for natural health products.
The department may suspend or revoke production licenses, issue public advisers, prohibit selling products, or capturing them in full. However, it may not compel a mandatory withdrawal, including when a product poses a serious or imminent risk of harm.
To determine if good manufacturing practices were being pursued before the products hit the market, the DeMarco office reviewed an example of 25 active manufacturing plants in Canada and abroad that the Department of Health licensed between 2017 and 2019.
In 13 of those countries, Health Canada relied on inspectors from other countries to license them. In 10 out of 13, the department had no evidence to show that inspectors reviewed natural health product lines, specifically.
For the other 12 sites, Health Canada obtained some site information before issuing a license, but did not verify that all criteria for good manufacturing practices were met.
Unlike natural health products, the department inspects facilities where medicines are produced before they hit the market. It’s also been informed when medicines appear on store shelves, but I do not know when natural products appear.
Once products are available to consumers, Health Canada responds to complaints, rather than first checking that the advertisement and label information meet the product license requirements.
The DeMarco office reviewed an example of 75 products licensed for sale on Canadian websites, of which 88 percent were advertised using misleading information. Fifty-six percent of products had misleading labeling information.
Label information includes health claims not authorized by Health Canada because they may not have been proven, such as they relieve fatigue, increase endurance, or burn fat. In other cases, the label includes an incomplete list of hazards and ingredients, or incorrect amounts of medicinal ingredients.
A quarter of the 75 products examined did not have a natural product number issued by Health Canada, indicating that a product has been rated for safety and efficacy.
Unlike in Europe, Health Canada does not conduct periodic on-site inspections of manufacturing facilities.
When it did, under a pilot program, many companies failed to meet production and quality standards.
The 46 sites he inspected between 2017 and 2019 revealed problems with product quality. Almost half of the countries requested departmental action, including seven whose licenses were revoked.
During the audit, DeMarco’s office found that one of the companies whose Health Canada license had refused to renew was still selling products online in October 2020.
Health Canada also lacks a program to actively monitor unlicensed high-risk products on the market.
Despite limited regulatory authority, from 2017 to 2019, the department managed to retrieve 36 of the 40 products from the market that were suspected to pose a serious health risk.
Health Canada was generally successful in fixing products, such as hand cleaners, during the pandemic, the control added.
In the audit, the department also said that, as part of its product licensing process, it had limited regulatory authority to compel companies to produce information, and there was a lack of consistent funding to regulate such products.
Health Canada agreed to follow DeMarco’s recommendations and said it would try to strengthen oversight, including adopting risk-based approaches to licensing and monitoring.
A statement from the department released on Thursday said “Canada has one of the best natural regulatory systems in the world health products. ”