Opening Statement before the Standing Committee on Public Accounts
Natural Health Products—Health Canada
(Report 2—2021 Reports of the Commissioner of the Environment and Sustainable Development)
24 March 2022
Jerry V. DeMarco
Commissioner of the Environment and Sustainable Development
Thank you, Mr. Chair. We are happy to appear before your committee today to discuss our report on natural health products, which was tabled in the House of Commons in April 2021. I want to start by acknowledging that this hearing is taking place on the traditional unceded territory of the Algonquin Anishinaabeg People. Joining me today is Heather Miller, Assistant Auditor General who was responsible for this audit.
Canada began regulating natural health products in 2004. At that time, the federal government wanted to balance consumer safety with freedom of choice and access to traditional medicine. To be lawfully sold in Canada, natural health products must be licensed by Health Canada. This is to ensure that products are safe and effective. Health Canada considers a natural health product to be safe when the product’s benefits outweigh the risks, so long as it is used as intended. The department considers a natural health product to be effective if the evidence supports that the product will provide the benefits described in the claims.
We focused our work on how Health Canada regulated the industry to make sure that the products were safe and effective. We looked at the licencing of manufacturers and the licencing of products. We further considered the monitoring of the marketplace once products were available for sale.
Overall, we found weaknesses in Health Canada’s oversight. We were concerned that too much reliance was placed on up front licencing approvals but that not enough was done to inspect manufacturing facilities. Inspections are meant to ensure that products are manufactured according to good manufacturing practices, for example using a sterile environment when appropriate.
With upwards of 91,000 natural health product licences in existence in Canada at the time of our audit, it is important to know where, how and when these products are being manufactured. Natural health product-licence holders are required to inform the department which licensed facilities manufactured their products before selling them. However, fewer than 5% did so. This makes it extremely difficult to adequately monitor the production of these products as a whole.
When Health Canada conducted site inspections, it found problems with product manufacturing and product quality. In nearly half of its inspections, the department took regulatory action in response to health risks.
Generally speaking, once products were on the market there was very little monitoring and it was largely complaints driven. Health Canada’s monitoring was insufficient to ensure that the label on products matched the product that was licensed for sale. We found that 88% of the products we examined carried potentially misleading information, including health claims that were not authorized by Health Canada. These included claims that products relieved fatigue, enhanced endurance or burned fat, as well as having incorrect dosage information. We also found that the department did not do enough to prevent the sale of unlicensed products.
We were completing our examination work as the COVID‑19 pandemic began. We expanded the scope of our audit to include the work the department was doing related to natural health products and COVID‑19. While we found some issues with the process, Health Canada responded to the urgent needs for COVID‑19 products, such as alcohol-based hand sanitizers. The department temporarily waived compliance with specific regulatory requirements to afford Canadian manufacturers some flexibility without increasing the risk of serious safety concerns. It also increased its oversight of the products marketed for COVID‑19.
Health Canada has agreed with all 5 recommendations provided in our report.
Mr. Chair, this concludes my opening remarks. We would be pleased to answer any questions the Committee may have. Thank you.