Thank you, Mr. Chair and committee members, for the opportunity to appear before you today.
Joining me today are Pam Aung-Thin, associate assistant deputy minister of the health products and food branch, which is responsible for product and site licensing, as well as monitoring of advertising; and Linsey Hollett, director general of health product compliance for the regulatory, operations and enforcement branch, which supports the compliance and enforcement of natural health products.
Natural health products are used by Canadians daily to care for themselves and their families. They include vitamin supplements, minerals, probiotics, herbal remedies, homeopathic products and traditional products, such as traditional Chinese medicines. Natural health products also include frequently used products such as toothpaste, mouthwash and sunscreen. Particularly relevant in the context of COVID-19, they also include alcohol-based hand sanitizers.
In Canada, these products are regulated under the Food and Drugs Act and the Natural Health Products Regulations. Through the natural health products program, Health Canada provides oversight to ensure that the natural health products available for sale in Canada are safe and effective.
Overall, the audit found both strengths and areas for improvement.
The audit found that Health Canada licensed products appropriately, based on evidence of safety and efficacy. The audit also found that, when an issue was brought to Health Canada’s attention, immediate action was taken.
It also identified areas for improvement, such as the need for increased oversight on the quality of natural health products, greater monitoring of labels and advertising and improving labelling compliance and enforcement activities. The recommendations validated key gaps that the department had already identified and started working on to address prior to the audit.
The audit supports the direction Health Canada is taking to strengthen the oversight of these products.
To address the recommendation to improve quality oversight, Health Canada has taken steps to require site licence applicants to demonstrate compliance with good manufacturing practices, such as by requiring test results instead of relying on an attestation-based approach.
In March 2021, Health Canada launched the natural health products good manufacturing practices inspection pilot to promote and verify industry compliance with the regulatory requirements through inspections of licence-holders across Canada. Results of the pilot to date are demonstrating a high rate of non-compliance and a need to further industry education as well as ongoing, proactive, risk-based oversight. In this regard, Health Canada is on track to implement a permanent good manufacturing practices inspection program to increase oversight of NHPs and better protect Canadians.
The department is building on work that began during the pandemic to expand its oversight of online advertising of natural health products to ensure that advertisements are consistent with the product license.
Additionally, the department recently consulted on a regulatory proposal to improve product labelling with the objective of ensuring that labels are clear, consistent and legible for consumers to support the safe use of these products.
In response to the audit, Health Canada indicated its intent to propose new tools to strengthen the department’s ability to deter and address non-compliance, notably the extension of powers under the Protecting Canadians from Unsafe Drugs Act to natural health products. Known as Vanessa's Law, which received royal assent in 2014, this law strengthened Health Canada’s ability to collect information and take quick and appropriate action when a serious health risk is identified for therapeutic products and medical devices. However, these authorities do not exist for natural health products, and as a result, we lack the authority to force a recall or a label change of a product, even in the case of a serious health risk such as contamination.
In our departmental response to the audit findings, Health Canada reaffirmed the need for sustainable and predictable funding through fees charged to industry to support increased oversight of these products. Natural health products are the only line of health products for which all regulatory activities are funded by the public. Revenues from fees would support pre- and post-market regulatory activities, including inspections of the facilities that make them.
In closing, Health Canada’s priority is the health and safety of Canadians. For many Canadians, natural health products are an important part of maintaining a healthy lifestyle. Health Canada welcomes the commissioner’s recommendations and is committed to the continuous improvement of the NHP program to ensure that the products sold in Canada are safe and effective.
Again, I would like to thank the committee for inviting me.
I will be pleased to answer any questions you may have.