Question Period Note: THE COMMISSIONER OF THE ENVIRONMENT AND SUSTAINABLE DEVELOPMENT’S AUDIT OF THE NATURAL HEALTH PRODUCTS PROGRAM

About

Reference number:
HC-2021-QP2-00013
Date received:
Nov 16, 2021
Organization:
Health Canada
Name of Minister:
Duclos, Jean-Yves (Hon.)
Title of Minister:
Minister of Health

Issue/Question:

• On April 22, 2021, the Commissioner of the Environment and Sustainable Development tabled an audit report of the Natural Health Products Program. Health Canada agrees with the findings and recommendations, and is committed to implementing measures to improve the oversight of natural health products and implement proactive risk-based compliance monitoring activities.

Suggested Response:

KEY MESSAGES
• Health Canada’s top priority is the health and safety of Canadians.
• Health Canada recognizes the importance of ensuring that natural health products available for sale in Canada are safe and effective.
• The audit focussed on natural health products available for sale in Canada to ensure that they are safe, effective and accurately represented to consumers.
• The audit found that Health Canada licensed natural health products appropriately, based on evidence of safety and efficacy prior to licensing. It also found that when an issue was brought to Health Canada’s attention, immediate action was taken.
• It also concluded that Health Canada acted appropriately to increase the supply of alcohol-based hand sanitizers in response to the COVID-19 pandemic.
• The audit also identified areas for improvement. Health Canada agrees with the recommendations from the Commissioner.
• The Department is already working to address all of the recommendations and is taking steps to accelerate its efforts to strengthen the Natural Health Products Program. This includes increased oversight of quality, advertising and labelling, enhanced compliance and enforcement efforts, and ensuring that the department has the tools to protect the health and safety of Canadians when a serious health risk arises.
IF PRESSED NATURAL HEALTH PRODUCTS ON THE MARKET
• Canada has one of the best regulatory systems in the world for natural health products, with some of the most stringent requirements.
• For many Canadians, natural health products are an important part of maintaining a healthy lifestyle.
• While manufacturers are ultimately responsible for ensuring the safety of the natural health products they sell in Canada, Health Canada assesses the products for safety, efficacy and quality prior to issuing a license for sale in Canada.
IF PRESSED AUDIT RECOMMENDATIONS AND THE DEPARTMENTAL RESPONSE
• The audit recommendations include; increased oversight of the quality of natural health products, greater monitoring of labels and advertising, improved product labelling, developing a risk-based inspection program, and introducing proactive risk-based activities for compliance and enforcement.
• Health Canada’s response focuses on strengthening the oversight of online advertising to ensure that Canadians have accurate and reliable information to inform their choices, launching an inspection pilot program intended to inform the development of a permanent inspection program, and bringing forward a regulatory proposal to improve labelling so product labels are clear, consistent and legible for consumers.
• The Department will work to ensure it has the tools to protect the health and safety of Canadians when a serious health risk arises by considering the expansion of Vanessa’s law authorities to natural health products.
• Health Canada is also working on stabilizing funding by developing a proposal to implement cost recovery for key regulatory activities related to natural health products in order to sustain increased oversight of these products, including through inspections of the facilities that make or import them.
IF PRESSED….HOW LONG WILL IT TAKE HEALTH CANADA TO IMPLEMENT THE RECOMMENDED CHANGES?
• In many of the areas of recommendation, work to address gaps has already begun. For example:
o An inspection pilot program was launched in spring 2021 to promote and verify compliance of site licence holders across Canada.
The Department is also expanding its oversight of online advertising of natural health products through a pilot program to ensure advertisements are providing Canadians with accurate and reliable information to inform their choices.
o In June 2021, the Department published a regulatory proposal to improve the labelling of natural health products for consultation, and is currently reviewing the feedback received.
• Other elements of the Department’s response will take more time to implement, such as the Department’s plans to take steps to propose fees for natural health products and expanding Vanessa’s Law to natural health products. To implement this, the Department will develop a proposal which will be subject to stakeholder consultation prior to implementation.

Background:

In 2019, the Commissioner of the Environment and Sustainable Development (CESD) began an audit of Health Canada’s Natural Health Products Program. The period covered by the audit is from January 2017 to May 2020. The purpose of the audit was to determine whether Health Canada ensured that natural health products available for sale in Canada are safe and accurately represented to consumers. In June 2020, the audit scope was expanded to include Health Canada’s response to the COVID-19 pandemic specific to the Natural Health Products Program.

Health Canada regulates natural health products sold in Canada to ensure they are safe and effective. Natural health products include products such as vitamins and minerals, herbal remedies, homeopathic products, traditional products (such as traditional Chinese medicines), and probiotics. Particularly relevant in the context of COVID-19, natural health products also include alcohol-based hand sanitizers.

The auditors made five recommendations, all of which the Department has accepted. The recommendations support the direction that the Department has been taking to improve the oversight of these products. Work to address many of these areas had already begun. The Department has developed a detailed action plan in response to the audit, which is expected to be implemented over the next three years.

The Department is committed to addressing the audit findings by implementing measures to improve the oversight of natural health products, including enhanced enforcement tools and more proactive risk-based monitoring activities.

Additional Information:

KEY FACTS

• Health Canada regulates natural health products sold in Canada to ensure they are safe and effective. Natural health products include products such as vitamins and minerals, herbal remedies, homeopathic products, traditional products (such as traditional Chinese medicines), and probiotics. Particularly relevant in the context of COVID 19, natural health products also include alcohol-based hand sanitizers.
• The auditors made five recommendations, all of which the Department has accepted. The recommendations support the direction that the Department has been taking to improve the oversight of these products.