Natural health product regulation in Canada: Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law)

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• Extending the Protecting Canadians form Unsafe Drugs Act to natural health products
• Key authorities that come into effect immediately

Extending the Protecting Canadians from Unsafe Drugs Act to natural health products

While NHPs are generally lower risk products, that does not mean they are without risk.

Health Canada has seen serious non-compliance that could be harmful to consumers such as product contamination and the presence of ingredients not listed on the label.

In June 2023, the Government of Canada passed legislation that amends the Food and Drugs Act (FDA), extending the authorities under the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) to NHPs. This allows Health Canada to take more action if a serious or imminent risk to health is identified with an NHP. An example of a serious or imminent risk is a product being contaminated with toxic elements, such as mold, lead or E. coli. Health Canada can now order a recall of a product or add warnings to support its safe use, if necessary, which it couldn't do before.

These authorities for NHPs are consistent with other health products regulated under the FDA.

Key authorities that come into effect immediately

A number of key authorities in the Food and Drugs Act came into force immediately for natural health products. These key authorities allow Health Canada to:

• order a recall of NHPs that present a serious or imminent risk of injury to human health
• require a label change or package modification, if necessary, to prevent serious injury to health
• impose higher fines and penalties for non-compliance
• order a person to provide information to determine if a product presents a serious risk of injury to human health
• disclose confidential business information when there is a serious risk of injury to human health or for the protection or promotion of human health or the safety of the public
• incorporate by reference
• prohibit false or misleading statements or information to the Minister

It is important to note:

• there will be no impact on compliant companies
• most of these new authorities are tools that Health Canada can access as needed to respond to or gain information about suspected serious health and safety risks
• Health Canada would only use these authorities if a company refused to take part in voluntary mechanisms

Regulations will be required before the coming into force of the remaining authorities which allow Health Canada to:

• add terms and conditions to authorizations
• require health care institutions to report serious adverse reactions
• require tests or studies to provide more information on risks and benefits
• require an assessment if risks and benefits have changed since an NHP was authorized

We will consult with stakeholders to determine when and how these regulations would come into force.

Related links

• Overview of Vanessa's Law
• Implementation of Vanessa's Law
• Protecting Canadians from Unsafe Drugs Act (Vanessa's Law): Questions and Answers
• Guide to authorities under the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law)
• Protecting Canadians from Unsafe Drugs Act (Vanessa's Law)
• Food and Drugs Act
• Natural Health Products Regulations
• Transparency measures