441-02445 (Health)

Health Canada recognizes that natural health products (NHPs) are important to Canadians to help support and maintain their health and is committed to supporting access to NHPs that are safe and of high quality.

While NHPs are generally lower risk products, that does not mean they are without risk, especially if products are adulterated, or used improperly.

In 2021, the Commissioner of the Environment and Sustainable Development completed an audit of Health Canada’s NHP program and found both strengths and areas for improvement. Health Canada committed to undertaking a number of initiatives to improve the oversight of these products to prevent health and safety risks, especially to vulnerable Canadians. 

Many Canadians use NHPs daily, and expect that the products they use are safe. In an effort to make the NHP market safer for consumers and support Canadians in making informed choices, Parliament recently expanded Vanessa’s Law to include NHPs, providing the Minister with more tools to address health and safety risks when they arise. Vanessa’s Law gives Health Canada the authorities it needs to take timely action to remove unsafe NHPs from the marketplace if a company refuses to do so voluntarily. It is an important tool to ensure that these widely used products are safe and that they work as advertised. These new authorities are only to be used if a serious risk to health is identified and if a company refuses to cooperate with voluntary measures. That is, there are no implications on companies with compliant and safe products.

Health Canada introduced new labelling requirements in 2022 to make NHP labels easier for Canadians to read and understand. Leading up to these changes, the Department undertook extensive and broad consultations with stakeholders and the public which began in 2016. The new requirements consider and reflect the feedback received through the consultations with a multi-year implementation timeline to ease costs. The Department will be engaging further on the guidance for the new labelling regulations to identify additional ways to support industry in implementing the new requirements and minimize costs.

Presently, NHPs are the only line of health products whose regulatory activities are fully funded by Canadian taxpayers. In 2023, Health Canada proposed fees that would allow it to begin recouping a portion of the cost of the services it provides to industry, such as evaluating applications for products before they are authorized for sale, and monitoring these products once they are on the market.

During the initial consultation from May to August 2023, Health Canada received thousands of comments. The Department heard concerns that overall fee amounts were too high and that fees should be brought in at a staggered pace to make the fees more manageable for companies. After carefully considering these comments, the Department substantially revised its fee proposal. This includes significantly reducing fees and easing the introduction of fees through a phased-in approach over seven years, while maintaining the rebates for small businesses. Costs were minimized to the extent possible, resulting in fees lowered by 38% to 72% (depending on the fee) once fully implemented.

The revised fee proposal continues to be guided by Health Canada’s objective of protecting the health and safety of Canadians. In response to stakeholder requests, Health Canada extended the comment period on its revised fee proposal from 30 to 60 days, until May 25, 2024. Ultimately, these initiatives are not about limiting the production of NHPs or consumers’ access to them. Rather, these efforts are about making sure the products Canadians use every day are safe and have the appropriate amount of oversight, aligned with risk.

The amendments to the Food and Drugs Act proposed in Budget Implementation Act, 2024 would give Health Canada additional regulatory tools to address situations that can affect the health and safety of Canadians. These changes are not specific to natural health products, as the proposed authorities would be available for all therapeutic products (prescription and non-prescription drugs, medical devices and natural health products). The proposed amendments are not intended to limit the availability of NHPs in Canada. If approved by Parliament, the changes would provide Health Canada with adaptable regulatory tools which could be used in a variety of situations, for example to maintain product availability in the event of a shortage, remove barriers that can lead to areas of unmet need or address potential health risks or adverse effects.