441-02658 (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 effective.

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 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 also 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 updated requirements consider and reflect the feedback received through the consultations with a multi-year implementation timeline to ease costs. The Department is engaging industry stakeholders to better understand their specific challenges with the implementation of the NHP labelling requirements.

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. Informed by these consultations, Health Canada made significant revisions to the proposed fees and on March 27, 2024, published these revisions for public consultation. This included 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 input will be considered before the fees for NHPs become final. Final fees will be published in Canada Gazette, Part II before implementation. 

The amendments to the Food and Drugs Act included in the Budget Implementation Act, 2024, gave 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) and are not intended to limit the availability of NHPs in Canada. Rather, they 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. The recent Ministerial Order that introduced new measures to prevent harms to youth from nicotine replacement therapies is an example of the new authorities in use.