F.A.Q. About Heath Canada’s Proposal

Health Canada has recently launched a proposal called the Consulting Canadians on the Regulation of Self-Care Products in Canada, which proposes changes that could significantly alter the way natural health products are regulated, and impact many of products you use on a daily basis. We've compiled some frequently asked questions below to help you understand the impact this new proposal could have.

What are natural health products (NHPs)?

Natural health products (NHPs) is a term used to define a category of products, including vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines such as traditional Chinese medicine, probiotics and other products like amino acids and essential fatty acids.

How do I know the NHP I’m using is safe?

Before a product can go to market in Canada, it must first be reviewed by the Natural and Non-prescription Health Products Directorate (NNHPD), a branch of Health Canada, for safety, efficacy and quality. This review gives the government the ability to ensure that the product does what it says it will, is safe for you to use when following the directions on the label, and is made with ingredients and in a place that is appropriate. 

A company making and selling an NHP must submit an application to Health Canada for review. If a product is authorized for sale, it will receive a Natural Product Number (NPN). The NPN is an eight-digit number found on the label of all NHPs legally licensed for sale in Canada, and is your assurance that the product has been reviewed and authorized for sale by Health Canada. You can find more information about a product by looking up its NPN on the Licensed Natural Health Products Database.

How do I know the NHP I’m using is going to work?

No NHP can be licensed for sale in Canada without providing evidence to support the claims being made. Evidence can come from a variety of sources, such as modern studies and traditional sources, including pharmacopoeias (books published by a government, medical or pharmaceutical society), and references supporting the traditional use of products like traditional Chinese medicines or herbals.

How are NHPs currently regulated in Canada?

The Canadian approach to regulation is often referred to as a “pre-approval” system, which means that all NHPs must be licensed by Health Canada before they are allowed to be legally sold to Canadians. NHPs are regulated by the NNHPD. NHPs have their own regulations, the Natural Health Products Regulations (NHP Regulations), which came into effect in 2004.

What changes could occur if this proposal is accepted?

This proposal suggests that Health Canada will no longer review some products, and product labels will then be required to have a disclaimer in line with, ”Health Canada has not reviewed.” Additionally, claims based on previously accepted evidence may no longer be allowed and would be removed from the label. This will limit the amount of information you receive about some of the products you buy, such as herbal remedies, for example.

While reducing oversight on some products, the proposal is suggesting increased oversight on others. These products may require a level of evidence similar to what is needed for drugs. Requiring this level of evidence, necessary for products developed in a lab, is not reasonable for NHPs when considering their safe nature and long history of use. This will result in the loss of some products from store shelves.

How will the proposal impact the products I use?

If the proposed changes go through, the impact on the products you love will be significant. For some products, the companies that make NHPs could face increased costs in providing the drug-level evidence required. Some products may no longer be available while the industry tests and transitions to the new regulations, and will be more expensive when they return. Others may simply disappear forever. This could include products like natural herbal remedies, cough and cold products, and probiotics, among others. This change will also hamper innovation and the development of new products.

Why do NHPs require different evidence to support their claims compared to non-prescription drugs?

When the Natural Health Products Regulations were developed, the Standing Committee on Health consulted experts in the field and performed a rigorous review of what types of evidence would be needed to support these products. They agreed that many sources of evidence, including traditional use, did support the safety and efficacy of these products. Requiring a drug level of evidence, necessary for products developed in a lab, is not reasonable for NHPs when considering their safe nature and their use without oversight from a health care practitioner.

Why can NHP companies make claims on their products without providing extensive scientific research? 

The level of evidence required depends on the claim being made, the overall risk of the product, and the condition it is being used for. A product such as a multivitamin that makes a claim, “helps with the maintenance of good health,” will have to provide different evidence than an omega-3 supplement that makes the claim, “helps to reduce serum triglycerides and support brain function.” NHPs also include many traditional medicines (Traditional Chinese Medicine and Ayurvedic Medicine, for example) that have been safely used for thousands of years. Suddenly requiring these products to be supported by modern research to accommodate the modernization of regulation does not respect the cultural heritage behind these products.

Why can NHPs make similar health claims to over-the-counter drugs without having to provide similar evidence?

NHPs are required to provide evidence to support all health claims made, and Health Canada reviews all claims made before approving each product. The company making the product is required to submit an appropriate amount of evidence to support the efficacy of the NHP. The amount of evidence required varies depending on the proposed health claim(s), but sufficient information must be provided before Health Canada will approve the use of a health claim. Details on the approved claims for a product can be found by looking up the product’s NPN on the Licensed Natural Health Products Database.

This sounds expensive. How will the development of and compliance to the proposed changes, if accepted, be funded?

Health Canada spent millions of dollars developing the existing NHP Regulations. The NHP industry has also spent millions more becoming compliant with the existing regulations, which has benefitted Canadians by giving us access to a huge variety of safe, effective, and high-quality products. In fact, there are currently over 100,000 licensed NHPs in Canada. If implemented, the changes in this proposal will have significant costs in tax dollars and will also require companies to spend millions more to comply with the changes. These costs will eventually have to be covered by raising product prices. Alternatively, companies may decide to stop making and selling products because the cost will become too expensive for customers, which will result in the disappearance of many products from store shelves.

A risk-based regulatory system seems like a sound, responsible framework. Why should I have a problem with it?

Yes, it is, and the current system we have in place already accounts for this. Why fix a system that is not broken? The level of evidence (type and amount) that is provided to support the safety and efficacy of an NHP varies depending on the proposed health claim(s) and the overall risk profile of the product or its ingredients. Prescription drugs and their ingredients are, in general, considered higher-risk and require a lot more scrutiny. Over-the-counter drugs are considered lower-risk when compared to prescription drugs, but should still be considered much higher-risk when compared to most of the NHPs available.  Furthermore, many traditional medicines have been used safely and effectively for thousands of years, which is an impressive track record.

I’m confused. How can I learn more?

Health Canada found that only 19 per cent of Canadians considered themselves well informed when purchasing NHPs. Statistics like this are what motivates us to work hard to help Canadians make educated decisions about the products they use and the variety of products available. You can learn more about the way NHPs are currently regulated in Canada by clicking here. Additional information about the existing NHP Regulations and the Natural Product Number (NPN) is also available here

If you disagree with this proposal click on the button below and send a message to your Member of Parliament, letting him or her know this is not OK. You can do this in just three easy steps — it takes less than a minute.