Canadian Regulation of Natural Health Products – Answering Your Questions

Recently there has been a lot of news about the regulations and quality of vitamins, minerals, herbals and other supplements available in Canada. To better navigate the market place, there are some important points that need to be remembered

Are vitamins, minerals and other supplements regulated in Canada?

In a word yes, these types of products often referred to as “supplements” are regulated as Natural Health Products or NHPs for short.

What is a Natural Health Product?

Natural Health Products are defined by Natural Health Product Regulations as:

• Vitamins and minerals;
• Herbal remedies;
• Homeopathic medicines;
• Traditional medicines such as traditional Chinese medicines;
• Probiotics; and
• Other products like amino acids and essential fatty acids

The regulations and Health Canada require NHPs to be “safe to use as over-the-counter products and not need a prescription to be sold”.[1] If a prescription is required due to such things as the amount that needs to be taken or the illness it is being used to treat, then the product will be regulated as some other form of therapeutic good such as a prescription drug.

How are NHPs regulated in Canada?

As with things such as drugs, foods and medical devices, in Canada NHPs are regulated under the Food and Drugs Act. In fact, unlike in countries such as the United States where products such as these are regulated as a type of food, in Canada, NHPs are regulated as a type of drug with specific regulations developed to reflect the sector’s specific characteristics.

The Canadian NHP Regulations take a life cycle approach in that they look at both what happens before (premarket) and after (post-market) a NHP is available for sale. Before a NHP can be sold, a product license must be obtained from Health Canada and requires information such as the product’s ingredients (both medicinal and non-medicinal), what it can be used for, any potential side effects or things that should be avoided and recommended dosage. When a NHP is licensed by Health Canada it is assigned a Natural Product Number (NPN) that must be displayed on the product’s label. Also, a site license providing details of the site where the product is made and verification that they follow recognized Good Manufacturing Practices (GMPs) must also be submitted and approved by Health Canada. Again, both of these steps must be successfully completed before a NHP can be sold.

Regulatory oversight does not end once the NHP is on the market. Products are required to submit any details they receive about unexpected or serious adverse effects they discover. This approach allows Health Canada to make sure the information that they have is current. At any point, if a problem is identified either with safety or product quality, Health Canada can take action to mitigate this risk. These steps can range from requiring new labeling to asking that the product be stopped for sale. More information about the Canadian NHP regulations can be found at www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php.

What kind of evidence is needed to support a product claim?

The NHP regulations recognize the importance of scientific research as well as a respect for traditional forms of health and healing. This approach supports innovations in the market place together with the health care traditions that reflect Canada as a multi-cultural nation. To do this, the NHP regulations balance the type and quantity of the evidence with the claim a company can make on the label.

For example, if a company wishes to make a claim based on traditional evidence, then the product license application needs to make reference to a set of approved texts being used. These claims are appropriately limited and must used wording such as “Traditionally used for………” If a company wants to make a specific clinically-proven claim, then in most cases, they must submit results from a high quality clinical trial for review by scientists at Health Canada.

Since there are so many similar products on the Canadian market, Health Canada has developed an extensive set of NHP monographs for the most popular ingredients such as echinacea, glucosamine and fish oils. These monographs are constantly updated when more information comes to hand. If a company wants to use one of these monographs in a product license application, then their product must comply completely with the monograph regarding such things as dosage, indication for use, usage and warning labels. Health Canada audits these types of NHPs once they are on the market to make sure that companies are following the contents of the monograph they are using. You can learn more about the NHP monographs at www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/index-eng.php.

Remember, a NHP cannot be marketed for anything but a self-limiting condition or for health promotion. So, for conditions such as heart disease, cancer and serious infections, the only route open for approval is as a prescription drug or biologic therapy.

Are the claims for NHPs evaluated less stringently than for conventional drugs?

The claims that specific NHPs can make are assessed in a way appropriate for the products themselves. For conventional prescription drugs, the evidence required reflects the serious conditions they are intended to treat together with the potential for serious side effects. This can only be obtained through extensive clinical trials. For a number of drugs used over-the-counter, many of which have been available for many decades, a monograph system is used just like with NHPs.

How were these NHP regulations developed?

Input from all sectors of the community was sought in both the development and implementation of the NHP regulations. This input came through numerous consultations held across the country ranging from large meetings to face-to-face conversations as well as information received on line. They reflect a gold standard in how to develop modern health product regulations.

How can I find out more about what specific products are regulated?

Health Canada maintains the Licensed NHP database which lists all the approved product licenses in Canada, and also provides some information as to whether the licenses are active or not. This database lists the NPN (Natural Product Number), approved claim, ingredients, recommended dosage as well as any possible side effects or safety concerns. This information being on line from a government agency is pretty unique in world. More information can be found about the Licensed NHP database at www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/lnhpd-bdpsnh-eng.php

Are the Canadian NHP regulations current?

Yes, they are very current and are considered by many to be cutting edge. They came into force in 2004 and are one of the newest regulatory frameworks for a therapeutic good or food in Canada at the moment. They are newer than the frameworks for prescription drugs, for over-the-counter drugs, biologics and foods, in some cases by decades.

These regulations are not static and change to reflect the sector. For example, some products in a food-like format such as energy drinks or supplements were initially regulated as NHPs. Since this may confuse consumers, these products are now more appropriately regulated as a type of foods. Also, Health Canada is considering whether they need to strengthen regulations around site licenses by requiring more detailed inspections.

How do the Canadian regulations compare to the regulation of similar products in other countries?

There is no uniform approach used around the world with respect to NHP regulation. Some countries simply have a basic registration system where companies must notify the national regulator if a product is marketed. Most countries have no specific process in place at all. Many countries have no specific process in place, not even a national registry for NHPs. Canada is one of only a few countries that have specific regulations for NHPs that ensure that all such products must be approved by a national regulator before they can be put on the market.

Should I be concerned about the quality of Natural Health Products available in Canada?

Though the Canadian consumer is in a better position than most consumers in other countries, concerns about quality should always be front and centre when you decide to take, or not take, a NHP. The market for NHPs is now global and very lucrative, with source ingredients and even finished products coming from places around the world. This has meant continued concerns about products containing or being adulterated by cheap ingredients, impurities or, in some cases, pharmaceutical drugs.

What should I look for in selecting a NHP?

Consumers should only take NHPs that are approved by Health Canada. For non-homeopathic NHP such as herbal medicines, vitamins and minerals, this can be confirmed by looking on the product’s label for an 8-digit Natural Products Number (NPN). An approved product has all the required information on the label including dosage, ingredients, and indications as well as any safety issues. Always remember to inform members of your health care team what NHPs you are taking.

[1] www.hc-sc.gc.ca/dhp-mps/prodnatur/index-eng.php

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