Canada: Canada’s Natural Health Products Regime – An Update

Last Updated: June 11 2007
Article by Tanya Baytor

This article first appeared in Update, Issue 3, May/June 2007.
Reprinted with permission of the Food and Drug Law Institute (FDLI) © 2007.

Canada’s Natural Health Products (NHPs) regime was implemented with the promulgation of the Natural Health Products Regulations (Regulations) on January 1, 2004. NHPs are Canada’s equivalent to dietary supplements in the United States, and include vitamins, minerals and herbs.

NHPs are considered a subset of drugs and were an addition to the scheme under the Canadian Food and Drugs Act, which governs food, drugs, medical devices and cosmetics. Previously, NHPs were not recognized under this legislation and were sold with the tacit approval of Health Canada. The intent behind the regime is to ensure that NHPs available to Canadian consumers were subjected to regulatory scrutiny and proven to be safe. The Natural Health Products Directorate (Directorate) maintains, "Our role is to ensure that Canadians have ready access to natural health products that are safe, effective and of high quality while respecting freedom of choice and philosophical and cultural diversity."

Under the Regulations, NHPs are materials, extracts or isolates of plants, algae, bacteria, fungus or animals; natural or synthetic amino acids, essential fatty acids or certain vitamins; minerals; probiotics; homeopathic or traditional medicines that are manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms, or for restoring, modifying or correcting organic functions in humans.

The Regulations require that all NHPs be approved by the Directorate in order to receive an NHP license and an NHP number (NPN). No NHP may be sold without an NHP license. The holder of that license has a continuing obligation to monitor all adverse reactions with respect to the NHP, to document these reactions in an annual summary report, and to report to the Ministry of Health all serious adverse reactions in Canada or serious unexpected adverse reactions anywhere in the world. The holder of the NHP license is obligated to maintain records related to the ingredients contained in each lot or batch of the NHP and sufficient information to enable the recall of every lot or batch made available for sale.

Canadian importers must have a site license and they have the onus to provide evidence that imported products come from sites that meet the Canadian Good Manufacturing Practices or equivalent standards. The Canadian importer is responsible for submitting a Quality Assurance Report for each site. Site licenses are issued only to Canadian sites (none are issued to foreign sites). Foreign manufacturers will be covered under the Canadian importer’s site license. Site license holders are required to comply with the specifications submitted in an application for an NHP license, as well as requirements related to recordkeeping, recall reporting, personnel, premises, sanitation programs, quality assurance, stability, operations, sterile products, ophthalmic-use products and lot or batch samples.

A Backlog of Applications

The use of NHPs is steadily on the rise. In 2005, Health Canada reported that due to the ever-increasing interest in the potential health benefits of these products, the proportion of NHP users was 71 percent of the Canadian population, with about 77 percent of Canadians believing that NHPs can be used to maintain or support health.

The vast number of NHPs to be approved is posing a challenge to the relatively young Directorate, which must process thousands of product and site license applications.

In April 2006, the Directorate reported a backlog of over 10,000 product applications and notified industry stakeholders that it would be introducing backlog-reduction measures. It said that it would process only complete product license applications and refuse those deemed incomplete. The Directorate began issuing Notices of Refusal and about 1,900 were removed from the processing queues. The backlog of unprocessed site license applications was 330 in October 2006.

The Directorate makes it clear that manufacturers should not market their products without a valid market authorization (NHP license). A submission number is only proof of the receipt of a complete Product License Application and is not an authorization for sale. However, under the Directorate’s existing policy, Health Canada will focus its compliance efforts on NHPs that have not been issued a submission number or those that have been identified as posing an unacceptable health risk. The product-specific submission number issued by the Directorate is further required to facilitate border entry of imported products. If such information is not provided, products will be detained at Customs, and inspectors will recommend refusal of entry.

As a result, many NHPs are currently on the market in Canada with pending NHP license applications. For manufacturers and importers of NHPs in Canada, the current state of the regulatory process has resulted in a legal quagmire.

Risk-Based Enforcement

Manufacturers of products that were licensed as drugs before the Regulations were enacted have until December 31, 2009, to obtain NHP licenses. Products new to the market after January 1, 2004, require pre-approval before sale.

In the Natural Health Products Compliance Guide, Health Canada outlines its risk-based approach to the enforcement of the NHP regulations, and states that "all NHPs identified as posing an unacceptable risk to the health of Canadians will be removed from sale." An NHP is considered to be noncompliant if it has no valid market authorization (an NHP license) or has such authorization but is otherwise non-compliant with the Regulations. Although any NHP posing a health risk will be subject to enforcement measures, Health Canada has created a category-based compliance strategy. This strategy complements, but is superseded by, the riskbased approach. Compliance deadlines for each product class are staggered from June 1, 2004, to June 1, 2008.

Health Canada considers as its No. 1 priority concern NHPs whose substances and formulations lack any, or adequate, information on their safe use; such lack indicates that their safety and efficacy for medicinal purposes have not been established. Its No. 2 priority comprises isolates, amino acids, fatty acids, concentrated volatile (essential) oils indicated for internal use. Its No. 3 category of prioritization includes algae, bacterial, probiotic, fungal and non-human animal materials because although they generally present less risk than selective concentrates, problems may arise from the application of these products as a result of improper concentration, inadequate ingredient identification or lack of adherence to Good Manufacturing Practices. Its No. 4 priority covers plant, plant materials, extracts prepared by traditional methods and volatile (essential) oils other than those that are concentrated and indicated for internal use because they present less risk than extracts or isolates. Its No. 5 priority includes vitamins and minerals, which are mostly well-known with regard to safe conditions of use as dietary supplements. And its No. 6 and last category of prioritization comprises homeopathic medicines, which are considered to present low risk because most do not contain a material dose of a medicinal ingredient, and standards for product quality are well-established in pharmacopoeia.

Industry Reaction

For many companies based in Canada and companies based in the United States with products on the Canadian market, the Regulations represented a significant shift in the industry, creating a substantially increased regulatory burden and requiring several changes in company practices. The lengthy license-application processing times and Health Canada’s risk-based approach to compliance creates further challenges for companies seeking to comply with the law while maintaining their presence in the NHP arena in Canada.

For some smaller companies in the industry, the process of attaining a product license is too lengthy and expensive; they have decided, therefore, to ignore the Canadian market altogether. Other large companies have decided to embrace the Regulations and use them to their benefit by gaining market advantage over competitors. Commentators noted, "A perceived market advantage is gained because a company that obtains [an] NPN is able to sell the product with a new health claim before other companies." The NHP license is regarded as beneficial because consumers are likely to prefer a product with an NPN over a product without one. The NHP regime is thus viewed as providing a strategic advantage to larger companies because by complying with the Regulations, a company can maintain its position in the NHP industry and "squeeze others out of the market."

The regulatory landscape is, however, fraught with uncertainty for companies whose NHP license applications are pending. Depending on the type of NHP, the licensing process can take years, by which time a company may have lost its position in the market. Given Health Canada’s risk-based approach to enforcement of the Regulations, many companies decide to enter the Canadian market without an NHP license. Prudent companies attempt to comply as closely as possible with the standards adopted by similar products for which the Directorate has already issued a license. Once the product license application is in the queue and a submission number has been issued, the manufacturer proceeds to market the product in Canada. Some companies push the envelope with respect to new products that may not comply with the standards imposed by the Regulations but face no penalties; this is frustrating to others in the industry that take the high road by adhering to the requirements under the new regime (to the extent they can).

As the Directorate works its way through its seemingly endless backlog of product and site license applications and as enforcement policies become less flexible, it will be interesting to observe how the NHP industry reaction develops and shapes the marketplace for NHPs in Canada. Only then will it be possible to conduct a meaningful assessment of the NHP regime in Canada.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

In association with
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.