Canada: The Evolving Self-Care Framework: A Work In Progress And The Questions It Raises - 26 February 2018

Last Updated: February 28 2018
Article by Jon-Paul Powers

Most Read Contributor in Canada, October 2018

As most health care product regulatory professionals are now aware, Health Canada is looking at changing the way cosmetics, over-the-counter drugs ("OTCs"), and natural health products ("NHPs") are regulated in Canada.

This is the culmination of many years of on-and-off proposals for one regulatory change or another that have mostly failed to come to fruition. This time, Health Canada is taking a bold and aggressive approach in its attempt to change the way multiple product categories are regulated by grouping them together under a single, proposed regulatory framework. Health Canada's stated goal is to change the way such products are classified from a current "formulation or indication" basis to a "risk" basis. Health Canada refers to this new and evolving proposal as the Self-Care Framework.

Over the past year, Health Canada has held a series of public and stakeholder consultations to inform Canadians about the proposed Self Care Framework. Industry response has varied significantly, often depending upon the current category of product an industry member sells. Companies selling primarily cosmetics and personal care-type products, which to date, may technically fall into other regulatory categories, appear to be more vocally supportive of the Self-Care Framework. The fundamental reason cited for this support is that this proposal can solve many of the longstanding challenges faced by such companies. For example, many toothpastes and mouthwashes may currently be regulated as a cosmetic, NHP, or OTC, depending on the indication or formula. Despite this patchwork of product categorizations, each product poses no meaningful difference in overall risk to the consumer. Similarly, companies primarily selling OTCs are also generally supportive of the Self-Care Framework, as it may relax certain regulatory and quality requirements for those OTCs regarded as being lower risk (i.e. by providing a regulatory framework more akin to the current approach to the regulation of NHPs).

Companies primarily selling NHPs are generally opposed to the proposed Self Care Framework, largely due to an absence of detail regarding the proposal. Perhaps most significant is the lack of information on the fate of over 100,000 currently-licensed NHPs. This industry has voiced opposition to the proposed changes, largely stemming from concerns that the gains made by this sector under the Natural Health Products Regulations will be lost. NHPs are currently regulated under the most modern regulatory framework of the three product categories proposed to be regulated under the new Self Care Framework. Beginning in 2004, companies selling NHPs made significant financial investments to comply with the newly enacted Natural Health Products Regulations. There is an added concern from this industry sector that such companies may effectively have to start over under a new framework – bringing uncertainty with respect to products they sell and a question mark as to whether past financial investments would be lost.

Characteristics of the Current System

Under the current system, cosmetics, OTCs and NHPs are subject to different regulations under the umbrella of the Food and Drugs Act. These various regulations have different evidentiary requirements for product licencing and notification, different approaches to the regulation of quality, and provide Health Canada with varying powers and authorities when it comes to enforcement. The latter is one of the reasons that Health Canada has emphasized as the impetus for revisiting the current regulatory framework. Health Canada is looking to strengthen, clarify, and align its post-market, licensing, and administrative powers across the various product categories.

  1. Over-the-Counter Drugs 

OTCs require a licence (market authorization) from Health Canada. Unless an OTC is consistent with either a Category IV monograph or Labelling Standard, as published by Health Canada, evidence must be provided to demonstrate the safety and efficacy of an OTC. Manufacturers and importers of OTCs require an Establishment Licence, are subject to regular inspections by Health Canada and Health Canada maintains the power to demand a recall or a label change.

  1. Natural Health Products 

Legally a subset of drugs, manufacturers of NHPs must obtain a licence (market authorization) from Health Canada. Unless an NHP is the subject of a monograph or Labelling Standard, as published by Health Canada, evidence must be provided to demonstrate the safety and efficacy of an NHP. In general, the level of proof of safety and efficacy is regarded as less onerous for NHPs than for OTCs. For example, clinical evidence in the public domain on individual medicinal ingredients can be used to support a combination product. The level of evidence required in support of an NHP product licence application varies based upon the nature of the natural health product as well as the proposed health claims. Manufacturers and importers of NHPs require a Site Licence, however, there is no formal Health Canada inspection as information is self-reported. Health Canada does not have the authority to force the recall of a natural health product. It should be noted that the current regulatory system acknowledges that patents are much less likely to be issued in the context of a natural health product, which can impact the incentive to financially invest in new clinical trials.

  1. Cosmetics 

Cosmetics are a unique category of self-care products, as there is no licencing requirement for cosmetics in Canada. These products are regulated through a post-market registration system whereby manufacturers and importers must notify Health Canada within 10 days of the first sale in Canada. This notification must contain information about the nature and quantity of the ingredients, and the purpose for which the cosmetic is meant to be used. Thus, it is not the case that Health Canada is unaware, or does not review the cosmetic products in the marketplace — Health Canada may reject the sale of a cosmetic product if it has any concern regarding the safety of the product or its ingredients. This is an important aspect of the cosmetic notification process, since cosmetics include a broad range of largely similarly formulated products ranging from soaps and toothpastes to moisturizers and make-up. Health Canada maintains authority to request safety data for these products, and can require manufacturers to cease sales in Canada should any product be deemed unsafe.

Proposed Changes

It is imperative to establish that while Health Canada has been somewhat consistent about the principles of the Self-Care Framework, the details, even at a high level, have either been lacking or continuously evolving. As a positive note, Health Canada seems to be reacting to the consultation process and the details regarding the proposed changes, outlined below, may have already evolved by the time you read this article.

The theme of the proposed Self-Care Framework is that of a "risk-based approach." Health Canada has indicated that a risk classification system was proposed in order to ensure that the level of oversight corresponds with the risks posed by a particular health product. The intent is that products of similar risk profiles would be treated in a similar manner notwithstanding their current classification as a cosmetic, NHP, or OTC drug. It should be noted that Health Canada has been revising what it considers to be risk throughout the consultation process, but at this time it is primarily focussed on the health risk of the ingredients (e.g. limited safety data or known safety risks) and risk of failed efficacy.

While the proposed product classes have been continuously changing throughout the consultation, it seems that this risk-based approach would include a number of risk categories or classes (either 2 or 3 classes, based upon recent Health Canada communications). Products currently regulated as OTC drugs and NHPs that do not conform to a current Labelling Standard or monograph would be funneled into a higher risk category. Homeopathic remedies, cosmetics, and NHPs with pre-cleared claims, authored by Health Canada, would be placed in a lower risk category. Lower-risk category products would not be licensed but would undergo a registration process, perhaps comparable to the current requirements for cosmetics. What remains fundamentally unclear is how many classes or subclasses will exist, how the spectrum of risk will be divided into those classes, and what many of the fundamental differences will be across the different classes and subclasses, including levels of evidence and quality requirements, including site licensing.

With respect to the low risk product group, it appears that Health Canada's current position is that either no health claims or very limited health claims would be permitted. Health Canada has also consulted on the concept of either a disclaimer or proclaimer to communicate that the product in question has not been reviewed for its effectiveness. Thus, under this proposed system, homeopathic products, for example, would still be permitted for sale; however, it is possible that Health Canada would require a statement making it clear that Health Canada has not reviewed the safety or efficacy of the product.

With respect to the higher risk group of products, which includes those products making health claims, these would have to be reviewed, licensed, and given a product number by Health Canada in order to gain market access. As part of licensing, scientific evidence would be needed to support any claims made by a product in this category. The review process for these higher risk self-care products would be more thorough than those considered a lower class of risk. We expect that products containing new claims for conditions with a high risk associated with failed efficacy, new ingredients, and new uses for susceptible subgroups (like children and pregnant or breastfeeding women), as well as those aimed at heart health, would likely be considered as higher risk. It remains to be seen how products that overlap both low and high-risk categories will be regarded. For example, fish oils are a source of omega-3 fatty acids, presumably a low-risk claim, yet have been actively studied for heart health -- presumably, a higher risk claim. In this instance, Homeopathic remedies, cosmetics, and NHPs with pre-cleared claims, authored by Health Canada, would be placed in a lower risk category. Lower-risk category products would not be licensed but would undergo a registration process, perhaps comparable to the current requirements for cosmetics. feature would a license or registration be required? Furthermore, can products normally considered low risk use scientific evidence to add claims?

It should also be noted that Health Canada has so far made it clear that products can move down and up classes. New evidence and information gained from market experience can change the risk profile of a product. It remains to be seen how such switching of categories would accomplished.

What Next?

If Health Canada chooses to go forward with the proposed changes, the current legislative framework will have to be remodeled. This process could easily take many years. While Health Canada has outlined its willingness to move forward at an expedited pace, there continues to be much uncertainly. This uncertainty relates to the fact that, while there has been much consultation on the principles of the proposed Self-Care Framework at a high level, there remains very limited to no consultation on many of the finer details that would be necessary for the Self-Care Framework to come into existence. The lack of information regarding the finer details of product classification, quality licence requirements, and the fate of the wealth of currently-licensed products on market is causing anxiety amongst industry members. It is paramount that Health Canada address these concerns such that a complete impact analysis may be performed.

From a legal perspective, Health Canada has not yet shared any information as to how it intends to accomplish the Self- Care Framework. It has also not confirmed whether it intends to move all products under a single regulation, use multiple regulations, or accomplish its goals under the regulations that exist today. That being said, we think it would be a significant challenge to achieve a Self-Care Framework, as it has been explained to date, without amending the Food and Drugs Act and, at least to an extent, restructuring the regulations currently under the Food and Drugs Act. This unknown is extremely significant. Opening the door to any legislative amendments has the potential to invite additional changes that have not yet been considered through any of the proposals to date. Certainly, if there are amendments proposed to the Food and Drugs Act, it will provide an opportunity for Parliament to serve a more active role in the process and the nuances may be the subject of increased scrutiny and public debate.

Overall, after a year of consultation, key details continue to remain absent from the consultation process. In effect, how will the proposed framework impact each company's approach to its day-to-day business? Will it be easier for a company to bring a product to market or more difficult? Will more or less evidence be required? Will companies be able to clearly convey to the consumer what the product is intended for? Will all products currently permitted on the market continue to be permitted on the market? Will products already on the market have an advantage over products not yet on the market? Will quality licences require third party auditing? In other words: what are the fundamental details that will determine how a product falls into a class and the practical impact of that class? How will the Selfcare Framework address incident reporting requirements across the various classes? We believe that if Health Canada can meaningfully and positively address all these questions in a clear and detailed manner, it would facilitate productive discussions and possible cooperation from industry.

When we were initially asked to write this article, we were hopeful we would have more clarity on the proposed framework, however, this has not been the case. It is human nature to fear the unknown and if Health Canada believes the Self Care Framework is the best way to regulate these products for Canadians, then we hope Health Canada will soon release the details needed so that all stakeholders, including Canadian consumers, can truly begin to understand how the proposed Self Care Framework would impact them and the products they use.

This article was originally published in NOC Fall 2017 and has been republished with permission.

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.

Similar Articles
Relevancy Powered by MondaqAI
Blake, Cassels & Graydon LLP
Bereskin & Parr LLP
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Blake, Cassels & Graydon LLP
Bereskin & Parr LLP
Related Articles
Related Video
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
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

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 or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq 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 of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions