Canada: Canada Proposes Amending The Food And Drugs Act And Creating Consumer Product Safety Legislation

On April 8, 2008, the federal government tabled legislation in the House of Commons to amend the Food and Drugs Act and to introduce new consumer product safety legislation in Canada. The legislative package introduces legislation that would explicitly give Health Canada the power to regulate consumer products and will effect amendments to the Food and Drugs Act to implement a "progressing licensing" framework in the context of the regulation of food and therapeutic products.

Revisions to the Food and Drugs Act and Progressive Licensing

The proposed changes to the Food and Drugs Act would create a definition for a "therapeutic product" that includes cells, tissues or organs, in addition to drugs and medical devices. The amendments would implement a "progressive licensing" framework for therapeutic products, which represents a shift from a pre-market review regime to a system that allows continuous assessment of a therapeutic product's risks and benefits both before and after it has received a market authorization. The Minister of Health would have the power to impose conditions on a marketing authorization and may amend an authorization on his/her own initiative. The Minister may also require revisions to the label of a therapeutic product if considered necessary to prevent injury to health.

The proposed amendments would give the Minister greater power to request information from holders of clinical trial authorizations, market authorizations and establishment licences. Holders of market authorizations or establishment licences may also be directed to compile information and conduct tests or monitor experience regarding their therapeutic products in the Canadian market and to report the results of these tests and studies to the Minister.

The proposed amendments would impose adverse-reaction reporting requirements on healthcare institutions. Under the current legislation, the onus to report rests with the holders of market authorizations for products. According to the proposed amendments, healthcare institutions would be required to provide the Minister with information about the adverse reactions of treated individuals that are associated with the use of therapeutic products.

The changes would also give the Minister the power to disclose confidential business information to the public, without consent of the owner of the information if the information is about a food therapeutic product that presents a serious and imminent risk of injury to health.

An inspector's powers would be significantly increased: inspectors who believe on reasonable grounds that the Act or regulations have been contravened would be allowed to direct a person to "take a measure that is necessary to identify or respond to a risk of injury to health that is related to the activity that is the subject of the contravention." The amendments would also give the Minister the explicit power to order a recall if he or she believes that a therapeutic product or cosmetic presents a serious or imminent risk of injury to health.

For contraventions of the Act or regulations, fines are proposed to be increased significantly. The most serious offences are punishable by fines of up to $5 million and/or imprisonment for up to two years. If the contravention is willful or reckless, the court would have discretion to determine an appropriate fine, with a maximum prison term of five years. In the case of corporate offenders, directors and officers may be found liable for contraventions of the legislation.

Canada Consumer Product Safety Act

The proposed Canada Consumer Product Safety Act is aimed at preventing and dealing with dangers to human health or safety posed by consumer products. Consumer products under the proposed Act are defined as products, including their components, parts or accessories, that can reasonably be expected to be obtained by an individual to be used for non-commercial purposes. Several classes of consumer products are exempted from the definition of consumer products, including foods, drugs, medical devices and cosmetics as defined under the Food and Drugs Act; pest control products; firearms; vehicles; plants and seeds; and controlled substances as defined under the Controlled Drugs and Substances Act.

The proposed legislation would grant the Minister the right to issue mandatory recalls in respect of consumer products. The legislation also contemplates the appointment of inspectors who would have the power to recall any consumer product that they believe on reasonable grounds is a danger to human health or safety. Inspectors recall orders would be subject to review prior to their enforcement.

The proposed legislation includes a number of provisions aimed at the reporting of an "incident," which is defined as (i) an occurrence in Canada or elsewhere that results, or that could reasonably be expected to have resulted, in an individual's death or in serious adverse effects on their health; (ii) a defect or characteristic that may reasonably be expected to result in an individual's death or in serious adverse effects on their health; (iii) incorrect or insufficient information on a label or in instructions that may reasonably be expected to result in an individual's death or in serious adverse effects on their health; or (iv) a recall or measure that is initiated for human health or safety reasons by a foreign entity, provincial government or public body established by provincial statute.

In the event of an incident, a manufacturer, importer or seller must provide the Minister with all information in their control regarding the incident within two days of becoming aware of it. Further to this, a manufacturer, or importer if the manufacturer is not located in Canada, must provide within seven days a written report to the Minister that includes additional information on any other products they manufacture or import that could be involved in a similar incident as well as measures they propose to take in respect of these additional products.

The proposed legislation would give the Minister the power to disclose any confidential business information to the public, without consent, about a consumer product that is a serious and imminent danger to human health or safety or the environment.

Fines and penalties for contraventions of the Canada Consumer Product Safety Act would be the same as those under the Food and Drugs Act.

Implications for Companies

The proposed changes in the legislative package will impose additional requirements on companies in the already-regulated food and drug industry. For companies selling consumer products in Canada, the creation of consumer product safety legislation will have a significant impact on their business operations in Canada because these types of products will now be explicitly subject to regulation by Health 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.