Canada: Health Canada Releases Consultation Paper On The Regulation Of Cannabis – Part 2

Last Updated: January 12 2018
Article by Andrew J. Wilder, Yale Hertzman and Vlad Mihaescu

In November 2017, Torkin Manes published an article that provided an overview of Health Canada's consultation paper, Proposed Approach to the Regulation of Cannabis (the "Consultation Paper"), which sets out proposals regarding the regulation of cannabis in Canada. Specifically, we considered the proposals related to licensing, permits and authorizations and security clearances. This article considers the remaining proposals in the Consultation Paper, namely:

  • Cannabis tracking system;
  • Cannabis products;
  • Packaging and labelling;
  • Cannabis for medical purposes; and
  • Health products and cosmetics containing cannabis.

Cannabis Tracking System

Under Bill C-45, An Act respecting cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and other Acts (the "Cannabis Act"), the Minister of Health (the "Minister") is authorized to establish a national Cannabis Tracking System (the "CTS") that enables the tracking of cannabis throughout the supply chain. The purpose of the CTS is to provide governmental authorities with data to verify compliance with federal and provincial cannabis laws and to prevent the diversion of cannabis into the illegal market. It is proposed that all persons authorized to conduct activities involving cannabis be required to report into the CTS on a monthly basis through an online portal.

Cannabis Products

Health Canada's proposals in the Consultation Paper enable the sale of a range of cannabis products to the public, specifically permitting the sale of the following classes of products: dried cannabis, cannabis oil, fresh cannabis, cannabis plants, cannabis plant seeds, edibles containing cannabis and cannabis concentrates. The Consultation Paper recommends permitting the sale of all the product classes upon the Cannabis Act coming into force, except for edibles and cannabis concentrates, which would be permitted within one year of the coming into force of the Cannabis Act.

Dosage forms of cannabis products such as pre-rolled cannabis and vaporization cartridges, which are not currently permitted under the Access to Cannabis for Medical Purposes Regulations ("ACMPR") regime, would be permitted for sale in the recreational market pursuant to the regulations proposed in the Consultation Paper. What would not be permitted, however, is the mixture of cannabis with prohibited substances listed in Schedule 5 of the Cannabis Act, which include nicotine, caffeine and alcohol.

In line with the purposes of the Cannabis Act, the proposed regulations in the Consultation Paper seek to deter and reduce the appeal of cannabis to youth. As such, the sale of cannabis that has any appearance, shape or other sensory attribute that would reasonably appeal to youth is strictly prohibited.

Packaging and Labelling

The Cannabis Act contains general prohibitions on the promotion, packaging, labelling, and display of cannabis and cannabis accessories. The Cannabis Act prohibits the sale of cannabis and cannabis accessories that are packaged and labelled in a manner that is appealing to youth or includes elements to encourage consumption, such as lifestyle branding elements or testimonials.

The Consultation Paper proposes comprehensive packaging and labelling requirements. Specifically, it calls for tamper-evident and child- resistant packaging for cannabis products, with no single package containing more than 30 grams of dried cannabis, or the equivalent amount of cannabis for other classes of products such as oil and edibles.

Labelling requirements include a product description, name and contact information of the processor, packaging date and THC/CBD content. There will be strict regulations with respect to the use of colour, graphics and font size on packaging, in order to reduce the appeal of products to youth. It is proposed that packages must include mandatory rotating health warnings, in a manner similar to what is currently in place for tobacco products. Health warnings must include messages with regard to health effects, impaired driving, use during pregnancy, risk of combining cannabis with other substances, and impact on mental health. Finally, a standardized cannabis symbol must be displayed on all products that contain more than 10 parts per million of THC.

Cannabis For Medical Purposes

Health Canada's proposals with respect to the regulation of medical cannabis are generally the same as under the ACMPR regime, with several proposed changes. Under the ACMPR, patients that have the support of their medical practitioner can access medical cannabis in one of the three ways: by registering with a federally licensed producer ("LP"), by cultivating their own cannabis if they are over 18 years of age or by designating another party to grow cannabis on their behalf.

One proposed change to the ACMPR regime is to enable the transferability of a patient's medical document, which is required by a patient to purchase medical cannabis from a LP. Under the ACMPR, a patient is limited to selecting one LP from which to purchase medical cannabis. The Consultation Paper proposes that a patient would be able to request the return of his or her medical document in order to select a different LP or, in the event of a merger or acquisition between LPs, the medical document could be transferred between LPs with the patient's consent.

Other proposed changes require Health Canada to notify LPs to not fill cannabis orders from health care practitioners who have contravened a rule of conduct or have been found guilty of certain offences. The regulations also propose to expand the grounds on which the Minister may deny an application by a patient to produce medical cannabis privately or arrange to have a designated producer produce it on his or her behalf on the basis of risks to public health or safety.

Health Products and Cosmetics with Cannabis

It is proposed that health products containing cannabis (including prescription and non-prescription drugs, natural health products, veterinary drugs and veterinary health products, and medical devices) be governed by the current framework under the Food and Drugs Act (the "FDA"). Under the FDA, such products can only be sold to the public once they have been approved by Health Canada following a scientific review process, which assesses the safety, efficacy and quality of the product. Also considered in the review process is whether there is a need for healthcare practitioner oversight, in which case the product would be available by prescription only.

Natural health products ("NHPs") are also subject to Health Canada's review process. Currently, there are approximately 220 NHPs containing cannabis that are authorized for sale, all of which contain parts of the cannabis plant that are not captured by the legal definition of cannabis in the Controlled Drugs and Substances Act ("CDSA") and contain no more than 10 ppm THC. A new pathway to market is proposed for NHPs containing parts of the cannabis plant that will be regulated under the Cannabis Act, however such products would still be subject to a 10 ppm THC limit.

Veterinary drugs, similar to drugs for human use, must be approved by Health Canada prior to being permitted for sale. In terms of veterinary health products ("VHPs"), which are products used to promote the health and welfare of animals (such as vitamins and minerals), VHPs that contain parts of the cannabis plant not subject to the legal definition of cannabis in the CDSA and containing no more than 10 ppm THC are currently permitted for sale, provided they comply with Health Canada's requirements. The Consultation Paper does not propose to change this framework.

The Consultation Paper provides that health products containing cannabis would be subject to certain provisions of the Cannabis Act. Manufacturers of health products containing cannabis would need to comply with the licensing requirements under the Cannabis Act. Subject to certain exemptions, health products would be subject to the restrictions on promotion, packaging and labelling under the Cannabis Act.

Precautions are being considered for health products that do not require healthcare practitioner oversight (such as non-prescription drugs and NHPs) by controlling the sale of such products behind a pharmacy counter or using the provincially regulated distribution system.

Certain exemptions from the Cannabis Act are proposed for health products containing cannabis. Given that such products would be subject to Health Canada's review process, restrictions on classes of cannabis and package size would not apply to such products. Prescription health products containing cannabis would be exempt from restrictions on access, such as place of sale, because such products have been reviewed by Health Canada and are subject to the oversight of a healthcare practitioner.

Cosmetics containing cannabis- derived ingredients are currently prohibited, with the exception of certain hemp seed derivatives that contain no more than 10 ppm THC. The Consultation Paper recommends that cosmetics containing cannabis- derived ingredients that are currently prohibited would be subject to the provisions of the Cannabis Act, thus making these cosmetics available for sale to the public.

Conclusion

As the proposed regulations in the Consultation Paper are for consultation purposes only, the public and interested stakeholders are invited to provide comments to Health Canada by January 20, 2018 by way of an online questionnaire or written submission. A set of consultation questions can be found in Annex 1 of the Consultation Paper, and more information can be found on the Government of Canada website.

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 Mondaq.com.

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

Authors
Andrew J. Wilder
 
In association with
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
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
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration
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 you may opt out by clicking here

    Terms & Conditions and Privacy Statement

    Mondaq.com (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 www.mondaq.com

    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 Mondaq.com’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.

    Disclaimer

    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.

    Registration

    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.

    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 unsubscribe@mondaq.com 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.

    Cookies

    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.

    Links

    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.

    Mail-A-Friend

    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.

    Emails

    From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

    *** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .

    Security

    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 webmaster@mondaq.com.

    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 EditorialAdvisor@mondaq.com.

    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 enquiries@mondaq.com.

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

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