Professional Documents
Culture Documents
SUMMARY OF
COMMENTS RECEIVED
DURING THE PUBLIC
CONSULTATION
Health Canada is responsible for helping Canadians maintain and improve their health.
It ensures that high-quality health services are accessible, and works to reduce health risks.
© Her Majesty the Queen in Right of Canada, as represented by the Minister of Health, 2018
This publication may be reproduced for personal or internal use only without permission provided
the source is fully acknowledged.
Cat.: H14-255/2018E-PDF
ISBN: 978-0-660-25597-2
Pub.: 170485
TABLE OF CONTENTS
1 INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1 Proposed Approach to the Regulation of Cannabis. . . . . . . . . . . . . . . . . . 1
1.2 Public Consultation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.3 Purpose of this Document. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
3 SECURITY CLEARANCES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.1 Overview of Proposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.2 What We Heard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
5 CANNABIS PRODUCTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
5.1 Overview of Proposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
5.2 What We Heard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
9 OTHER ISSUES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
As a practical matter, provinces and territories have indicated that there must be a sufficient
period of time between when the proposed legislation receives Royal Assent and when the
new laws come into force, and that a minimum period of 8 to 12 weeks is necessary for the
orderly movement of cannabis products from federally-licensed producers to provincially- or
territorially-authorized distributors and retailers. The Government of Canada has indicated
that it would prioritize an orderly transition to the new legal framework, including by
providing for this 8- to 12-week period of time.
The proposals set out in the consultation paper built upon established regulatory
requirements that have long been in place for current producers of cannabis for medical
purposes or industrial hemp, adapted as required to reflect that the proposed Cannabis
Act was designed in the broader context of legalizing, regulating and restricting access to
cannabis. In addition, many of the regulatory proposals reflected the advice provided by
the Task Force on Cannabis Legalization and Regulation, in their final report, A Framework
for the Legalization and Regulation of Cannabis in Canada (available at the following
link: www.canada.ca/en/services/health/marijuana-cannabis/task-force-marijuana-
legalization-regulation/framework-legalization-regulation-cannabis-in-canada.html).
To meet the Government’s commitment of bringing the proposed Cannabis Act into
force in a timely manner, final regulations would need to be published in the Canada
Gazette, Part II, as soon as possible following Royal Assent. Draft regulations will not be
pre-published. Instead, detailed regulatory proposals set out in the consultation paper
were intended to provide industry and stakeholders with as much detail as possible on
the proposed regulatory requirements so that their feedback and perspectives could
be incorporated into the final regulations.
The online portal generated 3,218 responses and Health Canada received 450 written
submissions. The majority of respondents identified themselves as individuals, while the
remainder identified themselves as a representative of a group or organization.
A total of seven in-person roundtables were held in Toronto, Montréal, Ottawa, and
Vancouver, which included general sessions with interested parties, as well as focused
sessions with current licensed producers of cannabis for medical purposes, patients
and patient advocates, and prospective licensees. In total, 192 interested parties
participated in these in-person roundtables. A further 343 interested parties participated
In addition, Health Canada held both multilateral and bi-lateral meetings with
representatives of all provinces and territories to collect their feedback on the
proposed regulatory approach.
The consultation paper also proposed that the regulations would establish rules
and requirements for the different categories of authorized activities that would be
proportional to the public health and safety risks posed by each category of activity.
The consultation paper asked stakeholders for views on what an appropriate threshold
would be to distinguish between micro- and standard-scale cultivators and processors.
There was general support for the proposed requirements for each class of licence.
Among those who answered this question, a majority generally agreed that the
proposed requirements were proportional to the public health and safety risks posed
by each category of licence, while a minority disagreed. Many of those who agreed
with the proposed regulatory requirements indicated that Health Canada should be
open to making adjustments to the regulatory requirements in the future in order
to quickly respond to emerging issues.
Multiple licences at a single site—The consultation paper did not specify whether
there would be any restrictions on the ability of a single person to conduct multiple
activities at a single site.
While respondents agreed with the government’s objective and supported transparency
and scrutiny around shareholders, a number felt that the proposed requirement would
be difficult to enforce, and that it would be relatively simple to structure investments
and assets to avoid the requirement. In response to this feedback, consideration is being
given to alternative options to reduce the risk of criminal organizations establishing a
financial relationship with legal cannabis producers in order to further their criminal
activities. Such measures could include requiring licence applicants to submit financial
information (including information about investors) as part of the licence application
process. This information could then be used in determining whether to refuse to issue
or renew a licence, should public safety concerns be raised. As well, the regulations
could require regular, ongoing reporting of financial information by licensees to help
identify suspicious financial relationships or arrangements that may warrant additional
regulatory action (including, for example, a licence suspension) or, in the appropriate
circumstances, referral to law enforcement for further investigation if needed.
Based on the government’s objectives, the feedback received during the consultation,
and drawing from the experience of U.S. states that have established similar categories
of licences for smaller producers, it will be proposed that the final regulations define
micro-scale licences as follows:
• Micro-cultivation licence would authorize the cultivation of a plant canopy area
of no more than 200 square metres (approximately 2,150 square feet). For a sense
of scale and what 200 square metres represents, see Figure 1.
• Micro-processing licence would authorize the processing of no more than
600 kilograms of dried cannabis (or equivalent) per year, or the entire output
of a single micro-cultivation licence.
200 m2
26 m
61 m
The consultation paper acknowledged that there are individuals who have histories of
non-violent, lower-risk criminal activity with cannabis (e.g. simple possession of cannabis or
smaller-scale cultivation of cannabis plants) who may seek to obtain a security clearance
so they can participate in the legal cannabis industry. The consultation paper asked
stakeholders whether they felt these individuals should be permitted to hold a security
clearance and participate in the legal cannabis industry.
Throughout this paper, there are references to actions that would be taken by the Minister of Health under the proposed Cannabis
1
Act or the regulations, often in the context of decision-making. In many cases, it is anticipated that the decision-making function
would not be exercised personally by the Minister, but instead by an official in the Department of Health who is in a capacity
appropriate to making the decision. This would be consistent with ministerial decision-making practices in many other contexts,
and in accordance with the common law and the Interpretation Act.
Health Canada appreciates the feedback that it has received from respondents on the
question of whether individuals with histories of non-violent, lower-risk criminal activity
should be able to obtain a security clearance and it will be taken into consideration in
the development of the final regulations.
Proposed rules and standards included a maximum THC concentration for cannabis oil
of 30 milligrams of THC per millilitre of oil, which aligns with the current THC limit under
the Access to Cannabis for Medical Purposes Regulations (ACMPR). In addition, the
consultation paper proposed a limit of 10 milligrams of THC per dose or unit for any
cannabis product intended for ingestion. As well, the consultation paper proposed that
the regulations would not prohibit the production of single-use forms of dried cannabis
products intended for inhalation (such as “heat not burn” vaporization cartridges).
It was proposed that such products could not contain more than 1 gram of dried
cannabis per unit.
As set out in the proposed Cannabis Act, dried cannabis, cannabis oil, fresh cannabis,
cannabis plants, and cannabis seeds could be sold to the public upon coming into force
of the proposed Act. The sale of edibles and other cannabis-based products, such as liquid
concentrates suitable for vaping, would be permitted within the following year to allow
time for the development of specific regulations to address the unique risks posed by
these product classes.
While the consultation paper was seeking input on product forms, many respondents
took the opportunity to urge the government to allow the sale of cannabis edibles
and concentrates immediately upon coming into force of the proposed Cannabis
Act (rather than enabling their sale within twelve months as set out in the proposed
legislation). These respondents cited the need for the legal industry to be able to offer
the same diversity of products that are currently available through the illegal market
A small proportion of respondents felt that the regulations should be more restrictive
in the types of cannabis products available through the legal system. These respondents
identified a range of different products that they felt should be prohibited, including
edibles, candies and solvent-based extracts. As well, some respondents suggested
that only dried forms of cannabis should be made legally available, while others felt
the opposite and that any product that encourages the smoking of cannabis should
be prohibited.
With respect to the proposed THC limit for cannabis oil and the proposed limit on the
amount of THC that could be in a single unit or serving, feedback was mixed. In general,
most participants in the consultation supported the proposed THC limit of 10 milligrams
per unit or serving of a cannabis product intended for ingestion. These respondents viewed
the proposal as a prudent safeguard against accidental overconsumption, which would
facilitate consumer education and awareness.
There were mixed views on the proposed concentration limit of 30 milligrams of THC
per millilitre of cannabis oil. On the one hand, many respondents did not support the
proposed limit, suggesting that it was either too low or that there should not be a limit at
all. These views reflected the desire of many stakeholders to have the regulations permit
the production and sale of concentrates, including liquids suitable for vaping, immediately
upon coming into force of the proposed legislation. In contrast, other respondents saw
the proposed limit as a prudent safeguard to mitigate against the risk of accidental
consumption or overconsumption of a product class primarily intended for ingestion.
The feedback received did not include scientific evidence to support the regulations
establishing a different, specific THC concentration limit for cannabis oil.
As well, the consultation paper proposed that the regulations would set strict limits on
the use of colours, graphics, and other special characteristics of packaging to curtail
the appeal of products to youth and to ensure that key information would be the most
prominently displayed elements. To help consumers make informed decisions and to
avoid misuse, products would be required to be labelled with specific information about
the product (such as potency), contain mandatory health warning messages, and be
marked with a clearly recognizable standardized cannabis symbol.
Among the majority of respondents who generally supported the proposed requirements,
opinions were mixed on whether the regulations should require “plain packaging” and
restrict the use of colours and branding. Some respondents expressed general support,
but felt that some branding should be allowed, while others advocated for strict
requirements that would prohibit the display of any branding or logos.
Among the minority of respondents who disagreed with the proposed packaging and
labelling requirements, a strong majority indicated the proposal was too strict. Of these
respondents, a subset specifically indicated that packaging requirements should allow
Health Canada also received feedback from a few industry stakeholders who indicated that
the accuracy of weight permitted for fresh or dried cannabis products under the ACMPR
(i.e. a tolerance of plus or minus 5%) presented operational challenges with respect to
smaller (e.g. 1 gram) package sizes. In response to this feedback, consideration is being
given to what measures, if any, are required in the final regulations to address the issue
of weight tolerances.
It is understood that, in order to provide for the orderly implementation of the proposed
Cannabis Act, the legal cannabis industry would need to understand, as soon as possible,
what the regulations would require with respect to packaging and labelling. To that end,
and to provide industry with as much information as possible, Annexes A and B of this
document provide detailed descriptions of label content and labelling requirements that
are intended to be proposed for the final regulations. These details include:
• a standardized cannabis symbol that would need to appear on every label, including
specific requirements with respect to its size, placement and appearance;
The intended proposal is that, consistent with the Task Force on Cannabis Legalization
and Regulation’s recommendation to require plain packaging of cannabis products, the
regulations would set strict requirements related to the use of branding, logos,
and colours. Specifically:
• only one other brand element (in addition to the brand name) could be displayed.
This element could include, for example, a slogan or logo. If it is a text element, the
font must be no larger than the font of the health warning message, and must be a
single, uniform colour. If the brand element is a graphic, image or logo, it would be
required to be no larger than the standardized cannabis symbol;
• it would be prohibited to display any other image or graphic;
• label and package backgrounds would need to be a single, uniform colour
(inside and outside);
• it would be prohibited to use any fluorescent or metallic colours;
• colours must contrast with the colours of the standardized cannabis symbol and
the background of the health warning messages (see Annex B for details);
• labels and packaging could not have any coating (e.g. could not be glossy),
embossing (raised or recessed relief images), texture, foil, cut-outs or
peel‑away labels;
• any over-wrap must be clear; and
• it would be prohibited to include any insert in a package.
To facilitate the orderly transition from the current packaging and labelling requirements
under the ACMPR to the new regulatory requirements, the intention is to propose a
transition period for cannabis products sold for medical purposes. Specifically, it is
proposed that for six months following the coming into force of the proposed Cannabis
Act, all cannabis products sold for medical purposes could be packaged and labelled
in accordance with the current rules under the ACMPR. This would mean that for
six months following the coming into force of the proposed Cannabis Act, cannabis
products delivered to patients would be required to meet either the requirements as
they currently exist under the ACMPR or the new requirements under the proposed
Cannabis Act.
Health Canada does not intend to propose any transition period for cannabis products sold
for non-medical purposes (i.e. those sold to adult consumers through a retail distribution
framework overseen by a provincial or territorial government). All of these products would
be required to meet the new packaging and labelling requirements immediately upon the
coming into force of the proposed Cannabis Act.
There would not be any transitional provisions for the packaging and labelling requirements
set out in the proposed Cannabis Act for any cannabis products regardless of whether they
are to be sold for medical or non-medical purposes (for example, no packages or labels
could be appealing to young persons or contain a celebrity endorsement immediately upon
coming into force of the proposed Act).
It is important to note that, in addition to the requirements set out above, there are a
number of packaging and labelling requirements set out in the proposed Cannabis Act,
as well as in the Annexes to the current report, to which regulated parties would be
subject. It is important that all of these requirements be considered in the context of
any decisions with respect to packaging and labelling that could be made between the
date of publication of this report and the anticipated coming into force of the proposed
Cannabis Act and its regulations.
All containers around a product, including the immediate container and any outer container, except the shipping container,
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rules for tobacco products and vaping products under the proposed Tobacco and Vaping Products Act
4. Given the broad diversity of potential cannabis products, including liquids, gel capsules, creams, along with requirements to be child-resistant, it is not practical to prescribe standard package shapes,
sizes or material. That said, the proposed cannabis regulations would prescribe a maximum amount of cannabis that could be in a single package.
5. Standard shape is specific for packages of cigarettes, little cigars, cigars, and devices. Standard size is only specified for cigarette packages. Package material is specified only for packages of cigarettes,
little cigars and cigars.
The consultation paper proposed that the medical access regulatory framework would
remain substantively the same as it currently exists, with certain adjustments to: create
consistency with rules for cannabis for non-medical purposes, improve patient access,
and reduce the risk of abuse of the system.
Some participants in the consultation raised specific topics, including recommending that
cannabis for medical purposes should be treated like other approved health products
and drugs and have some type of Health Canada approval so that it would be eligible for
coverage under private health plans; that it should be accessible through other distribution
means than the current system of secure ordering online and delivery by mail or by courier,
such as through pharmacies; and that cannabis for medical purposes should not have to
display mandatory health warning messages.
As part of their response to the Health Canada consultation, many stakeholders took
the opportunity to voice their opinion on a proposal to apply an excise duty to all
cannabis products in Canada that was made as part of a separate consultation process
conducted by the Department of Finance in the fall of 2017. Most respondents to the
Health Canada consultation did not support applying an excise duty to cannabis sold
for medical purposes, and also argued that cannabis for medical purposes should be
exempt from the federal Goods and Services Tax (GST).
As announced in Budget 2018, the excise duty framework will generally apply to
cannabis products that contain THC, the primary psychoactive compound of cannabis.
Recognizing the non-addictive, potentially therapeutic role of low-THC cannabis oils,
products that contain low amounts of THC will generally not be subject to the excise
duty. Pharmaceutical products derived from cannabis will also be exempt, provided
that the cannabis product has a Drug Identification Number and can only be acquired
through a prescription.
The consultation paper also proposed that any cosmetics containing cannabis would
be subject to all provisions of the proposed Cannabis Act and its regulations.
Health Canada would also continue to accept new applications through the current
approval process for prescription drugs containing cannabis, medical devices used for
consuming cannabis for medical/therapeutic purposes and Natural Health Products
(NHPs) and Veterinary Health Products (VHPs) that contain permitted cannabis parts
and no more than 10 ppm THC.
For these types of products, the regulations would outline the applicable requirements
under the proposed Cannabis Act. For example, it is intended that the regulations
would outline licensing requirements for holders of a Drug Establishment Licence that
manufacture prescription drugs containing cannabis, similar to those of the existing
Dealer’s Licence under the Narcotic Control Regulations. The requirements would focus
on security, record keeping, reporting and good production/manufacturing practices
under the proposed Cannabis Act, without duplicating requirements under the Food and
Drugs Act and its regulations. To support transition to the new licence, current Dealer’s
Licences would remain valid during a limited transition period.
As proposed in the discussion paper, medical devices used for consuming cannabis for
medical purposes would be subject to certain prohibitions for cannabis accessories under
the proposed Cannabis Act. This would include requiring the support of a healthcare
practitioner for their sale to young persons. The regulations, and updated policy guidance,
would also clarify how medical devices combined with, or for use with, prescription drugs
will be overseen.
Until these consultations and regulations for these types of products are complete, new
applications for health products with cannabis will be limited to prescription drugs, medical
devices, or NHPs/VHPs with permitted cannabis parts and no more than 10 ppm THC.
A significant number of respondents suggested that the government clarify the definition of
cannabis accessories when dealing with things used in the production of cannabis, so that it
would not cover products like fertilizers, pesticides, or gardening supplies. These respondents
noted that, with respect to fertilizers and pesticides, these categories of products are already
regulated under existing federal legislation (the Fertilizers Act and the Pest Control Products
Act). In addition, respondents noted that prohibitions related to cannabis accessories designed
to protect youth—for example the requirement that they only be sold behind the counter—
should not necessarily apply with respect to things like soil or pots, which could be used in the
production of cannabis.
In response to this feedback, consideration is being given to what measures, if any, are required
in the final regulations to address stakeholder feedback.
The following required elements must appear on the principal display panel:
• Standardized cannabis symbol;
• Health warning message; and
• THC/CBD content.
The following elements can appear on any surface of the package, except for the bottom:
• Other required information; and
• Non-required information.
It will be proposed that the following information would also be required, although
specific requirements would vary depending on the class of cannabis (fresh or dried
cannabis, or cannabis oil) and whether the cannabis is in discrete (i.e. unit) form:
• The net weight (and net volume, for cannabis oil);
• The number of discrete units, if applicable; and
• The percentage (or quantity, in milligrams) of THC and CBD.
The following specific requirements for the different classes of cannabis in non-discrete
and discrete forms will be proposed:
THE COLOURS
RED (Primary Colour)
C0 M100 Y92 K0
R235 G0 B41
HTML EB0028
PANTONE 185
THC
a
“Point” means the unit of measurement for type size that is known as an Anglo-American point
and is equal to 0.3527777778 mm
* Same font must be used for health warning message, THC/CBD content and other required information.
The text of the health warning message must be a larger point size than all other text.
WARNING: Do not use if pregnant or breastfeeding. Using cannabis during pregnancy may harm your baby and result in low
birth weight.
MISE EN GARDE : Ne consommez pas si vous êtes enceinte ou allaitez. Consommer du cannabis pendant la grossesse
pourrait être dangereux pour le bébé et réduire son poids à la naissance.
Horizontal/bilingual example
Brand name
• Brand name can be displayed in any font style and font size provided it is equal
to or smaller than the health warning message
• Font must be a single, uniform colour—no fluorescent or metallic colours
BRAND NAME
MARQUE NOMINATIVE
Bilingual example
Bilingual example
* Brand element includes a brand name, trademark, tradename, distinguishing guise, logo, graphic arrangement,
design or slogan that is reasonably associated with, or that evokes, (a) cannabis, a cannabis accessory or a service
related to cannabis; or (b) a brand of any cannabis, cannabis accessory or service related to cannabis.
COMPANY
NAME
THC
Example of FRONT (principal display panel) Example of BACK (secondary display panel)
with white/plain background and brand/producer name with white/plain background
Company
Logo
THC
BRAND NAME
MARQUE NOMINATIVE
THC 5% (Total THC 10% / THC Total 10 %) Dried Cannabis • Cannabis séché
CBD 5% (Total CBD 10% / CBD Total 10 %) Store in a dry place • Entreposer dans un endroit sec
KEEP OUT OF REACH OF CHILDREN
WARNING: Do not use if pregnant or breastfeeding. TENIR HORS DE LA PORTÉE DES ENFANTS
Using cannabis during pregnancy may harm your baby Licensed Processor | Titulaire d’une licence de transformation
and result in low birth weight. 123-456-7890 | name-nom@company-compagnie.ca
MISE EN GARDE : Ne consommez pas si vous êtes Expiry Date JAN 2020 | Date limite d’utilisation JAN 2020
enceinte ou allaitez. Consommer du cannabis pendant Packaged on Dec 21 2017| Emballé le 21 déc. 2017
la grossesse pourrait être dangereux pour le bébé et Lot 12345
réduire son poids à la naissance. Net weight 20 g | Poids net de 20 g
Example of FRONT (principal display panel) with solid Example of BACK (secondary display panel)
coloured background and brand/producer logo with solid coloured background
WARNING: Do not use if pregnant Using cannabis during pregnancy may harm your baby and result in
or breastfeeding. low birth weight.
WARNING: Do not drive or operate More than 4,000 Canadians were injured and 75 died from driving
machinery after using cannabis. after using cannabis (in 2012).
WARNING: Cannabis can Up to half of people who use cannabis on a daily basis have work,
be addictive. social or health problems from using cannabis.
WARNING: Regular use of cannabis Higher THC content can increase the risk of psychosis and
can increase the risk of psychosis schizophrenia.
and schizophrenia.
or Higher THC content can lower the age of onset of schizophrenia.
WARNING: Adolescents are at Early and regular use increases the risk of psychosis and schizophrenia.
greater risk of harms from cannabis.
or Using cannabis as a teenager can increase your risk of becoming
addicted.