Classification of edible cannabis

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Difference between cannabis extracts and edible cannabis

The classification of cannabis is based on the definitions set out in the Cannabis Act and the Cannabis Regulations. Subsection 1(1) of the Regulations defines both edible cannabis and cannabis extracts.

Edible cannabis

Cannabis extract

The definition of a cannabis extract specifically mentions that it doesn't include edible cannabis. Cannabis products intended to be consumed in the same manner as food are edible cannabis and therefore excluded from the definition of a cannabis extract.

What factors determine if cannabis is edible cannabis

Health Canada considers several factors when determining whether cannabis is intended to be consumed in the same manner as food including, but not limited to the factors below.

Product format

A cannabis product that is in a food format is generally considered to be intended to be consumed in the same manner as food and should be classified as edible cannabis. Examples of food formats can include:

For additional guidance, you may refer to the Classification of products at the food-natural health product interface: products in food format.

Note: How a product is dispensed, measured or packaged also affects if it's in a food format.

The fact that cannabis meets the requirements for child-resistant packaging doesn't influence whether something is in a food format, as all cannabis products are required to have child-resistant packaging under the regulations.

History of use

A product that, if it didn't contain cannabis, has a history of use mostly for a food purpose, is another factor to be considered in the classification as edible cannabis. This includes products historically consumed as a source of nutrition or energy or to satisfy hunger, thirst or a desire for taste, texture or flavour. For example, jellies, chews and gummies have an established history of use for a food purpose and are generally classified as edible cannabis.

Note: Cannabis and product formats that have an established history of use for medical purposes may be less likely to be classified as edible cannabis. For example:

However, the representation, physical and sensory characteristics and product format need to be considered to ensure they align with the history of use.

Product sensory and physical characteristics

A cannabis product that has sensory or physical characteristics that the public perceives as food is another factor to be considered in the classification of edible cannabis. These can include:

Product representation

A cannabis product that's represented as, or for use in, a food or drink is generally considered to be a product intended to be consumed in the same manner as food and should be classified as edible cannabis. For example, this can include the product's:

In addition to the information presented in this section, you can refer to Health Canada's Policy on the classification of ingestible cannabis products.

What licence holders should do

Licence holders should verify if their cannabis products are classified correctly. Licence holders are encouraged to review the definitions of, and requirements for, cannabis and cannabis products in the Guide on composition requirements for cannabis products and Packaging and labelling guide for cannabis products.

It's always the regulated party's responsibility to take appropriate and timely action to meet all requirements of the Cannabis Act and its regulations. In cases of non-compliance, Health Canada's preference is for regulated parties to voluntarily undertake actions to come into compliance. However, Health Canada may take enforcement measures to address non-compliance or mitigate risks to public health or public safety. Refer to the Compliance and enforcement policy for the Cannabis Act for more information.

It's ultimately the responsibility of those engaging in activities related to cannabis, cannabis accessories and services related to cannabis, such as their promotion, packaging, labelling or sale, to understand and comply with the act and its regulations and any other federal and provincial or territorial legislation that may apply to them or to their activities, and to seek legal counsel to that end if necessary.

Licence holders are reminded of their obligations to report serious adverse reactions to cannabis products and to prepare an annual summary report of all adverse reactions as per section 248.1 of the regulations.

For further questions, contact us by email at compliance-cannabis-conformite@hc-sc.gc.ca.

Disclaimer

This compliance promotion statement is provided to support compliance with regulatory requirements set out in the Cannabis Act and Regulations. It isn't intended to provide legal advice regarding the interpretation or application of the Cannabis Act and its associated regulations. The reader is encouraged to consult the Cannabis Act and applicable regulations carefully and in their entirety. In the event of any discrepancy between the legislation and this document, the legislation shall prevail. The reader is also encouraged to consult any other legislation that may apply to them or their activities, such as any applicable federal, provincial or territorial legislation.

Health Canada reserves the right to modify this document as appropriate and without notice.

Policy on the classification of ingestible cannabis products

Note: The following section contains the full text of Health Canada's Policy on the classification of ingestible cannabis products, which details how Health Canada officials classify cannabis extracts and edible products. This policy was first shared with licence holders in December 2023. Health Canada continually reviews policies and guidance and will inform licence holders of any future changes.

Policy on the classification of ingestible cannabis products

Disclaimer: The classification of a cannabis product does not mean that the product is compliant with all regulations pertaining to that class of cannabis. Licence holders are responsible for making sure their cannabis products meet all the applicable requirements of the Cannabis Act and Cannabis Regulations.

Background

On October 17, 2019, amendments to the Cannabis Regulations came into force, which expanded the classes of cannabis that are permitted to be sold. In addition to the previously permitted dried cannabis, fresh cannabis, cannabis plants/seeds and cannabis oil, licence holders became able to produce and sell cannabis extracts, edible cannabis and cannabis topicals if authorized to do those activities. The amended regulations introduced requirements designed to consider the public health and safety risks associated with the different classes of cannabis and restrict the classification of a cannabis product to a single class of cannabis. Moreover, the amended regulations included transitional provisions for the phase-out of cannabis oil from Schedule 4 to the Cannabis Act, which were extended until September 30th, 2021Footnote i. Therefore, licence holders producing cannabis oils needed to reclassify their products as cannabis extract, edible cannabis or cannabis topical. See Appendix 1 for regulatory definitions.

Some stakeholders raised concerns that some ingestible cannabis products that are swallowed could be classified as either cannabis extracts or edible cannabis. Some cannabis products promoted as cannabis extracts appeared to fit the definition of edible cannabis. The classification of a cannabis product affects the requirements that the product must meet. These requirements are designed to reduce the risk to public health and public safety posed by these products. Improperly classified products could increase these risks. For instance, edible cannabis has a limit of 10 mg THC per package, compared to 1000 mg THC per package for cannabis extracts and topicals. Parts 6 and 7 of the Cannabis Regulations and the Guide on composition requirements for cannabis products provide more details on the compositional requirements and packaging and labelling requirements by class of cannabis.

Scope

This policy concerns the classification of ingestible cannabis extracts and edible cannabis and is meant to:

  1. Define and explain factors to be considered when determining the classification of an ingestible cannabis product
  2. Facilitate consistent and predictable decision-making when evaluating if an ingestible cannabis product is appropriately classified, for example during the review of notices of new cannabis products submitted as part of subsection 244(1) of the Cannabis Regulations, during inspections, or during other instances of compliance verification.

For the purpose of this policy, as defined in subsection 1(2) of the Cannabis Regulations, a cannabis product means cannabis of only one of the classes set out in Schedule 4 to the Act — or a cannabis accessory that contains such cannabis — after it has been packaged and labelled for sale to a consumer at the retail level. It does not include (a) cannabis that is intended for an animal; (b) a cannabis accessory that contains cannabis that is intended for an animal; or (c) a drug containing cannabis.

Although dried or fresh cannabis plant parts such as leaves and flowers may be used in the manufacturing of ingestible cannabis products, dried cannabis, fresh cannabis and plants and seeds are outside the scope of this document, as well as topical cannabis and inhalable cannabis extract which may also come in forms that may appear to be similar or identical to ingestible cannabis products (for example, cannabis in an edible carrier substance like an oil).

General policy

The regulatory definition of "edible cannabis" is the primary basis for determining if an ingestible cannabis product should be classified as either edible cannabis or cannabis extracts. Cannabis products intended to be consumed in the same manner as food (that is, eaten or drunk, including mixed with food) are classified as edible cannabis products and therefore excluded from the cannabis extract class by the Cannabis Regulations.

Factors to be taken into account when determining how an ingestible cannabis product should be classified include the following:

  • Product format
  • History of use
  • Product sensory and physical characteristics
  • Product representation

All factors must be considered together to make a determination of whether the product is intended to be consumed in the same manner as food and is edible cannabis.

Product format

Q1. Is the product in a food format?

Principle: A product that is in a food format makes it closer to edible cannabis.

A food format is a product format consistent with food use. Examples of food formats are listed in the Guidance Document: Classification of products at the food-natural health product interface: products in food formats and include, but are not limited to, the following:

  • Prepackaged, ready-to-use drink products: cups, drink boxes, bottles, canettes or cans such as those in which soda, bottled water or fruit juices are sold
  • Conventional food formats: prepackaged or sold-in-bulk products such as whole foods (for example, nuts, seeds, fruits or vegetables), ingestible oils, spreads, bars, cereals (for example, bran, oat), dairy products, condiments and seasonings (for example, ketchup, salts, syrups, sweeteners), soups, purees, and bakery products (for example, breads, crackers)
  • Confectionary products and sugar-free equivalents: hard/soft/semi-soft candy (for example, sticks, lollipops), chocolates, chocolate bars, cookies, jellies, chews and gummies, gum, mints, fondants, glazes, syrups, wafers, fudges, toffee/taffy and caramels, frozen desserts, liquid or foam sprays, dissolvable strips and powders
  • Granulated or powdered formats: granules, powder, syrup, tea or gels which are intended to be reconstituted for consumption as a beverage

On the other hand, products that are not in a food format include, but are not limited to, the following:

  • Capsules and tablets: hard shells, soft shells, and other similar formats containing a single dose of cannabis intended to be swallowed intact

Additionally, the manner in which a product is dispensed, measured or packaged may also be considered when determining if a cannabis product is in a food format. For example, a liquid cannabis product sold with a measured spray device ensuring controlled doses are dispensed could support the product not being in a food format. Finally, the fact that cannabis meets the requirements for child-resistant packaging does not influence whether something is in a food format, as all cannabis products are required to have child-resistant packaging under the Cannabis Regulations.

History of use

Q2. Is the purpose of the product, with or without cannabis, historically considered as mainly for a food purpose?

Principle: A product that would historically be considered as serving a food purpose makes it closer to edible cannabis. Conversely, a product that has an established history of use for a medical purpose makes it closer to a cannabis extract.

For the purposes of the Guidance Document: Classification of products at the food-natural health product interface: products in food formats, a "food purpose" means a purpose that has been established by history of use, or by being regulated, defined or implied as food by the Food and Drug Regulations, or that has been accepted following a novel food notification. It includes products historically consumed as a source of nutrition or energy, to satisfy hunger, thirst, or a desire for taste, texture or flavour.

For example, confectionery products (for example, hard candies, jellies, chews and gummies) have an established history of use for a food purpose that supports classification as edible cannabis. Conversely, tinctures have an established history of use for medical purpose. This history supports the classification of cannabis tinctures as a cannabis extract. Additionally, Health Canada regulated ingestible cannabis oils as a product for medical purposes. Thus, cannabis oil has an established history of use for a medical purpose.

Product sensory and physical characteristics

Q3. Does the product have sensory or physical characteristics that the public would perceive as, or associate to, food or a food purpose?

Principle: A product that has sensory or physical characteristics of food or to address a food purpose makes it closer to edible cannabis.

These characteristics include:

  • Taste and smell
  • Appearance (for example, texture, size, shape, or colour)
  • Composition

For example, a product that has fruity flavours (for example, strawberry, pineapple, etc.), that is in the shape of a food (for example, in the shape of grapes), that mimics the colours of foods (for example, the green-red gradient of an apple), or that uses ingredients historically associated with foods (for example, chocolate powder, whole wheat flour, etc.) would be considered as more likely to be perceived by the public as intended to be consumed in the same manner as food. Inversely, a product with no flavour or one strongly associated with medicine or natural health products (for example, menthol, etc.) and a plain appearance is less likely to be perceived by the public as intended to be consumed in the same manner as food.

Product representation

Q4. Is the product represented as, or for use in, a food or drink, or to satisfy a food purpose?

Principle: A product that is represented as, or for use in, a food or drink or to satisfy a food purpose makes it closer to edible cannabis.

Representation of a product includes, but is not limited to, its brand name (for example, a brand name including the word "cooking"), its indications of use (for example, for use in drinks), and any additional information on the product label, manufacturer's website, or promotion, including directions for use, symbols, pictures or implications, recipes, etc.

Appendix 1. Regulatory Definitions

Cannabis Regulations

Cannabis extract means

  1. a substance produced by
    1. subjecting anything referred to in item 1 of Schedule 1 to the Act to extraction processing, or
    2. synthesizing a substance that is identical to a phytocannabinoid produced by, or found in, a cannabis plant; or
  2. a substance or mixture of substances that contains or has on it a substance produced in a manner referred to in paragraph (a).

It does not include a cannabis topical or edible cannabis

Edible cannabis means a substance or mixture of substances that contains or has on it anything referred to in item 1 or 3 of Schedule 1 to the Act and that is intended to be consumed in the same manner as food. It does not include dried cannabis, fresh cannabis, cannabis plants or cannabis plant seeds.

Food has the same meaning as in section 2 of the Food and Drugs Act.

Food and Drugs Act

Food includes any article manufactured, sold or represented for use as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose whatever.

Footnote

Footnote i

A communication by the Compliance Directorate of the Controlled Substances and Cannabis Branch dated March 4, 2021 extended the transition up to September 30, 2021.

Return to footnote i referrer

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