Classification of ingestible cannabis products: Edible cannabis and cannabis extracts

On this page

• Overview
• Definition of edible cannabis and cannabis extracts
• Factors Health Canada considers when determining if a cannabis product is edible cannabis or a cannabis extract
• Examples of how Health Canada assesses ingestible cannabis products

Disclaimer: Licence holders are responsible for making sure their cannabis products meet all the applicable requirements of the Cannabis Act (the Act) and Cannabis Regulations (the Regulations). This document should be read in conjunction with relevant sections of the Act, the Food and Drugs Act and their respective regulations. In the case of any discrepancies between this document and the legislation, the legislation takes precedence.

Overview

This policy concerns the classification of edible cannabis and cannabis extract products that are intended to be ingested (ingestible cannabis products). All other cannabis extracts and classes of cannabis set out in Schedule 4 to the Act are outside the scope of this policy.

This policy is meant to:

• explain the differences between edible cannabis and cannabis extracts intended to be ingested, how they are regulated and why it is important to classify them correctly
• define and explain the factors Health Canada considers when determining if an ingestible cannabis product is intended to be consumed in the same way as food
• facilitate consistent and predictable decision-making

Cannabis products are defined as cannabis of only one of the classes set out in 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:

• cannabis that is intended for an animal
• a cannabis accessory that contains cannabis that is intended for an animal
• a drug containing cannabis

Definition of edible cannabis and cannabis extracts

Edible cannabis

Edible cannabis is a substance or mixture of substances that contains or has cannabis on it and that is intended to be consumed in the same manner as food.

Food is defined in section 2 of the Food and Drugs Act and includes:

• any article manufactured, sold or represented for use as food or drink for human beings
• chewing gum
• any ingredient that may be mixed with food for any purpose

Edible cannabis does not include:

• dried cannabis
• fresh cannabis
• cannabis plants
• cannabis plant seeds

Cannabis extracts

Cannabis extracts are substances produced by, or a substance or a mixture of substances that contains or has on it a substance produced by either:

• subjecting cannabis to extraction processing
• synthesizing a substance identical to a phytocannabinoid produced by or found in a cannabis plant

It does not include:

• edible cannabis
• cannabis topicals

Differences between edible cannabis and cannabis extracts

The intended manner of consumption differentiates these 2 classes of cannabis. Cannabis products intended to be consumed in the same manner as food (for example, eaten or drunk, including mixed with food) meet the definition of edible cannabis. Therefore they are excluded from the cannabis extract class. In addition, edible cannabis and cannabis extract products are subject to different requirements to address the public health and public safety risks associated with each class of product regarding:

• the maximum amount of THC allowed
• permitted ingredients
• packaging
• promotions

Edible cannabis products are intended to be consumed in the same manner as food. Subject to the limitations set out in the Regulations, they can contain food and food additives. Edible cannabis products often have a pleasant taste and look like common food or drinks, which increases the risk of accidental and over consumption. As a result, edible cannabis has a precautionary limit of 10 mg of THC per immediate container.

In comparison, cannabis extracts can contain significantly higher amounts of THC than edible cannabis (up to 1,000 mg per immediate container) because they are not intended to be consumed in the same manner as food. In addition, cannabis extracts:

• cannot contain sugars, sweeteners, or sweetening agents
• have prohibitions relating to the promotion of certain flavours, such as dessert or confectionery
• are subject to additional product and packaging rules to address the risks associated with accidental consumption and overconsumption

Given the higher THC limit for cannabis extracts as compared to edible cannabis, it is important for licence holders to classify cannabis products correctly. Misclassification of a product as a cannabis extract will result in non-compliance with the Regulations and may result in enforcement action. Refer to the Compliance and enforcement policy for the Cannabis Act. Misclassification also increases the risk of accidental consumption or overconsumption of a high THC product and could result in serious cannabis poisonings.

If licence holders are uncertain if their ingestible cannabis product meets the definition of a cannabis extract, they are strongly encouraged to:

• take a precautionary approach by classifying it as an edible cannabis product
• follow the applicable requirements, including the 10 mg THC limit per immediate container

This approach aligns with the fundamental purpose of the Act which is to protect public health and public safety.

Factors Health Canada considers when determining if a cannabis product is edible cannabis or a cannabis extract

The regulatory definition of "edible cannabis" is the basis for determining if an ingestible cannabis product should be classified as edible cannabis or as a cannabis extract. Specifically, a cannabis product that is "intended to be consumed in the same manner as food" meets the definition of edible cannabis. It cannot be classified as a cannabis extract.

Health Canada considers the following factors when determining if a cannabis product is intended to be consumed in the same manner as food:

• the product is in a food format
• the product format has a history of use mainly for a food purpose
• the product has characteristics that the public would likely perceive as, or associate with, food or a food purpose
• the product is represented as food, to be mixed with food, or to satisfy a food purpose

Some factors are more influential than others. Depending on the circumstances of the case, product format or product representation is typically the primary factor when determining if a product is intended to be consumed in the same manner as food. In some cases, it is possible that a single factor may be sufficient. For example, a cannabis product that is represented to be added to a food would be considered as intended to be consumed in the same manner as food. Additional details about each factor are provided in the sections below.

When assessing the factors above, Health Canada takes into consideration:

• how the product is likely to be perceived and consumed by the public
• the information provided by licence holders

Health Canada takes public health risks into account when assessing whether an ingestible cannabis product is classified correctly, in line with the objectives of the Act.

The following provides additional information about how the factors may support that a product is intended to be consumed in the same manner as food and should not be classified as a cannabis extract:

The product is in a food format

A food format is a product format consistent with food use. A cannabis product in a food format is generally regarded as intended to be consumed in the same manner as food.

Health Canada considers the following, among other information, when determining if a cannabis product is in a food format:

• product characteristics
  • For example, a cannabis product with a composition or appearance similar to a food supports a determination that it is in a food format.
• dispensing mechanism of a cannabis product
  • For example, some liquid cannabis products have an integrated dispensing mechanism ensuring that it cannot be poured freely or drunk from the bottle and that controlled doses are dispensed. This helps the consumer know that it is intended to be taken in controlled amounts and supports a determination that the product is not in a food format.
• consumption method
  • For example, a capsule or tablet to be swallowed intact or an oral film that dissolves rapidly in the mouth (for example, in less than 30 seconds) supports a determination that it is not in a food format. A product that is intended to be chewed, drunk, or dissolve slowly supports a determination that a product is in a food format.

Examples of food formats include, but are not limited to:

• prepackaged, ready-to-use drink products packaged in a container typical of beverages such as:
  • bottles
  • drink boxes
  • cans such as those for soda, bottled water or fruit juices
• prepackaged products or sold-in-bulk products such as:
  • edible oils
  • dairy products
  • soups, puree
  • bars, cereals (for example, bran, oat)
  • bakery products (for example, breads, crackers)
  • whole foods (for example, nuts, seeds, fruits or vegetables), spreads, condiments, seasonings (for example, ketchup, salts, syrups, sweeteners)
• confectionery products and sugar-free equivalents such as:
  • mints, gum
  • cookies, wafers
  • dissolvable powders
  • toffee, taffy, caramels
  • jellies, chews, gummies
  • fondants, glazes, syrups
  • hard, soft or semi-soft candy
  • chocolates, chocolate bars, fudges
  • compressed powder candies (for example, confectionery tablet, chalk candy, candy wafer)
• beverage mix formats that are intended to be reconstituted for consumption as a beverage, including granules, powders, syrup, tea, gels, products

Of note, natural health products can often have formats that are common for food products. As such, having an appearance, texture and shape that is similar to a natural health product does not generally support that a cannabis product is not in a food format.

The product format has a history of use mainly for a food purpose

Health Canada considers a product format to have a history of use mainly for a food purpose if, historically, it has been consumed as a source of nutrition or energy, to satisfy hunger, thirst, or a desire for taste, texture or flavour. Products in these formats support a determination that the product is intended to be consumed in the same manner as food.

For example, it is Health Canada's position that confectionaries (for example, hard candies, jellies, chews and gummies) are expected to satisfy a desire for taste, texture or flavour and have a long history of being consumed as food. This supports a determination that a cannabis product in such a format is intended to be consumed in the same manner as food.

The product has characteristics that the public would likely perceive as, or associate with food or a food purpose

Characteristics likely to be perceived as food or associated with food or a food purpose include:

• taste, smell or texture that resembles a food (for example, chewy texture)
• appearance (such as size, shape or colour) that resembles a food (for example, shaped like a strawberry)
• ingredients associated with food (for example, chocolate syrup)
• ingredients likely to impart a taste associated with food (for example, a sweet taste or orange flavour)

Such characteristics could support that a product is intended to be consumed in the same manner as food.

The product is represented as food, to be mixed with food, or to satisfy a food purpose

Representation of a product includes, but is not limited to, information on:

• the product label or package
• branding or promotional material
• the manufacturer's or retailer's website

This could include brand elements, or other symbols, pictures, text or other means.

A cannabis product represented as food or to be mixed with food (including drinks) is considered to be intended to be consumed in the same manner as food. It should be classified as edible cannabis. This includes, but is not limited to:

• a brand name that references a food (for example, the name references a type of beverage such as "shot", "punch", "lemonade", "soda pop" or a confectionary product such as "cookies", or "candy")
• directions to add the product to food (for example, "mix with your favorite drink", "add to salads") or pictures depicting the product being mixed with food.

Representation that suggests an intent to satisfy a food purpose, could indicate that a product is intended to be consumed in the same manner as food. For example:

• food-related terms (for example, "yummy" or "delicious")
• pictures that suggest an intent to satisfy a desire for taste, texture or flavour
• prominent displays of the flavour, texture or taste of the product including by adding:
  • images of foods (for example, pictures of lemons and limes)
  • additional details (for example, wording such as "Chocolatey Funtastic Blast" or "with a splash of citrus flavour")

The use of a term such as tablet, capsule, lozenge, or variations thereof in a product name does not necessarily support classification as a cannabis extract. A product labelled with one of these terms could still be "intended to be consumed in the same manner as food", which is the basis for determining if a product should be classified as edible cannabis or as a cannabis extract.

Examples of how Health Canada assesses ingestible cannabis products

The following are simplified, hypothetical examples for the purposes of demonstrating how the factors could be applied. In a real case, all relevant information would be considered in an assessment to inform whether any compliance actions should be taken relating to classification.

Example 1: A small, white circular tablet, with an ingredient list of "starch, microcrystalline cellulose, tartaric acid, cannabis extract, stearic acid". The directions of use indicate that each tablet should be swallowed whole. The brand name is "THC Star Tabs". There is no other representation. The licence holder classified the product as an extract.

Health Canada's view:

This product can be classified as an extract because it is not intended to be consumed in the same manner as food.

• The product is not in a food format.
  • The size, shape and texture of the product align with directions of use to swallow whole. In general, the composition of the tablet is not similar to a confectionery tablet. The appearance of this product is consistent with some confectionery tablets. On balance, this non-sweet tasting tablet intended to be swallowed whole is a non-confectionery tablet.
• The product format does not have a history of use mainly for a food purpose.
  • Historically, non-sweet tasting tablets intended to be swallowed whole were not primarily consumed to satisfy hunger, thirst, or a desire for taste, texture or flavour.
• The product has some characteristics that the public could perceive as, or associate with food or a food purpose.
  • The appearance of the tablet (small, white and circular) is consistent with some confectionery tablets.
• The product is not represented as food, to be mixed with food, or to satisfy a food purpose.

Example 2: An oblong amber-coloured product, represented as a "Soft Capsule" with an ingredient list of "water, gelatin, citric acid, MCT oil, lecithin, cannabis extract, potassium sorbate" and a brand name of "THC Sun Gels". The licence holder classified the product as an extract.

Health Canada's view:

This product cannot be classified as an extract because it is intended to be consumed in the same manner as food.

• The product is in a food format.
  • The product is called a soft capsule. However, the product does not have the characteristics of a soft capsule. It does not have a shell and it contains no liquid.
  • The composition texture and appearance of the product are similar to gummies which are a food format. The products in this format are intended to be chewed before swallowing which supports a food format.
• The product format has a history of use mainly for a food purpose.
  • Historically, products in a confectionery format like gummies were consumed mainly for a food purpose.
• The product format has characteristics that the public would likely perceive as, or associate with food or a food purpose.
  • Gelatin is a common ingredient in some foods. The product has a chewy texture and its appearance is similar to some gummies.
• The product is not represented as food, to be mixed with food, or to satisfy a food purpose.

Example 3: An oral film that is small, amber-colored, rectangular and thin with an ingredient list of “Pullulan, a cannabis extract, glycerin, MCT oil, flavouring agent, polysorbate”. The label states that the product is intended to dissolve rapidly in the mouth. It is classified as a cannabis extract. The product webpage includes the statement, "Place 1 of our Slidez on your tongue and enjoy!" There are no other representations. The licence holder classified the product as an extract.

Health Canada's view:

This product can be classified as an extract because it is not intended to be consumed in the same manner as food.

• The product is not in a food format.
  • The appearance, shape, size, texture and composition are consistent with an oral film and it is intended to dissolve rapidly, both of which are not consistent with a food format.
• The product format does not have a history of use mainly for a food purpose.
  • Historically, oral films were not generally consumed as a source of nutrition or energy, to satisfy hunger, thirst, or a desire for taste, texture or flavour.
• The product has some characteristics that the public would likely perceive as, or associate with, food or a food purpose.
  • The product is flavoured.
• The product is not represented as food, to be mixed with food, or to satisfy a food purpose.

Example 4: An amber cannabis oil packaged in a small bottle, with an ingredient list of "Avocado oil, cannabis extract, natural flavours." The bottle is packaged with a restricting cap that must be used with a syringe to dispense the oil. The flavour is represented on the package as "lemon flavoured." There are no other representations. The licence holder classified the product as an extract.

Health Canada's view:

This product can be classified as an extract because it is not intended to be consumed in the same manner as food.

• The product is not in a food format.
  • Avocado oil is generally considered a food format. However, this product has an integrated dispensing mechanism that delivers controlled doses and it cannot be poured or drunk from the bottle which is not consistent with food use.
• The product's format does not have a history of use mainly for a food purpose.
  • Historically, oil in a bottle that must be used with a syringe was generally not consumed for a food purpose.
• The product has characteristics that the public would likely perceive as, or associate with, food or a food purpose.
  • Avocado oil is a type of edible oil associated with food and the product has a lemon flavour which is associated with a food purpose.
• The product is not represented as food or to be mixed with food or used in a beverage.
  • The term “lemon flavoured” on the package is a factual statement of the basic flavour. It is not considered to be prominently displayed and therefore does not support that the product is represented to satisfy a food purpose.