Guidance on cannabis products with intoxicating cannabinoids other than delta-9-THC
The guidance was updated to reduce administrative burden and improve alignment with the Cannabis Regulations, while maintaining key compliance objectives.
- The language related to the preventive control plan was revised to clarify it must identify and address the risk posed by the contamination of any chemical substances used in the production or synthesis of cannabinoids or the chemical by-products that may result from these processes.
- This change improves clarity and consistency while continuing to support public safety objectives.
On this page
- Who this is for
- What are intoxicating cannabinoids
- Guidance on intoxicating cannabis
- Requirements for all cannabis products
- Compliance and enforcement
Who this is for
This information is intended for:
- micro-processing licence holders
- standard processing licence holders
It provides guidance on cannabis products made with intoxicating cannabinoids other than delta-9-tetrahydrocannabinol (delta-9-THC).
To help mitigate the risks associated with cannabis consumption, Health Canada recommends that licensed processors apply the regulatory controls applicable to delta-9-THC to all other intoxicating cannabinoids in their cannabis products.
What are intoxicating cannabinoids
Health Canada uses "intoxicating cannabinoid" to refer to cannabinoids that bind to and activate the type 1 cannabinoid receptor (CB1 receptor). Delta-9-THC is the most researched intoxicating cannabinoid and causes the "high" of cannabis. The data on the effects of other intoxicating cannabinoids is very limited or unknown.
Other than delta-9-THC, there's evidence to establish that the following cannabinoids also bind to, and activate the CB1 receptor:
- delta-8-THC
- delta-10-THC
- delta-6a,10a-THC
- THC-O-acetate (THC-O)
- cannabinol (CBN)
- hexahydrocannabinol (HHC)
- tetrahydrocannabivarin (THCV)
- tetrahydrocannabiphorol (THCP)
- tetrahydrocannabutol (THCB)
We may revise this list as new evidence becomes available about these and other potential intoxicating cannabinoids.
Health Canada is aware of cannabis products that have been produced containing intoxicating cannabinoids like those listed above. We understand that not all intoxicating cannabinoids may cause the same level or type of effects as delta-9-THC. However, we don't have enough evidence to fully understand the effect of these other intoxicating cannabinoids relative to delta-9-THC, either alone, or in combination with others.
Cannabis products that contain these intoxicating cannabinoids to circumvent regulatory controls on delta-9-THC pose an increased risk to public health and public safety. Health Canada is concerned that consumers aren't aware of these products and of their potential risks.
Guidance on intoxicating cannabinoids
The Cannabis Regulations (the Regulations) set out requirements specific to delta-9-THC.
These include a maximum quantity of delta-9-THC in a cannabis product. This quantity takes into account the potential to convert delta-9-tetrahydrocannabinolic acid (delta-9-THCA) into delta-9-THC ("total delta-9-THC"). For example:
- Cannabis topicals or extracts can't contain more than 1,000 mg of delta-9-THC per immediate container, subject to the variability limits.
- Edible cannabis can't contain more than 10 mg of delta-9-THC per immediate container, subject to the variability limits.
- Each discrete unit of cannabis intended for ingestion, nasal, rectal or vaginal use can't contain more than 10 mg of delta-9-THC, subject to the variability limits.
The Regulations also include requirements to:
- test each lot or batch for the quantity or concentration of delta-9-THCA and delta-9-THC using a validated method
- display the amount of total delta-9-THC on package labels as well as the standardized cannabis symbol (THC)
These important controls reduce the risks of accidental consumption and overconsumption of cannabis. At the same time, they provide consumers with the information they need to make informed decisions before using a cannabis product.
We recommend that cannabis licence holders apply the specific controls on this page to all cannabis products made to contain intoxicating cannabinoids other than delta-9-THC. This is to minimize the risks of accidental consumption, overconsumption and adverse effects.
Important: Health Canada recognizes that intoxicating cannabinoids can:
- occur naturally at low amounts in cannabis plants
- be produced at low levels during processing, handling or storage
The recommendations on this page are not intended to address such situations.
Recommended specific controls
THC limit: The total amount of all intoxicating cannabinoids including delta-9-THC shouldn't exceed the regulatory limits for total THC per immediate container or discrete unit.
For example, an edible cannabis product containing 2 mg of CBN and 8 mg of delta-9-THC would align with our recommendations. This is because the total amount of intoxicating cannabinoids wouldn't exceed 10 mg, similar to section 102.7 of the Regulations.
However, an edible cannabis product containing 3 mg of CBN and 8 mg of delta-9-THC would not align with our recommendations. This is because the total amount of intoxicating cannabinoids would exceed 10 mg.
Validating the quantity or concentration of intoxicating cannabinoids: For products that contain intoxicating cannabinoids, it is recommended that licence holders use suitable validated methods to accurately measure the quantity or concentration of the intoxicating cannabinoids for each lot or batch of cannabis. This provision is similar to those in sections 90 and 92 of the Regulations.
Note: Be aware that certain test methods may not have the necessary specificity to tell certain expected cannabinoids, such as delta-9-THC, from other intoxicating cannabinoids that are unexpected or not typically found in significant quantities. This can lead to misidentification or incorrect quantification of cannabinoids by the lab conducting the testing. It is therefore recommended that licence holders clearly communicate to testing labs when samples they submit may contain synthesized cannabinoids or their by-products. This way, the laboratories can use a test method that has been validated in a way that has the specificity to tell expected cannabinoids from others that are less typical and may be present when synthesis takes place.
Labelling: Accurate information on all intoxicating cannabinoids should be put on the product label, including the name and quantity or concentration. The label should also display the standardized cannabis symbol (THC), similar to paragraph 123(1)(f) of the Regulations.
Requirements for all cannabis products
Besides delta-9-THC, many other cannabinoids, including their isomers and derivatives, are subject to the Cannabis Act (the Act). This means that cannabis products containing other intoxicating cannabinoids are:
- subject to a suite of public health and public safety controls
- included in the definition of "cannabis" under subsection 2(1) of the Act
Note: Whether a substance is controlled under the Act or the Controlled Drugs and Substances Act:
- depends on different factors
- is determined on a case-by-case basis and at a point-in-time
If you have any questions about whether or not a substance is controlled under the Act, email cs_sc@hc-sc.gc.ca.
Licensed processors must comply with the following applicable requirements when producing cannabis products, regardless of whether their products contain delta-9-THC or other cannabinoids. This list is not exhaustive. Licensed processors should ensure that they comply with all requirements set out in the Regulations, including:
- labelling
- reporting
- packaging
- record keeping
Preventive control plan
A preventive control plan is required for edible cannabis and cannabis extracts. The plan must include a description of:
- the biological, chemical and physical hazards that present a risk of contamination to cannabis
- anything that would be used as an ingredient in the production of the cannabis product
The preventive control plan should identify and address hazards that may present a risk of contamination. This includes the risk of contamination from:
- any chemical substances used in the production or synthesis of cannabinoids
- the chemical by-products that may result from these processes
Once identified, adequate control measures must be outlined in the preventive control plan as per subsection 88.94(2) of the Regulations.
Testing for contaminants
Unless otherwise specified, test each lot or batch of cannabis for microbial and chemical contaminants as per section 91 of the Regulations. Pay attention to potential chemical and microbial contaminants that may result from the production of cannabinoids through synthesis, such as precursors or other impurities. Conduct tests using validated methods on a representative sample as per section 92 of the Regulations.
Good production practices guide for cannabis
Adverse reaction reporting
As per section 248.1 of the Regulations, a holder of a licence that sells or distributes a cannabis product is required to:
- report all serious adverse reactions to Health Canada within 15 days after becoming aware of an incident
- prepare an annual summary report of all adverse reactions to a cannabis product that the licence holder became aware of during the previous 12 months
As per Health Canada's Cannabis adverse reaction reporting guide, it's recommended that licence holders collect as much information as possible. This way, reports submitted to Health Canada capture clinically relevant and complete information for evaluation. This would include providing information of all known cannabinoids in the cannabis product in the adverse reaction report.
Cannabis adverse reaction reporting guide
Compliance and enforcement
We strongly encourage licensed processors to follow the recommended specific controls for cannabis products made with intoxicating cannabinoids other than delta-9-THC.
It's always the licence processor's responsibility to:
- understand and comply with:
- the Act
- the Regulations
- all other federal and provincial or territorial legislation that may apply to them or to their activities
- seek legal counsel to better understand and comply, if necessary
Health Canada asks licensed processors to undertake actions to address public health and public safety risks or non-compliance with the Act and the Regulations. However, we may take enforcement measures, if required, in order to mitigate the risks to public health or public safety.
For example, we may order a licensed processor to:
- conduct tests or studies on a cannabis product and provide us that information and their results, per section 74 of the Act
- take any measures necessary to address an issue of public health or public safety, per section 75 of the Act
If you have any questions, email compliance-cannabis-conformite@hc-sc.gc.ca.
Compliance and enforcement policy for the Cannabis Act
Disclaimer
This guidance aims to support the purpose of the Act and the Regulations. It isn't intended to provide legal advice regarding the interpretation or application of the Act and the Regulations.
The Government of Canada can advance amendments to the Act or Regulations to address the public health and public safety risks posed by intoxicating cannabinoids other than delta-9-THC. Health Canada will continue to conduct research and monitor trends in the make up and availability of cannabis products containing intoxicating cannabinoids other than delta-9-THC and will take regulatory action if warranted. Health Canada publishes information on regulatory initiatives that are proposed in the next 2 years in the Forward Regulatory Plan.
Health Canada reserves the right to modify this guidance as appropriate and without notice.