Guidance on cannabis products with intoxicating cannabinoids other than delta-9-THC

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 deliberately made with intoxicating cannabinoids other than delta-9-tetrahydrocannabinol (delta-9-THC).

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.

Some cannabis processors have made cannabis products containing intoxicating cannabinoids like these, either instead of delta-9-THC or in addition to it. 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.

Deliberately including intoxicating cannabinoids to cannabis products to circumvent regulatory controls on delta-9-THC could increase risks 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 delta-9-THC and 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 deliberately contain intoxicating cannabinoids other than delta-9-THC. This is to minimize the risks of accidental consumption, overconsumption and adverse effects.

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 deliberately contain intoxicating cannabinoids, use suitable validated methods to accurately measure the quantity or concentration of the intoxicating cannabinoids for each lot or batch of cannabis. This is similar to sections 90 and 92 of the Regulations.

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

Licensed processors must comply with the following applicable requirements when producing cannabis products, regardless of whether their products contain delta-9-THC or other intoxicating 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

It must also:

• outline the control measures and other requirements as per subsection 88.94(2) of the Regulations
• identify and address the risks from the use of various chemical substances and all resulting by-products in the production or synthesis of cannabinoids

Preventive control plan

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 expected 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 deliberately 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.

Forward Regulatory Plan