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On March 12, 2022, the Canada Gazette, Part I, Volume 156, Number 11 outlined Regulations Amending Certain Regulations Concerning Cannabis Research and Testing and Cannabis Beverages. A 45-day consultation period (ending April 26, 2022) has been opened to obtain feedback regarding these amendments.
What are the issues that brought about these proposed amendments?
1. Non-therapeutic research on cannabis – The clinical trial framework under the Food and Drug Regulations have shown to create some challenges for the industry, leading to missed opportunities to advance knowledge about the use and effects of legal, regulated cannabis products available to adult consumers under the Cannabis Act. As a result, this knowledge gap limits Canadians’ ability to make informed decisions about their consumption of cannabis products and the associated risks of cannabis.
2. Reference standards and test kits – There are challenges associated with cannabis research and testing which have been identified by Health Canada. Currently, only licensed processors are able to sell reference standards/test kits. Cannabis test kits are used to test for the presence or quantity of cannabis (e.g. in a drug-testing device). However, many analytical testing license holders and government laboratories have the equipment and expertise to produce high-quality reference standards.
3. Head of Laboratory – Under the Cannabis Regulations, an analytical testing license holder must designate one individual as the “Head of Laboratory.” The Head of the Laboratory is responsible for all cannabis research and testing activities that take place at the analytical testing laboratory site. This individual must have a university degree in a relevant science field from a Canadian university or equivalent. These requirements are more stringent than those used for the qualified person in charge under the Regulations, which is comparable in roles and responsibilities to the Head of Laboratory. Therefore, these stringent requirements may limit the pool of eligible Head of Laboratory candidates.
4. Cannabis beverages – Cannabis beverages (i.e. edible cannabis to be consumed by drinking, and has a concentration of 3% or less of THC) are currently classified as “non-solids containing cannabis” by Health Canada approved labs. This means, in terms of equivalency, that 1 g of dried cannabis is equal to 70 g of non-solids containing cannabis. Industry feedback revealed that the dried cannabis equivalency unintentionally restricts the possession and sale of cannabis beverages, particularly those in standard-sized containers (e.g. 355 mL cans), more so than other forms of cannabis. This means consumers are limited to possessing only five standard-sized beverages (i.e. 5 x 355 mL cans) without going over the public possession limit.
What are the amendments being proposed?
1. Non-therapeutic research on cannabis – Amendments would be made to the Cannabis Exemption (Food and Drugs Act) Regulations to create an exemption from the application of the Food and Drugs Act for certain non-therapeutic research on cannabis authorized under the proposed regulations. This cannabis research and testing would still be regulated by the Cannabis Act and its Regulations. Non-therapeutic research on cannabis would be defined as research involving the distribution of cannabis to human participants (with certain exceptions). Distributing cannabis would also include administering cannabis. The exceptions would include research related to the diagnosis, treatment, mitigation, prevention of a disease, disorder, abnormal physical state or its symptoms, the restoration or correction of organic functions, in human beings or animals. It would also exclude any cannabis research and testing involving the participation of, or related to, young persons.
2. Reference standards and test kits – A series of amendments would be made to the Regulations to support testing activities with cannabis. Reference standards would not be considered cannabis products and therefore, the proposed amendments would exempt reference standards from certain requirements under the Regulations. The amendments would also authorize individuals working in government laboratories to produce, distribute, and sell reference standards, as well as to produce test kits. This would enable them to conduct a broader range of activities with cannabis for their own testing purposes and to sell and distribute reference standards to other license holders or authorized persons for cannabis testing activities. Additionally, the amendments would permit authorized activities for analytical testers, allowing them to produce, distribute, and sell reference standards as well as produce test kits.
3. Head of Laboratory – The cannabis research and testing amendments would be made to the qualifications required for a person to become Head of Laboratory. Eligibility credentials would be changed to include a diploma, certificate, or credential from a Canadian post-secondary educational institution in a field or occupation relevant to the duties of the Head of Laboratory position. International credentials for this position would also be expanded to allow for a bigger pool of potential candidates.
4. Cannabis beverages – The proposed amendments would intend to increase the number of cannabis beverages equivalent to 1 g of dried cannabis. This would have the effect of increasing the public possession limit for cannabis beverages. The proposal would replace the non-solids containing cannabis class with two new classes of cannabis in Schedule 3. Class 1 would encompass cannabis beverages, including those that are commercially prepared or homemade (equivalency would change to 570 g). Class 2 would encompass non-solids containing cannabis other than cannabis beverages, such as cannabis oils and topicals with a concentration of 3% or less of THC (equivalency would remain at 70 g). Therefore, the number of cannabis beverages that an adult could possess in public would be equivalent to 48 standard-sized beverage cans.
What is the benefit of these amendments?
These proposed cannabis research and testing amendments to the Regulations would reduce the regulatory burden on the industry and its stakeholders. Overall, there would be a net reduction in costs to small businesses and the amendments would introduce flexibility and efficiencies for the industry. From a consumer standpoint, the amendments to the Regulations around cannabis beverages would allow for a significant increase in the number of beverage cans that can be in possession while still within the public possession limit, making it a fair comparison to dried cannabis and other varieties of cannabis products.
To participate in Health Canada’s consultation, which is open until April 26, 2022, click here.
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