Cannabis research, testing and beverage rules

Summary#

These final rules — the Regulations Amending Certain Regulations Concerning Cannabis Research and Testing and Cannabis Beverages (SOR/2022-251) — took effect on December 2, 2022. They make several changes to how non-therapeutic human cannabis research is handled, loosen some limits on who can make testing materials, and change how much a cannabis drink counts toward public possession limits.

What it does#

• Creates a category called cannabis beverage: edible cannabis meant to be drunk with 3% w/w THC or less.
• Lets certain non-therapeutic human studies on cannabis be done under the Cannabis Regulations instead of the clinical-trial rules in the Food and Drug Regulations. Those studies must follow new safeguards, including:
  • the cannabis used must meet production and product safety rules (Good Production Practices and parts of Part 6);
  • reporters must notify Health Canada within 7 days and give a full report within 8 days for life‑threatening/fatal serious adverse reactions, or within 15 days for other serious ones;
  • adverse-reaction records must be kept for 15 years; other research records generally for 2 years.
• Gives a two‑year transition for existing research licence holders doing human research to get a new or amended research licence (deadline: the second anniversary after the rules came into force — i.e. by December 2, 2024).
• Allows holders of analytical‑testing licences and government laboratories to produce, sell and distribute cannabis reference standards and to make or assemble test kits. Reference standards:
  • are defined as standardized cannabis used for testing and calibration;
  • must not be used as ingredients or sold at retail for consumption;
  • are exempted from some production rules and from the federal ban on products that might be especially appealing to young people (so they can be made for testing purposes).
• Broadens who can be a “head of laboratory” for analytical testers by accepting diploma/certificate level credentials and wider foreign-credential equivalency checks.
• Splits the old “non-solids” class in Schedule 3 of the Cannabis Act into two classes and changes the dried‑cannabis equivalency:
  • cannabis beverages: 1 g dried = 570 g beverage (previously 70 g as part of the broader class);
  • other non‑solids (oils, topicals): remain 70 g per 1 g dried.
• That change raises the federal public possession limit for cannabis beverages for adults from 2,100 g (≈2.1 L) to 17,100 g (≈17.1 L).

Who's affected#

• Researchers and universities doing human studies with cannabis. Existing licence holders doing research with people must get a new or amended research licence within two years (see December 2, 2024 deadline).
• Analytical testing laboratories and government laboratories — more of them can produce and sell reference standards and assemble test kits.
• Licensed processors, producers and retailers of cannabis beverages — they must update labels and sales systems to reflect the new equivalency; a 12‑month labelling transition was provided for some processors.
• Consumers of cannabis beverages and provincial/territorial regulators and law‑enforcement bodies (because the public possession limit and what counts toward it changed).
• Health Canada and federal officials — more licence applications to process and new enforcement/oversight responsibilities.

If it is unclear who exactly will notice day‑to‑day, the most immediate effects will be felt by licence holders, researchers, beverage makers, and testing labs.

Why it matters#

• It aims to make it easier to do non-therapeutic human research on commercially available, regulated cannabis products. That could produce more real‑world data about how cannabis affects people.
• It improves access to testing materials (reference standards and test kits). That can help labs test products more reliably and support a quality‑controlled legal supply.
• It fixes an odd side effect of the old possession rules that limited how many ready‑to‑drink cannabis beverages adults could legally carry or buy in public. The new equivalency means adults can possess and (effectively) buy many more beverage cans without exceeding the federal public possession limit.
• Safety controls remain: for example, the maximum of 10 mg THC per immediate container and child‑resistant packaging rules are unchanged. The rules also add specific reporting, record‑keeping and licence requirements to protect research participants.
• The government estimated total costs of implementing the changes at $4,363,350 (present value over 10 years), most of which are costs to federal administration (about $4,090,931), and $272,420 to industry for things like label and application updates.