Poised to Move into the Mainstream: Health Canada Releases Draft Regulations for Three New Classes of Cannabis-Infused Products

On December 20, 2018, Health Canada released draft regulations for public consultation on three new classes of cannabis products: (i) edible cannabis; (ii) cannabis extracts; and (iii) cannabis topicals. These cannabis products will be permitted for legal sale under the Cannabis Act no later than October 17, 2019.

The proposed regulations and Regulatory Impact Analysis Statement (RIAS) were published in the Canada Gazette, Part I on December 22, 2018. According to the RIAS, proposed amendments to Schedule 4 to the Cannabis Act would add three new classes of cannabis-infused products that could be legally sold by federal licence holders and provincially and territorially authorized distributors and retailers. Amendments to the Cannabis Regulations are also proposed to establish new regulatory controls to address the public health and public safety risks associated with these new classes of cannabis, including their appeal to youth and the risks of accidental consumption, overconsumption, and foodborne illness, among others. These controls would include restrictions on product composition and ingredients, tetrahydrocannabinol (THC) limits, and new requirements pertaining to packaging and labeling, good production practices and record keeping. At the same time, proposed amendments to the Cannabis Regulations will allow for a broader variety of product forms within these new classes of cannabis, which is consistent with the federal government’s objective of displacing the illegal market.

The draft regulations propose the following in respect of each new class of cannabis product:

  • Edible Cannabis
    • Restricting the use of ingredients that could increase the appeal of edible cannabis to young persons, increase the risk of food-borne illness and accidental consumption, and encourage over-consumption.
    • Placing a hard cap of 10 mg of THC on the amount of THC that could be in a package of edible cannabis. 
    • Requiring child-resistant and plain packaging for edible cannabis to lower the risk of accidental ingestion and making packages less appealing to young persons. 
      • The label would need to display the standardized cannabis symbol and a health warning message. 
      • It would be prohibited to make any claims respecting health benefits or nutrition on the label.
      • Putting in place strict new manufacturing controls for the production of edible cannabis products to reduce the risk of food-borne illness; and
      • Prohibiting the production of food and edible cannabis in the same facility to ensure the safety and integrity of Canada’s food system.
  • Cannabis Extracts
    • Restricting the use of certain ingredients that could appeal to young persons, such as sweeteners and colourants, or ingredients that could encourage consumption, such as nicotine.
    • Prohibiting certain flavours that are appealing to youth from being displayed on a product label, consistent with rules for other vaping products. 
    • Placing a hard cap on the amount of THC that could be in a unit of a cannabis extract—such as a capsule—of 10 mg of THC per unit. The total amount of THC in a package would be capped at 1,000 mg (e.g., 100 10-mg capsules).
    • Requiring child-resistant and plain packaging for cannabis extracts. All packaging, as well as certain pre-filled accessories, such as a vape pen, would be required to display the standardized cannabis symbol.
    • Prohibiting any claims respecting health benefits or nutrition on the label.
    • Putting in place strict new manufacturing controls for the production of cannabis extracts to control the quality of the products.
  • Cannabis Topicals
    • Like edible cannabis and cannabis extracts, restrictions would be placed on the types of ingredients that could be added to cannabis topicals.
    • A hard cap of 1,000 mg of THC would be placed on each package of a cannabis topical.
    • The packaging would need to be child-resistant and display the standardized cannabis symbol and a health warning message.
    • Any claims respecting health benefits on the label would be prohibited.

Health Canada has produced a table summarizing the proposed regulations for the additional cannabis products, which is available online.

Health Canada is accepting comments on the draft regulations until February 20, 2019. Submissions may be made online or in writing either by (i) email at [email protected], or (ii) by mail to Health Canada, Strategic Policy Directorate, Cannabis Legalization and Regulation Branch, Address locator: 0302B, Health Canada, Ottawa, K1A 0K9.

CANADA GAZETTE Cannabis RIAS regulations cannabis act cannabis-infused products

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