Health Canada released the backgrounder on its finalized Regulations for the legal production and sale of edible cannabis, cannabis extracts and cannabis topicals (the “Finalized Regulations”) on June 14, 2019, and published the Finalized Regulations in the Canada Gazette on June 26, 2019.
The majority of the Proposed Regulations were adopted following Health Canada’s review of public comments and feedback. Here is an overview of the Finalized Regulations.
The most significant change to the Proposed Regulations is the increased emphasis on discouraging products which would appeal to young persons. This overarching rule applies with respect to promotion, packaging and even the type of product that may be sold.
The Finalized Regulations are not clear as to the extent that this principle will apply, or whether any product which could be appealing to young persons would generally be prohibited (i.e. any and all candy edibles). It is anticipated that more details will follow once the Finalized Regulations come into force.
As previously outlined, the Regulations limit edibles to contain 10mg of tetrahydrocannabinol (“THC”) per discrete unit per package, prohibit edibles from being fortified with vitamins or minerals, and do not allow any nicotine or alcohol to be added to any product. The Finalized Regulations place an allowable limit of 30mg of caffeine in each immediate container of edible products, but only with respect to ingredients that contain naturally occurring caffeine. The use of caffeine as a food additive is prohibited.
Packaging and Labels
The Proposed Regulations with respect to packaging and labelling have been adopted. Edibles producers will have to ensure that product packaging is plain and child-resistant, has the requisite standardized cannabis symbol for products containing THC, a health warning message, THC and cannabidiol (“CBD”) content, and notes the equivalency to dried cannabis to ensure consumers remain in line with the public possession limit of 7.5 grams of cannabis (equivalent to 30 grams of dried cannabis).
In addition, as previously noted, food labelling requirements would apply, including listing ingredients, an indication of any source of allergens, a durable life date and a nutrition facts table. Pursuant to the marketing rules, as previously discussed, the representation of edible products as a suitable means of meeting particular dietary requirements – or including additional information pertaining to the content of the product (i.e. high source of fibre, low in fat, etc.) – will not be permitted.
The Finalized Regulations further incorporate the marketing rules by prohibiting producers from making representations regarding any health benefit claims, nutrient content claims, cosmetic benefit claims, representations that associate a cannabis product with an alcoholic beverage, tobacco product or vaping product.
Although the Finalized Regulations will come into effect on October 17, 2019, it will take some time before edible products are available for purchase.
Federally licensed producers will need time to become familiar with and prepare to comply with the new rules and to produce new products. Furthermore, provincially authorized distributors and retailers will need time to purchase and obtain the new products and make them available for sale.
As a result, it is anticipated that edibles will not physically be available in stores or online until mid-December 2019.
Amendments to Federal Producer Licenses
In order to sell and produce edible products, federally licensed producers will need to seek an amendment to their licence and attest that all regulatory requirements specific to edible products have been met before they can be authorized to sell them.
Licensed processors will need to provide Health Canada with written notice at least 60 days before making a new cannabis product available for sale. Health Canada will not approve any products, but will merely verify that the proposed product is in line with the Finalized Regulations.
Federal licence holders can begin to submit their requests for licence amendments commencing July 15, 2019; however, Health Canada will not begin approving amendments and reviewing notifications for new products until the Finalized Regulations come into force on October 17, 2019.