This article originally appeared in Food in Canada and is republished with the permission of the publisher.

One part cannabis, three parts uncertainty - the impending introduction of a recreational market for cannabis offers an unparalleled opportunity for businesses to stake a claimin this uncharted territory. As Bill C-45, the proposed Cannabis Act, continues its forward momentum through the Senate, a new and complex legislative framework for cannabis is materializing. While details have started to emerge re- garding how certain forms of recreational cannabis (fresh, dried and oil) will be sold, the eventual regulation of cannabis edibles will present unique challenges.

The government proposes to allow the sale of cannabis edibles within one year following the coming into force of the proposed Act. This gives Health Canada additional time to develop regulations to address the unique nature and risks posed by this class of products.

The Act does not currently provide a definition for "edibles containing cannabis." Health Canada indicates that this class will include products such as foods or beverages that contain cannabis, and that a precise definition will be set out in subsequent regulations. Notably, the definition of cannabis under the Act is broad, referring not only to parts of the cannabis plant, but also to the phyto-cannabinoids produced by or found in the plant, including any identical sub- stance regardless of how the substance was obtained.

We anticipate that federal oversight for industrial hemp will be moved from the Controlled Drugs and Substances Act to the new Act. However, it is unclear what changes will be made to the Industrial Hemp Regulations to align in with the Act (or future regulations), and whether such changes will affect the regulatory status of derivatives such as oils.

With respect to the format of edibles, Health Canada suggested that it will limit the permitted food formats (e.g. truffles vs cookies), with the aim of reducing the likelihood that edibles will appeal to young persons. Portion control may also be a key consideration, favouring formats that allow edibles to be consumed in measured or controlled doses. Undeniably, in determining eligible food formats, there will be pressure from industry to strike a balance which provides sufficient flexibility for legal producers to offer a diverse range of products to successfully compete with the illegal market.

Although Health Canada advised that the THC content of edibles will likely be limited, consultation documents do not indicate whether there will be a limit on other phytocannabinoids. Packaging and labelling will also be a key issue, with the aim of ensuring that children don't accidentally ingest edibles. Indeed, format limitations, child-resistant packaging and prohibitions against the use of certain terms (e.g. "candy") have been proposed or adopted as measures to reduce the risk of accidental ingestion in other jurisdictions.

While Health Canada intends to exempt cannabis produced under the Act from certain requirements of the Food and Drug Regulations, it is not yet clear what elements of the current food regulatory framework will apply to edibles. In the next year Health Canada will consider many fundamental questions, such as whether edibles should carry a Nutrition Facts Table, if allergen labelling will be required, and whether other proposed nutrition labelling requirements, like front- of-package labelling, will apply. In addition to cannabis-specific labelling (e.g. symbols, warnings, THC/CBD), what other factual information about edibles should be available to consumers? Should nutrient content claims such as sugar-free, low fat, or source of fibre be permitted?

Other issues, such as restrictions on food additives and food safety requirements, will also need to be considered. Lastly, what about enforcement? Regulators will need to decide if Health Canada will

be solely responsible for enforcement of edibles, or if this task will also fall within the mandate of the CFIA.

Although there will be uncertainty until new regulations are proposed, it is evident that cannabis edibles will require a complex recipe of legislative and regulatory controls, due to their particular position at the intersection of the food-drug interface.