In late June 2019, Health Canada commenced a public consultation period on the potential market in Canada for health products containing cannabis. This new class of product is referred to as “Cannabis Health Products” or “CHPs”.
In launching the consultation period, Health Canada1https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/guidance-cannabis-act-food-and-drugs-act-related-regulations/document.html#a1 acknowledged:
- the existing public interest in Canada in potential therapeutic uses of cannabis for ‘minor’ ailments such as pain relief, anxiety and sleep in humans and animals, without the need for oversight of these therapeutic uses by health care practitioners such as a doctor or veterinarian; and
- the need to displace the illegal market that is currently selling cannabis products marketed with unauthorized health claims (e.g., cannabidiol (CBD) products claiming to provide relief from muscle aches, joint pain and inflammation).
PROPOSED DEFINITION OF CANNABIS HEALTH PRODUCTS
Health Canada proposes to define Cannabis Health Products as a drug that contains cannabis and that makes health claims regarding treatment, which can be sold without the need for oversight by a health care practitioner.
Currently, cannabis products, whether sold for medical or non-medical purposes, cannot be sold with labels or marketed in a manner that provides information about health benefits of the product, dosing, or other information about the use of a cannabis product as treatment for a health condition. As such, the only existing avenue for the sale of a cannabis product marketed with health claims is as a prescription drug containing cannabis (e.g., Sativex), like any other prescription pharmaceutical.
Health Canada is proposing for Cannabis Health Products to be allowed to contain medical and non-medicinal ingredients in addition to cannabis, provided such ingredients are supported by evidence showing the mixture of ingredients is safe and effective.
Health Canada also proposes that all Cannabis Health Products claiming to provide a health benefit to either humans or animals will require authorization from Health Canada. Specifically:
- general health claims would not be permitted (e.g., claims with low therapeutic value);
- specific health claims would need to be supported by scientific evidence; and
- cannabis must be listed as an active ingredient and could not be included without a direct link to the health claim. Evidence would need to sufficiently demonstrate the association of the ingredient (e.g., specific phytocannabinoid) with the health claim.
SALE OF CANNABIS HEALTH PRODUCTS
Health Canada is proposing to allow for the sale of Cannabis Health Products to consumers by:
- provincially licensed retailers that currently sell non-medical (recreational) cannabis products; and
- federally licensed sellers that hold a medical sales license (but without the need for the purchaser to have a medical document issued by their doctor or a registration certificate as is currently the case).
Similar to other cannabis products, Cannabis Health Products will not be permitted to be sold over-the-counter in grocery and drug stores alongside Health Canada approved Natural Health Products such as vitamins and minerals.
During this consultation period, Health Canada is interested in receiving feedback on what potential products industry may be seeking to manufacture and bring to market, and what types of products consumers would be interested in purchasing, to better understand the types of product formats and health claims that would be of interest to Canadians in this retail environment.
If you are interested in purchasing, manufacturing or selling Cannabis Health Products in the future, please ensure you provide your comments to Health Canada through their online consultation platform.
The consultation period will be open for feedback from Canadians and all interested stakeholders until September 3, 2019.
CARSCALLEN LLP’S CANNABIS EXPERTISE
An experienced cannabis lawyer is essential to assist businesses in understanding and navigating the complex regulatory and legal framework for cannabis products in Canada. The Carscallen Cannabis Group provides comprehensive and sophisticated legal services to businesses involved at every stage of the cannabis industry, and works with its clients to find the most strategic and practical solutions to their legal needs.
If you have any questions or comments related to Health Canada’s public consultation on Cannabis Health Products, or any other cannabis-related inquiries, please contact John Davidson or any member of the Carscallen Cannabis Group.