The Canadian Government’s “Proposed Approach to the Regulation of Cannabis”, was released November 21, 2017. Over the course of the coming days, Canada Cannabis Legal will be breaking down the proposed regulatory regime. Today, we take you through the section of the proposal that deals with health products and cosmetics containing cannabis in more detail.
Health Products and Cosmetics currently on the market are subject to the legislative framework of the Food and Drugs Act, (“FDA”) the Controlled Drugs and Substances Act (“CDSA”)and the Cosmetic Regulations (“CR”).
Health Products are defined by Health Canada as: prescription and non-prescription drug products for human and veterinary use, natural health products (NHPs) such as vitamins, minerals, herbal remedies and homeopathic medicines, veterinary health products (VHPs) and medical devices.
Health Canada’s Review Process
The only health products that may be available for sale are ones that have been approved by Health Canada after a scientific review and drug review process. Without successfully completing the drug review process, health products cannot be sold or make a health claim. As part of the review process, Health Canada considers the need for the oversight of a healthcare practitioner, including the level of uncertainty respecting the drug and its potential harms or risks to human or animal health. Products with indications requiring practitioner oversight are added to the Prescription Drug List, known as the “PDL”. If Health Canada determines that physician oversight is required for the product, the product would be available by prescription only.
Prescription vs. Non-Prescription Health Products
Currently, the only drugs authorized by Health Canada and on the market that contain cannabis are by prescription-only. This is because cannabis is classified as a controlled substance under the CDSA. Under the current framework, only two forms of prescription drugs containing cannabis have been approved (Sativex and Marinol). Health Canada plans to review the prescription status of these drugs but “expects that the dosage, route of administration and conditions of use of THC and CBD included in these products would be listed on the PDL” and they would remain accessible by prescription-only.
For the currently-approved prescription products and any that may be approved in the future, it is proposed that no additional access restrictions as contemplated under the Cannabis Act be imposed.
Health Canada is anticipating receiving submissions for new health products with lower levels of THC and CBD. If these products can be safe and effective for use without physician oversight, they will be available as non-prescription products.
Veterinary Drugs and Health Products
Veterinary Drugs and Health Products are also subject to Health Canada’s drug review process before sale and are subject to many of the same restrictions as drugs and health products for human-use. New applications for veterinary drugs will be assessed against the potential need for health practitioner oversight.
Natural Health Products (NHPs)
There are 220 NHPs with cannabis currently authorized for sale which will continue to be available. The reason they are authorized is either because they (a) use parts of the cannabis plant that fall outside the CDSA definition or (b) are exempt under the Industrial Hemp Regulations, AND they contain less than 10 ppm THC. New proposed NHPs will be subject to this same criteria.
Medical devices are defined in the FDA’s Medical Device Regulations and cover a wide range of instruments. There are two medical devices currently authorized for sale in connection with the consumption of cannabis.
Any new submissions for medical devices will be subject to the usual review process under the Medical Device Regulations. Health Canada proposes that further precautions be put in place as to avoid the use of such devices by youth to consume cannabis for recreational purposes.
Currently, cosmetics are not permitted to include any cannabis-derived ingredients. This excludes hemp seed derivatives with less than 10 parts per million THC. Under the proposed approach, cosmetics containing such ingredients would be subject to the provisions of the Federal Cannabis Act.
Cosmetics are not subject to pre-market review or approval the way that Health Products are. The Cosmetic Ingredient Hotlist, known as the “Hotlist” is a Health Canada tool that communicates the substances that may contravene the FDA or the CR. Cannabis is addressed in three separate entries on the Hotlist. Some restrictions would not be affected by the proposed Cannabis Act. Others, like cannabis-derived ingredients currently captured as “narcotics” on the Hotlist, will be subject to the provisions of the proposed Cannabis Act related to licensing, product classes and forms, place of sale, packaging and labelling, promotion and possession.
The Cannabis Act
The requirement for processing and research licenses in addition to restrictions on promotion, packaging and labelling that are contained in the proposed Cannabis Act will also be applicable to Drugs and Health Products under the proposed regulations. The proposal also explores the potential of “further precautions” including options to control the display and sale of health products to youth.
To allow for the proper use of health products, the regulations will include exemptions from the Cannabis Act for:
- Classes and Forms of Cannabis: “limitations to classes that could be sold would not apply to health products with cannabis because the precise dosage, route of administration and conditions of use of each of these products would be subjet to Health Canada’s review of each product.”
- Appeal to Youth: “to allow for pediatric formulations, an exemption is proposed to control the sale of cannabis products with traits that appeal to use”
- Possession Limits: “health products will be regulated under strict conditions of sale, so it is proposed that possession limits and packaging size restrictions would not apply”
These proposed regulations are very exciting for many as they will open up the door for sales of popular products such as topical creams, oils and concentrates, vaporizers, other medical device technologies, and the list goes on.