I have had many enquires from people concerning the addition of Cannabis in the products they make now that Cannabis is legal in Canada so I sent a letter off to Health Canada. Below is their reply with links for all the information you will need to be compliant.
Dear Sir or Madam:
Thank you for your email concerning the legalization and regulation of cannabis. We apologize for the delay in responding.
Over the past year, more than 13,000 queries have been sent to the firstname.lastname@example.org email address as stakeholders, members of the public, and others have prepared for the coming into force of the Cannabis Act and its regulations. In order to respond to your questions, we would like to provide you with the following general information on cannabidiol (CBD). If, after reading the response below, you still have specific questions related to the Cannabis Act and its regulations, please do not hesitate to write to us again at email@example.com, and we will provide you with an answer as soon as possible.
On October 17, 2018, the Cannabis Act came into force. The Cannabis Regulations and the Industrial Hemp Regulations, which support the Cannabis Act, create a strict framework for controlling the production, distribution, sale, and possession of cannabis and industrial hemp in Canada.
It is important to note that cannabis, including the principal cannabinoids tetrahydrocannabinol (THC) and CBD, are controlled substances under international drug conventions. As such, CBD is a controlled substance under Schedule 1 of the Cannabis Act. Prior to the Cannabis Act, CBD was listed as a controlled substance, along with all cannabinoids, under the Controlled Drugs and Substances Act, and its production, sale, import and export for non-medical purposes was not permitted.
Under the Cannabis Act, CBD and products containing CBD, are subject to all of the rules and requirements that apply to cannabis under the Cannabis Act and its regulations. This applies to CBD derived from industrial hemp, as well as CBD derived from other varieties of cannabis.
This means that:
· A licence under the Cannabis Regulations is needed to manufacture products containing CBD that do not make a health claim; and
· CBD and products containing CBD that do not make a health claim can be sold only by a provincially- or territorially-authorized cannabis retailer, or by a federally licensed seller of cannabis for medical purposes.
Please note that, under the Cannabis Act, only five classes of cannabis are currently permitted for sale: fresh cannabis, dried cannabis, cannabis oil, cannabis plants, and cannabis seeds. As will be described further below, regulations for three new classes of cannabis (edible cannabis, cannabis extracts, and cannabis topicals) will come into force on October 17, 2019.
Hemp CBD oil vs. Hemp-seed oil
It is important to note that “hemp CBD oil”, also referred to as CBD oil, refers to a product that consists of cannabis in the form of a CBD-rich extract. It is derived from the leaves and flowering tops of the cannabis plant (which can include plants classified as industrial hemp), and a vegetable-based or plant-based oil (such as canola, olive, grape seed, or hemp-seed oil). Due to its CBD content, this type of oil is controlled under the Cannabis Act as cannabis.
In comparison, “hemp-seed oil” is distinct from “hemp CBD oil’’. “Hemp-seed oil” refers to oil derived from pressing only the grain or seed of hemp plants. “Hemp-seed oil” contains negligible amounts of CBD. Hemp-seed oil is marketed in Canada in natural health products, veterinary health products, cosmetics, and food.
Individuals who wish to access cannabis products containing CBD can buy them at provincially- or territorially-authorized retail outlets or their associated online sales platforms.
Individuals who wish to access cannabis products containing CBD for medical purposes are encouraged to do so under the advice and supervision of their health care practitioner. Health care practitioners are responsible for providing their patients with information on dosing, usage, and health effects of cannabis.
Canadians who have been authorized by their health care practitioner can access cannabis for medical purposes in three ways:
- purchase quality-controlled cannabis from a wide variety of federally-licensed sellers inspected by Health Canada;
- produce a limited amount of cannabis for their own medical purposes; or
- designate someone to produce it for them.
CBD in products regulated under the Food and Drugs Act
Under the Cannabis Act, cannabis products, whether sold for medical purposes or non-medical purposes, cannot be sold with labels or marketed in a manner that provides information about the health benefits of the product, appropriate dosing, or other information about the use of the product as a treatment for health conditions. Cannabis products produced under the Cannabis Act are also only intended to be sold for human consumption.
Operating alongside the regime established by the Cannabis Act, the Food and Drugs Act (FDA) and its regulations provide a regulatory pathway for the manufacture and sale of prescription drugs that contain cannabis, including drugs for human use and veterinary drugs. Under the FDA, prescription and veterinary drugs must undergo Health Canada’s drug review process before they can be sold in Canada, to ensure that they are safe, effective, and of high quality for their intended use.
Health Canada added all phytocannabinoids (including CBD) to the Human and Veterinary Prescription Drug List (PDL) on October 17, 2018. This means that any drug containing a phytocannabinoid can only be sold in Canada on a prescription-only basis. The listing of all phytocannabinoids on the PDL reflects a current lack of clinical evidence supporting the safety and efficacy of the chemicals found in cannabis for therapeutic purposes. As experience grows and knowledge is gained (through robust scientific evidence), the prescription status of certain phytocannabinoids (for specific conditions of use) may no longer be necessary.
Health Canada is aware that some Canadians are interested in the potential therapeutic uses of cannabis, such as pain relief, for human use and in animals, without the need for practitioner oversight. On June 19, 2019, Health Canada launched a consultation to seek feedback from Canadians and industry on the kinds of products they would be interested in purchasing, manufacturing or selling if such products were to be legally available in Canada. This consultation is open until September 3, 2019. For more information on this consultation, or to share your views, please see: https://www.canada.ca/en/health-canada/programs/consultation-potential-market-cannabis.html.
As noted above, it is permitted to use hemp-seed oil or other derivatives of non-viable hemp seeds, provided they contain no more than 10 parts per million THC, in natural health products, veterinary health products, cosmetics and foods. In addition, it is permitted to use limited parts of cannabis or hemp plants (non-viable seeds; mature stalks that do not include any leaves, flowers, seeds, or branches; fibre derived from such stalks; and roots) in natural health products and cosmetics, but not derivatives of those substances such as oil made from hemp stalks.
For information to support the development of an application for a drug for human use, a natural health product, or a medical device, the cannabis single window can be reached at: firstname.lastname@example.org.
For information about veterinary drugs, the Veterinary Drugs Directorate can be reached at: email@example.com.
For information about veterinary health products, please contact: hc.VHP-PSA.firstname.lastname@example.org.
Importing or Exporting CBD or products containing CBD
It is illegal for individuals to take cannabis and cannabis products, including those with CBD, across the Canadian border, whether a person is leaving or coming to Canada. This applies to all countries, whether cannabis is legal there or not.
The import or export of cannabis requires a permit from Health Canada. As set out in the Cannabis Act and its regulations, import or export permits are only available for medical or scientific purposes, and are only available to licence holders.
The control and the movement of cannabis and cannabis products between countries is covered by three United Nations drug conventions, including the Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol. CBD is currently a controlled substance under the Single Convention, and as a result, the international movement of goods containing CBD is limited to medical and scientific purposes and is subject to strict controls, including the requirement for export and import permits.
Regulations for Edible Cannabis, Cannabis Extracts, and Cannabis Topicals
On June 14, 2019, Health Canada announced the Regulations Amending the Cannabis Regulations (New Classes of Cannabis), which establish new regulatory controls for the production and sale of new cannabis products, namely edible cannabis, cannabis extracts, and cannabis topicals. As with the current Cannabis Regulations, these new rules and requirements will apply to cannabis products containing CBD.
Consistent with the public health approach to the regulation of all cannabis products, the amended regulations have been designed to reduce the public health and public safety risks associated with these new cannabis products, including appeal to young persons, and the risks of accidental consumption and overconsumption.
The amended regulations introduce a series of controls, including restrictions on product composition and ingredients, THC limits and new requirements pertaining to promotion, packaging and labelling, good production practices and record keeping. These amendments will also enable a comprehensive range of product forms, consistent with the objective of enabling the legal industry to displace the illegal industry.
In order to produce edible cannabis, cannabis extracts, and cannabis topicals, an individual will need to hold a processing licence issued under the Cannabis Act and Cannabis Regulations.
The amended regulations will come into force on October 17, 2019. However, it will take time before new cannabis products become available for purchase. It is expected that a limited selection of products will appear gradually in physical and online stores, and no earlier than mid-December 2019.
Health Canada is undertaking public education efforts to help Canadians understand the public health and public safety risks associated with the new cannabis products and lower-risk use practices. Additional information is available at:
For your reference, please find attached a fact sheet on CBD that you may find useful.
If you have any further questions, you can contact the Controlled Substances and Cannabis Branch by email at email@example.com or toll-free at 1‑866‑337‑7705.
Thank you for writing.
Controlled Substances and Cannabis Branch
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