What You Need to Know About Cannabis and Personal Care Products


Posted Date: 17-October-2018

Consultation on Potential Market for Cannabis Health Products

 

Q: What is cannabis?

A: Cannabis refers to the plant Cannabis Sativa. It is also known as Marijuana. It includes any part of a cannabis plant, including phyto cannabinoids. It is a psychoactive drug used for medical and recreational purposes.

Q: What are cannabinoids?

A: Cannabinoids are a group of active compounds found in Cannabis. Cannabinoids are the chemicals which give the cannabis plant its medical and recreational properties. Examples are THC and CBD.

Q: What is THC?

A: THC stands for delta-9-tetrahydrocannabinol. THC is responsible for the way your brain and body respond to cannabis, including the high and intoxication.

Q: What is Industrial Hemp?

A: Industrial hemp means the plants and plants of the genera Cannabis, the leaves and flowering heads of which do not contain more than 0.3 % THC w/w and includes the derivatives of such plants and plant parts. It also includes the derivatives of non-viable cannabis seeds. It does not include plant parts of the genera Cannabis that consist of no-viable cannabis seed other than its derivatives, or mature cannabis stalks that do not include leaves, flowers, seeds or branches or fibre derived from those stalks.

Q: Where can I find more information on industrial Hemp?

A: You can find more information on Industrial Hemp in the Industrial Hemp Regulations enabled by the Controlled Drugs and Substances Act.

Q: Where can I find a list of approved Industrial Hemp Cultivators?

A: Section 39(1) of the Industrial Hemp Regulations, allows a variety of industrial hemp to be designated as an approved cultivator provided that the variety will produce a plant that will contain 0.3% THC or less in its leaves and flowering heads. Section 39(2) also permits the Minister to exempt an approved cultivar from THC testing. Section 8 (1)(g)(i) if the IHR requires that a person who applies for a license or authorization indicates the approved cultivar that will be sown. The cultivar indicated must be on the list of hemp varieties approved by Health Canada.

Q: What is the Cannabis Act?

A: An Act respecting Cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and other Acts. The Cannabis Act was passed in the House of Commons on November 21, 2017.

Q: When will the Cannabis Act come into effect?

A: The Cannabis Act will come into force October 17, 2018.

Q: What are the Controlled Drugs and Substances Act?

A: An Act respecting the control of certain drugs, their precursors and other substances and to amend certain other Acts and repeal the Narcotic Control Act in consequence thereof.

Q: What is the relationship between the Controlled Drugs and Substances Act (CDSA), Cannabis Act and the Industrial Hemp Regulations (IHR)?

A: The Controlled Drugs and Substances Act prohibits certain activities with controlled substances. Regulations under the CDSA such as the Industrial Hemp Regulations authorize certain activities with specific controlled substances. The Cannabis Act is an act that legalizes the use of Cannabis for recreation and is a regulatory framework for controlling the production, distribution, sale and possession of Cannabis in Canada.

Q: Are there restrictions or prohibitions concerning Cannabis and its derivatives on the Cosmetic Ingredient Hotlist?

A: Yes, there are restrictions and prohibitions on the Cosmetic Ingredient Hotlist. The Hotlist has been recently amended to reflect the promulgation of the Cannabis Act. Below are the recent amendments.

Prohibited:

cannabis

Restricted:

Cannabis Restrictions

Q: How does the legalization of Cannabis effect Natural Health Products (NHPs)?

A: The Natural Health Product Regulations (NHPR) have been updated to align with definitions of cannabis in the Cannabis Act. Under the updated regulations, which comes into effect October 17, 2018. NHPs can only contain Cannabis parts which either do not meet the definition of Cannabis in the Cannabis Act or that have been exempted from the Cannabis Act through the Industrial Hemp Regulations. Any previously approved NHPs would be unaffected by the transition to the new legislative framework and can continue to be marketed as they are now. Applications for NHPs that contain ingredients compliant with the above requirements would be reviewed under the requirements of the FDA and the NHPR.

Q: What types of Cannabis are required to be sold with a prescription?

A: Phyto cannabinoids produced by or found in the cannabis plant and substances that are duplicates of such phyto cannabinoids.

Two exceptions are:

  1. derivatives of Cannabis as defined in subsection 2(1) of the Cannabis Act that are exempt from the application of the Cannabis Act under the Industrial Hemp Regulations and that do not contain an isolated or concentrated phyto cannabinoid or a synthetic duplicate of that phyto cannabinoid
  2. anything referred to in Schedule 2 to the Cannabis Act that contains no more than 10 µg/g delta-9-tetrahydrocannabinol and that does not contain an isolated or concentrated phyto cannabinoid or synthetic duplicate of that phyto cannabinoid

Q: Do I need a license to use Cannabis in my Natural Health Product?

A: To be legally sold in Canada, all Natural Health Products must have a product license and the Canadian sites that manufacture, package, label and import these products must have site licenses.

Q: What type of application is required for NHPs containing cannabis?

A: For an NHP containing Cannabis the product license application will be considered a Class III with a 180-day review.

Q: What is CBD?

A: The cannabis plant contains hundreds of different chemical constituents, such as cannabinoids, terpenes and flavonoids. Cannabinoids that are derived from cannabis plants are sometimes referred to as phytocannabinoids. Cannabidiol (CBD) is one of these cannabinoids. Unlike tetrahydrocannabinol (THC) – the most well-known cannabinoid in cannabis, responsible for the high or intoxication of consuming cannabis – CBD does not produce a high or intoxicating effect. However, there is some evidence that CBD may influence some of the effects that THC has on the brain.

CBD can be found in varieties of the cannabis plant, including hemp plants. All phytocannabinoids, whether derived from a cannabis plant or produced by synthesis, including both THC and CBD, are regulated.

Q: How is CBD Regulated in Canada?

A: Under the Cannabis Act, many activities with phytocannabinoids, CBD included, remain prohibited, except for the specific cases authorized by the Act and its regulations, which include strict controls on possession, production, sale, and distribution. While Health Canada oversees the production of cannabis products, the provinces and territories oversee the distribution and retail aspects of the cannabis supply chain. Health Canada remains responsible for overseeing the distribution and sale of cannabis and any CBD-containing cannabis products for medical purposes.

Q: What is the Difference Between Cannabis Oil and Hemp-Seed Oil?

It is important to note that “cannabis oil” is a product that consists of cannabis (usually in the form of a THC and/or CBD-rich extract 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). Cannabis oil is one of the 5 classes of cannabis (i.e. fresh cannabis, dried cannabis, cannabis oil, cannabis plants and cannabis seeds) that can be legally sold by provincially and territorially-authorized retailers as of October 17, 2018.

Hemp-seed oil is distinct from cannabis oil. Hemp-seed oil refers to oil derived from pressing the grain or seed of hemp plants (processed similar to other oil seeds, like canola) and contains very little THC (no more than 10 ug/g of THC) and negligible amounts of CBD. For hemp-seed oil to be exempted from the Cannabis Act, neither THC nor CBD could be added, or concentrated via processing, and any trace presence of THC or CBD would be the incidental result of the harvesting and processing steps. Hemp seeds are required to be handled in such a way to limit THC and CBD contamination. Hemp-seed oil is marketed in Canada in food, cosmetics, and natural and veterinary health products.

Q: Can Natural Health Products and Cosmetics contain CBD?

A: No. Only limited parts of cannabis or hemp plants may be used as a medicinal ingredient in a natural health product (NHPs) under the Natural Health Product Regulations. NHPs can only contain parts of the cannabis and hemp plants that are not considered cannabis under the Cannabis Act, such as hemp-seed derivatives and non-viable seeds. Trace levels of phytocannabinoids (e.g. no more than 10 parts per million THC) may be present in such products as a result of the isolation process. However, the deliberate addition of phytocannabinoids to such products is not permitted. These same restrictions also apply to cosmetics, which can only incorporate hemp seed derivatives or other excluded parts of the cannabis or hemp plants.

As all phytocannabinoids are subject to the Prescription Drug List, any health product wishing to contain CBD, and make a health claim, would require approval as a prescription drug under the Food and Drugs Act. CBD products that do not make any health claims may be sold lawfully under the Cannabis Act — either through the provincially or territorially-authorized retail system, or through the federal access to cannabis for medical purposes system — provided they follow all requirements of that Act and regulations.

Q: Where can I pose questions regarding Cannabis to Health Canada?

A: Questions regarding Cannabis can be directed to hc.hpfb_cannabis_dgpsa.sc@canada.ca.

 

Resources;

  1. Cannabis Act
  2. Cannabis Regulations
  3. Controlled Substances and Drugs Act
  4. Industrial Hemp Regulations
  5. Food and Drugs Act
  6. Food and Drugs Regulation
  7. Cosmetic Regulations
  8. Natural Health Product Regulations
  9. Cosmetic Ingredient Hotlist

References:

  1. Hemp and the Hemp Industry Frequently Asked Questions

Health Canada – https://www.canada.ca/en/health-canada/services/health-concerns/controlled-substances-precursor-chemicals/industrial-hemp/about-hemp-canada-hemp-industry/frequently-asked-questions.html

  1. Bill C-45 – https://openparliament.ca/bills/42-1/C-45/
  2.   Cannabis in Canada

Service Canada – https://www.canada.ca/en/services/health/campaigns/cannabis.html

  1. Guidance For Health Products Containing Cannabis or For Use with Cannabis

Health Canada – https://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.html