FAQ: What You Need to Know About Cannabis and Personal Care Products

Posted Date: 27-August-2019

Reminder from Health Canada – Regulation of Cannabis and its Derivatives

 

Q: What is cannabis?

A: Cannabis refers to the plant Cannabis Sativa. This includes hemp and marijuana. It includes any part of a cannabis plant, including cannabinoids. The psychoactive component of the drug, THC, is used for recreational purposes. Cannabis also contains non-psychoactive components, including CBD, which contributes to its medicinal uses.

Q: What is Hemp?

A: Hemp (in Canada regulated as Industrial Hemp), is the classification of a plant of the genera Cannabis sp. for which the leaves and flowering heads of the plant do not contain more than 0.3 % THC w/w and contain only trace amounts of 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 marijuana?

A: Marijuana is also the classification of a plant of genera Cannabis sp. However, unlike hemp, marijuana contains more than 0.3% THC and can have either low or high amounts of CBD depending on the strain. The term cannabis is often used interchangeable with marijuana.

Q: What is the difference between hemp and marijuana?

A: The difference between hemp and marijuana is the THC and CBD content. Hemp has 0.3% or less THC and trace amounts of CBD and marijuana has more than 0.3% THC and high or low amounts of CBD.

Q: What are cannabinoids?

A: Cannabinoids are a group of active compounds found in Cannabis. There are about 113 different cannabinoids. Cannabinoids are the chemicals which give the cannabis plant its medical and recreational properties. The most notable examples are THC and CBD.

Q: What is THC?

A: THC stands for delta-9-tetrahydrocannabinol. THC is perhaps the most well-known cannabinoid and is responsible for the psychoactive effects of cannabis, including the way your brain and body respond to cannabis, including the high and intoxication.

Q: What is CBD?

A: CBD stands for cannabidiol.  CBD is likely the second most frequently referenced cannabinoid.  Unlike THC, CBD does not produce a high or intoxicating effect, however, is believed to be responsible for the medicinal properties of cannabis.

 

Section 2: Topical Cannabis Products in Canada

Q: What kind of topical cannabis products are on the market right now?

Cosmetics:

Cosmetic topical products with hemp meeting the Cosmetic Ingredient Hotlist restriction for THC (refer to section 3 for the restriction) and does not make any health claims. These types of products meet the Industrial Hemp Regulation and the Food and Drugs Act and Cosmetics Regulations. These types of products are found in any retail store.

Topical Natural Health Products:

NHP topicals products with not more than 10 parts per million of THC. Contains naturally derived ingredients and health claims. These types of products meet the Industrial Hemp Regulations, Natural Health Product Regulations and Food and Drugs Act and Regulations. These types of products are found in any retail store.

Topical Prescription Drugs:

Prescription topical products that can either contain THC and/or intentionally added CBD whether derived from hemp or cannabis with associated health claims. These types of products meet the definition of Cannabis under the Cannabis Act but are exempt from the Act and meet the requirements of the Food and Drugs Act. The products are available prescription at the pharmacy.

Recreational:

Recreational topical products contain high amounts of THC (usually derived from cannabis) and are intended to give a psychoactive effect when applied. These products will be legally allowed to be sold on the market on October 17, 2019. These types of products will meet the Cannabis Act and Regulations. These products can be found in a provincially or territorially authorized cannabis store.

Medicinal Cannabis:

Medicinal cannabis (formerly Medical Marijuana) are products that contain high amounts of THC and CBD and are intended to give psychoactive effects. These products do not contain any specific health claims however benefits are prescribed directly by the practitioner. These products are available through a prescription prescribed by a health care practitioner and are available through a federally licensed medical cannabis store. These products were previously regulated under the Access to Cannabis for Medical Purposes Regulation which was replead following the promulgation of the Cannabis Act.

NOTE:

Products that do not fall into the above-mentioned categories and are found on the market should be considered illegal/illicit products.

Section 3: Regulatory Lanscape – How Recreational Cannabis Products, Cosmetics Containing Hemp and Cannabis Health Products are Currently Regulated in Canada

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. Cannabis before October 2018 was under the CDSA.

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

A: 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: How is CBD Regulated in Canada?

A: Under the Cannabis Act, many activities with cannabinoids, 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. CBD is on the Prescription Drug List (PDL).

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: How does the legalization of Cannabis affect Natural Health Products (NHPs) containing cannabinoids?

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 came 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: How does the legalization of Cannabis affect cosmetics?

A:  The cosmetic ingredient hotlist has been updated to reflect the legalization of cannabis. Please see question below. Cosmetics 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.

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 affect medical cannabis?

A: Medical cannabis is now controlled under the Cannabis Act and must meet all the labelling, packaging and licensing requirements of the Act.

Q: Do I need a license to use hemp 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: Do I need a license to use hemp in my cosmetic?

A: To be legally sold in Canada, all cosmetics must be notified within 10 days of sale of the products.

Q: Is a product license application required to be filed for NHPs containing hemp?

A: For an NHP containing hemp a product license application is required.

Q: Is a product license application required to be filed for cosmetics?

A: For cosmetics containing hemp a product licensed application is not required. However, the cosmetic needs to be notified through the Cosmetic Notification Form within 10 days of sale of the product.

Q: Can Natural Health Products and Cosmetics contain CBD?

A: Yes AND No, NHPs and cosmetics can contain CBD that is naturally found in trace amounts in hemp. However, cosmetics and NHPs cannot contain intentionally added CBD whether derived from Hemp or cannabis. CBD is on the prescription drug list. Therefore, to be legally sold on the Canadian market today, health products containing intentionally added CBD must follow the prescription pathway to be sold (i.e. market authorization – new drug submission).

Only limited parts of hemp plants may be used as a medicinal ingredient in a natural health product (NHPs) under the Natural Health Product Regulations. The parts of hemp plants legal for use in NHPs are those not considered as ‘cannabis’ under the Cannabis Act, such as hemp-seed derivatives and non-viable seeds. Trace levels of cannabinoids (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 cannabinoids to such products is not permitted.

Note:

If a NHP or Cosmetic contains intentionally added CBD today, it should be considered illegal/illicit product.

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

A: Cannabinoids produced by or found in the cannabis plant and substances that are duplicates of such 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 cannabinoid or a synthetic duplicate of that 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 cannabinoid or synthetic duplicate of that cannabinoid

Q: What kind of Cannabis products are legally sold on the market today?

A: Following the ‘coming into force’ of the Cannabis Act, Recreational Cannabis products are sold in provincially or federally licensed cannabis stores. These products can be purchased online or in store.

Prescription cannabis products are sold in pharmacies and are available through a prescription from a doctor. Medical cannabis is also available in federally licensed medical cannabis stores and requires a person to have a medical cannabis card prescribed by a doctor.

Q: What are recreational Cannabis products?

A: Recreational Cannabis products are products containing high amounts of THC that can be smoked, vaped or ingested to achieve a psychoactive effect. Recreational cannabis includes dried cannabis, fresh cannabis, cannabis oil (including cannabis oil for topical use), cannabis plants and seeds.

Section 4: Importing and Exporting Cannabis Products and Raw Material

Q: Are cosmetics products containing hemp allowed to be imported or exported?

A: A cosmetic product containing hemp meeting the restriction stated in the Cosmetic Ingredient Hotlist can be imported and exported. The shipment must be accompanied with a certificate of analysis from a competent laboratory in the country of origin of the derivative or product that sets out the THC concentration in μg/g in the samples. Please refer to section 2 of the industrial hemp regulations.

Q: Are Natural Health Products containing hemp allowed to be imported or exported?

A: Natural Health Products containing hemp are allowed to be imported and exported. To import an NHP with hemp the importer must have a product license and a site license, and a site license is required to export.

Q: Can products containing CBD be imported or exported?

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.

Therefore, the import and export of CBD products may only be done under very specific conditions, and is covered by the Cannabis Act and its regulations, where any import or export must meet all of the following criteria:

  • Can only be done by a holder of a licence issued under the Cannabis Regulations;
  • Can only be done under an import or export permit issued to the licence holder by Health Canada for that shipment; and
  • Could only be done for a legitimate scientific or medical purpose, as per international agreements.

Q: Can medical cannabis and prescription cannabis products be imported or exported?

A: Medical cannabis and prescription cannabis products can only be imported or exported for medicinal or scientific purposes.

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.

Section 5: What the Future Holds for Topical Cannabis Products in Canada

Q: What’s Next for Cannabis in Canada?

Part I:

A: The next stage for cannabis legalization is the addition of other recreational products which are edibles, extracts and topicals. Schedule 4 of the Cannabis Act will be amended to add three new classes (edibles, extracts and topicals) of cannabis that could be legally sold by federal license holders and provincially and territorially authorized distributors and retailers. These cannabis products will be permitted for legal sale under the Cannabis Act no later than October 17, 2019.

Part II:

The Government of Canada is looking into the potential market for Cannabis Health Products (CHPs). A preliminary consultation was initiated on June 19, 2019 and closing on September 3, 2019. The purpose of this consultation is to seek preliminary feedback from Canadians and cannabis and health products industries regarding the kinds of products they would be interested in purchasing, manufacturing or selling should a legal pathway to market for CHPs be established.

This consultation could potentially lead the way to legitimizing the manufacture/import of low risk cannabis self-care products that can contain THC or CBD (from hemp or cannabis) to market with a specified THC and CBD limit.

Q: What is edible cannabis, cannabis extracts and cannabis topicals?

A: Edible cannabis, cannabis extracts and cannabis topicals are recreational cannabis products that are intended to cause a psychoactive feeling when used. Edibles are intended to be consumed via eating or drinking and are made with either cannabis flower or concentrates. Extracts (also known as concentrates) have been extracted from the cannabis flower and processed into a concentrated form. Topicals are cannabis-infused products that are intended to be applied to skin, hair or nails.

Section 6: Important References

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.

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.

Summary of Cannabis Terms:

Cannabis refers to hemp or marijuana (the term marijuana is interchangeable with cannabis)
Marijuana is a cannabis plant specifically cultivated with 0.3% or higher of THC content and high or low amounts f CBD (depending on the strain)
Hemp is a cannabis plant specifically cultivated with only 0.3% THC or less and has trace amounts of CBD
Cannabinoids active compounds found in hemp and cannabis. Two major ones are THC and CBD
THC is a cannabinoid is found in cannabis and hemp and is responsible for psychoactive effects of cannabis
CBD is a cannabinoid found in cannabis and hemp. Does not contribute psychoactive effect but believed to be largely responsible for cosmetic and medicinal benefits

 

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