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Cannabindiol in NHPs and Foods: The Current Truth

 

You might have heard a little something in the news recently about the legalization of Cannabis coming to Canada. Needless to say, we have all been hearing it. The government published the proposed Cannabis Act (Bill C-45) in May 2017 and more recently a corresponding consultation paper to seek feedback from stakeholders on the proposed laws & regulations surrounding the non-medical use of cannabis. Details and comments have been provided for the regulation of dried cannabis, cannabis oil, fresh cannabis, cannabis plants and cannabis seeds. But what does this mean for companies who want to bring their cannabinoid isolates to market?

Currently, cannabis and cannabis-derived isolates are primarily governed under Controlled Drugs and Substances Act (CDSA) and the Food and Drugs Act (FDA). Under the current CDSA and its corresponding Access to Cannabis for Medical Purposes Regulations (ACMPR), cannabis and its derivatives are regulated as controlled substances meaning that only authorized persons are permitted to use, produce and sell cannabis or its derivatives, such as Cannabidiol (CBD) or Tetrahydrocannabinol (THC). Further to this, the current ACMPR allows for registered persons access to fresh/dried cannabis, cannabis oil and for licensed producers to handle, sell and produce only cannabis and cannabis oil. Unfortunately, these regulations do not allow for the production and sale of CBD isolates.

While the government intends to regulate cannabis concentrates at a later date, in the present day isolates such as CBD would be regulated as narcotics. Since the regulation of CBD is not governed under the current ACMPR exemption, we default to the Narcotic Control Regulations. Under these regulations, a dealer’s license is required for the production, handling, distribution & sale of a narcotic. Furthermore, the licensed dealer must have on staff a qualified person in charge, such as a pharmacist/medical doctor/veterinarian/dentist who is registered with a provincial professional licensing authority, or alternatively, an individual who possesses a degree in an applicable science (e.g. pharmacy, medicine, dentistry, veterinary medicine, pharmacology, organic chemistry or chemical engineering) from a recognized Canadian University (or foreign equivalent). In addition to this, the qualified person in charge must also have no criminal conviction within the previous 10 years of their adult life and a product license would be required for the sale of CBD.

In comparison, a licensed producer under the current ACMPR requires a senior person in charge who is an adult and is familiar with the act and regulations which govern the licensed producer’s activities.

As outlined above, there is currently a big difference in the regulatory work which would be required for the marketing of isolated CBD when compared to that required for the production of fresh/dried cannabis & cannabis oil.

 

Moving forward….

In the proposed legislation which is set to come into force this summer, companies can apply for a standard processing license which includes the production, packaging & labelling of cannabis products, including synthesized phytocannabinoids, and the manufacturing of products such as pre-filled oil capsules. A standard processing licence would also authorize related activities, including but not limited to possession, transportation, storage, and the intra-industry sale of cannabis to other federally recognized licence holders or authorized sellers with a separate authorization for the sale of these products to medical patients and the general public.

Moreover, it has been proposed that a scientific evidence-based licensing pathway will be undertaken for cannabis-containing health products, such as prescription/non-prescription drugs, natural health products, medical devices, veterinary drugs and veterinary health products and that the licensing will be governed by the Food and Drugs Act. It is important to note that market access for already approved health products will be maintained. Applications for new cannabis-containing products which provide no more than 10 ppm THC will continue to be accepted for review and this framework will continue to be applied to new products until regulations governing these types of cannabis-containing products have been implemented.

 

What about edibles?

It has been proposed that the use of cannabis-containing foods with a maximum THC content of 10 mg will be permitted. The recently obtained consultation comments highlighted the importance of allowing for the use of edibles to occur at the same time as dried/fresh cannabis, cannabis oil, cannabis plants and cannabis seeds. This is in response to the original statements in the proposed Cannabis Act stating that the regulations governing the manufacturing, sale and use of these products will be finalized at a later date. The government intends to have regulations for these types of products in effect in 2019.

 

In summary, until the proposed Cannabis Act comes into force, the current regulatory framework is being upheld for cannabis-containing products. Companies can continue to market their Cannabis-containing health products as outlined in the current Food and Drugs Act and Controlled Drugs and Substances Act. What this means for CBD isolates is that in order to manufacture and sell a product containing CBD you would have to be a licensed dealer, employ a qualified person in charge, carry out the outlined duties as per the current Narcotic Control Regulations and obtain a product license.

 

Since it is the aim of the government to maintain market access for cannabis-containing products through the transition, you may wish to get a head start on your regulatory work. Quality Smart Solutions has a team of specialists who can assist you in becoming a licensed producer or a licensed dealer. Contact us today to discuss how we can be your solution!

 

Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 10 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Medical Devices and OTC drugs. Ask us for details or visit our website at www.qualitysmartsolutions.com.

 

Resources:

 

A Framework for the Legalization and Regulation of Cannabis in Canada: The Final Report of the Task Force on Cannabis Legalization and Regulation. December 2016https://www.canada.ca/en/services/health/marijuana-cannabis/task-force-marijuana-legalization-regulation/framework-legalization-regulation-cannabis-in-canada.html

 

Legislative Background: An Act respecting cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and other Acts (Bill C-45). May 2017http://www.justice.gc.ca/eng/cj-jp/marijuana/c45/c45.pdf

 

Proposed Approach to the Regulation of Cannabis. November 2017https://www.canada.ca/en/health-canada/programs/consultation-proposed-approach-regulation-cannabis/proposed-approach-regulation-cannabis.html

 

Proposed Approach to the Regulation of Cannabis: Summary of Comments Received During the Public Consultation. March 19, 2018.https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/summary-comments-public-consultation-regulation-cannabis.html#2.2