Canada’s Green Rush

Last month on January 15th, we hosted a webinar which was designed to help viewers navigate the regulatory landscape. Specifically, for those who are interested in developing CBD self care products in North America. The wonderful duo of Andrew Charrette (Director of Regulatory Affairs) and Najla Guthrie (CEO & President) delved into the regulatory grey area surrounding Cannabis and attempted to give viewers clarity. The speakers showed the current scope of legislations and attempted to give their outlook on anticipated changes. Today we will be providing you an overview of the main takeaway points from the talk. For those of you who missed it, it will be a great recap on what you missed!

Health Products Containing Cannabis

To keep things simple, it makes the most sense to analyze regulations through a national lens — splitting up Canada and the US. Currently in Canada cannabis is legal for recreational and medicinal use in flower or oil extract form. In October we will see the legalization of edibles, concentrates and topical forms of cannabis as well. However, making health claims on any of these products is out of the realm of possibilities. Health claims are currently allowed to be made on cannabis containing health products approved as prescription drugs. In order to manufacture a cannabis drug, a dual licensing system is in place. Manufacturers are required to have both a Drug establishment license and a Cannabis Drug License and meet the requirements of the Food and Drug Act and Cannabis Act; additional hurdles that needs to be taken into consideration.

Marijuana is still illegal federally in the US so regulations must be looked at on a state by state basis. Yet, two major events have recently impacted the regulatory landscape in the US regarding hemp. First, the FDA rescheduled CBD containing drugs from Schedule 1 to Schedule 5 which opens up the research, development and marketing of these drugs. The major implication that comes with this is that it limits CBDs potential to be listed as an dietary supplement due to its status as an Investigational New Drug. The next major milestone is the passing of the 2018 Farm Bill. Legalizing interstate trade of hemp knocks down a major barrier for the industry as accessibility to CBD will significantly increase. The FDA has thus far maintained it’s opinion that CBD cannot be used as a food or dietary ingredient, but they have shown a willingness to open discussion on the topic. What does this mean for you as a Hemp company? You should now be gearing towards assembling a self affirmed GRAS or New dietary ingredient notification to stay ahead of any potential regulatory changes.

The main concern of regulators in both countries is going to be whether they should allow cannabinoid health products to be openly sold in a store or require a prescription. Health Canada has expressed that there is a lack of evidence to support removing the requirement for a prescription and FDA will want to see similar evidence supporting safety. They are encouraging the industry to provide the safety data to drive changes in the regulations!

What Will Regulators Consider?

Regulators will begin to look at what is currently working with the existing regulations. Standardized cannabis symbols, drug fact panels, plain language labelling requirements, child-resistant packaging and requirements for differences in the name of products and look of labels are all most likely. These requirements are likely to be embraced by the industry as the cannabis industry has demonstrated that they are legitimately concerned with ensuring their products are safely used. It is also important to note that they hold organizations like the World Health Organization to a high standard. WHO’s current stance is that CBD is a safe substance that shows no abuse or dependency potential. They even go as far as to say that they see it as a great potential therapeutic product and that there is currently widespread unsanctioned medicinal use. This suggests that regulations need to evolve.

Although there is some evidence that some level of THC may be required for some of the medical benefits of CBD, regulators will also recognize that it is an intoxicant and will likely limit the amounts that are allowed in products.

Regulators will be considering the arguments for and against making CBD (and other cannabinoids) available for use without a prescription. Many of the considerations that go into this decision support CBD for self-care and indicate that allowing companies to develop products targeted and labelled for specific health conditions may improve safety. In order to support the conclusion that would allow regulations to evolve, research must be completed and presented to the regulatory bodies.

Final Thoughts

We are at crossroads. The potential associated with self-care products in the cannabis space is enormous. Many companies have begun getting their foot in the door and building relationships in the industry. Federal regulators are taking a cautious approach to addressing the matter at hand but are encouraging medical research. Now where does this leave us? This means that the path to market is facilitated by research. Good quality research is what drives regulation. With robust research in place you are ensuring that your product is ready to be marketed and is regulatory ready!

Andrew Charrette

Senior Manager of Regulatory Affairs, KGK Science.

London, Canada.