On July 11, 2018, the Cannabis Regulations were published in the Canada Gazette Part II (Vol. 152, No. 14, http://www.gazette.gc.ca/rp-pr/p2/2018/2018-07-11/pdf/g2-15214.pdf). The Cannabis Regulations are to come into force on October 17, 2018, the same day as the Cannabis Act (64-65-66-67 Eliz. II, c. 16.), the act under which they are made.
The Cannabis Regulations are, as expected, voluminous and Byzantine. They run to nearly 400 pages in bilingual side-by-side format.
There are some significant surprises for Canada’s natural health product community in the Cannabis Regulations. While the Cannabis Act removes cannabis from Schedule II to the Controlled Drugs and Substances Act (thereby “decriminalizing” it), the Cannabis Regulations now adds cannabis to Schedule 2 of the Natural Health Product Regulations. Schedule 2 to those regulations is a list of products that are defined as not being natural health products.
(Derivatives of cannabis captured by Industrial Hemp Regulations or those listed on Schedule 2 of the Cannabis Act (seeds, stalks, fibres and roots) which have less than 10ppm THC are exempted.)
Also on July 11, 2018, Health Canada announced that it will add a corresponding list of forms of cannabis to the Prescription Drug List (PDL) https://bit.ly/2uKPfbb. Since drugs on the PDL cannot be natural health products (NHPs), this is a second nail in the coffin of cannabis-containing NHPs outside the exemption noted above.
This closes many doors for innovative and non-“herbal” cannabis-containing NHPs in the short term. The government has committed (and the commitment is reflected in the Cannabis Act) to permitting cannabis “edibles” by October 17, 2019, but it remains to be seen how this commitment to permitting the sale of edibles and the NHP regime will interact.
Summary By: Gordon S. Jepson