On the 28th of July the Medicines Control Council, in consultation with the Minister of Health gazetted a regulatory notice scheduling various substances in terms of section 22A(2) of the Medicines and Related Substances Act (Act No. 101 of 1965).
This post was originally posted on tnha.co.za
One of the substances hidden on the bottom page 27 of the gazette was Cannabidiol, or more commonly known as CBD Oil.
All products imported and sold with claims relating to therapeutic effects were to be scheduled as Schedule 6 medicines, requiring the public first obtain a doctor’s prescription.
In our communication to the industry this past Sunday we pointed out that the listing of this substance stated “Cannabidiol, when intended for therapeutic purposes“.
This meant that products imported and/or sold without therapeutic claims fell outside of the schedules, and could be sold without having to be registered as a medicine, nor prescribed exclusively by a doctor.
Now four days later, on the 2nd of August, the MCC has published a notice of intention to amend the schedules to declare all Cannabidiol (CBD), whether carrying therapeutic health claims or not, a Schedule 4 medicine, still requiring a doctor’s prescription.
The problem we foresee here is that ALL Cannabis products (including hemp), whether for medicinal or industrial purposes, contains some amount of Cannabidiol, rendering them all Schedule 4 medicines and registrable under the Medicines Act. This means that demonstrably innocuous food products such as hemp protein powder will effectively become a drug due to having a CBD content. This is patently absurd.
The scheduling of Cannabidiol needs to be challenged. We would like to know what current science did the MCC reply upon to restrict this product’s availability to the public in terms of risk.
It appears this recent move is an attempt to expropriate this substance from the health-food sector and to hand it to the pharmaceutical sector, which has the ability to jump the regulatory hurdles to register and market this substance as a pharmaceutical drug.
If you or your company would like to assist in launching an appeal against the MCC Scheduling Committee’s decision to schedule this substance as a schedule 4 medicine, please contact us urgently at [email protected]