MCC to reschedule ALL Cannabidiol-containing products to Schedule 4

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).

One of the substances hidden at the bottom of page 27 of the gazette was Cannabidiol, or more commonly known as CBD.

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 clearly stated –  “Cannabidiol, when intended for therapeutic purposes“.

This meant that products imported and/or sold without therapeutic health 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 Cannabidiol (CBD) containing products, whether sporting 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) and flax [Linum usitatissimum], whether sold 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 and flaxseed oil will effectively become drugs due to having a CBD content. This is patently absurd and a gross over-reach of the powers of the Medicines Act.

The scheduling of Cannabidiol needs to be challenged. The Medicines Act allows for decisions of the Council and its expert committees to be taken up on review within a prescribed time-frame.

We would like to know what current science did the MCC’s Scheduling Committee reply upon to restrict this product’s availability to the public in terms of risk. In many other countries CBD oil is sold over-the-counter without these these restrictions and are no verifiable deaths related to it’s usage.

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 join us in launching an appeal against the MCC Scheduling Committee’s decision to schedule this substance as a Schedule 4 medicine, please contact us.

Download the 02 July Re-scheduling Notice (49 Kb)