The TNHA is pleased to announce that the South African Health Products Regulatory Authority (SAHPRA) and Minister of Health have reconsidered their stance towards Cannabidiol (CBD) as a prescription-only medicine. New exemptions for companies selling CBD-containing products now allow for the public to access CBD products without a prescription. This is a significant victory for all South Africans, who can now gain free access to CBD and CBD-containing products for the first time since all cannabis-related products were banned decades ago.
There are no CBD or CBD-containing products currently registered as medicines in South Africa. Until now there was no way for South Africans to access CBD legally, except through a laborious Section 21 exemption permit scheme, applied for by a doctor importing CBD for a bona fide patient for a period not exceeding three months.
All existing CBD and CBD-containing products were deemed illegal up until now, and resulted people resorting to buying products on the black market, many of which were of poor quality, questionable safety and even fake.
The new exemptions now open up legal access to products produced with CBD oil in South Africa as over-the-counter / non-prescription items.
This comes after the TNHA successfully motivated the SAHPRA to review their earlier restrictive scheduling of CBD as a schedule 6 and then schedule 4 medicine in 2017. The TNHA believed that the higher schedules for this non-psychoactive, non habit-forming and low risk substance did not have the same comparative risk profile of other high risk medications in schedule 4 and schedule 6, and that when used judiciously (at a suggested 20mg upper daily limit) with low risk / health supporting claims would be more appropriate.
We also noted the international trend of progressive regulators around the world allowing CBD to be sold as a health supplement and an approved food ingredient. Recently the World Health Organization (WHO) and World Anti-Doping Agency (WADA) recognized and acknowledged that CBD is a non-addictive, non-habit-forming and safe substance in appropriate daily upper dosage limits, and have recommended the substance not be scheduled by Medicines Regulatory Authorities, or be listed as a banned substance in competitive sports.
The TNHA’s call for a more appropriate scheduling and regulatory framework for CBD and CBD-containing products began in October 2017 when a group local CBD product importers formed a CBD task group under the banner of our association and decided to challenge the restrictive schedules.
The task group, led by TNHA National Chairman Anthony Rees, consulted with Prof. Karen Du Toit (lawyer and expert pharmacologist) and our then legal counsel Albert Grobbelaar on the matter.
On the 31st of January 2018 the TNHA served a letter on the Minster of Health requesting reasons for the scheduling of CBD in schedule 6 and schedule 4 respectively. A written acknowledgement of receipt was received on the 1st of March 2018 from the Minister’s office stating that the matter would be brought to his attention. It was expected that he would consult with the SAHPRA on the matter and revert to us timeously in terms of the Promotion of Administrative Justice Act (Act 3 of 2000).
In March 2018 the majority of the SAHPRA’s staff, which were still Department of Health employees, joined the industrial action (stay-away) initiated by National Education and Health Allied Workers Union (NEHAWU), the Public Servants’ Association (PSA) to protest against the poor working conditions in the Civitas Building (Pretoria) where the National Department of Health’s main administration and SAHPRA were housed. This industrial action continued for almost a year and resulted in a small handful of the then 220 SAHPRA employees remaining in active service, literally crippling the launch of the new SAHPRA regulator, which had just replaced the former Medicines Control Council.
With no official in over 10 months, and CBD products being seized by the Port Health Authority on instruction by the SAHPRA, the TNHA launched a North Gauteng High Court application to review the scheduling of CBD through our new attorneys of record, Jacobs Liebenberg Attorneys Inc. We received a notice to oppose our application.
On the 12th of February this year, a few days before the SAHPRA’s and Minister’s answering affidavit was due, we received a letter from the Acting CEO of the SAHPRA Ms. Portia Mkhambule suggesting that the TNHA and the SAHPRA have a round table meeting to find a more ‘rational’ approach to the issue at hand. We accepted the invitation and met with the SAHPRA on the 25th of April at their offices in Pretoria.
At the meeting it was agreed that CBD should be either down schedules to either Schedule 0, or be exempted from the schedules at a reasonable daily upper dosage. It was also agreed that products should be of good quality and not make health claims for serious diseases. The TNHA agreed to park our court case, pending the future resolutions of SAHPRA in the matter. We then received a written undertaking that the SAHPRA would publish their final resolutions within 15 working days.
Yesterday, on the 23rd of May (15 working days later, as promised), the exemption notice was published in the government gazette, signed by the Minister of Health earlier on the 15th of May.
We have also received notice that the blanket Port Health embargo on CBD imports has now been lifted.
The TNHA is pleased with the SAHPRA’s resolution and gazetting of the exemption notice, as this will allow companies to continue to trade legally and in a responsible manner. The public will now have the benefit of having free access to good quality CBD products in South Africa, for the first time legally.
The TNHA’s CBD working group are committed to assist the SAHPRA and legislature in creating a fair and appropriate regulatory framework for CBD products in future, and to make sure that products sold in South Africa are ‘true to label’.
We invite all current CBD importers and interested parties to join the TNHA so that they can be kept up to date on evolving regulatory matters, and to form part of the ongoing realization of a safer, ethical and vibrant CBD industry.
We thank all our loyal industry supporters and the public who signed our recent petition to free CBD oil.
We will soon be releasing a technical commentary document on the specifics of yesterday’s exemption notice and how it applies to TNHA members, so please visit our website in the next few days.