Last month the South African Health Products Regulatory Authority (SAHPRA) gazetted a regulatory notice titled “Exemption Of Certain Cannabidiol Products From The Operation Of The Medicines Act” on the 23rd of May, followed by an official press release on the 27th of May. This followed our organization launching a High Court application in December 2018 to review the 2017 scheduling of CBD as a schedule 4 medicine, and which threatened to eliminate all CBD and CBD-containing products then sold on the market. With no SAHPRA registered CBD medicines approved in South Africa for doctors to prescribe, the schedule would effectively banned the product completely.
This impasse led to the SAHPRA and the TNHA agreeing to try solve the issues and to engage in further negotiations for a more fair, appropriate and modern framework to accommodate the consumer’s continued access to CBD, the rights of sellers to continue to offer CBD products and to satisfy the regulator that industry will take responsible steps to guarantee the safety, quality and efficacy of CBD products in future.
This regulatory notice legally created an exclusion of certain preparations containing cannabidiol (CBD) from the operation of provisions of the Medicines and Related Substances Act 101 of 1965 (Medicines Act). The exclusion referred to has been made in accordance with section 36(1) of the Medicines Act.
36. Exclusion of any medicine, Scheduled substance, medical device or IVD from operation of Act.
(1) The Minister may, on the recommendation of the Authority, by notice in the Gazette exclude, subject to such conditions as he or she may determine, any medicine, Scheduled substance, medical device or IVD from the operation of any or all of the provisions of this Act, and may in like manner amend or withdraw any such notice.
A medicine may be excluded from any or all provisions of the Medicines Act. In this case certain CBD preparations have been excluded from the operation of the schedules to the Act published in terms of section 22A(2).
22A. Control of medicines, Scheduled substances, medical devices and IVDs.
(2) The Minister may, on the recommendation of the Authority, prescribe the Scheduled substances referred to in this section.
CBD is currently classified as schedule 4 substance according to the Medicines Act, when intended for therapeutic purposes, and schedule 7, except when intended for therapeutic purposes. Whilst schedule 4 medicines are only available on a doctor’s prescription schedule 7 medicines are banned.
It is clear that the purpose of the exclusion is specifically to exclude certain CBD preparations from the provisions above, albeit with conditions.
Preparations containing CBD must not exceed a daily dose of 20 mg CBD which means that a single dose in whichever form must contain 20 mg or less of CBD. However, there is no prohibition of the % CBD contained in the preparation as long as the daily dose does not exceed 20 mg.
In terms of the claims made, a low risk claim or health claim may be made which only refer to general health enhancement without any reference to specific diseases; health maintenance; or relief of minor symptoms (not related to a disease or disorder).
It has to be noted that making a claim is not prohibited here and is in any event not prohibited by the Medicines Act. However, the type of claim and substantiation of a claim are always of importance.
Two types of processed products are mentioned. Firstly, products from cannabis raw plant material and secondly products from other sources, where only the naturally occurring quantity of cannabinoids found in the source material are contained in the product.
It has to be noted that processed is defined in the schedules as treated by mechanical, chemical or other artificial means but does not include harvesting or the natural process of decay.
The schedules historically provided exceptions with regard to processed products from cannabis seeds only. However, currently, processed products from any cannabis plant part as well as cannabinoids from any other source material is excluded with a condition that such a processed product does not contain more than 0,001% (10 parts per million) tetrahydrocannabinol (THC) and not more than 0,0075% (75 parts per million) CBD.
The processed products, historically provided for, were intended as supplements of nutritional substances such as omega fatty acids and were not used for the CBD content per se. To ensure that such processed products from any source which contain small amounts of CBD will not fall within the schedule 4 ambit and cause major regulatory issues, provision has been made for products containing these small amounts of CBD to be excluded from the scheduling status. In the absence of such a provision many oils from cannabis and other sources containing small amounts of CBD (e.g black pepper, flax seeds, echinacea, cocoa etc) currently on the market would have had to be withdrawn from the market.
Thus, this latest change in legislation provides for CBD products used specifically for the CBD content as well as processed products not necessarily used for the CBD content thereof. All of these products are excluded from the operation of the schedules to the Act which means, rationally, also the schedule 7 status of such preparations for non-therapeutic purposes.
The Medicines Act provides the mandate of SAHPRA which is limited to medicines only and all medicines fall within schedules 0 to 8. It can be deducted that exclusion from the operation of the schedules refers to the current scheduling status of CBD.
Lastly, the exclusion is effective immediately and will continue to be effective for twelve months from 15 May 2019. After twelve months the exclusion may continue or an amendment in the schedules may follow. Alternatively, further exclusion may not be allowed. However, the substantiation of such a non-allowance may prove difficult in the light of the current allowance, unless substantial evidence is provided.
It has to be noted that the exclusion only relates to the scheduling status and provisions relating to the status. All other provisions of the Medicines Act and General Regulations will still have to be adhered to. This includes labelling, advertising, manufacturing and importation requirements. The TNHA will be engaging on an ongoing basis with the SAHPRA to establish fair and appropriate guidelines for the labeling, advertising, manufacturing and importing CBD and CBD-containing products so that products are true-to-label, safe and of good quality.
14. Prohibition on the sale of medicines, medical devices or IVDs which are subject to registration and are not registered.—(1) Save as provided in this section or sections 21 and 22A, no person shall sell any medicine, medical device or IVD which is subject to registration by virtue of a declaration published in terms of subsection (2) unless it is registered.
CBD-containing products not meeting the conditions for exclusion will remain subject to the scheduling status (schedule 4 or schedule 7) as per the schedules.
- CBD or CBD-containing products sold may NOT be sold in daily dosages of more than 20 mg. If they exceed 20 mg / day they are deemed Schedule 4 (prescription-only) medicines and are registerable as such.
- CBD or CBD-containing products sold may not have more than 0,001% (10 parts per million) tetrahydrocannabinol (THC) by volume. If they exceed this amount, they are deemed Schedule 7 medicines (prohibited substances).
- CBD or CBD-containing products may not have any label claims or associated marketing material claims (i.e internet, adverts, pamphlets etc) implying the product has a therapeutic purpose. In other worlds, expressly intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or any function of the body. The only permissible health claim which can be made is for ‘general health enhancement’.
- The prior seizure and embargo of unregistered CBD and CDB-containing products at customs by the Port Health Authority on entry into South Africa (under instruction of the SAHPRA) without accompanying registration documentation has been lifted.
- In the near future the TNHA and SAHPRA will engage in creating a framework to manufacture locally produced CBD and CBD-containing products. This will include sourcing raw ingredients, appropriate Good Manufacturing Practice (GMP) labeling requirements, raw ingredient and product testing and post-marketing surveillance.
What we all need to remember is that up until July 2017 CBD was considered a ‘part of the cannabis (dagga) plant’ and was by default a schedule 7 (prohibited substance) medicine under the Medicines and Related Substances Act, just like cocaine and heroin. It was also illegal in to import, sell or posses in terms of the Drugs and Drug Trafficking Act 140 of 1992.
On the 28th of July 2017 CBD was declared a schedule 6 (prescription-only) medicine with therapeutic claims, and remained a schedule 7 (prohibited substance) for any other use.
Then on the 17th of November 2017 CBD was declared a schedule 4 (prescription-only) medicine with therapeutic claims, and remained a schedule 7 (prohibited substance) for any other use.
This new exemption of CBD from the schedules, gazetted on the 23rd of May, is a major departure from the previously restrictive framework adopted and enforced by the SAHPRA and its former Medicines Control Council (MCC). It represents a new liberal and pragmatic approach to regulating a substance which is gaining rapid acceptance as a food supplement and approved food ingredient around the world by other foreign Medicines Regulatory Authorities.
As of now, South Africa is ahead of many developed countries in providing a certain and legal framework for purveyors to legally sell CBD as both a non-scheduled health supplement, and as a shedule 4 (prescription-only) medicine, depending on the daily dose limit, label claims (if any) and THC content.
It provides a means for the public to access CBD freely as either a daily supplement for general health enhancement (health promoting), or as a prescribed medicine for therapeutic use under the expert supervision of a doctor who can monitor their treatment outcomes.
The TNHA invites all CBD importers, potential local manufactures and retailers to become TNHA members and to join our CBD working group which will work pro-actively with the SAHPRA to create an appropriate regulatory framework for CBD in the future, beyond the 12 month relief provided by the current exemption.
* The TNHA would like to thank Prof. Karen Du Toit, our expert regulatory advisor from Pharma Law for her valuable input and assisting the TNHA in all regulatory CBD matters, as well as our lawyer Chris Liebenberg of Jacobs Liebenberg Attorneys Inc for his professional services to date. We also thank members of the SAHPRA who constructively and openly engaged with the TNHA to set the wheels in motion for a new regulatory approach to CBD and other cannabis related products.