If you manufacture, import or sell hemp extracted CBD oil or CBD-containing products [including foods and skincare products], YOU NEED TO SUPPORT our recently launched HIGH COURT APPLICATION to have the irrational scheduling of CBD as a Schedule 4 prescription-only medicine and banned Schedule 7 narcotic overturned, and to help us apply for an INTERIM INTERDICT to stop ALL imported CBD oil and CBD-containing products currently being seized by the Port Health Authority at our border.
CANNABIDIOL (CBD) IS NOW A SCHEDULE 4 PRESCRIPTION-ONLY MEDICINE
Despite CBD being sold as a safe and popular dietary supplement in many other countries around the world, the South African Health Products Regulatory Authority [“SAHPRA’] have declared CBD a prescription-only Schedule 4 (S4) medicine (when sold or advertised as a medicament for health conditions), and as a highly restricted Schedule 7 (S7) narcotic (for any other use, including as a health supplement or skin care product ingredient).
There are only a small handful of S7 substances regulated under the Medicines Act, including methaqualone (also known as mandrax) and heroin.
The Medicines Control Council  explains that S7 substances (like the controlled substance, heroin) aren’t recognized for medicinal use apart from scientific study, and have a very high risk of dependence and abuse. Cannabis has been listed as a S7 drug for many decades, however the Constitutional Court passed a ground-breaking judgement in September 2018, declaring certain sections of the Medicines Act prohibiting cannabis use as unconstitutional, and are currently being redrafted by Parliament.
CBD has an extremely low risk profile. It is non-addictive (dependence-forming) and non-psychoacive. It clearly does not belong in the same basket of restrictive S7 or S4 schedules.
CBD is demonstrably safer to use than many common over-the-counter Schedule Zero (S0) medicines like paracetamol and aspirin, which are responsible for tens of thousands of reported life-threatening adverse drug reactions and deaths each year worldwide.
The current scheduling of CBB is so absurdly broad that all health products, foodstuffs and skincare products containing CBD as an ingredient are illegal unless registered as S4 medicines. Further, other plants and their seeds which also contain traces of naturally occurring CBD used by millions of South Africans are also now illegal until registered. These include hempseeds, flaxseeds, cocoa, black pepper and the common cold and flu herb Echinacea.
In many progressive countries like the USA, EU, Canada and UK, CBD is not scheduled as pharmaceutical drug and is openly sold as a dietary or food supplement without needing a doctor’s prescription.
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.
So safe is CBD that no human study has yet established the LD50 for the substance. The LD50 (LD stands for “lethal dose”) of any given chemical compound is the amount that it would take to kill 50% of test subjects at a certain dose.
Below are the three current LD50 studies for CBD on animals conducted worldwide between 1946 and 1981.
Referencing the above studies, consider a relatively “average sized” human at 75kg. By these numbers, it would take roughly 18 750mg (18.75g) of CBD consumed within a very short amount of time (as per the monkey LD50 study) to result in any potentially fatal effects. By comparison, most typical CBD oil users consume no more than 100mg of the substance — and that’s throughout the course of an entire day.
For some inexplicable reason our medicines regulator, the SAHPRA, deems CBD so potentially dangerous that the public should not be able to choose it for themselves, or access it for themselves without a doctor’s prescription.
See: Referencing the above studies, consider a relatively “average sized” human at 75kg. By these numbers, it would take roughly 18 750mg (18.75g) of CBD consumed within a very short amount of time (as per the monkey LD50 study) to result in any potentially fatal effects. By comparison, most typical CBD oil users consume no more than 100mg of the substance — and that’s throughout the course of an entire day.
For some inexplicable reason our medicines regulator, the SAHPRA, deems CBD so potentially dangerous that the public should not be able to choose it for themselves, or access it for themselves without a doctor’s prescription.
This decision was signed off by our Minister of Health Dr Aaron Motsoaledi, and became law in a Scheduling Notice gazetted on the 17th of August 2017.
HOW DOES THE SCHEDULING OF CBD AFFECT YOUR CURRENT MANUFACTURING, IMPORTING, DISTRIBUTING OR RETAIL BUSINESS?
All Schedule 4 (S4) medicines under the Medicines and Related substances Act (Act 101 of 1965) are first required to be registered by the SAHPRA before they are authorized to be sold legally. Selling an unregistered medicine is illegal.
In order to manufacture a S4 medicine in South Africa you need to set up a SAHPRA and SA Pharmacy Council licensed pharmaceutical manufacturing company with Good Manufacturing Practice [“GMP”] certification.
In order to obtain the required licensing you will need to invest in excess of fifty million Rand to satisfy basic manufacturing and skills requirements. You will be required to hire full-time regulatory and production pharmacists as ‘Responsible Pharmacists’ who sign off on all processes, certification and product applications.
A qualified and registered pharmacist commands a monthly salary of R45 000 upwards (depending on their experience). At present there is a three to five year delay in licensing new manufacturing facilities, due to severe capacity backlogs at the SAHPRA.
If you grow (cultivate) or process raw cannabis you will require a cannabis growing, cultivation and processing license from the SAHPRA. New regulations and guidelines to make this happen are still being drafted and have not yet been gazetted.
Currently there are no CBD manufacturing companies in South Africa which comply with the requirements to grow and manufacture CBD for the local market, neither are there any SAHPRA registered and approved CBD products at this time. The only licenses which have been doled out to date are for exporters which are not selling cannabis products in South Africa (export only), and for bona fide medical research purposes.
IMPORTING AND DISTRIBUTING
If you import CBD or CBD-containing products you require a medicines Importers License and medicines Distributors License.
You will have to satisfy the SAHPRA that the manufacturer which produces the products you import are produced by a manufacturer licensed by the Medicines Regulatory Authority (“MRA”) in the country of manufacture. This however does not guarantee that a product produced abroad and registered by another MRA will be automatically approved for sale locally. In many cases local SAHPRA inspectors will have to visit these foreign manufacturers at the importer’s cost and assess whether their regulatory requirements and manufacturing facilities match our own rigorous manufacturing regulations and guidelines.
As an importer you will be required to store all CBD products in a licensed warehousing facility for medicines. You will also be required to employ a full-time Responsible Pharmacist who will oversee your day-to-day operations.
REGISTERING A CBD PRODUCT AS A S4 MEDICINE
In order to register a medicine in South Africa at least one health claim to prevent, treat or cure a specific health condition or symptom must be applied for when applying for assessment and registration of a medicine.
In the case of CBD or CBD-containing products Phase 3 double-blind, randomized, placebo controlled clinical trials will be required to support applications for health claims. This research and development (R&D) for what is essentially a ‘novel drug’ will cost billions of Rand and will take many years to complete.
Currently the SAHPRA has a historical backlog of medicines applications numbering 16 000. These date back up to seven years. Therefore an application made today may take up to seven years to be assessed and approved. Add the R&D time, time to license a manufacturing company and the time it takes to have a new medicine registered and one soon realises that it may take more than a decade to bring a registered local CBD product to market legally.
COST RECOVERY – CBD is a naturally occurring substance from nature and therefore cannot be patented. Therefore any company prepared to make these considerable investments will not be able to protect its intellectual property. This will result in other companies being able to sell the equivalent product on the market using the innovator’s original research for a fraction of the price.
RETAILING & SELLING
Only Pharmacies may sell S4 medicines. Pharmacies many not sell S7 medicines. Selling unregistered S4 CBD products is a contravention of the Medicines and Related Substances Act and therefore illegal. Selling unregistered CBD-containing products anywhere but at a pharmacy without a doctor’s prescription is currently illegal.
Pharmacies can lose their pharmacy licenses for selling unregistered medicines and responsible pharmacists who run/own such pharmacies can also be taken to task by the Pharmacy Council which regulates their practice and Code of Conduct.
Selling CBD oil products in health shops, on local websites, or through by other method of exchange is also now illegal. So is importing for personal use from overseas illegal, so expect customs to seize personal orders sent by international mail or courier.
Please note the broad definition of the word ‘sell’ in Section 1 of the Medicines Act.
“sell” means sell by wholesale or retail and includes import, offer, advertise, keep, expose, transmit, consign, convey
or deliver for sale or authorize, direct or allow a sale or prepare or possess for purposes of sale,
and barter or exchange or supply or dispose of to any person whether for a
consideration or otherwise; and “sale” and “sold” have corresponding meanings;
In terms of this definition it is illegal to advertise unregistered CBD-containing products for sale in South Africa. All associated advertising materials (including newspaper, radio or TV advertising, social media advertising, website advertising, pamphlets, displays, etc.) for unregistered CBD and CBD-containing products is now illegal.
THE POTENTIAL CONSEQUENCES OF BREAKING THE CURRENT LAW
Any contravention of the Medicines Act is a criminal offense, whereby the inspectorate and police can confiscate and destroy any offending products and issue an arbitrary fine without a statutory limit. You can also face a of a maximum prison sentence of 10 years.
THE NEW IMPORT BAN
It has come to our attention that companies and individuals that import CBD oil and CBD-containing products have in recent months and weeks had their shipments stopped at ports of entry and impounded by the Port Health Authority under instructions issued by the SAHPRA.
No CBD-containing products declared by importers are being allowed clearance into South Africa unless they are:
- registered as S4 or S7 medicines by the SAHPRA and imported by a duly licensed Medicines Import company, or are
- accompanied by a Section 21 Exemption Permit allowing the once-off import of non-registered CBD-containing medicines for a maximum of three months by a medical doctor for a single bona fide This is in terms of Section 21 of the Medicines and Related Substances Act.
All current importers now face the prospect of their products being seized at all ports of entry, and having to either return them to sender (the least painful option), or face investigation by the SAHPRA. If they are impounded, they are kept in a bonded state warehouse until the products are either registered or they expire. If they expire they are destroyed. Importers will also have to bear the full costs of this storage and destruction, which isn’t cheap.
Regulation 12(1) of the Medicines and Related Substances Act states that no person shall import any medicine or Scheduled substance into the Republic except through one of the following approved ports of entry:
(a) Cape Town airport or harbour;
(b) Port Elizabeth airport or harbour;
(c) Durban airport or harbour;
(d) Oliver Tambo International airport (Johannesburg)
It is illegal to import any CBD thorough any other airport, harbour or land border crossing.
THIS MATTER IN NOW BEFORE THE HIGH COURT
The Traditional & Natural Health Alliance (“TNHA”) has been at the forefront of protecting, educating and empowering the natural health product industry, its practitioners and consumers for the last five years.
The TNHA has a strong and reputable track record of holding the Minister of Health, National Department of Health and MCC (now SAHPRA) to account in attempting to pharmaceuticalize and restrict the public’s access to natural health products.
This has been achieved through official stakeholder engagements with regulators, commenting on and opposing draft regulations, attending stakeholder workshops, making oral and written submissions at Public Hearings on legislation before the Portfolio Committee for Health and the Portfolio Committee for Science and Technology in Parliament, and more recently challenging unconstitutional, irrational and procedurally defective regulations in the High Court.
In February 2018 the TNHA, with others, launched a High Court application to have the controversial complementary medicines regulations rescinded (overturned). That case is still on-going.
THE TNHA IS AN INCUBATOR FOR AN ENVISAGED CBD TRADE ASSOCIATION
It is envisaged that the TNHA will act as an incubator for the fledgling CBD industry in South Africa until it has enough CBD importers, distributors, prescribing practitioners, retailers and consumers to form a fully-fledged and independent CBD trade association.
Until then, the TNHA will continue to spearhead legal proceedings for the sector and be a nerve center for regulatory affairs. It will also begin to draft responsible regulatory policies for possible adoption into law in South Africa, aligned with best practices in other countries where CBD is regulated as a food supplement.
NON-THERAPEUTIC CBD CONTAINING PRODUCTS MUST BE REGULATED AS OVER-THE-COUNTER (S0) PRODUCTS
We believe that non-psychoactive, non-addictive and non-toxic naturally occurring CBD sold without health claims up to an agreed daily safe dosage should rightfully fall under the control of the Foodstuffs Cosmetics and Disinfectants Act (Act No. 54 of 1972), or as a Schedule 0 (S0) health product under the Medicines Act. This will allow consumers to purchase it over the counter or over, by mail order or over the internet without a prescription.
If health claims for disease conditions are made for the products, they should be registered as medicines.
Locking CDB into a ‘pharmaceutical industry product only’ is not only opportunistic but irrational. It’s the same as trying to lock oranges and vitamin C into pharmaceutical only products.
Manufacturers, purveyors and users should be able to make their own choices of how they convey and consume their products accordingly.
The aim of the TNHA going forward is to convince the Court and SAHPRA that CBD stakeholders can establish a set of rules, guidelines and standards that would enable the industry to comply with its requirements for medicinal CBD products, supplements and food and skincare ingredients, while protecting the public.
Our main purpose is to work with industry and government to ensure this market continues to grow, providing safe, effective and tested products for consumers and job security for its workers in the industry.
The TNHA is willing to work with all CBD product companies in the industry to advocate the case for a fully regulated market while negotiating with government to develop a more liberal regulatory framework.
The TNHA would like to adopt a reasonable and pragmatic regulatory framework locally, such as that set out by the European Industrial Hemp Association (EIHA).
WE HAVE FILED A HIGH COURT APPLICATION TO DOWN-SCHEDULE CBD
THE HISTORY – On the 31st of January 2018 the TNHA served letter on the Minister of Health who signed the CBD schedule into law, requesting cogent reasons for the scheduling of CBD as a S4 medicine and S7 narcotic, after noticing that it had been rescheduled from S6 just three weeks prior.
In it we invoked the Promotion of Administrative Justice Act (Act 3 of 2000), requesting written reasons for the scheduling.
For more background information, visit https://www.tnha.co.za/cbd-oil-now-illegal-tnha-poised-to-legally-challenge-scheduling-of-cannabidiol-cbd/
An official receipt of acknowledgment from the Minister’s office was received on the 1st of February 2018. In it, it was stated that the matters we raised would to be brought to his attention. We expected the Minister to confer with the SAHPRA and provide us a timeous reply. No reply from either the Minister or SAHPRA was forthcoming for many months and the prescribed period for him to reply in terms of the Promotion of Administrative Justice Act expired.
Unwilling to wait further for a the Minister’s or SAHPRA’s reply, or an appropriate down-scheduling, we applied for a Declaratory Order at the North Gauteng High Court on the 14th of December 2018. In it we asked that the Court declare the S4 and S7 scheduling irrational and unlawful.
On the 14th of February 2019 we received a letter from SAHPRA’s Law Enforcement Manager, Mr Griffith Molewa. The letter signed by the Acting CEO of the SAHPRA Ms Portia Nkambule stated that the SAHPRA viewed it unfortunate that we had not communicated our concerns raised in our substantial founding affidavit with them directly prior to launching our application, and that they had not been informed by the Minister of the previous correspondence addressed to him. We find this irregular as the Minister was the person who signed the Scheduling Notice further to consultation with the SAHPRA.
It was further expressed that the SAHPRA was open to open discussions with the TNHA on the matters raised in our founding affidavit. In the letter it was also acknowledged that the scheduling of CBD was, in her worlds, “subject to regulatory evolution which might LOGICALLY ensue in the possible rethinking of its status including the possibility to re-schedule, or entirely de-schedule CBD”. To this end we replied to Ms. Nkambule on the 15th of February 2019 requesting an urgent meeting with the SAHPRA in order to discuss the matters raised in our founding affidavit, and to hear what current science and logic was relied upon by the SAHPRA to schedule CBD in it’s current schedules. Numerous attempts were then made by our legal representatives to confirm a date and time for a round-table meeting, however no reply was forthcoming by the 31st of March 2019.
A letter has now been sent to the Ms. Nkambule (Acting CEO of SAHPRA) informing her that the TNHA will no longer pursue round-table discussions with the SAHPRA and will proceed with the High Court application. This is also in lieu of the fact that in the time we have been waiting for a reply, they have allegedly launched enforcement activities aimed at CBD stakeholders and imposed a literal ‘ban’ on CBD by instructing the Port Health Authority to stop all CBD-containing products entering our country.
We have also received information of SAPS raids on local food and beverage manufacturers who use CBD in their products, by virtue of adding hempseeds as a food additive and fermentation medium. SAPS have been conferring with the SAHPRA in these matters. We consider this enforcement action to be in bad faith in lieu of our current High Court application and their calling for us to engage with them and then ignoring our requests for round-table negotiations.
WE NEED TO APPLY FOR AN URGENT INTERIM INTERDICT
Because of these recent enforcement activities there is now a great urgency to safeguard the public’s access to safe and affordable CBD and CBD-containing products. We need to apply for an Interim Interdict to prohibit the SAHPRA and Port Health Authorities from continuing to impose the import ban.
IF YOU IMPORT, DISTRIBUTE OR SELL CBD OIL OR CBD-CONTAINING PRODUCTS, YOU ARE URGED TO JOIN THE TNHA URGENTLY!
THE TIME TO FIGHT FOR YOUR CBD BUSINESS OR CONTINUED ACCESS TO CBD IS NOW.
If you use CBD as natural health product, food additive or skincare ingredient and want to have continued access to it without having to pay your doctor a visit and pay an extortionate amount of money to import it as a pharmaceutical drug costing hundreds of thousands of Rand per year, you need to join the TNHA today and make your voice heard.
Currently the SAHPRA will grant Section 21 Exemption Permits for EPIDIOLEX®, an FDA approved pharmaceutical CBD product from the USA which costs US $32,000 [almost half a million Rand) a year. For obvious reasons this is not an option for the majority of CBD consumers in South Africa.
If your or your company are not a TNHA member yet, we will not be in a position to assist in defending your rights you if you become a target for prosecution or product seizure.
If you have to plan your own defense case and pay for it individually it will very time consuming, costly and stressful. The TNHA have already done most of the heavy lifting for you. All you have to do is join us NOW!
The TNHA have already secured funding for and launched its High Court. However, we will need more members to co-fund the on-going litigation and Interim Interdict application by means of donations to our legal fund. The TNHA as an organization also has costs to cover for its daily administration, legal research and policy directives, which is derived from annual membership fees. The TNHA invites you to become a member by visiting our website and filling in our membership application form at www.tnha.co.za
When we have received your application and received your annual membership fee you will be invited to take part in our upcoming activities, gain further insight into our court application and will receive regular feedback on our legal challenges. We are currently preparing a ‘CBD Purveyor’s Emergency Kit’ to use if you are targeted. This will only be made available to members.