RECENT NEWS AND HEADLINES

A Push for Rational De-prescribing and More Supplementation in South Africa By Anthony Rees (TNHA Chairman) While the world witnesses a constant evolution in style, governance, and personal aesthetics, a contrasting trend emerges in the realm of healthcare. A significant number of patients find themselves in a cycle where their medical prescriptions remain unchanged over time, with the only variation being an increase in the quantity of medications they must manage. Polypharmacy, the concurrent use of multiple medications by a patient, particularly afflicts the elderly and those with multiple chronic conditions. While it can be a necessary aspect of managing... Read More

By Anthony Rees (TNHA Chairman) Demystifying CBD Extracts for Everyday Understanding Cannabidiol, or CBD, has become a household name, promising relief from various ailments. CBD products come in different forms: ‘full spectrum’, ‘broad spectrum’, and ‘isolate’. Full spectrum CBD is like a full choir, with a range of cannabinoids including THC, and terpenes, which are the plant’s aromatic elements. Broad spectrum CBD is the choir without the soloist and many other minor cannabinoids and terpenes – THC is always absent. CBD isolate is the pure solo voice, with only CBD and no other cannabinoids or terpenes. Defining the Spectrums of... Read More

Analysis Report: SAHPRA’s Regulatory Overreach on Complementary Medicines Issued by the TNHA Introduction Ladies and gentlemen, let’s talk about the South African Health Products Regulatory Authority (SAHPRA) and their latest move — a draft Road Map guideline for regulating what they call ‘category D medicines.’ Now, you won’t find this easily; it’s tucked away on their website, with a comment period open until October 17, 2023. But don’t be fooled, they’re not playing by the rules, and they didn’t even bother to announce this in the guideline itself. It’s a classic case of ‘hide and seek’ with public information. The... Read More

The Controversy Surrounding the Regulation of Natural Health Products in South Africa The Traditional and Natural Health Alliance (TNHA), a representative body for stakeholders in the natural health products sector, has raised concerns over both the Minister of Health and the South African Health Products Regulatory Authority (SAHPRA) recently publishing draft Amendments to its 2017 General Regulations and a Road Map Guideline for the continued regulation of ‘Category D’ medicines. The TNHA argues that the amendments and the guidelines are both invalid and unlawful for several reasons. The Legal Battle Over Complementary Medicines In 2017, regulations were introduced that for... Read More

By Anthony Rees – National Chairman (TNHA) Despite the default skepticism of natural health product detractors, regulatory technocrats, and lazy media reporters, local statistics conclusively demonstrate that the majority of commercial natural health products are likely among the safest substances regularly consumed by tens of millions of South Africans. A growing number of every-day South Africans are asserting their rights to choose and prioritize natural approaches for maintaining their health and wellness, witnessed by the expansion of brick and mortar health shops, online health stores, direct selling companies and informal markets where a growing variety of natural health products are... Read More

Official TNHA comments submitted to SAHPRA in relation to the Roadmap and Transitional Process for the Regulation of Category D Medicines (16 July 2023). The TNHA rejects the unlawful manner in which SAHPRA is attempting to revive and validate the constitutionally flawed complementary medicine regulations in a continued unlawful manner, and which were stuck down by the full bench of the Supreme Court of Appeal in April 2022. This contemptuous and recalcitrant behavior will not go unchallenged. The battle for freedom of choice in health care continues!   Download the comments (PDF).  

Official TNHA comments submitted in relation to draft amendments gazetted on the 24th of March 2023, regarding the General Regulations for Medicine of 2017 (Notice No. 859 of 25 August 2017), under the Medicines and Related Substances Act (Act No. 101 of 1965).   Download the PDF.  

  Written by Anthony Rees National Chairman – TNHA In the vibrant tapestry of South Africa’s history, a poignant narrative unfolds – one that speaks of betrayal and unfulfilled assurances from the very government that promised liberation. In an era where Western health practices have been embraced without reservation, the ancestral wisdom and cultural heritage of the nation have seemingly been forsaken. This story resonates deeply with tens of millions of proud South Africans who find solace and strength in the steadfast practice of their African traditional belief systems. These sacred customs passed down through generations, are intertwined with the... Read More

  Written by Anthony Rees National Chairman – TNHA Nutrient depletion is an often overlooked side effect of some common medications. In the context of medication usage for symptom management, it is important to acknowledge that several of the top 100 prescribed drugs in South Africa have been found to deplete various nutrients. Regular intake of these commonly prescribed medications can lead to a reduction or depletion of essential vitamins, minerals, and other nutrients crucial for maintaining overall health and well-being. Optimal bodily functioning relies on an adequate supply of vitamins and minerals, as they support vital processes such as... Read More

The 39th Annual Report for the year 2021 published by the American Association of Poison Control Centers, as published in the coveted U.S Toxicology Journal, indicates that a variety of natural health products did not result in any fatalities. These included recorded statistics for dietary supplements, herbal products and homoeopathic medicines. It is worth noting that despite these findings, this information may not be widely disseminated through mainstream news channels. Nevertheless, it is important to acknowledge and examine these findings, as they pertain to the public’s well-being and the appropriate use of natural health products. The United States of America... Read More

The complementary medicine regulations of 2017 have fallen and became legally unenforceable on April 11. The twelve-month suspension of invalidity ordered by the Supreme Court of Appeal in its judgment in April 2022 has expired without any lawfully gazetted amendments extending or validating them. This came after a unanimous five-member bench of the Supreme Court of Appeal (“SCA”) ruled on April 11, 2022 that the regulations for complementary medicines were defective and ultra vires [beyond the scope of power allowed or granted by law]. Both the High Court and SCA came to the rightful conclusion that the complementary regulations were an unlawful overreach by... Read More

SUMMARY The natural health product industry in South Africa has been alerted to a draft amendment notice in the government gazette, attempting to amend the ultra-vires “complementary medicine” provisions. The notice specifies a 30-day comment period, which conflicts with the minimum three-month comment period mandated by Section 35(2) of the Medicines and Related Substances Act. The Minister of Health was granted 12 months by the Supreme Court of Appeal to address the unconstitutionality and unlawfulness of attempting to regulate complementary medicine and health supplements beyond the scope permitted by primary legislation, which expires on 9th April 2023. The Minister has... Read More

The Traditional and Natural Health Alliance (TNHA) is cognizant of the fact that SAHPRA inspectors are currently conducting unannounced compliance checks by visiting natural health product purveyors across South Africa. Because the regulation of the natural health products sector is new, it has come to our attention that many company owners and their management teams are not fully aware of the laws applicable to their businesses, or their rights and responsibilities when inspectors arrive unannounced. Consequently, we receive numerous frantic phone calls from both members and non-members seeking guidance on how to handle such situations. This guide is our response... Read More

A TUMULTUOUS YEAR FOR THE NATURAL HEALTH PRODUCT INDUSTRY By Anthony Rees – National Chairman (TNHA) It has been nine months, give and take a few days, since the Supreme Court of Appeal (SCA) in Bloemfontein delivered its five-seat unanimous judgement, upholding the 2018 North Gauteng High Court judgment declaring the 2017 complementary medicines regulations under the Medicines and Related Substances Act ultra vires (invalid), and unconstitutional. Although the High Court and SCA both found the SAHPRA’s overreach in regulating non-medicinal health supplements and non-scheduled substances without disease or symptom claims inconsistent with the stated definition of ‘medicine’ in the... Read More

The passage of the National Health Insurance Bill has been a hot topic of discussion for the Portfolio Committee for Health in Parliament. Many have hailed the NHI scheme as a step towards inclusivity and the progressive realization of Section 27 of the Bill of Rights. However, concerns have been raised about the exclusion of Traditional African Medicine (TAM) from the universal NHI. TAM is the health modality most utilized and accessible to 80% of the South African population. Unfortunately, it has been sidelined and excluded from being recognized under the NHI. This exclusion has echoes of the colonial and... Read More

By Anthony Rees – National Chairman (TNHA) There hasn’t been a week which has gone by recently where I haven’t fielded regulatory queries from frustrated importers and local manufacturers of CBD-containing products. They all want guidance on how to legally sell foods and drinks (edibles) containing CBD, or complain about shipments of imported CBD products being detained by either the Port Health Authority, the South African Health Products Regulatory authority [SAHPRA] and/or the Food Control Directorate of the National Department of Health. Hopefully, this article will assist local CBD product purveyors to navigate the dense thicket of current legalities and... Read More

South Africa’s Cabinet Approves African Medicines Agency Treaty By Anthony Rees – National Chairman (TNHA)   The South African cabinet has finally given the green light to sign the African Medicines Agency Treaty and adoption of the African Union Model Law on Medical Products Regulation. Cabinet has approved the signing of the African Union treaty establishing the African Medicines Agency (AMA), and submitted it to Parliament for ratification, according to a government statement on 23 September. South African Health Minister Mathume Joe Phaahla affirms support for the AMA on a February 2022 visit of WHO Director-General Dr Tedros Adhanom Ghebreyesus.... Read More

Those who have unlawfully inflicted harm on the natural health products sector need to held to account. 15 July 2022 he TNHA are calling upon companies in the natural health product industry to come forward and share with us their experiences in dealing with the South African Health Products Regulatory Authority [SAHPRA] since the 2017 complementary medicines regulations were gazetted. Has your company gone to great lengths, and at great cost in order to comply with this fatally flawed and unlawful regulatory scheme? Have you had to close down your business, or sell it, fearing you would not be able... Read More

IMPORTANT UPDATE: The Minister of Health has made a turn-around decision, not to appeal the 11 April Supreme Court of Appeal Judgment, and the SAHPRA are proclaiming belligerently that it’s ‘business as usual’, threatening to continue to enforce their ultra vires 2017 complementary medicines regulations, non-legal Guidelines and to continue to throttle the importation of natural health products which are deemed ‘medicines’ according to the SCA judgment. TNHA STATEMENT The TNHA notes the Minster of Health and SAHPRA’s intentions communicated in their media release (below). The ANHP(SA) will release a statement on studying of their papers once filed. The TNHA... Read More

Overturning of Complementary Medicines Regulations in South Africa Introduction to the Case In a landmark legal battle, Anthony Rees, representing the Alliance for Natural Health Products South Africa (ANHP), successfully challenged the South African government’s attempt to regulate natural health products under the same framework as pharmaceutical medicines. This case culminated in a ruling by the Supreme Court of Appeal (SCA) that sided with the ANHP, thereby overturning the contentious 2017 Complementary Medicine regulations.   The Legal Journey The journey began with the ANH P’s objection to the 2017 regulations, which sought to categorize natural health products, including vitamins and... Read More

The Battle for Natural Health: Alliance vs Minister of Health in South Africa In a landmark case that has gripped the nation, the Alliance of Natural Health Products (ANHP) took on the Minister of Health and the South African Health Products Regulatory Authority (SAHPRA) in a legal battle over the regulation of complementary medicines and health supplements. The Controversial Regulations The controversy began when the Minister of Health introduced the General Regulations under the Medicines and Related Substances Act, 1965. These regulations, published on 25 August 2017, introduced a new category of medicines – ‘complementary medicines’, which included health supplements... Read More

The Supreme Court of Appeal (SCA) in Bloemfontein ruled on 11th of April that the controversial regulations for complementary medicines under the Medicines and Related Substances Act (Act 101 of 1965) are invalid and unlawful. The SCA dismissed an appeal by the Minister of Health and the South African Health Products Regulatory Authority (SAHPRA) against a previous North Gauteng High Court (Pretoria) judgement in favour of the Alliance of Natural Health Products South Africa (ANHP), by Judge Elizabeth Kabushi on the 1st of October 2020. The verdict follows after the ANHP, a TNHA partner, took the Minister of Health and... Read More

MEDIA RELEASE & UPDATE On Monday the 7th of March the regulatory fate of a large segment of the natural health product industry will be argued before a full bench of five judges in the the Supreme Court of Appeal (SCA) in Bloemfontein. The appeal comes after our alliance partner, the Alliance for Natural Health Products South Africa (ANHPSA) won a Gauteng North High Court judgement (Case 11203/2018) which struck down as unlawful and unconstitutional, the 2017 complementary medicine regulations under the Medicines and Related substances Act (Act 101 of 1965).  The High Court judge presiding was Judge Elizabeth Kabushi... Read More

Written by:  Anthony Rees (National Chairman: TNHA) Signatories to the new African Medicines Agency Treaty have now reached 28 countries – more than half of the African Union’s 55 member states – with the balance tipping as Uganda signed the treaty instrument last week.  On Friday, 5 November, after more than a decade of preparations, the African Medicine Agency (AMA) Treaty also came into force officially – clearing the way for the AMA to begin operations as a formal supranatural regulatory authority. But with the AMA treaty coming into full force, exactly one month after the first 15 countries ratified and deposited... Read More

Written by: Anthony Rees (National Chairman : TNHA) More than a decade after the idea for the African Medicines Agency (AMA) was broached at the 60th session for the World Health Organization Regional Committee for Africa, the agency will officially begin operating the 5th of November 2021 under the African Union (AU). Instead of acting as a stand-alone regulatory body at inception, it will coordinate national and regional regulatory efforts. The new agency hopes to take full advantage of recently adopted AU African Continental Free Trade Area (AfCFTA), and to open up pharmaceutical markets to the entire continent.  Over time... Read More

Written by:  Anthony Rees (National Chairman: TNHA) Our mainstream media regularly publishes alarming articles about the ‘dangers of natural health products’. Such articles invariably exaggerate and misinterpret the studies they refer to. At the same time, the thousands of studies showing how an insufficient intake of vital nutrients and phyto-chemicals (protective and health promoting chemicals in fruits, vegetables and herbs) can contribute to many health problems, and how regular use of science-based natural health products has shown impressive health benefits, are far less publicized. More often than not, such research is virtually ignored. This is no accident, of course. Ultimately,... Read More

Written by:  Anthony Rees (National Chairman: TNHA) HOW GOVERNMENT AND THE MEDIA USED A CON “PROFESSOR” AS THEIR VACCINE INFLUENCER With the first phase of the national Covid-19 vaccine rollout finally underway, and a reported 67,000 healthcare workers having already been vaccinated, our government has indicated that vaccines will soon be offered to the estimated 220,00 traditional healers in our country as part of the extended healthcare workers rollout. This comes after a certain Limpopo based traditional healer and multinational traditional healers association chief demanded that traditional healers be included in the first vaccine rollout. His bold calls were swiftly... Read More

Written by: Anthony Rees (National Chairman: TNHA) Europe’s CBD market is optimistic after a recent ruling from the EU’s highest court (European Court of Justice) not to classify the ingredient a narcotic – going against the European Commission’s shock preliminary view in July. This will pave the way for Novel Food applications for CBD products to re-start. French law has until this ruling prohibited the sale of CBD extracted from the whole cannabis plant (meaning only CBD extracted from fibre and seeds was permitted). An e-cigarette company named KanaVape which extracts CBD from whole plants and exports to other EU... Read More

Written by:  Anthony Rees (National Chairman: TNHA) Judgement in the Alliance for Natural Health Products South Africa (ANHPSA) vs. Minister of Health and the South African Health Products Regulatory Authority (SAHPRA) was delivered on Thursday the 1st of October in the Pretoria High Court , and found in favour of the applicant. In her judgement Judge Elizabeth Kubushi found that not all complementary medicines and health supplements are necessarily medicines requiring pre-approval (registration) by the SAHPRA, and by extension companies selling such products would not be required to be licensed as pharmaceutical importers, wholesalers, or distributors. It is only when... Read More

Written by:  Anthony Rees (National Chairman: TNHA) SUMMARY – In the near future the African Union’s new African Medicines Agency (AMA) will be formally established, and will begin evaluating, regulating & controlling access to marketed African Traditional Medicines in the same manner as synthetic pharmaceutical drugs. This will advance the profits of pharmaceutical companies and their shareholders, who will culturally expropriate African herbal traditions, while outlawing existing & trusted products which are not pre-authorised with a license for sale in the continent. Small and medium sized manufacturers will effectively be locked out of the market they pioneered with the ancestral... Read More

Written by:  Anthony Rees (National Chairman: TNHA) IMPORT EMBARGO The TNHA have begun receiving an alarming number of reports from our members relating to millions of Rands worth of inbound shipments of natural health products being impounded by the Port Health Authority at various official points of entry into the country. On inquiry by clearance agents and importers, Port Health Authority officials are now demanding South African Health Products Regulatory Authority (SAHPRA) issued medicines import licenses for medicines in terms of Section 22(c) of the Medicines & Related Substances Act (Act 101 of 1965) before releasing shipments. This includes all... Read More

On Tuesday and Wednesday this week Anthony Rees, Chairman of the TNHA, will be representing the Alliance of Natural Health Products South Africa (“ANHPSA”) before the Gauteng North High Court.   This case places under judicial review contentious and inappropriate Complementary Medicine Regulations first gazetted in 2013 and further expanded as recently as 2017 by the Minister of Health, under direction of the South African Health Products Regulatory Authority (SAHPRA).  According to many businesses and practitioners in the natural health product sector, the said regulations threaten the public’s continued access and variety of demonstrably safe natural health products used for... Read More

Written by:  Anthony Rees (National Chairman: TNHA) The interest in cannabidiol (CBD) use in health products, foods, and even as an ingredient in skincare products has gained much momentum in the past twelve months in South Africa, ever since the substance was liberated from prescription-only status. But …. things are about to change and WILL affect the CBD industry and consumers choices of CBD products they currently use.  On the 8th of May Health Minister Zwele Mkhize signed into law the new scheduling status for certain Cannadidiol (CBD) containing products. This was gazetted on the 22nd of May seven days... Read More

Written by:  Anthony Rees (National Chairman: TNHA) The South African consumer’s non-prescription access to CBD has legally come to an end. On the stroke of midnight on Friday the 15th of May, over-the-counter Cannabidiol (CBD) containing products which have been freely traded in South Africa reverted back to being Schedule 4 medications requiring them to be registered and sold with a doctor’s prescription, despite there being no registered (legally approved) prescription CBD medicines available in South Africa. This situation is due to the 12-month exemption notice for certain CBD products expiring without an extended exemption despite the substances impeccable safety... Read More

HEALTH FOOD STORES ARE ‘ESSENTIAL SERVICES’ WHICH SELL ‘ESSENTIAL GOODS’ Many countries who have placed restrictions on economic activity to protect their communities against Covid-19, are trying out new measures, but in some instances emergency regulations just don’t make sense, are too strict or lead to different interpretations by law enforcing officials. The TNHA is currently inundated with queries from its members and non-members in the natural health product industry value chain relating to whether walk-in health food stores and their suppliers (importers, manufacturers and distributors) will be shut down during the 21-day shutdown staring at midnight on the 26th... Read More

This communication has been updated. CLICK HERE FOR THE LATEST INFORMATION    

In February 2016 the TNHA published a report detailing strident, yet little publicized steps taken by the African Union Commission (AUC), the Pan-African Parliament (PAP), the NEPAD Agency’s African Medicines Regulatory Harmonization Programme and various international donors to establish a supra-national Medicines Regulatory Agency for the entire African continent, styled similarly to the European Medicines Agency (EMA) in Europe. In the past, five Regional Economic Communities have tried to harmonize their medicines laws with limited success due to chronic capacity constraints. There is now a major drive on the continent and from interests outside the continent to sew up this... Read More

CBD edibles, beverages and cosmetic imports are being blocked at ports of entry into South Africa despite a legal exemption for certain CBD-containing products by our medicines regulator. It has been eight months since our medicines regulator, the SAHPRA, in consultation with the Minister of Health created a special exemption for CBD as an over-the-counter substance for human consumption. This came after our organization broke the CBD’s schedule 6 and 4 prescription-only scheduling status deadlock by instituting court action and reaching an agreement with the SAHPRA to make CBD available to the public without a doctor’s prescription under certain exemption... Read More

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 outlaw... Read More

MEDIA STATEMENT 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... Read More

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... Read More

THE END OF AN ERA After seventeen years of offering the only Allied Health Professions Council of South Africa (AHPCSA) accredited degree programs in the complementary medicine professions of Naturopathy, Phytotherapy (Medical Herbalism), Traditional Chinese Medicine & Acupuncture and Unani-Tibb, the University of the Western Cape’s School of Natural Medicine has officially closed its doors to new students as from next year. Students already enrolled in these programs have been offered the opportunity to complete their respective degrees in order to register as practitioners. There have been a dwindling number of graduates over the past decade. Last year only six... Read More

According to a circular [below] sent out to all striking employees of the National Department of Health (NDoH) by the Director-General of Health, Malebona Precious Mtsoso last Friday, they must return to work today or face ‘no work, no pay’. This follows a Labour Court ruling issued on Friday compelling the workers to return to their desks after seven months of protesting ‘unsafe and unhealthy working conditions’. In the beginning of the industrial action approximately 2,000 NDoH employees worked half day shifts [on full pay] between April and August, after strained negotiations between their trade unions, namely the National Education... Read More

The TNHA is exploring legally challenging the recent scheduling of cannabidiol (CBD) as a prescription-only drug. Despite a growing body of incontrovertible evidence supporting the extremely low risk profile of non-psychoactive cannabidiol, otherwise known as CBD oil, the expert scheduling committee of the South African Health Products Regulatory Authority (SAHPRA) have arbitrarily declared all CBD-containing products as schedule 4 and schedule 7 drugs respectively. This was done in terms of section 22A(2) of the Medicines and Related substances Act. (Act No. 101 of 1965). This will severely restrict the public’s access to this beneficial health-promoting substance. In a growing amount... Read More

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... Read More

Yesterday we posted an article about the dodgy group of protesters outside the Pretoria High Court after linking them to certain organisations and individuals linked to this trial. Today Jules Stobbs of the Dagga Couple made a video of this mob as he returned to the court after a lunch recess. Below is a leaked photograph of the professional catering that was provided to the protesters outside the court at lunchtime (see below). As you can see, someone or some organisation with deep pockets has mobilised this crowd. None appear to be genuinely aggrieved citizens against cannabis use, due to... Read More

On what was supposed to be the first day of the Trial of the Cannabis Plant at the Pretoria High Court yesterday, a ragtag mob of about thirty predominantly male protesters stood in front of the court shouting rhetorical anti dagga epithets and holding placards with slogans like ‘No to dagga’ , ‘Dagga Ruins Lives’ , ‘Dagga Kills’ etc. What was apparent is that all the placards were produced by one person, having the same font style and constructed from the same materials. Who are these people? The protesters appear to have been a coalition of two separate groups made... Read More

By: Anthony Rees (National Chairman – TNHA) On the 28th of July, and just four days preceding the Trial of the Cannabis Plant by the Dagga Couple, the Medicines Control Council, after consultation with the Minister of Health spuriously gazetted a list of substances to be included in the schedules in terms of section 22A(2) of the Medicines and Related Substances Act (Act No. 101 of 1965). One of the substances hidden on the bottom page 27 of the gazette is Cannabidiol, or more commonly known as CBD Oil. Cannabidiol is one of the most exciting cannabinoids — natural compounds... Read More

The Western Cape High Court has made a landmark ruling, declaring that it is an infringement to ban the use of dagga by adults in private homes. In making the ruling on Friday, it has allowed for the possession, cultivation and use dagga at home, for private use. It has also ruled that Parliament must change sections of the Drug Trafficking Act, as well as the Medicines Control Act. It has 24 months to do so. The successful application to decriminalise dagga was driven by Dagga Party leader Jeremy Acton and Rastafarian Garreth Prince who argued on December 13 and... Read More

From March 20th, 2017 the Austrian Federal Office for Safety in Health Care (Austrian Medicines and Medical Devices Agency) has become an associated member  of the ICMRA (International Coalition of Medicines Regulatory Authorities). ICMRA is voluntary, executive-level, strategic coordinating, advocacy and leadership entity of regulatory authorities that work together to address current and emerging regulatory and safety-related issues with regard to human medicines by providing direction and identifying potential synergies.  

  At the end of last year we reported that government indicated it planned to legalise medical cannabis-derived drugs in South Africa. The Medical Controls Council (MCC) has just released its medical new guidelines for the cultivation, production and use of medical cannabis. This is of significant importance to prospective medical cannabis growers, patients and all South Africans who are interested in seeing a legal cannabis market. View the 32 page medical marijuana guidelines here: Strictly controlled The document provides strict guidelines and information to applicants wanting to grow, test or manufacture medical cannabis related products in South Africa. It... Read More

The Medicines Control Council have just released new guidelines for the CULTIVATION OF CANNABIS AND MANUFACTURE OF CANNABIS-RELATED PHARMACEUTICAL PRODUCTS FOR MEDICINAL AND RESEARCH PURPOSES. Stakeholders have been given one month to submit comments and suggestions to the MCC. These guidelines precede imminent new regulations for Cannabis-related medicines, and will accompany them as a framework for local licensed growers producers.    

The long awaited draft General Regulations which will accompany the new Medicines and Related Substances Amendment Act towards mid-year this year, and which will create the legal mechanism to launch the new South African Health Products Regulatory Authority (SAHPRA), were gazetted for comment by the Department of Health on the 27th of January. The SAHPRA will replace the Medicines Control Council which has existed for over half a century. The SAHPRA will no longer fall directly under the National Department of Health’s control and will become a Section 3(A) public entity in terms of the Public Finance Management Act (Act... Read More

On the 26th of January we submitted written comments and made an oral submission to the Parliamentary Portfolio Committee on Science and Technology on the Protection, Promotion, Development and Management of Indigenous Knowledge Systems Bill (Bill 6 of 2016). This controversial Bill in its current form threatens the on-going practice of African Traditional Medicine by an estimated 200 000 traditional healers by restricting their accreditation criteria for registration to practice legally, and could potentially create a new government bureaucracy called the National Indigenous Knowledge Systems Office (NIKSO) under the Department of Science and Technology. The NIKSO, if established by law,... Read More

ICMRA HARMONISATION UPDATE In June this year the TNHA broke the news of an international medicines regulatory harmonisation scheme being orchestrated behind closed doors by the heads of twenty international drug regulatory bodies, called the International Coalition of Medicines Regulatory Authorities, or ICMRA in short. We are particularly concerned about this secretive organisation, following revelations about it having established a Complementary Medicine and Herbal Medicine Working Group which was first mooted by, and now chaired by the Australian Therapeutic Goods Administration (TGA). The first meeting of this working group took place in the Netherlands in 2014. In a response to... Read More

THE CAM CROSSROADS – WHERE ARE WE HEADING? Today the South African Natural Health Product (NHP) industry stands at a crossroads and its stakeholders remain dazed and confused like antelope caught in oncoming headlights.  With only two years left for manufacturers, importers and distributors to submit applications to the Medicines Control Council (MCC) to register their products, we are fast reaching a tipping point, where without renewed political will and a true desire to protect the industry by its stakeholders, millions of South Africans will lose their access non-drug therapies and natural health products which they rely on for their... Read More

HAVE YOU EVER WONDERED WHY LABELS ON SUPPLEMENTS ARE SO VAGUE? By: Julia Rucklidge, PhD & Bonnie Kaplan, PhD   The NZ government is currently writing a new law (Natural Health Products Bill) aimed to regulate natural health products (NHPs). What is happening in New Zealand is not unique: the push for tighter controls on NHPs is occurring all over the world, including Europe, Canada and South Africa. However, if it wasn’t evident before, these newer regulations make it crystal clear that prescription drugs have a monopoly over the terms “medicine” and “therapeutic benefit,” and that it is very difficult... Read More

OPPOSITION TO INDIGENOUS KNOWLEDGE SYSTEMS BILL MOUNTS The Protection, Promotion, Development and Management of Indigenous Knowledge Systems (Bill 6 of 2016) is facing strong head winds from traditional healers and some political parties, leading up to the Public Hearings which are expected to be held in Parliament early next year. The Portfolio Committee on Science and Technology have been meeting various governmental stakeholders to discuss the bill over the last six months. The TNHA have attended a key meetings on the bill and have noted that there is still a lot of confusion about the bill, and even reservations about... Read More

CHINESE MEDICINE FOR AFRICA On the 2nd of November last year (2015) South African President Jacob Zuma and Chinese President Chinese Xi Jinping officiated 26 new trade and skill-based transfer related agreements on President Jinping’s first state visit to South Africa. During this visit the Forum on China-Africa Cooperation (FOCAC) was established and deals between both countries worth R96 billion were pledged. A Special Memorandum of Understanding on Co-operation in health and medical sciences was countersigned by Chinese Health Minister Li Bin and South African Health Minister Dr Aaron Motsaolaedi, which included a strong focus on introducing of Traditional Chinese Medicine... Read More

THE COMPLEMENTARY MEDICINE REGULATIONS MUST FALL! Anthony Rees (TNHA Chairman) In last month’s newsletter we announced that the long awaited draft regulatory amendments for natural health products had been gazetted on the 25th of July, and that we would provide you with our official comments on them. After reading them closely we have concluded that the Medicines Control Council (MCC) have not listened to any of the comments raised by stakeholders over the past two and a half years, and that they have again attempted to widen their net to capture the CAM sector. Despite many warnings from the TNHA... Read More

PROTECTION OR ETHNOPIRACY? Is Government Protecting The Traditional Medicine Knowledge of Our Indigenous People, or Imposing a State-Run Ethnopiracy Scheme for Big Pharma and the Biotech Industry? A Critical Review of the Protection, Promotion, Development and Management of Indigenous Knowledge Systems Bill Written by Dr Anthony Rees (National Chairman- TNHA) GLOSSARY OF ACRONYMS USED IN THIS DOCUMENT DST – Department of Science and Technology IK – Indigenous Knowledge IKS – Indigenous Knowledge Systems IP – Intellectual Property NIKSO – National Indigenous Knowledge Systems Office THPHCSA – Traditional Health Practitioners Council of South Africa INTRODUCTION Southern Africa possesses a remarkable diversity... Read More

ADVERTISING STANDARDS BODY SLAMMED BY HIGH COURT Anthony Rees (Secretary : TNHA) The private company known as the Advertising Standards Authority of South Africa (ASA) was ordered by the Gauteng High Court on the 5th of May to stop accepting complaints or making rulings on advertisements published by non-members.  The interdict effectively prohibits the ASA from banning ads by marketers of natural health products (and any other advertiser in any industry) which do not subscribe to the ASA’s private Advertising Code. In August last year we broke the story in our newsletter about the difficulties manufacturers and distributors of natural... Read More

ONLY SIX HEALTH PRODUCTS PASS FIRST ‘COMPLEMENTARY MEDICINES PRE-REGISTRATION TEST Anthony Rees (Secretary-General TNHA) ‘Medicines Control Council inspectors are gearing up to seize scores of illegal products claiming to treat diabetes, heart disease, cancer and viral illnesses in a blitz aimed at enforcing tough regulations for complementary medicines’ – Business Day The Medicines Control Council (MCC) gazetted a notice three weeks ago on the 15th of April in terms of section 14(3) of the Medicines and Related Substances Act (Act No. 101 of 1965). This notice served to inform stakeholders, including the public, which current products are to be further... Read More

IFP AND ANC MAKE DEAL TO LIMIT MEDICAL INNOVATION BILL TO CANNABIS DERIVED DRUGS FOR PALLIATIVE CARE ONLY Anthony Rees (Secretary-General: TNHA) The Inkatha Freedom Party (IFP) and the African National Congress (ANC) have settled on a compromise on the Medical Innovation Bill (Bill No. 1 of 2014), agreeing that the scope of the Bill will be limited to the provision of Cannabis derived medicines for palliative care only. Essentially this means that these medicines may only become available to terminally ill patients where no orthodox medical treatments are considered viable. At a press briefing I attended today on the... Read More

OUR CONTINUED ACCESS TO NATURAL HEALTH PRODUCTS IS A FUNDAMENTAL HUMAN RIGHT Anthony Rees General-Secretary: TNHA Despite the best efforts of our National Department of Health to reduce the burden of disease in South Africa, many of today’s most common diseases including cancer, heart disease, diabetes and other diseases of lifestyle continue to rise sharply in numbers. Just yesterday I read in the foreign and local media that the number of those diagnosed with type 2 diabetes continues to rise unabated, despite increasing disease management interventions. In 1980 the World Health Organization estimated there were 108-million adult diabetes sufferers in... Read More

THE “DRUG-IFICATION” OF NATURAL HEALTH PRODUCTS By Richard DeSylva RH DNM The Canadian experiences with Natural Health Product regulations, similar to those adopted by South Africa It has been a little more than 10 years since the Natural Health Product Directorate (NHPD) officially brought into force the regulations governing the manufacture & sale of what are now known as ‘NHPs’ (Natural Health Products) in Canada.  While it may well be argued that there is greater validity and social sanction given to these substances, the trade-off seems to have been that the Natural Non-Prescription Products Directorate (NNPPD) will only assign a... Read More

HERBAL HEALTH PRODUCTS: SHOULD THEY BE REGULATED AS FOODS, DRUGS OR AS A NEW CATEGORY? Anthony Rees (General-Secretary: TNHA)  As a person who has practiced herbal medicine clinically, and worked in the natural health retail sector, and even owned a herbal health product companies over the last twenty years, I often pondered on whether herbal health products were merely unprocessed drugs, a segment of the food matrix, or whether they are unique substances which need to be defined and regulated separately.   I have steadily come to the conclusion that for the most part, herbal health products fit somewhere between what... Read More

AFRICAN MEDICINES REGULATORY HARMONIZATION A NEW THREAT TO TRADITIONAL & NATURAL HEALTH PRODUCTS THROUGHOUT AFRICA Anthony Rees (Secretary-General: TNHA) A newly adopted African Union Model Law on Medical Products Regulation and the establishment of an African Medicines Agency threatens to undermine the sovereignty of all African Nation-States in their regulation of medicines. This scheme, drafted behind closed doors, will significantly boost Big Pharma’s market-share on the continent, and will ensnare Traditional & Natural Health Products, foods and cosmetics into a harmonised regulatory framework. THE AFRICAN MEDICINES AGENCY AND THE MODEL LAW ON MEDICAL PRODUCTS REGULATION A few days after President... Read More

TNHA REJECTS DRAFT REGULATIONS FOR THE REGISTRATION OF TRADITIONAL HEALTH PRACTITIONERS On the 3rd of November last year the National Department of Health gazetted draft regulations for the registration of traditional health practitioners (Gazette No 39358 / Notice 1052).  Three months have been given for comment, ending on the 3rd of February 2016. The draft regulations lay out the criteria which practicing traditional health practitioners and those who undergo training must adhere to before they will be eligible to register with the statutory Traditional Health Practitioners Council of South Africa (THPCSA).  Registration with the THPCSA will be mandatory for all... Read More

BILL 6 SIGNED INTO LAW On January 8 President Jacob Zuma assented to, and signed the Medicines and Related Substances Amendment Bill 6 of 2014 into law in terms of section 84(2) of the Constitution of the Republic of South Africa. Anthony Rees (Secretary-General: TNHA) This new Act creates a new legal framework for the Medicines Control Council (MCC) to be scrapped, and for the establishment of a new South African Health Products (sic) Regulatory Authority (SAHPRA), similar to the FDA in the USA (read on to see why). The SAHPRA will no longer be an organ of State, but... Read More

NATIONAL HEALTH INSURANCE WHITE PAPER MAKES NO PROVISION FOR TRADITIONAL & NATURAL HEALTHCARE On the 11th of December last month, Health Minister Aaron Motsoaledi released the White Paper on the National Health Insurance (NHI) as approved by Cabinet.  The R220 billion universal healthcare scheme was announced immediately after the axing of Finance Minister Nene, who was putting a halt on major government spending. The burning question is how the NHI will be financed, considering the precarious and fragile state of our economy. The TNHA have studied the White Paper and note that nowhere are Allied Health Practitioners, registered with the... Read More

CAMS REGULATIONS DERAILED Anthony Rees (Secretary-General: TNHA) Are natural health product suppliers still compelled to register their products as ‘Complementary Medicines’? Many companies in the natural health product industry scrambled recently to meet the November 15 deadline to apply for registration of certain of their products deemed ‘Complementary Medicines. These products included weight-loss products and sexual enhancement products. Many retailers have become nervous about acquiring or retaining stock of these kinds of products, fearing many may end up being illegal. THE ROAD MAP TO NOWHERE Section 14 of the Medicines and Related Substances Act of 1965 (Act 101 of 1965),... Read More

UNNATURAL REGULATIONS Anthony Rees (Secretary-Gerneral: TNHA) There is no denying that the last year was a frustrating for many stakeholders in the natural health industry, as well as for many patients and consumers who rely on these products to achieve and maintain wellness.  Each passing day we receive queries from either retailers, practitioners or health conscious consumers, asking us where they can source natural health products which are no available longer on health store of pharmacy shelves.  Sadly, some of these products have been either scheduled and reclassified as pharmaceutical drugs (requiring a doctors prescription), or have been withdrawn from... Read More

TNHA TAKES THE HEALTH FREEDOM BATTLE TO PARLIAMENT On October the 29th, more than 300 traditional healers and many other guests crowded into the Old Assembly Hall of Parliament to listen as the Traditional and Natural Health Alliance presented its views on an amendment to the Medicines Act Bill 6 (also known as the SAPHRA Bill) to the Portfolio Committee of Health. Almost 50 years had passed since the Medicines Act of 1965 was passed in the same Parliamentary building, in the era of stiff suits and white faces. Now, the benches were filled with African Traditional Healers, mainly dressed... Read More

THE EFFECT OF NEW REGULATORY SYSTEM ON THE NATURAL HEALTH VALUE CHAIN, SECTOR BY SECTOR MANUFACTURERS In terms of the current regulations, NHP manufacturers are compelled to first register as pharmaceutical companies, following the letter of the Good Manufacturing Practice (GMP) regulations and guidelines imposed on multi-billion rand pharmaceutical manufacturers.  They are compelled to place a disclaimer on all their products stating that ‘This medicine has not been evaluated by the Medicines Control Council’, a trap ensnaring companies to hand over jurisdiction of their products under the Medicines & Related Substances Act and to the MCC. All manufacturers are now... Read More

THE CAM BAN SCAM THE FUTURE AS WE SEE IT According to many opinion leaders in the Natural Health Product (NHP) industry, the public’s future access to natural health products (NHPs) and those tied to them by profession looks bleak in South Africa.  There is a systematic ‘shut-down’ of natural health products (NHP’s) and choice underway, and it needs to be stopped NOW! We do not want to find ourselves in a situation like in Canada, where tens of thousands of safe, effective and good quality products were withdrawn either voluntarily from the market because of the high cost of... Read More

REGULATORY UPDATE About six months months ago rumours begun to trickle through to the natural health sector that the Medicines Control Council were realizing that the November 2013 Complementary Medicines regulations were unimplementable for various reasons. We heard the Medicines Control Council were looking abroad for a system that would (a) be less human-resource dependent, and (b) allow for the fast-tracking of applications for the majority of Complementary Medicines.  In the few rare meetings held between the industry and the MCC, the MCC revealed that the five-year Road Map for the phased registration for Complementarty Medicines had also become problematic.... Read More

HOW MUCH OF ORTHODOX MEDICINE IS EVIDENCE BASED? Anthony Rees (Secretary-General: TNHA) Many medical ‘experts’ deplore natural health products, claiming that their use isn’t supported by orthodox scientific rationale. In the absence of cost prohibitive, double blind, randomized, placebo controlled trials for most natural health products, this notion persists, despite these substances being used traditionally with success for hundreds, and if not thousands of years. While natural health products continue to be subject to these negative rantings, these ‘experts’ conveniently ignore the mounting evidence that over 50% of the pharmaceutical drugs they prescribe or sell are unlikely to be beneficial... Read More

  IS THE ADVERTISING STANDARDS AUTHORITY A SHAM? – YOU DECIDE WHAT POWER DOES THE ADVERTISING STANDARDS AUTHORITY OF SOUTH AFRICA REALLY WIELD? Anthony Rees (Secretary-General: TNHA) Let us introduce you to the Advertising Standards Authority (ASA).  This is not a government body as you might expect from the “Authority” in its name. It is a private, limited company that is self-appointed, self-regulating, and industry funded. It is registered and incorporated according to the Companies Act of 1973. As such, its powers are circumscribed by its Memorandum of Incorporation and Articles of Association (“Articles”), and not an Act of Parliament.... Read More

NATURAL HEALTH THERAPIES AND PRODUCTS CAN SIGNIFICANTLY REDUCE GOVERNMENT HEALTH SPENDING There is mounting evidence that daily use of natural health products can decrease national healthcare costs.  In a recent article published in the Journal of Dietary Supplements, researchers conducted a cost/benefit analysis that, when applied to at-risk populations who take natural health products, demonstrated a reduction in the odds of individuals experiencing a costly medical interventions. The publication of this article follows a ‘game changing’ economic report released in September last year, which concluded that dietary supplements could save billions of dollars in healthcare costs in the United States. ... Read More

MCC SCHEDULING COMMITTEE REVERSES RESTRICTIONS ON MILK THISTLE HERB The TNHA confirmed yesterday that the Milk Thistle herb (Silybum marianum) and its main active constituent ‘silymarin’ have been rescheduled from Schedule 3 to Schedule 0, after months of appeals to the Scheduling Committee of the Medicines Control Council (MCC). This herb has been proclaimed safe by many drug regulators around the world, and has an unblemished safety record when used responsibly. Last year this herb and / or silymarin was unilaterally recalled from all health stores and front-shop pharmacy shelves, forcing tens of thousands users to obtain these products with... Read More

TNHA REFUSES TO JOIN PHARMACEUTICAL INDUSTRY SECTOR BARGAINING GROUP Anthony Rees (Secretary-General: TNHA) Just over a month ago the CAMS Working Forum (CWF), of which the TNHA has been a member since its inception, met with Ms Joey Gouws, the Registrar of Medicines of the Medicines Control Council (MCC).  This was the second meeting which she has afforded the CAMS industry since the Health Products Association (HPA) launched its Gauteng High Court action in May 2014.  After the HPA suspended its court case, and after sustained pressure brought to bear on the MCC by the TNHA and HPA, it appeared... Read More

  TNHA JOINS THE INTERNATIONAL CHORUS AGAINST GMO CROPS Anthony Rees (Secretary-General: TNHA) During last weekend’s cold and rainy weather, hundreds of Captonians from all walks of life took to the streets of Cape Town to protest against Monsanto, as part of a global march on the same day in over 500 cities and towns across the globe. This was the TNHA’s first debut into lobbying for GMO-free food and the call for the ban on potentially carcinogenic (cancer causing) glyphosate, a common weedkiller manufactured by Monsanto as RoundUp, and found in other licenced products. The Monsanto Company has continually... Read More

DEMOCRATIC ALLIANCE PARTY SHUNS AFRICAN TRADITIONAL MEDICINES Anthony Rees (Secretary-General: TNHA) While on a visit to the friendly city of Port Elizabeth on Monday last week an article in the EP Herald proclaimed that the Democratic Alliance (DA) had voted on whether they would or wouldn’t support the inclusion of African Traditional Medicines (ATMs) into the Medicines & Related Substances Amendment Bill (Bill 6 of 2014). This took place at their federal congress in Port Elizabeth over the previous two days. This contentious Bill has been hotly debated by the Portfolio Committee on Health in Parliament for almost a year,... Read More

GOVERNMENT INTENDS REGULATING AFRICAN TRADITIONAL HEALERS AND THEIR MEDICINES Anthony Rees (Secretary-General: TNHA) By May 1st all African Traditional Practitioners were required to have been registered with the Traditional Health Practitioners Council, or face jail time for practicing illegally. However, almost a year after an Interim Council was set up and eight years since the passing of the Traditional Health Practitioners Act, it is still not functioning due to lack of government seed funding. The TNHA has been monitoring efforts by the government to regulate Traditional Healing Practice and African Traditional Medicines, and I have personally been following this process... Read More

CAM REGULATION CRITIQUE BEING HEARD BY GOVERNMENT Anthony Rees (Secretary-General: TNHA) Over the last 15 months, since the Medicines Control Council published its regulations for Complementary Medicines (CAMS) in November 2013, there has been little or no dialogue afforded between a growing number of aggrieved stakeholders and the Medicines Control Council (MCC), despite a plethora of requests for urgent clarity on matters affecting the manufacturing industry, health practitioners and consumers. It is rumored that various officials and sub-committee (CMC) members of the MCC received instructions from high up in Department of Health not to engage with parties who oppose the... Read More

BOILING THE FROG SLOWLY WITH CAM REGULATORY CREEP Complementary Medicines Regulations:  Unacceptable Regulatory Creep Anthony Rees (Secretary-General: TNHA) The ‘boiling the frog’ story is a widely-known anecdote describing a frog slowly being boiled alive. The premise is that if a frog is placed in boiling water, it will immediately react and jump out, but if it is placed in cold water that is slowly heated, it will not perceive the danger and will be slowly cooked to death. True or not, the metaphor could not be more fitting for the regulatory regime for the natural health product sector in South... Read More