Change in CBD regulation in South Africa

Regulatory experts at Webber Wentzel educate us on the recent change in CBD regulation: if CBD products contain less than 20mg for a daily dose, they will be considered over the counter products.


Constitutional Court ruling

Since the Constitutional Court, in September 2018, effectively decriminalised the possession, use and cultivation of cannabis in private dwellings in South Africa, there has been a rapid surge of cannabidiol (CBD)-containing products on the South African market.

CBD is an active non-psychoactive ingredient within cannabis which cannot make users of the product “high” as is the case with THC. THC is the other ingredient found within cannabis. The reported therapeutic benefits of CBD have resulted in it being featured in products, ranging from wellness, to dog treats and even in your morning smoothie.

The surge in CBD products was also spurred on by the uncertain and difficult regulatory regime that suppliers and distributers found themselves navigating.

Change in CBD regulation: from scheduled substance to OTC

CBD was considered a scheduled substance in terms of the schedules to the Medicines Act. This meant that products that contained CBD and were intended for therapeutic purposes could only be sold by pharmacists to consumers who held a prescription. This view was emphatically publicised by the South African Health Products Regulatory Authority (SAHPRA) in the media.

The Department of Health has since made a turnaround, by creating a significant space for CBD products to be sold to consumers. As of 23 May 2019, all products that contain a maximum daily dose of 20 mg of CBD, and are intended for general health enhancement or relief, are exempted from the operation of the schedules to the Medicines Act.

Arguably, products that fall within this threshold that are intended for therapeutic uses may still be required to register as complementary medicines with SAHPRA. But, once registered, will be capable of being sold directly to a consumer. In other words, CBD products which contain less than 20mg for a daily dose will be considered over the counter (OTC) products and may be sold openly in pharmacies, wellness stores and other outlets.

All products that contain a daily dose of more than 20mg of CBD will still be considered a scheduled substance in schedule 4 of the Medicines Act and would require a prescription to be sold.

Implications for commercial use of new CBD regulation

Notably, all processed products that contain naturally occurring CBD and THC (provided that no more than 0,0075% of the product contains CBD and not more than 0,001% of the product contains THC) may now be sold to consumers without any restrictions.

This change in the CBD regulations has implications for the commercial use of CBD in the manufacture of other products, including foodstuffs and alcohol. Before the recent amendment, consumer products, such as beer brewed from hemp seeds; hemp seed protein; hemp cooking oil; and even flax seeds were classified as scheduled substances by the authorities due the presence of trace amounts of CBD in these products.

The Department of Health’s announcement changes the legal status of these products and removes them from the strict regulation of the Medicines Act. These products may still, however, be subject to other regulatory regimes that govern foodstuffs and liquor.

These changes in the CBD regulations are exciting to the consumer sector and are music to the ears of suppliers of CBD products giving them scope to introduce their products into South Africa more easily. It will be interesting to keep an eye on SAHPRA’s attitude to the changes given that they will no doubt be flooded with registration applications in the coming months.

Exemption applies for one year only

While these changes signify the Department of Health’s relaxation of the regulation of CBD, the exemption applies for one year only. This signals that government is adopting a wait-and-see-approach before committing firmly to a policy position on CBD.

After last year’s Constitutional Court ruling, cannabis will also be squarely on Parliament’s agenda as they have been ordered to make changes to the laws regulating the private use of cannabis. This presents an opportunity for the public’s voices to be heard, not only regarding the private use of cannabis but also in shaping the approach to the commercialisation of cannabis derived products in South Africa going forward.

The recent change to the legal status of CBD, together with the issue of the first three licences to cultivate cannabis for medical use earlier this year by SAHPRA, signals a shifting perspective on the role of cannabis which will hopefully pave the way for the expansion of the cannabis market in South Africa in the near future.

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Megan Adderley has experience in judicial review proceedings in the High Courts and litigation relating to municipal powers and functions, providing strategic advice to private sector clients in negotiations with organs of state, preparing and presenting training workshops for local government officials, assisting in drafting the legal aspects of various government policies, advising on co-operative governance responsibilities of various organs of state and conducting due diligence investigations on potential projects and developments. She advises a wide range of clients including all spheres of government and private sector on the administrative and criminal enforcement of environmental, heritage and planning laws. Megan also advises non-profit clients on a wide variety of administrative appeals and reviews, and industry associations on the constitutionality of proposed amendments to legislation.


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Rodney Africa specialises in all matters relating to procurement, local government and general administrative law. He also practices constitutional, public private partnership and general regulatory and compliance law. Rodney has advised clients from both the public and private sectors, and has been involved in various matters relating to procurement, access to information, public decision making, public finance management, the valuation and rating of properties, and all aspects of land use planning and development law. He is an expert in matters involving the public sector and has advised on regulatory matters in a variety of industries. Rodney has extensive experience in litigation in respect of the above areas of law, with a specific focus on judicial review and mandamus applications, tender disputes, interdicts and declaratory relief. He has been a member of the audit committees of various local government departments.


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Deerah Pillay-Lungoomiah focuses on of public and regulatory law, administrative and constitutional law. She also has experience in advising on procurement law related matters. From a regulatory perspective, she has particular expertise in transport, renewables, tourism, tobacco and fishing.


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Adriano Esterhuizen is an expert in procurement, local government law, administrative law and constitutional law. He has extensive experience in dealing with matters relating to property rights, procurement, environmental law, land use planning law, legislation relevant to municipal governance, as well as general statutory and regulatory compliance matters. His services are open to public and private sector clients. He regularly litigates in both the Magistrates’ and High Courts and is able to assist clients with specialist review applications, tender disputes, interdicts and declaratory relief.


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The challenge of change

Rosemary Flynn explains the four changes needed when diagnosed with diabetes.


When you are diagnosed with diabetes, you have to make some important changes in your lifestyle to remain healthy. The main changes will be: to eat differently, to be more active and to take medications (whether they are tablets or injections).

All people find it difficult to change and it usually takes a whole lot of effort to establish the new way of living and thinking. As Einstein said, “We can’t solve our problems with the same thinking we used when we created them.”

So, what changes do you have to make with your thinking?

The first change:

Find out all you can about diabetes and how to apply the treatment you are given. That means you have to both gain knowledge and apply the new knowledge. You will have to unlearn some things and relearn another way to do it.

The second change:

You need to know that although a doctor can support you and prescribe the right treatment, diabetes is a condition that you have to manage on a daily basis, and you will need to practise a lot of ‘self-healing’.

With Type 1 diabetes, you have to figure out how much insulin to take for the meal you are about to eat. You have to know how to test your blood glucose and work out your dose of insulin. You have to know how to treat high or low blood glucose. You have to know how to exercise safely so that you don’t have hypoglycaemia.

With Type 2 diabetes, you have to know what food is good for you and try to stick to those foods. If you are usually a sedentary person, you have to become more active to keep your circulation healthy and reduce your insulin resistance. If you are overweight or obese, you have to make an effort to lose weight. You have to be conscientious about taking your medication.

The doctors and others on your diabetes care team can help and guide you, but you will have to practise these things on your own and take responsibility for managing your diabetes. Diabetes is not a condition where the doctor tells you what the recommended treatment is and fixes it for you. You have to work on your own body on a daily basis, making decisions that will keep your body as healthy as possible. You can’t just live from a previous appointment to the next appointment to care for yourself.

The third change:

This change, you need to make, is in your attitude towards having a chronic condition. You have to move onwards from the disappointment and distress of having diabetes, to accepting it and learning to work with it. Then, you will develop the right attitude towards it which will enable to manage it successfully.

The fourth change:

Develop a working relationship with your doctor, so that you feel free to discuss your pitfalls and problems without feeling judged or criticised.

If your doctor does too much, you will not do enough. If your doctor is too critical or judgemental about your control, listen to what he/she is criticising. If he/she is right, work on the first three changes and try to achieve better control. If he/she is wrong or does not understand your situation, or involve you in decision making, tell him/her the truth about the matter. If he/she remains critical and judgemental after you have addressed the situation, change doctors, but remember that ultimately, you are your own best doctor.

Changes worth making

It can take many months to feel comfortable with the new lifestyle, and you will be able to develop internal motivation to continue your new lifestyle. You will feel less distressed about your diabetes and you will be able to act on your knowledge to manage well even in difficult times. There may be occasions when you feel like giving up, but these will become fewer as you become more resilient and able.

Success feels good and when you feel healthy, you feel good. Now you are ready to develop a new appreciation for life and your purpose in it. It really is worth making the changes!

Rosemary Flynn

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Rosemary Flynn is a clinical psychologist at the Centre for Diabetes in Johannesburg. She has worked with children, families and adults with diabetes for 24 years, enabling them to overcome their anxieties about their condition and to deal with the difficult events in their lives.


Agents for Change by Noy Pullen

Happier healthier lunch boxes for children

Why does a 30-second video called Japanese school lunches puts the rest of the world to shame have more than 42 million likes in a few days? What is the project The Grab 5 doing right when they can claim: ‘There definitely has been an improvement in behaviour and children are healthier now than they were a year ago’? Lunch boxes are changing. Lunch time is seen as part of education, not a break from it. Will South African schools join in happier healthier lunch boxes?


Criteria

The World Health Organisation and the Basic Dietary Guidelines recommends that at least five portions of rainbow coloured food are consumed every day as part of a balanced diet. This advice is easy to understand and remember in theory, and psychologically strengthening, because it does not ask us to give something up. But, sadly, this is not happening.

The Diabetes South Africa (DSA) Agents for Change team knows that in the rural areas, most meals consist of brown and white (very little colour). According to a British project, The Grab 51, some children do not even have one coloured piece of fruit or vegetable per day.

Agents for Change model

We, at Agents for Change, target health providers, patients and families living with and working with diabetes and share creative ideas for changing habits. At a recent site visit with our international funders, World Diabetes Foundation, their project manager, Hanne Strandgaard, accompanied us to the Red Cross War Memorial Children’s Hospital in Rondebosch, Cape Town. We interacted with parents and children at the diabetes clinic and demonstrated simple effective ways of presenting healthy, economical and enticing food options.

Dr Steve Delport, the consulting endocrinologist, told us that his little patients kept darting in and out of his rooms to fetch another snack. The snacks definitely passed the taste test, especially the green grapes which Hanne placed on tooth picks and called green balloons. Her ‘boiled egg mice’ were also popular.

Happier healthier lunch boxes
‘Boiled egg mice’ with Vienna or ham slices for ears and chive tails prepared by Hanne Strandgaard from World Diabetes Foundation, Denmark.
Happier healthier lunch boxes
Noy Pullen replenishing a platter for the food demonstration of healthier snacks at the Diabetes Clinic at Red Cross War Memorial Children’s Hospital in Cape Town.

The fathers were most interested in tasting all snacks and finding out how to make them. Those who took part in this demonstration also had fun choosing from the available variety of tomatoes, cheese blocks, Vienna rounds, grapes, pawpaw, apple slices, and building their own ‘toothpick towers’. They were overjoyed at being given a copy of the booklet Rainbow in my kitchen14, which contains ideas of how to shop for a basic pantry, and recipes using whatever you have.

Self-feeding vs spoon-feeding

According to recent studies on eating habits of babies, nutritional ‘schooling’ starts long before schoolgoing age. Early healthy nutrition develops healthy balanced thinking processes and develops the subtle sense of knowing when you have had enough to eat.

Recent UK studies show that spoon-fed babies are more likely to become obese children6. If someone else shovels in the food (with the best motives), this bypasses this subtle sense. Let the children guide the way to what and how much they want to eat. The study shows that the self-feeders had a lower obesity rate than the spoon-fed children. Allowing them to choose from a selection of finger foods means they learn to regulate the amount they eat and are less likely to become overweight. They are also more likely to opt for healthier options than spoon-fed babies, who tend to favour sweet things.

The study suggests infants weaned through the baby-led approach learn to regulate their food, resulting in lower body mass index and a preference for healthy foods. This has implications for combating the well-documented rise in obesity in society. Tam Fry, from the National Obesity Forum, said, “Babies have this wonderful rapport with their mother when breastfeeding and indicate how much milk they want and when they are ready to go on to solids.” Adding, “It is important they experience all five food groups and experiment with variety as much as possible. If half of it finishes on the floor, so be it – the value of experimentation in the early months of nutrition is incalculable and babies won’t willingly starve themselves.”

The study comprised 92 children who had been weaned on finger foods and 63 who were traditionally spoon-fed. Parents filled in questionnaires on how their children had been weaned, including how often they ate certain foods when they were aged six months and six years.

The Grab 5 project research

Aiming for a holistic approach to school lunches and healthy tuck shop, they found:

  • Well-fed pupils are calmer and concentrate better.
  • Well-fed pupils have fewer days off due to illness.
  • School food activities, such as tasting events and playground markets, are good ways to involve parents and community groups in school life.
  • School food activities, such as cooking, growing and tasting, are often good ways to engage children that are otherwise reluctant to get involved in school life.
  • Serving meals and snacks increases school revenue and children develop a positive attitude towards what they eat.
  • Curriculum links with food projects and events bring subjects alive and are responsible for healthier more socialised children1.

How can we change the school food environment?

  • Free fresh fruit and vegetable food tasting tables offered to pupils at the tuckshop. This would be a gradual means of finding out what they like and introducing them to new foods textures, colours and combinations.
  • Integrating talks on nutrition about all food groups and their service to the body – energy foods (carbohydrates), protection foods (vegetables and fruit), nutrients (milk products), building foods (meat and other protein) and food that protects our nerves (fats)4. Tasting tables prepared by children in the classroom.
  • A visit to a fruit and veg shop or food farmer.
  • Introducing practical demonstrations of how to put food together in balanced, fun healthy and economical combinations. This could be done in the form of fund raising projects, and help to wean children off the unhealthy options offered in tuck shops.

  • Introducing all aspects of food into the curriculum in each age group. This would involve maths – budgeting, ordering and invoicing, being able to apply the concept of a planned balanced meal; science – cooking, processes of heating and freezing; biology – learning the various components of hygiene, digesting and nutrition, portion sizes etc.; life-skills – co-operation through supervised preparation of and cooking of simple dishes and clearing up; geography – cultural differences in serving and eating; horticulture – encouraging children to ‘grow their own’ simple bean or spinach plants and to demonstrate sprouting of various pulses and seeds for immediate micro-nutrients.
  • Developing new standards for the tuck shop stock e.g. practical fruit and vegetables options, bread sticks, plain popcorn or sprinkled with healthy herb salts, crumpets with honey, natural yoghurt with chopped fruit and toasted snacks5,6,7,8,9,10..
  • The more children taste different kinds of fruit and vegetables, prepared in different kinds of ways, the more they will learn to like them. It is a learning curve for children to try new foods. Exploring new tastes is an educational adventure in itself.

A working model for schools

In Japan, children’s lunch time is part of the curriculum, where fresh simple meals are made from scratch by pupils in rotation for less than $2,50 (roughly R35) per day. They study the menu and cultural history, and assess the nutritional value. The children prepare, cook and serve the meal and then clear up. This teaches cooperation and manners. They harvest from their own gardens where possible. It is no wonder that they have one of the lowest obesity rates in the world.

As the first verse of the song The Greatest Love of All says:

I believe the children are our future
Teach them well and let them lead the way
Show them all the beauty they possess inside
Give them a sense of pride to make it easier
Let the children’s laughter remind us how we used to be

Please contact Noy Pullen if you would like more information on her resources: [email protected] or 072 258 7132.

Agents for Change by Noy Pullen

African traditional medicine and Western medicine:

how, when and where can we meet?

The significance of the traditional healer in contemporary society

The World Health Organisation (WHO) estimates that 80% of people in Africa regularly consult traditional healers, and advocates incorporating safe and effective traditional medicine into primary healthcare systems1.

South Africa was one of the first countries to recognise the significance of collaboration. In 2005, parliament approved a law to recognise the country’s estimated 200 000 healers as healthcare providers in an attempt to bring traditional healers into a legal framework2. Recent meetings, held in Pretoria, have strengthened relationships and possibilities for collaboration between the Department of Health and the recognised traditional medicine organisations.

Credo Mutwa – renowned Zulu sangoma and author – experienced both Western Christianity and traditional African folklore as a child. In his view, traditional and modern medicine both serve the well-being of their patients and contribute to a healthy community. However, traditional healing encompasses body, spirit, the personality and ancestors of a patient, and the prescription of traditional medicine, whereas the formal health sector tends to focus on specific symptoms, treating the disease rather than the individual situation3.

Dr Velaphi Mkhize, an initiate regarded as an authority on African traditions, culture, ancestral wisdom and African healing, pleads for recognition of both disciplines in his comprehensive article: ‘Africa’s two worlds of healing: their challenges’. As the origin of both is Ancient Egypt, Western medicine should acknowledge the African uniqueness of being able to heal both the physical body and the soul, which allopathic medicine does not claim to do. Some conditions cannot be cured by Western medicine and others cannot be cured by African medicine so the two systems need each other in service of all South Africans. He posed the question: How can we marry the two for the betterment of our communities and for humanity?4

Can training in diabetes management emulate the success of the HIV/AIDS model in KwaZulu-Natal?

The South Africa prevalence (> 7%), increasing and risk factors (BMI, obesity and cholesterol levels) for diabetes make a case for urgent intervention and cooperation of health practitioners in all our communities5. Dr James Hartzell, a professor at South Africa’s University of KwaZulu/Natal medical school, initiated a project to improve collaboration between doctors and 350 healers trained in caring for people with HIV/AIDS.

In his experience, people take their traditional healers seriously, and when the healers are willing to be trained, they recognise symptoms and refer to the health facilities. When referring patients to the clinics, they wish to be regarded as part of the team. According to Dr Hartzell, “They are just asking for at least basic information back from the biomedical team, which is often hostile to them, such as what were patients given in terms of treatment.”

The training of 350 healers included prevention, voluntary counselling and testing, home-based care and antiretroviral therapy. The healers are empowered to make an impact on patient compliance and management when there is collaboration with the biomedical team. Traditional healers can assist with advice on good nutrition, lifestyle changes, a positive attitude, and many good herbal remedies strengthen the immune system6. Together with the formal healthcare sector, they could ensure improvement in diabetes awareness, prevention and management.

Why are they sidelined?

For the most part, healers, according to Itai Madamombe, a United Nations staffer, are not officially recognised by governments. Not including them in the formal structures could have serious consequences. Patients, putting their trust in the healer, may disregard their medical doctor’s advice or take herbal medicines without regard for possible dangerous interactions with pharmaceuticals. By working with these healers, doctors would find colleagues in the patient’s own community7.

Collaboration with all stakeholders

As an outreach project of Diabetes South Africa (DSA) – Agents for Change – seeks to empower all those living with (i.e. patients and families) and working with (i.e. health providers) diabetes-related conditions with knowledge and skills, so they can collaborate as a team.

Traditional doctor and community leader, Joseph Makhubu, recently heard about the project and, with great enthusiasm, booked 30 traditional healers and invited us to Duduza Township in Ekurhuleni to offer the first module of the Agents for Change training. This module focuses on the pathophysiology of diabetes, signs and symptoms, risk factors, and the significance of lifestyle changes of the participants themselves.

He explained that the formal health sector has shown continued interest in the role of sangomas and the efficacy of their herbal remedies. Some of which are being researched include buchu, aloe and Sutherlandia frutescens. On the other hand, traditional healers were most willing to be a part of the diabetes team and to learn more about diabetes and how the two disciplines can collaborate for the benefit and health in the communities.

Dr Henning Morr – a medical doctor supporting departmental programmes, training and research, including community health and community development – works with traditional doctor Joseph Makhubu. Their research found that traditional healers empowered with basic medical knowledge feel safer in their decisions and have more patients. ‘Co-educational’ training is requested, role plays, dialogues, not aiming at shifting traditional healers to the modern system, but rather to understand and find ways of collaboration8.

A role play between Dr Ethel Ndlovo Phillips and traditional doctor Joseph Makhubu during the Agents for Change project.

A role play between Dr Ethel Ndlovo Phillips and traditional doctor Joseph Makhubu during the Agents for Change project.

How, when and where can we meet?  

In the South African medical Journal, J P de V van Niekerk, posed the question: how is it possible for such a diverse and often conflicting range of systems and views to be accommodated sensibly, peacefully and to the benefit of South Africa’s people? He concludes in his editorial, that establishing a council for traditional healers could face insurmountable problems. However, acceptance and respect for their respective domains of truth has enabled health professionals to collaborate successfully with traditional healers to address some of South Africa’s major health challenges9.

References:

  1. Traditional healers boost primary health care – Reaching patients missed by modern medicine Itai Madamombe <http://www.un.org/africarenewal/taxonomy/term/290> : Africa Renewal: January 2006 <http://www.un.org/africarenewal/taxonomy/term/322>  www.un.org/…/traditional-healers-boost-primary-health-care
  2. Ibid
  3. http://credomutwa.com/books/zulu-shaman/
  4. http://soaha.org.za/wpp/africas-two-worlds-of-healing-their-challenges
  5. http://www.idf.org/membership/afr/south-Africa
  6. http://soaha.org.za/wpp/africas-two-worlds-of-healing-their-challenges  (Footnote 1)
  7. Ibid
  8. 2010: Morr H., Makhubu, J., McKay V.: “Primary health care and traditional health practitioners (THP): lessons learned from a comprehensive health and life skills pilot project in Duduza, South Africa” Oral presentation, Traditional Medicine Conference, Durban, July 2010.
  9. South African Medical Journal March 2012, Vol. 102, No. 3 SAMJ editorial www.samj.org.za/index.php/samj/issue/view/123/showToc