New Laws Governing Alternative and Complimentary Health Products
Created: 11 April 2014
Latest date Modified: June 2017
(As no information to the public seems to be readily available, this article has been compiled for our customers’ information. It is an interpretation only, so please follow the various links to other articles containing more information.)
As of 1 June 2017, the new Medical Laws comes into effect, with 6 months to conform before legal action will be taken against any manufacturer, distributor or reseller of any and all unregistered products deemed 'medicine' by the new Medical Enforcer SAPHRA.
With effect from June 1 2017, the Medicines and Related Substances Amendment Act, No 72 of 2008, came into force by proclamation by the President of the Republic of South Africa.
The coming into force of the Amendment Act is significant insofar as it shifts and fundamentally changes the medicines regulatory regime in South Africa, and alters the Medicines and Related Substances Act, No 101 of 1965, as amended (the Medicines Act).
The Amendment Act of 2008 must be read together with a further Amendment Act, being the Medicines and Related Substances Amendment Act, No 14 of 2015. Both Amendment Acts come into force simultaneously and give effect to numerous amendments to the Me-dicines Act."
https://www.timeslive.co.za/news/2017-06-15-a-new-regulatory-br-regime-for-medicines-br-comes-into-force-in-sa/ (Copy and Paste links please)
8 January 2015
It is with optimism that we would like to notify Healing Oil Product clients that the definition of 'Natural Medicines' has been officially deleted from the new laws regulating medicines, hopefully ending three years of uncertainty and turmoil in the complementary and alternative health industry.
You may expect a slow re-introduction of natural medicines back onto the shelves from companies that have survived this onslaught, be it very few, as many have simply closed down, whereas the larger, more lucrative companies have been bought over by mainstream pharmaceutical companies.
We have been informed that we are one of only a handful of companies in our market segment that has managed to stay independent and will strive to continue doing so.
24 October 2015 -
The Press Release states that the Committee adopted the Medicines and Related Substances Amendment Bill (B6D-2014) after 'deliberations and considerations'.
The Bill will now be forwarded to the National Council of Provinces. All provincial delegations voted in favour of the Amendment Bill.
Please read my comments here.
In November 2013, stringent regulations to control the Complementary and Alternative Medicines (CAMS) industry were published by the Minister of Health.
It is predicted that 60-80% of natural health supplements (and now also natural skin products) currently on the market will disappear from shops.
Unrealistic regulations will make it impossible for smaller companies to survive because of the millions of rands per product needed to comply, resulting in the cost of tens of thousands of South African job losses across all affected industries from farm to store, as well as Health Stores closing their doors.
Articles of interest:
Medicines and Related Substances Bill Raises Red Flags When Special Interest Runs Health Department https://www.uspiked.com/health/2015/05/25/medicines-and-related-substances-law-raises-red-flags/
Join the TNHA - Traditional & Natural Health Alliance - Become a Member - Your call to action in keeping Original Traditional Medicine alive in South Africa
1 August 2014 Odyssey Magazine- Odyssey Magazine PDF update on draconian CAMs Regulations (Note this article has since been removed from the Odyssey website)
Of vital importance see page 29 - Secret accord behind new Complimentary and Alternative registrations / laws?
Natural Health Alliance - Open letter to Industry 24 July 2014: http://naturalhealthalliance.co.za/LettertoIndustry.htm
Public update regarding CAMs aired on DSTV 6 July 2014 by Carte Blanche: http://carteblanche.dstv.com/player/574814/
New Laws governing Alternative and Complimentary Health products came into effect in November 2013. These are some highlights that concern all end users, i.e. The Public.
Obligatory Disclaimer for all (yet) unregistered medicines (products) as per new laws governing Complimentary and Alternative Medicines in South Africa: The information on this website and all consumer information brochures are intended for educational purposes only. Neither the statements nor the medicines (products) have been evaluated by the MCC. These medicines (products) are not intended to diagnose, treat, cure or prevent disease. Anyone suffering from any disease, illness or injury should consult with a qualified, registered health care professional.
As no claims regarding efficacy of any products may be made until said products have been evaluated and registered with the MCC, CAMs may only state that these products (now officially called medicines and regulated as such), which natural ingredients have been used traditionally for thousands of years by man as a means of alleviating or preventing the discomfort of ailments, may assist with specified discomforts.
What new legislation means for the end user:
Alternative and Complimentary products (medicines) registered with the MCC will have the full backing of scientific proof of efficacy, with assurances to the end user that the product (medicine) was manufactured to the highest standards in certified laboratories from ingredients free from harmful substances, and is regulated and sold as 'proper' medicine by licensed, qualified, knowledgeable and accountable companies.
Products (medicines) not conforming to standards will be recalled as per date stipulated in the amended act. Some high risk substances have already been removed from the supply chain.
The manufacturer and distributor of the 'newly' registered alternative medicine will also have to comply with a host of regulations, registrations and licences in order to sell their medicines (products) legally to the public.
The (un-guaranteed) process of registering an alternative or complimentary product will in most regards be similar to a patented chemical or pharmaceutical product. This will most assuredly result in the cost of manufacture drastically increasing and a host of products not being available to the public any longer.
As more information becomes available we will pass it on to interested members of the public.
What is a CAM?
Nov 2013 Extract from (Note: Article removed - Link no longer landing on CAMS)
" 2. DEFINITIONS
DEFINITIONS - TERMS
"Complementary and Alternative Medicines and/or Substances"include but are not limited to the medicines and remedies pertaining to all of the"CAMs Paradigms", which include"African Traditional Medicine";"Anthroposophical Medicine";"Aromatherapy";"Ayurvedic Medicine";"Biochemical Tissue Salts";"Chinese Medicine";"Energy Substances";"Gemmotherapy";"Herbal Medicine";"Homoeopathic Medicine";"Homotoxicological Medicine";"Mineraloids";"Nutraceuticals";"Nutritional Food Substances"; "Orthomolecular Medicine"; "Sowa Rigpa Medicine"and"Unani-Tibb Medicine", that :
2.1.1. are complementary to the innate healing power of the human being or an animal; and/or
2.1.2. are medicines, substances, or mixtures of substances, including foods containing ingredients, which originate from plants, minerals or animals and include sarcodes, nosodes, allersodes, or isodes; and/or
2.1.3. are used or intended to be used for, or manufactured or sold for use in assisting the innate healing power in humans to mitigate, modify, alleviate, or prevent illness, abnormal physical or mental state or the "Symptoms" thereof in humans and animals.
and"CAMs"will have the same corresponding meaning.
"African Traditional Medicine"means the sum total of all knowledge and practices based on the African Tradition, whether explicable or not, used in diagnosis, prevention and elimination of physical, mental, or societal imbalance, and relying exclusively on practical experience and observation handed down from generation to generation, whetherverbally or in writing."African Traditional Medicines"are formulated on the basis of this Tradition and Knowledge.
"Anthroposophical Medicine"means a holistic extension of modern medicine and the art of healing. The Anthroposophical understanding of man and nature is not only based on the physical body, but also on knowledge of different aspects of the human being, namely the life (etheric), soul (astral) and spirit (ego) organisations. The process and functions of the body underlying these four aspects are differentiated into three corresponding and interrelated systems, namely the nerve-sense, rhythmic (circulatory and respiratory) and metabolic movement systems. It is through these systems that the individual, in thinking, feeling and willing, interacts with the world. Anthroposophical medicine treats illness and associated"Symptoms"by correcting disturbances within these interrelationships, thereby reinstating a healthy balance. Medicines are formulated in conjunction with the foregoing understanding.
"Aromatherapy"uses volatile oils to bring about "healing". These volatile oils contain odiferous elements of the plant which are produced by several methods. Methods include but are not limited to steam or water distillation of vegetable plant matter, the mechanical pressing of peels or via CO2extraction and / or other distillation methods that are used only for their therapeutic purposes. Aromatherapeutic essential oils include but are not limited to all essential oils, attars and absolutes.
"Ayurvedic Medicine"means medicines that are manufactured according to Ayurvedic principles from plant, animal or chemical substances. Both single herbal or combination preparations (formulae) are used. Ayurveda means "the science of life" (Ayus– life;Veda– science). Ayurveda is an ancient practitioner and health care system that emphasises the prevention of"Disease"and the promotion of good health through diet, exercise, daily routines, rejuvenation procedures, food supplements and medicines.
"Biochemical Tissue Salts"means a limited number of mineral compounds, which are present in the human body in their elementary form. They include the 12 biochemical medications designated by Dr Schuessler and twenty-seven other adjunctive biochemical medications as well.
"Chinese Medicine"means practices according to the age old traditional systems of China. It includes medicines that contain herbal, mineral and animal substances in order to maintain health and treat ill health. The substances are usually used in traditional formulations or as single substances together with modalities or techniques such as acupuncture moxa and massage to treat ill health.
"Energy Substances"means substances such as magnetised water; flower, gem and other nature essences; mixtures of coloured water and/or oils that facilitate healing, for example, aura soma oils and sprays. These substances operate on the principle of ‘vibrational’ healing.
"Gemmotherapy" means a therapeutic method which, prompted by principles of homoeopathic drainage uses plant bud extracts or other embryonic vegetal tissue which is freshly harvested from the growing plant. It utilizes substances which include ethanolic / glycerine macerates that are prepared from fresh, embryonic young plant tissue such as young shoots, rootlets, inner bark of roots, stems or and plant sap.
"Herbal Medicine" means any plant material or a multi-component material derived from a plant that is used for medicinal purposes. These plants include lower plants such as non-pathogenic fungi, algae and lichens but not including bacteria or cyanobacteria [blue-green algae]. They include extracts, isolates or derivatives of these substances.
"Homoeopathic Medicine"means any substance or mixture of substances, preparation, compound, product, or thing which:
2.11.1. is compounded, formulated, manufactured, prepared, manipulated, altered or adjusted in accordance with homoeopathic principles, techniques or philosophy;
2.11.2. is obtained by a method of successive dilution and succussion and / or trituration whether achieved manually, mechanically or whatever scale of dilution; and
2.11.3. includes but is not limited to starting substances, nosodes, allersodes, isodes and sarcodes.
"Homotoxicological Medicine"means any substance or mixture of substances, preparation, compound, product, or thing which:
2.12.1. is compounded, formulated, manufactured, prepared, manipulated, altered or adjusted in accordance with homotoxicology principles, techniques or philosophy;
2.12.2. is obtained by a method of successive dilution and succussion and / or trituration whether achieved manually, mechanically or whatever scale of dilution;
2.12.3. includes but is not limited to starting substances, nosodes, allersodes, isodes and sarcodes.
"Mineraloids"means original biochemic cell salts essential to cellular structure and function in material form, used according to the principles of Fisher’s Mineral therapy, singly or in combination.
"Nutraceuticals"means any natural or nature identical food or food component, extract, salt, derivative or concentrate, thereof. A nutraceutical includes vitamins, minerals, fats, fatty acids, phospholipids and sterols, protein, peptides and amino acids, carbohydrates and fibre (soluble and insoluble), organic alcohols, enzymes, antioxidants, bioflavonoids, animal foods, plant foods, and probiotics, as well as salts and derivatives thereof.
"Nutritional Food Supplement"means a preparation intended to supplement the diet and provide nutrients which include any natural or nature identical food or food component, extract, salt, derivative or concentrate, thereof. A Nutritional Food Supplement includes vitamins, minerals, fats, fatty acids, phospholipids and sterols, protein, peptides and amino acids, carbohydrates and fibre (soluble and insoluble), organic alcohols,
antioxidants, bioflavonoids, animal foods, plant foods, and probiotics, as well where applicable, salts and derivatives thereof.
"Symptom"means any subjective evidence of"Disease"or of a patient’s "Condition", that is, such evidence as perceived by the patient and / or health practitioner.
"Orthomolecular medicine"means a form of complementary and alternative medicine aimed at maintaining health through nutritional supplementation. It is sometimes referred to as megavitamin therapy as the practice often uses doses of vitamins and minerals many times higher than the recommended Dietary Reference Intake. Orthomolecular practitioners may also incorporate a variety of other treatment modalities into their approaches, including dietary restriction and mega doses of non-vitamin nutrients. The term "orthomolecular" was coined by Linus Pauling to mean "the right molecules in the right amounts with treatments based on patients' individual biochemistries.
"Sowa Rigpa Medicine"conforms to the Traditions of Tibet, and means medicines which are manufactured and/or formulated according to the principles of Sowa Rigpa from substances traditionally used, i.e. plant, animal, mineral or chemical substances, and addresses the state of health and/or"Disease"in the human body in order to preserve, maintain or restore health.
"Unani-Tibb Medicine"means a medicine that is manufactured and/or formulated according to the original patho-physiological, diagnostic and therapeutic system of the humoral theory of Greek medicine using plant, animal, mineral or chemical substances in order to preserve, maintain or restore health.
"CAMs Paradigm"means the different paradigms relating to CAMs that are based on different belief systems. Each differs with respect to how it views the world and the human being. Each"CAMs Paradigm"has its own philosophical and theoretical framework that stems from the underlying belief system on which the theories, laws, assumptions and values intrinsic to it are based. Many have existed for hundreds and even thousands of years. No"CAMs Paradigm"is superior or inferior to the other. "
Definitions of CLAIMS:
Extract from: Link broken - Article REMOVED http://www.asasa.org.za/Default.aspx?mnu_id=126
" DEFINITIONS – DESCRIPTOR WITHOUT CLAIMS AND INDICATIONS
"Descriptor without claims and Indications"means a descriptor that contains no claims, whether direct or indirect, which refer to "symptoms" and as such are neither "Low Risk Level claims and Indications" nor "high risk level claims and Indications". Examples include descriptors such as: "Antioxidants; Multivitamins; Minerals etc."
DEFINITIONS - LOW RISK LEVEL CLAIMS AND INDICATIONS
"Low Risk Level claims and Indications" include "health claims and Indications"; "vitamin and / or mineral supplementation claims"; "relief of symptoms claims"; "reduction of risk of a disease claims"; "structure - function claims"; "reduction in frequency of a discrete events claim"; and / or "claims of aiding or assisting in the management of a named symptom" when not attached to a High Risk Indication or Claim and provided that they are, where applicable :
1. "Self-diagnosable"; and
2. are "Self-limiting in the acute situation"
3. and contain the on-pack statement "If symptoms persist consult your healthcare practitioner after a suitable period of time" or words to that effect. The suitable period of time must be explicitly stated.
means consumers are able to diagnose the "Condition" themselves.
"Self-limiting in the acute situation"
means that if the "Condition" is not treated it will become better with time on its own accord. Sometimes there are exceptions where the ‘self-limiting in the acute case’ criteria are not applicable. For instance, this can apply to "Conditions" such as corns, where the "Condition" in the acute case is not self-limiting but is also not dangerous, - although it is not self-limiting.
"Health Claims and Indications"means"Health Maintenance Claims including Nutritional Support claims"and / or"Health Enhancement Claims".
"Health Maintenance Claims including Nutritional Support claims"
means"Claims"or"Indications"that refer to an effect a product or substance may have in maintaining health (or words to that effect). They may also relate to the normal physiological consequences for good health associated with a product or substance, or to the provision of nutritional support and to the use of the terms, cleansing, detoxification and tonic.
"Health Enhancement Claims"
means"Claims"or"Indications"which relate to health enhancement for normal healthy people, such as "improving", "promoting", "enhancing" or "optimising" (or words to that effect) body organs or systems.
"Vitamin and / or Mineral Supplementation claims"means"Claims"or"Indications"referring to the supplemental intakes of a vitamin or mineral.
"Relief of Symptoms Claims"means"Claims"or"Indications"relating to the relief from"Symptoms"but are not related to a named"Disease"/"Disorder"or"Condition". They relate specifically to the temporary relief of a particular"Symptom".
"Reduction of risk of a Disease claim"means"Claims"or"Indications"relating the reduction of risk of a particular"Disease","Disorder","Condition","Symptom"or ailment.
"Structure - Function Claims"means"Claims"or"Indications"that focus on maintaining or supporting particular body structures or functions, such as supporting bone cartilage integrity, or maintaining healthy intestinal flora. They do not focus on"Disease".
"Reduction in frequency of a Discrete Events claim"means"Claims"or"Indications"referring to the ability of a product or substance to reduce the frequency of a discrete event such as a migraine, which has an observable beginning and end.
"Claims of Aiding or Assisting in the Management of a Named Symptom"means"Claims"or"Indications"which relate to aiding or assisting with the treatment or prevention of named"Symptoms"and are"Low Risk Level Claims and Indications".
Claims which relate to Aiding or Assisting with pre-diagnosed conditions
will be considered to be Low Level Risk Claims when used together with the statement, "Aids and assists in the treatment of [‘pre-diagnosed’ condition]".
"Claims of Aiding or Assisting in the management of a named disease"; "Claims of Aiding or Assisting in the management of a named "Disorder"; "Claims of Aiding or Assisting in the management of a named condition"
have the same corresponding meaning.
DEFINITIONS - TRADITIONAL USE:
"Traditional use"means use of the designated active ingredient/s that:
2.30.1. Is/are well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over a period of time; and
2.30.2. accords with well-established traditional procedures of preparation, application and dosage.
DEFINITIONS - HIGH RISK CLAIMS AND INDICATIONS:
"High risk level Claims and Indications"means reference to serious"Diseases"or"Disorders"and which relate to the:
2.31.1. Treatment, cure or management of a serious
"Claims"to be able to prevent a serious"Disease"/"Disorder"or"Condition".
"High Risk Level Claims and Indications"means"Claims and Indications"that exceed the Low Risk Level Criteria of Self Diagnosable, Self-Limiting together with the appropriate consumer warnings to consult a health practitioner if the condition persists."
* * *
Extract below from a presentation found on the website of the Regulating Complementary Medicine in South Africa, Allied Health Professionals Council: Vassen, 12.05.2007
* * *
Copy of amended bill to date: http://www.saflii.org/za/legis/consol_reg/marsa101o1965rangnr510723/
Interpretation of the new regulation by Werksmans Attorneys:
Complementary and Alternative Medicines (CAMs): Know the basics,BRAND ACTIVITY, Apr 3rd, 07:56
Amendments to legislation
MCC website with links (Note: ALL links broken/404 errors/pages no longer exist)
Links to presentations done