Herbalism is an ancient and respected form of medicine. The use of plants for medicinal purposes is an integral element of all cultures and has played a significant role in healing since prehistoric times. Also known as phyto medicine or botanical medicine, herbalism refers to the use of a plant’s seeds, berries, roots, leaves, bark, fruits or flowers for therapeutic purposes. Herbalism is the science of using plants for treating and managing various conditions – from minor health complaints to serious illnesses – and the art of utilising nature’s medicine to protect and augment health and prolong life.
The power of plants is once again gaining momentum and recognition in scientific circles. According to a recent analysis from Kew Gardens in the United Kingdom, there are over 28 000 plants currently being used as medicine throughout the world. The second annual report from Britain’s Royal Botanic Gardens at Kew, London, is the result of the research and analysis by 128 scientists from 12 countries around the globe. According to their findings, there are 28 187 plants “currently recorded as being of medicinal use.”
To view the report: https://stateoftheworldsplants.com/2017/useful-plants.html
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REGULATORY UPDATES FROM THE MCC
On Tuesday, 23 May 2017, HPA Technical & Regulatory Affairs Director, Wayne Robinson, and HPA Exco Committee Member, Celecia Pleass, attended a meeting in Pretoria with the Medicines Control Council (MCC) at which MCC and Department of Health (DoH) members, Dr Joey Gouws, Dr Jeanette Lotter and Dr Kaizer Thembo were present. The HPA submitted specific questions to be answered.
Various subjects were discussed. First and foremost was the Regulations issue. The DoH revealed that Regulations were anticipated to be published in the near future. The government representative stated that the South African Health Products Regulatory Authority (SAHPRA) would officially go ‘live’ when its first meeting is held, but the Health Minister would first have to sign off on the Regulations for this process to be enacted. SAHPRA, however, will not fall under a government department.
There is still a problem with the registration of CAMS products and the lack of feedback on the dossiers submitted according to the Discipline Specific CAMS Roadmap. The government delegates advise that, “Health Supplements are not yet ‘in law’ and it is still uncertain whether they will have a separate road map or will be a part of the current road map. If a health supplement is submitted now, there is no regulation for it to be assessed under, so will therefore be assessed under Category A. It is suggested that submissions for health supplements are not made until there is regulatory clarity.”
Other subjects discussed included the HPA/MCA alliance, Section 18C, Bonusing and Commissions, Customs / Port Health and GMP Licences.
ORGANIC PROFITS SURGE
Going organic is reaching all-time highs in the United States. The American organic food market has for the first time broken through the $40-billion mark, reaching a high of $47-billion. According to the Organic Trade Association (OTA) 2017 Organic Industry Survey, organic sales in 2016 reflected new sales of almost $3.7 billion from the previous year. Organic food now accounts for 5.3% of total food sales.
“The organic industry continues to be a real bright spot in the food and ag economy, both at the farm-gate and check-out counter,” said OTA’s CEO and Executive Director, Laura Batcha. “The theme of our conference is ‘Organic. Big Results from Small Seeds’ because of the wide and positive impact of organic. Organic farmers are not just staying in business, they’re often expanding. Organic handling, manufacturing and processing facilities are being opened, enlarged and retooled. Organic farms, suppliers and handlers are creating jobs across the country, and the organic sector is growing and creating the kinds of healthy, environmentally friendly products that consumers are increasingly demanding.”
According to Dublin, Ireland’s Research and Markets, the global organic food and beverage market is expected to reach $320.5 billion by 2025, up from $77.4 billion in 2015: https://www.researchandmarkets.com/reports/4240439/organic-foods-and-beverages-market-analysis-by#pos-0
HPA AND MCA JOIN FORCES FOR THE ETHICAL MARKETING OF HEALTH PRODUCTS.
The HPA has formally signed a Memorandum of Understanding with the Marketing Code Authority (MCA). This alliance aims to support credibility and accountability for the dietary supplement/CAMS industry and its products. The HPA-formulated CAMS Marketing Code has been incorporated into the MCA Code in order to provide HPA members with a CAMS-specific approach to marketing and advertising.
The HPA assures its members that any CAMS-related complaints tabled with the MCA will be handled by a committee which includes, where possible, CAMS-cognate people. The MCA Code has provisions for managing vexatious complaints, and therefore all procedures and rulings will be conducted strictly according to the Code. Membership of a body of this nature will provide customers and consumers with the verification that these products are subject to a Code of Ethics, and that the related company has committed to being responsible. Should a complaint be tabled against your company or product, being a member of the MCA will be invaluable to the process of handling such a complaint.
MCA Chairman, Wayne McDuling, and MCA Executive Officer, Val Beaumont, gave presentations outlining the benefits and procedures of joining the MCA at recent HPA meetings in Cape Town and Johannesburg. An HPA Workshop will be arranged in due course to explain the Code in detail. The MCA invites all individual members of the HPA to join the organization in terms of the HPA policies.
“The incorporation of CAMS manufacturers into the MCA is a significant step forward for the ethical marketing and promotion of health products in the interests of consumers, patients and healthcare practitioners,” says MCA Executive Officer, Val Beaumont.
NOT-TO-BE-MISSED HPA WORKSHOPS – SAVE THE DATES
Following the success of the HPA workshops on A Practical Guide to GMP for CAMS & an Insight into Stability that took place in Johannesburg and Cape Town, the HPA will now be hosting additional relevant workshops in the near future. The first will be presented by the Chairman of the Complementary Medicines Committee (CMC) division of the MCC, Dr Neil Gouwer. The topic will be: Proposed Regulations: Dissecting the Regulations with specific reference to Health Supplement Classifications. The workshop is provisionally scheduled for Thursday 3 August in Johannesburg and Thursday 17 August in Cape Town. The next workshop, entitled A Practical Guide to CTDs, PIs & PILs, is scheduled for Thursday 5 October in Johannesburg and Thursday 12 October in Cape Town – the speakers are to be announced.
COUNTERFEIT MEDICINES INDABA
Counterfeit medicines and unauthorised sale of medicines on the internet is gaining momentum and becoming a problem. In an attempt to reach a solution to this predicament, the MCC will be hosting a workshop on Friday 4 August 2017. The Self Medication Association of South Africa (SMASA) initiated the process and is assisting in the organization, but this is officially a MCC meeting with Griffith Molewa as the MCC contact person. The objective is for MCC, DTI, Port Health, SAPS, Legal and Pharma to constructively discuss the situation. There will be no cost to attend.
HPA REPRESENTED AT IADSA AGM
HPA Honorary President, Bruce Dennison, represented South Africa at IADSA’s 2017 AGM which took place in Seoul, South Korea. In his presentation entitled The South African CAMS & Dietary Supplements Climate 2017, Dennison outlined the size, value and growth of the market, as well as discussing the current situation regarding legislation. And he returned with the positive news that IADSA is willing to assist and support South Africa in the challenges faced with regard to regulations.
Dennison explained to the delegates of IADSA the problems facing the industry in South Africa. “The HPA is working closely with the MCC to make proposed regulations more suitable for the CAMS industry,” said Dennison, ”and workshops are being held to assist industry to understand how to implement the regulations. Despite the lack of new products, market growth is at 15%. There is great potential for this industry in RSA and other African countries, and the possibilities for harmonised regulations present enormous opportunities.”
The presentation and IADSA report can be found on the HPA website.
THE POWER OF ARTEMESIA
Artemisia annua (sweet wormwood) has proven to be highly effective in the fight against malaria – a disease that killed over 400 000 people in 2015. A chemical extract of the plant together with other drugs – known as ‘artemisinin combination therapy’ or ACT – is often used for malaria treatment. Now an international team has discovered that the dried leaves of the plant alone may combat malaria.
The international team was led by Pamela Weathers, Ph.D., a professor of biology and biotechnology at Worcester Polytechnic Institute (WPI), who has spearheaded the use of dried leaves from sweet wormwood in the treatment of malaria. The team documented efforts to treat 18 malaria patients in the Congo, who were not responding to conventional treatment with ACT therapy. All 18 patients, who were critically ill, made a full recovery within just five days of treatment. Weathers and her co-authors also showed that the whole plant could be used to overcome the increasing resistance to ACT and could help to slow down the evolution of malaria drug resistance.
THE HPA’S SELF MONITORING ADVISORY COMMITTEE – AT YOUR SERVICE
In 2009 the HPA established its own industry regulatory body, the Self-Monitoring Advisory Committee (SMAC). The role of this committee is to advise member companies on numerous pertinent issues including ingredients, labelling and packaging. It also serves to guide members on general advertising practices for their products, and to ensure that they have the correct information relating to promotion, marketing and advertising.
SMAC meets on a regular basis to process complaints from the marketplace, give advice on advertising and promotional material, as well as address member queries. The Committee follows strict procedural protocols when dealing with matters brought to its attention, and if necessary engages experts to assist. This Committee promises to provide sound and constructive advice to all HPA Members, as well as offer insight into the guidelines necessary for introducing new products into the market.
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