| Edition #8 |
December 2006 |
| Editor: Monica Fairall |
Writer: Suzanne Ellis |
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REGULATION PROGRESS ON THE HORIZON?
THE long walk towards the establishment of appropriate regulations for complementary medicine by the Department of Health continues steadily and HPA chairman, Dr Alan Tomlinson, observed that recent Complementary Medicines’ Committee meetings had been very encouraging.
The CMC was “making good progress” in their workshopping of proposed regulations, he said. “We’re hoping the draft regulations will be ready for publication and comment early next year.”
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Dr Tomlinson added that the HPA and CSMC (Complementary and Traditional Medicines Stakeholders’ Committee) were also invited to make a presentation to a new DoH ministerial task team dealing with complementary and traditional medicines. |
This is being chaired by Professor Ronald Green-Thompson and will be evaluating the structure and function of the Medicines Regulatory Authority (MRA) and the Medicines Control Council (MCC) as well as looking at the future regulatory structure of Complementary and Alternative Medicine (CAMS) and Traditional African Medicine (TAM).
“We have found the task team to be very open-minded so far, “ Dr Tomlinson commented, “so we’re hoping that any decisions they come to will provide a helpful structure for all of us to continue to function optimally. We would also hope to see a closer alignment in future between Foods, Food Supplements, CAMS and TAM.”
This would ideally see a separate directorate created for this purpose - and seeing how close we are to the season of good wishes, is there any harm in hoping? |
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SAD FAREWELL TO DR ELZABE STOFFBERG
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It was with deep sadness that HPA members learned of the death recently of Dr Elzabe Stoffberg. She died peacefully in her sleep after a long and valiant fight against cancer - and her courage at every turn impressed all who had contact with her.
Dr Alan Tomlinson paid tribute to Elzabe at the last general meeting and said what a privilege it had been to know such a wonderful and warm person. “Elzabe worked tirelessly for many, many years for our industry and achieved an enormous amount for us.
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She was loved and cherished as a friend and a colleague by those who knew and worked with her,” he said. “We have missed her presence during her illness and now we mourn her death but her pain is at an end and that we must be grateful for.”
Deirdre Allen observed that Elzabe would want to be remembered as she was when well: flying her micro light with husband Jan or providing someone with a ready hug or word of encouragement.
The HPA offered its condolences to Jan and Elzabe’s children, to the staff at Natura Laboratories and to her many friends worldwide.
The world is an emptier place without her.
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SELF-MONITORING HAS BEGUN IN EARNEST
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THE Self Monitoring Technical Committee (SMTC) is now fully operational, its chairman Denise Maidment confirmed to HPA members at the last general meeting.
With 12 complaints currently on the table, the committee has found companies complained against generally to be co-operative. “They are agreeing to withdraw brochures and change their advertising material,” Maidment said.
It’s been found that most of the issues complained about have arisen from ignorance. “Companies are preparing advertising material without knowledge of the rules and regulations around medical claims, the fact that one cannot make reference to medical conditions and cannot use testimonials,” she explained.
Maidment reminded members that companies competing against each other should not try to use the SMTC mechanism to discredit their opposition and gain market edge. “This would not be appropriate. We’re here to assist and make appropriate recommendations about claims.”
This does not mean that the SMTC does not have teeth. Should recalcitrant companies refuse to co-operate and all other avenues have been exhausted, the muscle of the Department of Health Inspectorate could be called upon - as well as the Advertising Standards Authority (ASA).
“When the regulations come in to being, we’ll have to comply anyway so let’s get our house in order now and of our own volition,” Maidment stated. “It’s the best way to protect and grow our industry.”
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TACKLING FOOD & NUTRIENT STANDARDS
CODEX report-back from Thailand
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ANNE Pringle, registered dietician, Sportron resident nutritionist and HPA National Codex Representative, attended the 28th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses in Changmai, Thailand in November. She was one of the members of the South African delegation led by the Department of Health.
| There are 165 member countries of Codex, all under the umbrella of the Food & Agricultural Organisation (FAO) and the World Health Organisation (WHO). The main objectives of Codex are to ensure that food products confirm to standards that enable them to be traded freely; to provide a reference point for trader disputes and to provide a basis for national and international regulation. |
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Of importance on the agenda was the subject of the scientific basis for health claims. “The question is the same for all regulators, namely: what is the level of scientific evidence needed in order to allow health claims?” reports Pringle. “We need to ensure that we’re allowed levels of supplements safe and fair to the consumer, levels that are based in scientific risk-assessment studies. We also need to protect our industry in terms of unsubstantiated claims, and establish appropriate regulation for our industry in order to protect the consumer from unscrupulous manufacturers.
“The FDA in the USA appears to have become considerably stricter about the level of evidence required for claims,” she added. “It was decided to focus on procedures for the review of scientific evidence of health claims but the pre-Codex meeting gave the impression that these procedures could become formidable.”
Pringle said that much time was spent on the Standard for Infant Formula and Formulas for Special Medical Purposes on which “progress was made but work on the standard was not completed”. Agreement was reached on revised standards for gluten free foods. South Africa led the Electronic Working Group on Nutrient Reference Values for the third time. And Pringle reports that little progress was made on the agenda point, Implementation of the Global Strategy on Diet, Physical Activity and Health.
Says Pringle: “Although progress is slow, it is important to be present as we need to be involved when decisions are made.”
The aim of having an HPA representative at Codex meetings is to support the Department of Health delegation (particularly on issues relating to the regulation of dietary supplements) and to track the progress of guidelines and standards that may influence our government when regulating the local health products industry. Codex standards are particularly relevant to manufacturers wanting to engage in international trade in supplements or food products. |
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SCHEDULE ‘O’ MEDICINES IMPACT STUDY
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In 2004, the Self-Medication Manufacturers Association of South Africa (SMASA) - an industry association dedicated to furthering the safe use of OTC medicines and looking after the interests of its members - made application to the Minister of Health for a Section 36 exemption for Schedule 0 medicines from the provisions of the Single Exit Price Regulations (Section 22G of the Medicines and Related Substances Act).
The application was successful and all companies who were granted exemption have benefited greatly from it. However, the exemption was granted for a limited period of three years, subject to an Impact Study being carried out to prove that such exemption was warranted and that the prices of Schedule ‘O’ medicines had stayed relatively constant due to the pressure of market forces. The deadline for the submission of the Impact Study to the Pricing Committee is May 2007.
“All companies that were granted the exemption are required in terms of the Notice to conduct an Impact Study which we believe will prove the case for a continued exemption or complete exemption from Section 22G,” explains SMASA Executive Director, Allison Vienings. “Companies can conduct a study on their own or they are invited to participate in the SMASA initiative to provide the Pricing Committee with a meaningful document.”
Schedule O medicines are those medicines that fall into Schedule 0 of the Medicines and Related Substances Act and are registered with the Medicines Control Council. They are available without prescription and can be sold through pharmacies or other retail stores. Examples of such medicines are certain cough and cold medicines, pain killers, infant gripe waters, nappy rash creams, rubifacients and the like.
Complementary medicines are not subject to the Single Exit Price Regulations so they are not required to be part of the impact study.
Companies handling Schedule 0 medicines are encouraged to participate in the SMASA initiative: the benefits will be worth it.
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2007 CALENDAR DATES
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MAKE a note in your diary of HPA meetings taking place in the first few months of next year….
Gauteng: Thursday, 25 January - Bryanston Country Club
Cape Town: Thursday 15 March - Vineyard Hotel
Gauteng: Thursday 29 March – BCC
The AGM is set for Thursday 10 May at BCC, Gauteng.
A limited number of HPA members get a chance to mingle with the media at our countrywide briefings. These are scheduled for:
Cape Town – Friday 4 May
Johannesburg – Friday 11 May
Durban – Friday 18 May.
Contact Deirdre Allen if you would like to attend.
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DO YOU KNOW HOW TO TALK TO THE MEDIA?
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ALL you’ve ever wanted to know about talking to the media – and how not to do it! That’s the topic that health journalist and broadcaster Monica Fairall will cover for Gauteng members attending the first general meeting on 25 January.
This is valuable information for companies without a public relations or communications service who want to promote their media and public profile. “It’s not that difficult to build a relationship with journalists, editors and producers,” Monica said, “but you need to understand the sort of stories they might be interested in and how best to communicate these. I have a lot of practical suggestions and tips to help get one started.”
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NATURAL HEALTH FOR S.A. BABIES
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THE revamped and expanded Sister Lilian Centre was recently launched in Lynnwood, Pretoria. In keeping with her commitment to promote effective parenting and childcare, Lilian Leistner – a recipient of the HPA Newsmaker of the Year award - has plans to open similar centres throughout the country.
“We believe we can make a huge, positive impact on South African society by promoting a simple but effective childcare approach that can be adapted for all situations, from the poorest and least developed to the most sophisticated and urban,” she states
| A trained nurse and midwife, Sister Lilian has achieved national recognition as a pregnancy and parenting advisor, and is a regular contributor to popular magazines and radio shows. She believes that a balanced society is only possible with a foundation of ‘emotionally sound, healthy, baby-friendly and parent-considerate families’. “It is our view that many of the problems of modern South Africa - as well as elsewhere - stem from absent parenting, loss of strong core family values and disempowerment of individuals regarding the co-responsibility for basic facets of life like health and childcare,” she continues. |
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“Emotional nurturing in childcare has been eclipsed by emphasis on skills development at the cost of social adjustment, a sense of security and human caring and compassion. These are all vital to an economically sound society.”
Apart from her medical qualifications, Sister Lilian is also a reflexologist with some training in Ayurvedic medicine, and makes a point of combining a conventional medical approach with complementary health knowledge.
The Centre currently offers courses on pregnancy, parenting, health and nutrition, as well as support groups, workshops and talks. A free helpline provides ‘caring, commonsense, innovative and responsible advice’. Sister Lilian also works with companies on self-help health training programmes and offers a consultancy service as the Mother & Baby website expert.
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FEEDBACK:
NATURAL & ORGANICS EXHIBITION
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THE natural and organic products industry has turned a corner from being a new age curiosity and lifestyle experiment to serious business.
This is the conclusion of Natural & Organics Exhibition Director, David Wolstenholme, after their latest event at Gallagher Estate in October. An increasing number of South African consumers and businesses are demanding the option of choice as well as credible and accurate information on the subject.
“Exhibitors commented on the high quality audience that attended the show and the increased interest in chemical-free lifestyle and business options,” added exhibition manager, Janine Johnstone. “The participating companies contributed to an impeccable, styled and interactive showcase of the industry.”
New products displayed included cosmetics, natural and organic medicines, environmentally friendly textiles and a range of imported foods. On the downside, the show confirmed what every retailer complains about – very little locally-grown organic fresh produce was represented. Said Wolstenholme: “The demand for organics is growing at over 200% a year, making it our fastest growing industry. Until local growers make the mind-shift from complacency to profitability, we will see imports taking up the opportunity.” |
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The BLACK COHOSH saga continues …
IN September 2006, the European Medicines Agency (EMEA) and its Committee on Herbal Medicinal Products issued a public statement based on a review of 42 case reports of Black Cohosh and hepatoxicity – four of which showed a temporal association between the medicinal plant and liver damage.
As a result of this statement, the UK Medicines and Health Care Products Regulatory Agency (MHRA) announced that it would require Black Cohosh products to carry a label warning related to liver problems.
Subsequently, the American Herbal Products Association (AHPA) sent a letter to the MHRA providing new information that challenged one of the published case reports associating Black Cohosh with liver damage to a US patient.
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The US District Court for Nebraska dismissed a lawsuit filed against two manufacturers of Black Cohosh products. The Court ruled that the plaintiffs – a woman who required a liver transplant five months after starting to use the products, and her husband – ‘have no evidence to establish either general or specific causation’. The testimony of the plaintiff’s expert witnesses was also excluded.
In reaching its decision, the Court considered testimony from the patient and her physician. Contrary to the previously published case report where the link between the patient’s condition and Black Cohosh products was seen as ‘probable’, the new evidence heard by the Court revealed that the woman regularly drank wine, used anti-inflammatory drugs and had been prescribed a drug which listed ‘liver enzyme abnormalities’ as a potential adverse reaction.
The information provided about this case may be relevant to future discussions and decisions related to Black Cohosh in the UK and EU.
However it is anticipated that the results of the meta-analysis of available scientific data on Black Cohosh, jointly commissioned by the US Food and Drug Administration (FDA) and the Canadian Natural Health Products Directive (NHPD) will shortly be available. In anticipation that the meta-analysis results will confirm the need for a warning label on products containing Black Cohosh, the NHPD is currently revising the monograph on the herb. Canadian industry expects to be informed soon of the wording that will be required on product labels and the timescale for implementation.
In Sweden, discussions are being held on improving information currently required on product leaflets by listing the symptoms of liver damage. In Australia, warnings on Black Cohosh products are already mandatory.
The herb has found favour among South African women as a means of reducing some of the short-term symptoms of menopause.
GLUCOSAMINE UPDATES
EUROPE: The Committee for Medicinal Products for Human Use of the European Medicines Evaluation Agency has recommended that a glucosamine product for the relief of symptoms of mild to moderate osteoarthritis of the knee should be granted a European-wide marketing authorisation. If (as is expected) this recommendation is confirmed, the market-authorised product - with a recommended dosage of 1500mg per day - will be available in early 2007.
AUSTRALIA: Efforts are being made to counteract reports questioning the safety of glucosamine. Dr Tony Lewis, executive director of the Complementary Healthcare Council of Australia, responded to negative media reports on research by the University of Adelaide’s Centre for Reproductive Research, and said, “The report contains inaccuracies which claim that products with glucosamine are not clearly labelled and that glucosamine is not regulated. That is untrue.”
Dr Lewis pointed out that, as with all complementary medicines, glucosamine is regulated by the Australian Therapeutic Goods Administration, and the Therapeutic Goods Act requires that all ingredients of complementary medicines are clearly labelled.
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VITAMIN A FACT SHEET PUBLISHED
A series of Fact Sheets have been published on Japan’s Food Safety Commission website. The latest relates to over-intake of Vitamin A, and lists foods that include Vitamin A, its structure, absorption and metabolism in the body and symptoms of over-intake.
There are two warning statements on the intake of Beta-Carotene via supplements – the German wording: Do not exceed 2mg per day, and that of Japan’s National Cancer Centre: Taking more than 20mg of beta-carotene in supplement form without quitting smoking may increase the risk of lung cancer.
These science-based overviews of current issues concerning food safety aim to provide easy-to-understand information to the general public. Four Fact Sheets have been published since 2005 including one on the effect of alcohol on unborn babies, and another on trans-fats.
BUSY BEES IN FRANCE
FRENCH authorities have carried out a survey on the quality of royal jelly and royal jelly products. Seventy-one samples were analysed. Of 44 samples of the actual jelly, four were incorrectly presented, leading the consumer to believe they were of French origin, and four others did not have the correct physico-chemical characteristics. Of 27 product samples containing royal jelly, 21 had labelling anomalies and several contained Chinese pollen, the import of which became subject to an EC ban in 2004 because of concerns about contamination.
ALL CLEAR FOR NONI JUICE
NONI juice came on to the European market in 2003 as an authorised novel food ingredient. The European Food Safety Authority (EFSA) was subsequently asked by the European Commission for a scientific assessment of possible links between case reports of acute hepatitis and the safety on noni juice. EFSA’s Panel on Dietetic Products, Nutrition and Allergies has concluded that there is no convincing evidence for a causal relationship between acute hepatitis observed in the case reports and the consumption of noni juice. |
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