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‘USE SCIENCE TO SET UPPER SAFETY LIMITS’
Top nutritionist to address local health industry
DON’T miss the opportunity to attend important talks in the new year by John Hathcock, vice president of the Scientific & International Research Council for Responsible Nutrition (CRN).
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Hathcock - author of the highly regarded publication Vitamin and Mineral Safety: 2nd Edition - will highlight why safety assessment of vitamins and minerals should be based on scientific evaluation. Taking place in February, his presentation is titled Scientific Research Endorses the Safety of Vitamins and Minerals and Bioactive Substances and will be delivered in Cape Town and Johannesburg. |
“I stake out a rational approach to regulatory policy so that this is not arbitrary but scientifically founded,” explains Hathcock. “RDA-based upper limits for vitamin and mineral supplements have no scientific validity and consequently should have no role in determining safety or upper limits.
“Governmental and regulatory organisations worldwide need to look more closely at how to evaluate the safety of vitamins and minerals. In the absence of upper limits there is leeway for governments to set their own standards without scientific basis. And without an appropriate and accepted number, I’m worried that governments around the world will set arbitrary upper limits.”
HPASA honorary president, Bruce Dennison, believes Hathcock’s research is of great value to the health products industry. “The safety research - with particular reference to an upper safe level (USL) - undertaken by the CRN under Hathcock’s leadership, now provides us with irrefutable scientific proof of not only the safety of vitamins and minerals but also their upper level intake safety. This extensive scientific data makes it much easier for legislators and nutritionists to make recommendations and promulgate new laws.
“We believe future legislation regarding vitamins, minerals and bio-actives should be based on the USLs. We also believe that there should be harmonisation among countries when it comes to safety evaluation because a science-based risk assessment is the only realistic approach.”
Hathcock is visiting the country as a guest of the HPASA, which supports USLs for supplements in line with Codex. The HPASA also believes that legislation for nutritional supplements containing vitamins, minerals and bio-actives should be legislated under food law and that it should be based on scientifically proven USLs for daily intakes.
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HEADLINE ACTS
This is the 12th edition of HPA Headlines and HPASA executive secretary
Deirdre Allen believes that this e-newsletter has proved to be a valuable public relations boost for the health products industry.
“Our newsletter has been very well received,” states Allen. “We are getting reliable and essential information out to many relevant people and this is vitally important to the promotion, development and visibility of our industry.”
With an extensive mailing list, HPA Headlines reaches far and wide - informing the industry, media, government, natural health professionals, health shops, trade and industry and various affiliated associations of current developments relevant to the health products industry. |
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DAMIANA TO BE RE-EVALUATED?
NUMEROUS health companies were instructed in August by the Department of Health to withdraw all products containing Damiana on the grounds that it is a banned substance in South Africa.
Following a meeting between the Medicines Control Council registrar, Ms Mandisa Hela, and HPA representatives Mathabo Kona and Dr Alan Tomlinson, it was decided to re-submit a memorandum to the MCC recommending that the Council re-evaluate the removal of Damiana from the market in the view of the very wide safety data now available.
A further meeting is imminent. |
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WATCHDOG INITIATIVE SETS A PRECEDENT
The Self Monitoring Technical Committee that was set up by the HPA just over a year ago is being taken seriously by players in the health industry - and the small team is kept busy examining complaints about inappropriate indications and claims being made in the advertising of CAMS products.
Committee head, Denise Maidment, said that the majority of companies about whom complaints were received were normally unaware of any transgression. “They are not always familiar with the rules and regulations pertaining to the labelling and marketing of CAMS products so are generally pleased to co-operate,” she said. “We are also able to assist them with the correct and acceptable wording for claims and adverts.”
She added that, so far, only one company had been unresponsive to the advice of the SMTC so had been referred to the Advertising Standards Authority and Department of Health Inspectorate. “I cannot tell you who it is as we treat all cases with total confidentiality.”
The HPA has been approached by other professional associations wishing to implement similar self-monitoring processes for. “They want to know more about our modus operandi and are requesting copies of our master letters and documents,” she said, “which is a real pat on the back for our industry initiative.” |
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SMOOTHING OVER TROUBLED WATERS:
HPA exec puts DA in the picture
THE HPA often has to put out fires around inaccurate and misleading media information on complementary and alternative medicine. And one of the most recent blazes came from an unexpected quarter: the Democratic Alliance’s spokesperson on health, Mike Waters MP.
In an article published by Health24 in July, the safety and efficacy of CAMS in South Africa came under attack and, in order to set the record straight, members of the HPA executive met with Waters on October 19.
“We had a detailed and helpful discussion,” reports Dr Alan Tomlinson. “We were able to update Mr Waters on what is happening within our industry and the delays we have experienced in the publication of appropriate regulations for CAMS products. We also informed him that legislation is being worked on by the Complementary Medicines Committee and a task team set up by the Medicines Regulatory Authority.”
Tomlinson pointed out that the DA had been highly distressed by the fact that, although the original draft regulations were published in 2004, nothing has since been forthcoming. “The DA felt that it was inexcusable to have a three year delay since the first draft regulations,” says Tomlinson.
Since the DA comments appeared however, things appear to be moving. As members heard at the HPA meeting of 4 October, a sense of urgency seems to have gripped the Department of Health to ensure that new draft regulations are published as soon as possible. |
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POSITIVE PROGRESS AT CODEX
THE latest meeting of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CNNFSDU) in Bad Neuenahar, Germany, was attended by HPA member Anne Pringle (registered dietician and Sportron nutritionist) together with two representatives from the DOH.
“Several issues of interest to the health products industry were discussed, resulting in more positive progress than has been evident in previous years,” reported Pringle.
Subjects under discussion included provisions for dietary fibre, application of nutritional risk analysis principles by CNNFSDU, development of nutrient reference values, implementation of WHO global strategy on diet, physical activity and health and recommendations on the scientific basis for health claims.
On the last point, Pringle said that there was significant support for the proposal that it was impractical and not feasible to substantiate all health claims on the basis of human intervention studies. “It was suggested that more weight be given to epidemiological and observational studies – in other words, consideration of the totality of evidence when substantiating any health claim,” she told HPA Headlines.
The SA government has accepted an invitation from Germany to host the next CCNFSDU meeting in 2008 and is expected to take place in Cape Town during November. The HPA will be one of the hosts and plans to hold an evening function for delegates - possibly in conjunction with SAAFOST. |
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WHAT’S IN A NAME?
EVERYTHING, says SA Natural Products
CONSUMERS and members of the health industry will have noticed a subtle shift in the branding of the well-known Bioforce range of natural medicines and organic food products from Switzerland.
| New-look labels that gradually came on to the shelves over the past year are now branded as “A.Vogel” rather than Bioforce. And the reason is simple, says Estie Schreiber, marketing director for SA Natural Products who distribute and market Bioforce in SA. |
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The man behind the range was Swiss herbalist and naturopath, Alfred Vogel, and after his death in 1996, Bioforce head office decided to use the company name to brand the herbal, homeopathic and food products. “Sales took a massive knock,” Schreiber recalls, “and when one of Europe’s top marketing gurus was consulted, his research pointed to the wrong focus in the product name!”
“We tried to tell them this in 1991 when my mom – Irma Schutte - and I met Dr Vogel. He had such a passion for his work and the healing power of nature, and it’s wonderful to see how this is touching people again through the re-branding. The brand has come alive again in all 26 countries where it is sold.”
The ‘migration’ of the brand began last year, and all 60 plus products sold in SA now display the Vogel signature and fresh look.
OFFER OF PRODUCT DEVELOPMENT
INTAKA Nutri, a division of the rapidly expanding Intaka Group, would like to offer the services of its sales and mechandising team, its R&D department and their state-of-the-art merchandising facility to fellow HPA members and other interested parties.
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The company has its own product range with specific expertise in the production of powdered blends, instant beverages, soups, desserts, table top sweeteners and meal replacers – all of which are approved by the Muslim Judicial Council (HALAAL) and the Jewish Beth Din (PAREV/MILCHIK). |
Intaka Nutri currently assists a variety of customers and food and health orientated businesses with R&D, new product development and perfecting product ranges. The company’s manufacturing facility boasts four state-of-the-art sachet machines, two high-tech labeling machines, and three technologically advanced ribbon blenders for blending and packaging powdered products. The facility has a calculated mixed product-packing capacity of 200 tons a month which can be increased to 400 tons if required.
Contact to Marc Wilensky for a confidential discussion on services and facilities.
PRODUCT INNOVATION FROM
MARGARET ROBERTS
MARGARET Roberts is a household name in South Africa. Her affinity for herbs and knowledge of herbal products has earned her a glowing reputation in the field of natural health. Her quality products have graced the shelves of health shops and supermarkets for years but this doyenne of the herbarium has added another innovative range to her repertoire. Working closely with the Fithealth research team, Roberts has developed a unique combination of herb and tissue salt remedies.
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Both herbs and tissue salts are known to help alleviate various ailments and, by combining the two, the new Herb & Tissue Salt Remedies offer convenience as well as more effective results. There are currently nine products in the range, including combinations for nervous conditions, anxiety, depression, pain, cholesterol, menopause and insomnia as well as an intestinal cleanser and natural antibiotic. |
NEW TEAM TO MANAGE PHARMA NATURA
2007 saw big changes in the management team of Pharma Natura (Pty) Ltd.
| Frits Waldeck was appointed as Executive Chairman of the Board with Bob Constandse taking over the reigns as the new CEO. Mark Mortimer took up the post of Financial Manager designate and Natalie Smith stepped in as Human Resources Manager. |
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The appointment of Christa van Wyk as Marketing Executive and Taryn Minihold as Sales Executive has lead the way for an enhanced consumer and customer drive. The key focus of this drive is to re-entrench Pharma Natura’s well known and trusted brands – Vitaforce, Bettaway, Herbaforce and Homeoforce Tissue Salts – in the minds of consumers and customers.
Celeste Naude took on the challenge as Head of Operations and Responsible Pharmacist overseeing the factory and supporting functions, which includes a revamp of the factory to ensure that MCC standards are maintained while maximising efficiency.
This dynamic team is focused on not only growing Pharma Natura’s existing brands but to lead the way through new and innovative products that meet the modern consumer’s health and well-being demands. |
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MANNA FROM AFRICA
ORGANIC, eco-friendly and proudly South African, Manna products were innovatively pioneered by Brandt Coetzee in the Northern Cape in 1997 – and are all made from the seeds of the alien invader Proposis tree which originated from northern Mexico and southern Texas.
“I was researching the utilisation of the biomass of alien plants in the area when I noticed that animals were very fond of the Proposis seeds so sent samples from different species to various laboratories for analysis,” explains Coetzee. The results showed the seeds to be high in amino acids, vitamins, minerals, proteins and sugars which prompted him to investigate their potential as supplements for humans.
He found that the properties in the plant provided valuable blood sugar control effects. After eight years of research - during which he identified the primary efficacy of only three of the 42 different species of tree - he formulated the specialist range of Manna nutritional supplements, all of which are made from these seeds.
The trees grow naturally in the wild so the products are 100% organic. Harvesting the seeds of this invasive plant is beneficial to the environment as it controls its spread. The local community also benefits from the Manna initiative as seed harvesting provides much-needed employment.
The first phase of manufacturing is done by Dune Foods after which it moves to contract manufacturers. All marketing and distribution is handled by Dune Foods.
Coetzee is continuing to research the plant with the Universities of the Free State and Stellenbosch. |
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CAST YOUR NET WIDER WITH THE WEBSITE
THE re-designed and increasingly informative HPASA website is not only providing members with greater visibility but also providing valuable insights into industry issues.
Currently featured are short profiles of each member company with website addresses, the executive committee, HPA history and objectives, membership conditions and downloadable membership applications forms. Information about legislation, partnerships and relevant CAMS modalities is gradually being added to the site.
A section on training and development is also listed and members are encouraged to submit details on courses, workshops or seminars they intend hosting (for the trade or consumer) so that these can be showcased on the website.
News updates will be posted at regular intervals and members are invited to submit information for posting online. It’s your website: use it!
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FSA REVISES ADVICE ON COLOURANTS
UK: Research commissioned by the Food Standards Agency (FSA) and carried out by Southampton University has suggested that eating or drinking certain mixes of certain artificial food colours together with the preservative sodium benzoate could have a negative effect on children’s behaviour. As a result the FSA is advising parents of children showing signs of hyperactivity that cutting these colours from their diets might have a beneficial effect. The colours in questions are Sunset yellow (E110), Quinoline yellow (E104), Carmoisine (E122), Allura red (E102), Ponceau 4R (E124) and Sodium benzoate (E211). Initial meetings with the food industry have been held and the report has been forwarded to the European Food Safety Authority (EFSA) for consideration. EFSA has confirmed that the study will be taken into consideration by its AFC panel on additives, flavourings, processing aids and materials in contact with food as part of its current safety review.
MEDIA TO BE RESPONSIBLE FOR MISLEADING ADVERTISING?
US: In a major policy shift, the US Federal Trade Commission (FTC) may soon hold media companies liable for preparing and running allegedly deceptive advertisements for someone else’s products or services. In a letter related to an investigation of a national radio network that ran a purportedly deceptive diet-supplement advert, the FTC likened media companies to advertising agencies, which have historically been liable for deceptive advertisements in cases where an agency was actively involved in developing and producing the advertising campaign. To require media companies to substantiate advertising claims would increase cost, preclude or severely limit advertising to many smaller advertisers and raise significant issues with regard to commercial speech.
CANADA PUBLISHES MULTIVITIMIN & MINERAL MONOGRAPH
CANADA: A new monograph relating to natural health products sold in pill form has been published by Health Canada. Geared at products containing two or more vitamins and minerals, it sets out instructions on preparation, safety and labeling. Health Canada has issued a number of monographs on natural health products since the Canadian Natural Health Products Regulation came into effect in 2004. These dealt only with single vitamins and minerals whereas the new publication will feature an expanded list of materials. It is also expected to make licensing easier for new products since manufacturers will need to refer to only one document. It will also ensure that the consumer has access to well prepared, safe and effective products with clear label instructions.
RAPID ALERTS OF SUPPLEMENTS
EU: A high number of food supplements were included in the Rapid Alerts reported to the European Commission by European member states in mid-2007. The main reasons for the notifications are irradiated herbal ingredients, heavy metal contamination and unauthorized novel food ingredients. The problems have been found in most EU Member States but particularly in Germany, the UK, Norway, Malta and some eastern countries.
SUPPLEMENT ANALYSIS METHODS SCRUTINISED
US: The American Herbal Products Association (USHPA) is surveying the members of its Analytical Laboratories Committee to determine the methods used to analyse the vitamin and mineral content of supplements. The results of the survey – which is carried out on the understanding that many of the methods in use may not be suitable for all individual supplement products – may then be presented at the Office of Dietary Supplement Analytical Methods and Reference Materials Programme Stakeholders Meeting to help determine whether the National Institute of Health should invest in developing analytical methods for quantifying vitamins and minerals in dietary supplements.
COURT RULES ON GARLIC SUPPLEMENTS
GERMANY: In Germany, garlic supplements are currently classified as medicines so the health industry noted with interest the ruling expressed by the European Court of Justice Advocate General’s that the intended use of garlic supplements was not indicated or recommended for treating or preventing illnesses and was not typically presented as a medicinal product. This demonstrated support for the important principle of ‘intended use’ in distinguishing between medicinal products and food supplements.
Germany has been taken to court by the European Commission because it did not consider garlic supplements to be medicinal products. It viewed them as widely available foodstuffs whose sale should not be restricted and felt that limitations proposed by the German authorities were a clear-cut example of national over-regulation that would create unnecessary burdens for industry.
IMPORT LEGISLATION TO BE REVIEWED
CANADA: As a result of concerns about the quality of imported products – most recently toothpastes with unacceptable levels of diethylene glycol – the Canadian government is carrying out a review of its import legislation. Its intention is to amend the Hazardous Products Act so as to ensure that Canadian consumers are protected from counterfeit or dangerous imported products.
HEAVY METALS UPDATE
EU: A meeting has been held between European Commission officials and representatives of the European Federation of Associations of Health Product Manufacturers (EHPM) to address the Commission’s proposal for maximum levels for heavy metals in food supplements. While it was clear that the Commission appreciated the problems potentially faced by industry, they confirmed that member states wished to agree on maximum levels for finished products, which in their view was the easiest option for control authorities to enforce. The Commission said that only when they have all available data will they be able to judge whether the various levels proposed are manageable for industry.
NEW REFERENCE STANDARD FOR GINKGO
US: The US National Institute of Standards and Technology (NIST) has issued a group of Standard Reference Materials for the herbal supplement Ginkgo biloba. Their purpose is to help researchers validate the accuracy of analytical methods for flavonoids and terpene lactones (constituents which are associated with the perceived efficacy of Gingko), as well as toxic trace elements in the herb including arsenic, cadmium, lead and mercury. |
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HERE’S WHY SHOULD YOU SHOULD
JOIN THE H.P.A.
Manufacturers, wholesalers and distributors of complementary medicines, food supplements and health foods and beverages can derive great benefits from becoming members of the Health Products Association of Southern Africa.
Established in 1978, the HPASA maintains the public profile of the health products industry as a dynamic, organised and responsible force. Having grown in strength and stature over the years, the HPASA now represents over 100 health product manufacturers and distributors in Southern Africa who work together as a unified voice to protect and represent the industry.
The benefits of becoming a member are many– for both small companies and giant multi-nationals. As a credible and scientific association, the primary focus for the HPASA is responsible regulation of the health products industry. To this end the HPASA continuously liaises with government bodies and works tirelessly to deal with regulation issues.
Of particular importance has been the establishment of the Self Monitoring Technical Committee (SMTC). The association undertook this initiative to serve the interests of members and consumers and ensure that high ethical standards of production, quality control, marketing and advertising would be maintained.
The HPASA also ensures that Good Manufacturing Procedures (GMP) are being employed by manufacturing concerns that are subject to the legislative controls of the Department of Health. The Association also assists member companies with claims and indications to ensure they stay within the CAMS parameters. Members are entitled to a range of benefits including media and advertising assistance, introductions to international distributor networks and access to a significant pool of information and resources as well as legal assistance.
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If you would like to share your company news with the industry please email:
fairallm@mweb.co.za or zansu@iafrica.com
Health Product Association of South Africa
PO Box 55544 • Northlands • Johannesburg 2116 •
South Africa
Tel : +27 11 789 4464 • Fax : +27 11 789 4464
email: hpasa@hpasa.co.za | website: www.hpasa.co.za
The opinions expressed in this newsletter are not necessarily endorsed by the HPA.
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