TAKING INDUSTRY MATTERS TO TASK

THREE task teams have been put in place by the HPA to address matters critical to the efficient functioning of the industry: CAMS marketing requirements, responsible advertising and GMP guidelines.

HPA executive director Mathabo Mashiane explained that the Marketing Code of Practice team would look at the marketing code requirements for CAMS as stipulated in the Medicines Control Act. Direct selling will come in for particular focus. She reminded members that the draft code was available on request.

The team tackling the Advertising Standards Authority (ASA) code will be working on documents to be submitted to the ASA by 30 March.  “We want to make sure that there is ethical behaviour in the industry in terms of responsible advertising, protecting the rights of the consumer and not misleading the public with unsubstantiated claims," Mashiane said.

"Our comments will emphasise the Appendices that affect the HPA - and anyone wanting to look at the Code can do so on the website:  www.asasa.org.za. The Appendices of interest are A, D, E, F, H and M.”
 
The third task team has attended to comments from the HPA on draft amendments for GMP guidelines. “These have been completed and submitted, keeping in mind the challenges faced by CAMS manufacturers,” said Mashiane, “but interested parties are welcome to give further input and advice. We’re grateful for all the work and input that’s gone into these initiatives so far.”

• For input and information, contact Mathabo Mashiane:
• 082 377 6170
• excodirector@hpasa.co.za

DRAFT REGULATIONS: Slow and steady...

THE word from the Department of Health is that comments submitted towards the end of last year on the CAMS draft regulations are being processed.

The HPA’s Dr Alan Tomlinson and Mathabo Mashiane, in discussion with the DoH, were informed that a select committee was working on the evaluations.  Ten submissions were received from various organisations and associations plus some from individuals.

“This is an arduous task,” points out Tomlinson, “but we were told that there is pressure from above to complete it as soon as possible so as to move towards publishing the new regulations. However no dates have been set so we remain in anticipation.”

HISTORIC FIRST FOR AFRICAN MEDICINAL HERBS

AN African Herbal Pharmacopoeia that took nearly three years of research involving five African and European universities and 17 scientists is about to be launched.

This is the biggest achievement to date of the African Association of Medicinal Plant Standards (AAMPS) and marks a historic moment for those scientists involved in African medicinal plants.

The AAMPS-African Herbal Pharmacopoeia will be the most up-to-date and extensive publication on the uses, quality, safety and efficacy of 52 of Africa’s most important medicinal plants. It promises to be indispensable for industry, science and research as a reference work of this nature is essential for the advance and global acceptance of African herbal medicines.

“The most important thing about this pharmacopoeia is that it will be a living database of African medicinal plants, as information will be updated continuously on the AAMPS website,” said Professor Kobus Eloff, chairman of AAMPS and head of the Phytomedicine Programme, University of Pretoria. "It will also be of great value in setting international standards for the therapeutic plants of the African continent."

Each of the monographs will provide comprehensive botanical, phytochemical and commercial information on the individual species. These were selected on the basis of a systematic review of published and unpublished literature. Extensive consultation across the continent ensured maximum diversity of input and data collection, with plant samples subjected to state of the art phytochemical analysis and fingerprinting. Each profile contains information and technical data relevant to collectors, practitioners, traders, producers and researchers.

AAMPS is a trade association that includes many of Africa’s leading scientists and organisations working in the field. All are dedicated to the development of quality control and standards for African medicinal plants and herbal products.

For more information write to...

• Professor Kobus Eloff: kobus.eloff@up.ac.za
  
• Denzil Phillips: denzil@denzil.com
  
• www.aamps.org

MEDICAL SCHOOL PARTNERSHIP?

LINKS are being forged between the HPA and the Natural Medicine Department at the Nelson R. Mandela Medical School at UKZN. At a recent meeting between the HPA’s Mathabo Mashiane and head of department, Professor Nceba Gqaleni, areas of common interest and possible collaboration were identified. And these could include:

• Education - via a partnership with the HPA’s Institute of Complementary Health as CAMS modules are included in the course offered to GPs
  
• Infrastructure - this could entail support in the area of research such as access to laboratories and product development. "This is available to HPA members," Mashiane said, "and I have the details."
  
• Medical Aids - as a partnership to lobby for recognition of African Traditional Medicine and CAMS by healthcare funders.

Prof Gqaleni will be speaking at the next general meeting of the HPA.

CONSTITUTIONALLY SPEAKING

THE Constitution of the HPA is about to have a face-lift. Members who attended the Association’s general meeting in January agreed that it was time to look anew at the constitution and update it where necessary. The job will be in the hands of a committee chaired by Dr Victor Korsten with support from Bruce Dennison, Dr Alan Tomlinson, Deirdre Allen and the HPA legal advisor at Sonnenbergs.  A completion date will be set so the task does not drag on.

DONATE PRODUCTS FOR
COMMUNITY WELLNESS

A wonderful opportunity is open to HPA members to introduce their products to new communities and future complementary medicine practitioners by supporting an outreach progamme of the School of Natural Medicine at the University of the Western Cape.

Part of the students’ training involves work at two community clinics where natural medicines from several modalities are dispensed. Head of the School, Dr James Campbell, said that supplies were used up very quickly due to the large number of patients treated. "We receive limited funding so any products that HPA members could donate would be much appreciated."
The School’s five year programme consists of a three year B.Sc. in Complementary Health Sciences and a two year Bachelor of Complementary Medicine degree in various disciplines including Unani Tibb, Naturopathy, Chinese Medicine, Phytotherapy and Acupuncture.  The clinics need urgently need donations of basic and discipline specific medication as well as basic medical supplies and equipment.
Dr Campbell said that companies supplying products are able to put up advertising material in the clinics. All support is recorded in reports to the Department of Health which is increasingly interested in bringing complementary modalities into the healthcare system.
 “Obviously, the better the results we see from donated products, the more they will be supported by communities,” he noted, “and students are exposed to products that they could use in future."

• Contact Dr Campbell: 021 959 3886
• Mariam Petersen: 021 959 3064
  
• The University of Johannesburg has similar needs.
  Contact Dr Neil Gower: 011 406 2430.

COMPANY PROFILE

QUALITY SUPPLEMENTS FROM EUROPE

WHEN Roussina Veleva and Maya Nikolova decided to establish Nutrizest Natural Products, their objective was to import products of the highest quality.

For these two Bulgarian women, supplements with a good track record in their native European market were the obvious option. In the course of their search for something unique, authentic and effective, two products attracted their attention:

CitroPlus800, a grapefruit seed extract, and Urovit, a powder produced from the fruit of the American Cranberry. “We were aware that CitroPlus is prescribed by health practitioners in Bulgaria,” explained Veleva, “and discovered that it’s also had excellent feedback from European consumers.”

With Veleva’s background in the import industry and Nikolova’s experience in food and chemical industry - coupled with a shared interest in health - this enterprising team has the necessary credentials to enter the health products industry. And they have achieved their primary objective. CitroPlus and Urovit are now available on the SA market.

Nutrizest Natural Products recently became the exclusive distributor for the German manufacturer GSE-Vertrieb GmbH in South Africa.

Nutrizest has ensured that the products abide by the strict regulation requirements of the EU and SA legislation. They are developed and manufactured in the European Union by GMP certified laboratories and manufacturers, are GM free and organically certified.

“The products are tested by Bionach, one of the most highly regarded and dependable testing laboratories in Germany,” Veleva told us. “Each batch is regularly tested for its content to make sure that it does not contain any residues, artificial preservatives or harmful substances.” Both products have NAPPI codes, which potentially enable consumers to claim on medical aid.

The team recently embarked on a drive to introduce their products to health shops and was very pleased by the response. The two supplements will initially be available from healthcare practitioners, and in health shops and selected beauty salons. For Veleva and Nikolova, this is just the beginning. They recently signed an agreement with Specialbalance Ltd in the UK to distribute their GMP quality nutritional supplements under the NutriZest banner.

BOUQUETS TO THE HPA…

TWO bouquets came the way of the HPA recently for the association’s relationship with the media.  HPA Honorary President, Bruce Dennison, passed on compliments from two high-profile visitors who were guest speakers at HPA functions in Cape Town and Johannesburg last year.

FORTHCOMING EVENTS ...

TALKING ABOUT INFERTILITY

THE problem of infertility is increasingly being tackled with CAMS options and this will be the focus of a conference to be held at the Indaba Hotel in Johannesburg from 27 to 29 March.

Initiated by Inge Dougans, head of the International Academy of Reflexology & Meridian Therapy, the conference is open to the public and therapists. There will be considerable discussion of the use of reflexology, and international and local experts will highlight ear, hand and foot reflexology as well as body reflexes and meridians in relation to infertility.

• 076 038 3134
• mcollett@pnp.co.za.

WORKSHOPS FOR HPA MEMBERS

HPA members have indicated their interest in attending two workshops later this year to cover specific industry needs. One will cover Good Manufacturing Practice and the second will concentrate on Merchandising. Both are scheduled for the second half of the year in Cape Town and Johannesburg. Watch this space!

HEALTHY LIVING EXPO RIDES AGAIN!

THE Appletiser Healthy Living Expo 2009 has been booked again for Sandton City, so diarise 4 to 6 September. With Appletiser on board this year as Platinum Sponsor, this is a great opportunity to showcase products, supplements and equipment pertaining to a healthy lifestyle and healthy living.

The 2008 expo was a huge success, with more than 11 500 people coming through the show over the weekend.

The event is held in the Fountain Court with space for 30 exhibitors: get cracking and reserve your place now.

Contact Heather Hook

• 021 713 3360
• heather@fairconsultants.com

IT’S YOUR WEBSITE – USE IT!

THE re-designed and increasingly informative HPASA website is not only providing members with greater visibility but also offering useful info on industry issues. You can also make it work for you by providing information about company events and achievements. Send us details of courses, workshops or seminars you intend hosting (for trade or consumers) so that these can be showcased for you. News updates are posted at regular intervals so send in your news - and it could be anything from staff appointments, product launches, social responsibility initiatives and the like.

Send news or information for the website to:

• fairallm@mweb.co.za
• zan.e@mweb.co.za

RESEARCH & REGULATION NEWS FROM AROUND THE WORLD (Supplied by IADSA)

HOW CLINICALLY IS IT “PROVEN”?

AUSTRALIA: Concerned by the increasing use of the term "clinically proven" in health product adverts, the Australian Therapeutic Goods Authority has issued a warning notice...
Given the strength of this claim and the clear potential for it to mislead and deceive consumers, the Complaints Resolution Panel considers that its use in advertising should not even be contemplated unless unequivocally supported by robustly designed, published, peer-reviewed clinical trials which have been conducted upon the actual product being advertised or an identical formulation (as a minimum). Even where such evidence is available, the claim must also reflect the weight of all available evidence and not just the specific research being relied upon.

TIGHTENING UP ON COUGH MEDICINE

CANADA: Health Canada has released its decision on the use of cough and cold products, including natural health products, for children. A preliminary recommendation in 2007 stipulated that no OTC cough and cold product should be used in children under the age of two unless directed by a health-care practitioner. Following further analysis and input from a Scientific Advisory Panel, Health Canada has decided that certain over these OTC medicines should be labelled as not for use in children under six. Products for children from 6 to 12 will require enhanced labelling, child resistant packaging and dosing devices for liquid formulations.

FDA GUIDANCE ON CLAIMS & LABELING

US: Problems with claim substantiation and labeling are not limited to SA. The Food and Drug Administration (FDA) guidance on claims for dietary supplements is that manufacturers must possess adequate substantiation for each reasonable interpretation of a claim - and competent and reliable scientific evidence should be available. With regard to labelling, the guidance requires manufacturers to provide a prominent statement that their address or phone number is for reporting any serious adverse events associated with the product. The supplement industry maintains that the label changes sought by the FDA go beyond what the legislation requires, and would mean unnecessary and heavy costs.

ANYONE FOR A CUPPA NONI LEAF?

EU: Dried and roasted leaves of the Noni plant (Morinda citrifolia) have received authorization in the European Community as a novel food ingredient. The approval only extends to the use of the leaves in infusions with a set limit per cup.

LIST OF COLOURANT-FREE BRANDS

UK: The Food Standards Agency is encouraging food manufacturers to advise them of brands to be included on a list of foods free from certain colours: Sunset Yellow FCF (E110), Quinolene Yellow (E104), Carmiosine (E122), Allura Red (E129), Tartrazine (E102), Ponceau 4R (E124). The list will be published on the FSA website and, while not specifying individual products, will help consumers ascertain whether a product is likely to contain these colours.

SWEETENING WITH PURIFIED STEVIA

US: Two purified sweeteners made from the leaf of the stevia plant have been granted Generally Accepted as Safe status by the FDA for use as a general purpose sweetener in food, drink and supplements. The approval applies only to a highly purified form of stevia (95% or above) known as rebaudioside A.

BOTANICALS IN THE EU

EU: The first issue of the European Botanical Forum Fact File – a series of fact sheets on topics such as the history, usage, legal basis, benefits and claims for botanicals    - was launched at the European Botanical Forum’s 4th Annual Workshop last December. Agenda items included health claims, quality and safety issues and the borderline between food and medicine products.

TOXICOLOGY IN THE 21st CENTURY

US: A recent report form the US National Academy, Toxicity Testing in the 21st Century: A Vision and a Strategy, is calling for faster development and use of tests on human cells – conducted in the laboratory or simulated on computer – as a way to predict health hazards. This would not only avoid animal testing but would facilitate further testing - particularly on combinations of compounds where safety information is currently incomplete.

WHY YOU SHOULD JOIN THE HPA

Manufacturers, wholesalers and distributors of complementary medicines, food supplements and health foods and beverages can benefit enormously from joining 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 primary focus for the HPASA in recent years has been to support the move for appropriate regulations for the health industry. To this end the HPASA continuously liaises with government bodies and professional bodies associated with the industry.
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 to 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 can assist 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.

Sign up by contacting Deirdre Allen

• 011 789 4464
• hpasa@hpsa.co.za