Health Products Association of Southern Africa Get in touch with us here!
Editor/Writer: Suzanne Ellis EDITION #20 APRIL 2010
In this edition ...
Foul Play Damages Industry Image
Supplement Safety & Quality: Stick To The Rules
Regulations: Ready For Kickoff

Did You Know?

New Foodstuffs Regulations: A Winner
SMAC Appoints A New Captain
Company Profiles
Passionate About Producing Quality Products
OTC Pharma Appoints New Pharmacist
To Have & To Hold
Social Responsibility
Training: Journey To Wholeness & Healing
Forthcoming Events
IADSA News
Team Up With HPA
healthy LIVING

FOUL PLAY DAMAGES INDUSTRY IMAGE

In recent months, numerous products masquerading as health supplements have been recalled for containing prescription drug ingredients. Following tests which showed that many so-called 'herbal viagra' products were adulterated with unauthorised ingredients of this kind, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) warned the public against all herbal products offering to treat erectile dysfunction. Singapore, the US, Canada, Hong Kong, Australia and the Netherlands recalled those supplements.

In South Africa, many slimming products that claimed to be 100% natural were found to contain the scheduled substance sibutramine. As a result, all imported diet products now need Medicines Control Council (MCC) clearance.

Not only is the inclusion of prescription-only drug ingredients in purportedly natural products illegal, it is also potentially harmful to the health of unsuspecting consumers. Taking medicines which contain random, uncontrolled quantities of chemical compounds may cause serious adverse reactions such as heart attack, stroke and severe hypotension – or even a toxic overdose.

"It is this type of unethical behaviour that gives the CAMS industry a negative image," states HPA Executive Director Director Mathabo Mashiane. "The HPA is working closely with the Department of Health (DoH) to supply information on unethical marketing practices. We will continue to work tirelessly to eliminate the manufacture and marketing of unethical products."


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SUPPLEMENT SAFETY AND QUALITY:
STICK TO THE RULES

Compliance with Good Manufacturing Practices (GMP) is essential to ensure that all nutritional products available in South Africa are safe and of high quality. The HPA actively promotes GMP and has therefore adopted 'GMP Compliance' as its theme for 2010. The association is encouraging manufacturers to be GMP compliant and is assisting with access to the necessary licenses from the DoH. "We have engaged with the Inspectorate at the MCC to assist CAMS manufacturers in obtaining manufacturing licenses," assures Mashiane.

"SMAC is going to become more involved in the GMP aspect in an attempt to eliminate substandard practices," says SMAC Chairperson Celecia Pleass. "What many people don't realise is that GMP is not only applicable to local manufacturers, but also to imported products."

According to Pleass, many demands are made on contract manufacturers to produce supplements without ingredients undergoing the relevant testing. "When manufacturers explain that they have to abide by GMP requirements, certain clients will seek a facility that doesn't play by GMP rules to make their products. This is very damaging to the industry as a whole."

With the implementation of CAMS regulations on the horizon, upgrading industry standards is imperative. "Once the regulations are finalised, the CAMS industry will have a formal benchmark in legislation with which to comply," says Mashiane. "The GMP compliance theme is one way for the HPA to facilitate preparation of the CAMS industry for the ensuing legislation."

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REGULATIONS ... ready for kick-off

The HPA continues to collaborate with the DoH on formulating legislation and regulations which are in keeping with the CAMS paradigm. The initial draft regulations were issued in 2004 but rejected as inappropriate for the industry. In the wake of protracted negotiations, it seems that light has now appeared at the end of the tunnel, thanks to Health Minister Dr Aaron Motsoaledi getting the ball rolling.

"I am encouraged by the new health minister," enthused HPA Chairman Dr Alan Tomlinson. "He's a man of action, determined to get things done. He's also brought a new spirit of anticipation to the DoH and is exerting pressure on his people to finalise new draft regulations."

The DoH has assured the HPA that the development of regulations is progressing well: the current anticipated date for completion is June 2010.


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DID YOU KNOW?

Two of the Amendments to the Schedules published on 31 December 2009 that affect Complementary Medicines are:
Niacin
When this is used in a product intended for hypercholesterolaemia, it is now a classified Schedule 4.
Zinc salts
If the daily dose of elemental Zinc in a product intended for oral ingestion is greater than 50mg, the product is considered Schedule 1.


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NEW FOODSTUFFS REGULATIONS: A WINNER

On 1 March 2010 the Minister of Health approved new regulations relating to the Labelling and Advertising of Foodstuffs in order to provide consumers with authentic, accurate data for making informed food choices. The regulations form part of South Africa's commitment to the World Health Organisation's Global Strategy of Diet, Physical Activity and Health - an international initiative aimed at improving human health globally.

 

Due to come into effect on 1 March 2011, the regulations cover a wide range of technical and commercial topics and will apply to both locally-manufactured and imported products. They afford clear guidance on the 'do's-and-don'ts' regarding information provided on labels and in advertisements of foodstuffs. This will be advantageous to consumers and manufacturers alike.

Full of praise, Sportron's registered dietician and resident nutritionist, Anne Pringle, said it was "pleasing to note that many of the shortcomings of the existing regulations have been addressed. The new regulations are specific and prescriptive in terms of the requirements for both manufacturing and labelling of foodstuffs. They will certainly offer consumers access to accurately labelled products and protect them from misleading health and nutrition advertisements."


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SMAC APPOINTS A NEW CAPTAIN

In 2008, when a self-monitoring committee was established by the HPA, Solgar's Denise Maidment took the reins as Chairperson. Under her astute guidance, this committee which primarily advises members on advertising claims, labelling and related issues gained noteworthy momentum. Maidment bowed out in March 2010 and was replaced by the Technical Director of Regal Nutrients, Celecia Pleass.

"We extend our heartfelt thanks to Denise for all the work she put in over the years," said HPA Executive Secretary Deirdre Allen. "Her enthusiasm for the industry and dedication to the HPA are greatly appreciated and she'll be sadly missed. We welcome Celecia to her new role. She is highly respected and well qualified to take up this position."

A registered pharmacist, Pleass has working experience in retail and hospital pharmacy as well as more than a decade in the health products industry, dealing with product development and registration.

"This is a fantastic challenge," she declared. "As we have nothing specific to fall back on in terms of regulations, in order to protect the industry and consumers we must make decisions based on what we as an industry feel is right."


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COMPANY PROFILE

ENERGY MATTERS AT MCNABS

McNabs colourful sachets wink seductively from pharmacy shelves and supermarket checkouts: their promise of energy attracts the physically weary, the mentally overwhelmed and the emotionally drained. Many are tempted to test the product and soon discover, often much to their surprise, that it lives up to all claims made on the packaging. "The essence of our brand is stimulant-free energy that works in one dose," says McNabs founder and CEO Rupert McKerron. "We provide the nutrients which are missing in a fast-food meal. Our tablets, bars and brew all contribute to energy."

McNabs Energy Enhancers

It was a personal energy crisis that prompted McKerron to venture into the health products arena. In 1988 he contracted ME while working for a merchant bank in London. Conventional medicine proved to be of no help so, with great scepticism, he began exploring natural medicine. To his amazement, therapies such as reflexology, aromatherapy, homeopathy, yoga and nutritional supplements had a dramatic impact on his health. His experience convinced him of the role played by nutrition in health and he created the McNabs range to provide the nutrients necessary to help people achieve and maintain optimum health.

McNabs Salubrity (Pty) Ltd was established in 2002. "We're a small, private, family business," explains McKerron. "I work with my wife, Sarah, and fortunately we complement one other. I handle the marketing, she's in charge of selling and we run the enterprise like a family."

Their products appeal to the average person and this, McKerron insists, helps increase awareness of the power of natural medicines. "We sell vitamins by sleight of hand and educate by stealth," he laughs. "Most of our clients won't even bother to read our labels because they aren't the kind of people who are interested in health details. But when they try our products and find they work, they become more aware of natural alternatives. We are however very mindful of the fact that we don't produce silver bullets. Our products are simply one element in energy."

McKerron believes that energy is a multi-faceted phenomenon, consisting of physical, mental and emotional/spiritual aspects. "Energy is affected not only by the way we feed and exercise our bodies," he emphasises, "but also by the people we associate with, the environment in which we work and live and the thoughts we have, because thoughts are real energy forces, too." Which is why motivational messages designed to inspire and uplift are featured on each McNabs sachet. 

A self-proclaimed 'energy entrepreneur', McKerron enjoys sharing his insights on energy creation and is the author of the inspirational book How to Have a Big Life. "One of the most effective ways to become happy and stay happy is to smile a lot," he enthuses. "We all know that when we feel happy we smile, but it seems the reverse is also true. According to an area of research known as proprioceptive psychology, getting people to smile or nod their heads makes them instantly feel happier or more agreeable. So if you want to cheer yourself up, behave like a happy person and your physiology will do the rest."

In keeping with the company philosophy of sustainable energy, McNabs built an eco-friendly office building, The Energy Works, which runs on renewable energy. "In many ways, what is happening to our planet is also happening in our own bodies and spirits," says McKerron. "We as a company are trying to create a set of sustainable energy values that people want to absorb and implement in their lives."
http://www.mcnabs.biz/


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PASSIONATE ABOUT PRODUCING
QUALITY PRODUCTS

Pharma Natura - a pharmaceutical company with a long and respected history – is offering GMP compliant and MCC licensed manufacturing facilities to parties interested in producing quality complementary medicines.

"Pharma Natura has a committed team with a passion for excellence in everything we do, and will strive to produce quality-assured complementary medicines on time and in full," states Manufacturing Executive Dave Hudson.

The company has a dedicated research and development division which constantly researches the latest industry trends in order to stay at the cutting edge of technology and product development. The Gauteng-based manufacturing plant is capable of producing and packing tablets, soft gel capsules, hard capsules, liquids, creams and lotions, gels, oils, dry blends - both granular and powder - and tea. It can also offer third-party procurement services and insert printing.

"We have embarked on a formal program of continuous improvement in our facility, products and best practices with the aim of becoming the 'manufacturing partner of choice' and 'employer of choice' in the industry," explains Hudson. "Our business model currently enables us to be very flexible in terms of customer requirements without compromising quality."

While Pharma Natura specialises in manufacturing complementary medicines, the MCC license enables it to produce certain scheduled medicines, which the company already does for various multinationals. Local and export markets can be catered for.

Dave Hudson
Tel: +27 11 4456157
Fax: 0865584682
Cell: +27 82 7770922
Mail: daveh@pharma.co.za

Zane Ferriera
Contracts Coordinator
Tel: +27 11 4456081
zanef@pharma.co.za

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OTC PHARMA APPOINTS NEW PHARMACIST

Giulia Criscuolo (B.Pharm – Wits) has been appointed OTC PHARMA SA's responsible pharmacist and education officer. Criscuolo qualified as a pharmacist in 1992 and worked in the pharmaceutical industry until she discovered the world of complementary medicine. After completing a four-year, part-time diploma in homoeopathy through the British Institute of Homoeopathy she worked at Weleda Pharmacy for seven years, specialising in homeopathic, herbal and other complementary medicine modalities. Since 2004, Criscuolo has been involved in education and training on all matters related to supplementation, health and wellness.

She joined OTC PHARMA SA in September 2009 as education officer, taking responsibility for all education-related initiatives such as training, seminars, the development of training manuals, evaluation and development with regard to staff, trade and consumers. She also assumed the role of marketing executive for Italy, where she co-ordinates marketing-related drives, promotions and programmes under International Marketing Director, Maria Ascencao, who praised Criscuolo as a "highly respected pharmacist, an extraordinary human being and an asset to OTC PHARMA".

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TO HAVE AND TO HOLD

It was a perfect day for the ideal couple. On 13 February 2010, Celecia Roos and Quentin Pleass exchanged vows at Waterfall Cove in Muldersdrift, surrounded by family and close friends.
While Celecia has a respected history in the health products industry, IT professional Quinton hails from a family with industry background: he is the son of well-known natural health practitioner, Dr Leslie Pleass. We congratulate the couple on their nuptials and to quote Shakespeare, "May heaven give you many, many merry days!"

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SOCIAL RESPONSIBILITY

NATUREX COMMITS TO
COMMUNITY BUILDING
 

French company Naturex, represented in South Africa by Sharon Bolel Chemical Marketing, is totally committed to improving the living conditions of the communities from which it sources raw materials. The Naturex Foundation, established to concentrate on these upliftment programmes, has in the two years since its inception notched up several successes in education, medical, environmental and basic-needs projects. For example, in northern India's Sahhaspur region the Foundation supports 'Poverty Alleviation through Promotion of Agricultural Micro-Enterprises', which is a project that helps to create small farms specialising in aromatic plants. The aim is to establish 20 new farms during 2010.

"The Naturex Foundation's activities represent the underlying principles of integrity and responsibility that have always been inherent within the company," says Sharon Bolel. "These projects represent a long-term commitment to responsible corporate citizenship and sustainable development. We've no doubt that the ongoing success of these projects will pave the way for further projects in other areas that provide Natruex with raw materials. In our experience, when Naturex sets itself goals, it makes sure it reaches them – responsibly and authentically." Bolel is proud to be associated with Naturex and its strong policies of social investment.

Naturex, which has production facilities in France. Morocco, the USA and Italy, manufactures natural ingredients for the pharmaceutical, cosmetic, nutraceutical and food industries.

 


WILDCARE CENTRE APPEALS
FOR PRODUCTS

Wildlife rescue and rehabilitation require enormous effort, dedication and compassion. These are attributes that Craig Hoskens and Ina de Koker of the Crags View Wildcare Centre have in abundance. What they lack are sufficient healthcare products to adequately treat their ever-growing numbers of injured, maimed and orphaned wildlife. Situated outside Port Edward on the KZN Lower South Coast, this is the only facility of its kind in the area and is constantly inundated. At any given time, Hoskens and de Koker will be treating some 25 distressed animals – including blue duiker, bushbuck, porcupine, bush pig, dassie, jackal, mongoose, caracul, gennet and monkey - and as many as 50 birds. The duo works around the clock, juggling their day jobs with their voluntary Wildcare operation.

Hoskens does most of the rescue and re-release work, while de Koker is primarily the rehabilitation nurse and fundraiser. The centre receives no financial assistance from the province and relies entirely on the public for support.

It is a Section 21 company registered as a NPO/NGO. Medicine stocks are quickly depleted and the undertaking is always in urgent need of healthcare products, specifically calcium tablets and powders, probiotics, multi-vitamins, brewer's yeast, rescue remedy, micro-pore tape and any appropriate supplements. The role of Crag's View is invaluable and seeks your much appreciated support.

Contact: 039-311-2488 (phone/fax), 076-933-927;
email: wildlife@cragsview.co.za
website: www.cragsview.co.za


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TRAINING

JOURNEY TO WHOLENESS AND HEALING

For many people, questions regarding life's journey abound. Answers, however, are difficult to find. To assist those eager to access these elusive solutions, the owner of Reform Distributors, Sue Du Plessis, is offering workshops simply entitled Questions & Answers. A self-confessed over-achiever with an impressive medical and holistic healing background, she invites interested parties to "bring your deeper questions about life, love and destiny so that we can explore the answers together in a loving an accepting environment."

Having conducted numerous lectures and workshops on subjects including stress management, assertiveness, parenting, first aid, women's health and emergency medicine, Du Plessis is a well-qualified facilitator.  For these workshops, she will utilise different approaches incorporating her medical, dietetic, holistic healing and counselling expertise, with an emphasis on spirituality and wholeness to aid the self-development process.

"The workshops have no specific topic…we can explore any questions and I will guide people to access their innate wisdom and look inward to find answers. I work with the basis of good science to help people explore the deeper levels of self and aid them on their journey to wholeness and healing."

The workshops are scheduled for every 2nd Saturday afternoon from April to November and will be conducted in Lammemoor at a cost of R300 per person.

Contact: 072 2277272/ 0110236696
Email: we_are@yebo.co.za


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FORTHCOMING EVENTS ...

NATURAL & ORGANIC EXCEEDS EXPECTATIONS

The Cape Town leg of the 2010 Natural & Organic Exhibition surpassed the expectations of exhibitors, visitors and organisers. According to the organisers, "Our Cape Town show was completely outstanding and broke all of our attendance numbers." Visitors increased from 10 000 in 2007 to more than 30 000 this year and exhibitors recorded better sales than they could have imagined.

The show that supports and promotes the 'green revolution' is now heading north and promises to be even bigger and better at the Coca-Cola Dome in Johannesburg from 27 – 29 August. A highlight will be the Green Home exhibition – the first dedicated to inspire greening the home. Apart from showcasing a wide range of organic products, the exhibition will also boast a lifestyle stage featuring live performances, interactive demonstrations, eco-fashion shows and green business and lifestyle trends.

The Natural & Organic Exhibition is South Africa's premier green trade and consumer event, designed to inform and inspire businesses and individuals to make better choices and to introduce the natural and organic way to the widest possible audience. It's an awesome experience not to be missed.

Contact: (021) 671 0935
Muriel@specialised.com

www.naturalandorganic.co.za


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IADSA NEWS

SOUND SCIENCE IS A PRIORITY

Numerous important issues were addressed at the IADSA AGM held in Istanbul in February. One of the most significant, according to HPA President Bruce Dennison, is the IADSA 3-year scientific programme. "The main thrust of this programme," explains Dennison, "is the development of scientific support for supplements to provide good evidence that they are effective and provide benefits."

The scientific programme is to focus on three main pillars:

  • Development of scientific publications and papers
  • The IADSA Scientific Alert System, which will deal with positive and negative media
  • The organisation of an annual international Scientific Forum to help discuss issues with leading scientists across the globe and to promote solutions
Global legislation and GMP were also in the spotlight but, says Dennison, one of the major issues of concern is the situation in Europe. "The European Food Safety Authority is questioning supplement claims as it believes these lack sufficient supporting evidence. The EU is the biggest economic bloc in the world: when it begins questioning, this can easily spread to other countries like a virus – they may also begin to think that something suspicious is going on with supplements. We could then have a potential problem on our hands, as unfavourable EU regulations could change the face of the industry."

 

IADSA LOOKS TO THE FUTURE

Foundations for future IADSA initiatives were implemented during 2009 as the organisation expanded its influence in novel ways and into uncharted regions. With a new Executive Council in place, members have taken on a significant and important role for the future of the dietary and food supplement sector. Globally, IADSA members assisted in forging links with governments and thus enabled the achievement of further success with Codex. The association expanded its reach to include Latin America, Russia and the South East Asian region.

"Our focus for 2010 will continue to be on Codex, ASEAN, Latin America and Russia," announced IADSA Executive Director Simon Pettman. "We will also be engaging very closely with China's regulatory and scientific decision-makers as they review their regulatory framework for food supplements. We will be adding further elements to our website to help it become an ever better tool to help associations and governments. We are also conscious of the challenges faced by the EU's claims regulation and will of course be taking the necessary action to support the European associations in their battle in this area." 

The IADSA scientific group again proved itself to be influential and its network of leading experts across the world grows in both extent and influence through the annual IADSA Scientific Forum.

"2009 allowed us to bring into play the scientific response mechanism," continued Pettman. "We know that this has already helped many associations in dealing with their media and governments on negative science."

CAMS PROVISIONS IN OBAMA'S
HEALTHCARE REFORM BILL

US: Several provisions that address CAMS are included in the new Healthcare Reform Bill signed into law by President Barack Obama. The Patient Protection and Affordable Care Act embodies details that primarily serve to better incorporate alternative practitioners into the U.S. healthcare system. Included in the final law, Section 4206, are provisions that will have a direct effect on dietary supplements for which there are FDA-approved health claims, by setting up a pilot programme for "wellness plans" which can now include supplements with "health claims approved by the Secretary." Currently approved health claims include those for calcium and osteoporosis; soluble fibre and coronary heart disease; folic acid and neural-tube birth defects.

The new healthcare law is a starting point for a broader inclusion of CAMS within the U.S. healthcare system. If managed properly, greater inclusion of alternative practitioners in healthcare should pave the way for increased acceptance of the dietary supplement products they provide.

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TEAM UP WITH THE HPA

Since its inception in 1978, the HPA has been committed to establishing a reputable and robust health products industry in Southern Africa. Having grown in strength and stature over the years, the HPA now represents more than 100 companies in the region: these incorporate manufacturers and distributors of complementary medicines, food supplements, health foods and beverages.

It is imperative that the health products industry be perceived as reputable, relevant and contributing positively to healthcare worldwide. As the goal of the HPA is to achieve these aspirations it is crucial that all stakeholders team up with the HPA to present a unified and responsible front. The HPA has over the years constructively and effectively dealt with many challenges to the industry and remains ready to meet any future issues which may arise.

"If there had not been an industry association that was alert and in touch with the various government departments and regulators, the Recision of the 2002 Call-Up Notice would have been put in place and the industry would be in turmoil," says HPA Executive Secretary Deirdre Allen." The HPA immediately reacted to protect the CAMS industry when it learnt that such a decision had been taken by the MCC and activated the necessary legal procedures to stop this recision."

Further challenges facing the industry in 2010 and beyond include:

  • Responsible Regulations
  • National Health Insurance
  • GMP
  • ASA CAMS Appendix

"HPA Members are also entitled to a range of benefits including media and advertising assistance, introductions to international distributor networks and access to a significant pool of scientific information and resources, as well as legal assistance," concluded Allen. "Joining the HPA will provide numerous advantages to all health industry stakeholders, from small companies to giant multinationals."

  • Sign up now by contacting Deirdre Allen on 011 789 4464
  • hpasa.co.za

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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

DISCLAIMER
The comments and opinions expressed in this newsletter are not necessarily the views or position of the Health Products Association.