CAMS REGULATIONS: A little closer?

THE end of the long journey to establish appropriate regulations for complementary medicine by the Department of Health may be in sight.

Commented HPA Chairman Dr Alan Tomlinson: “The intention of the Department of Health is to publish draft regulations for comment within the next six weeks. The chief of the legal unit of the DoH, Advocate Sello Ramasala, has been working to achieve a final document for publication. He’s been interacting with a working group set up by the Medicines

Regulatory Authority (MRA) in a combined attempt to develop acceptable regulations.

“We are hoping to have an opportunity to view the regulations before they are published so that we can give input,” Dr Tomlinson added, “but we’re hoping they will be fundamentally in order so there won’t be the need for any major changes or interventions.”

TOP TEAM TO SURVEY HEALTH INDUSTRY

IMS Health, the world’s leading provider of healthcare information, has teamed up with the HPA to conduct a survey of the South African health products industry.

“We are thrilled to have such a professional international team to help us gather the fullest possible figures on the status of the industry,” said HPA Executive Secretary, Deirdre Allen. The HPA is aiming to provide its members with updated information on the complementary health products market as well as to be able to furnish information to other local and overseas associations.

Allen emphasised the importance of all HPA members co-operating in the endeavour. “This survey will give us a better understanding of the broad healthcare market, which will be most beneficial to all industry stakeholders,” she explained. “With a concerted effort from everyone, we should have accurate and valid industry figures in the next couple of months.”

IMS Health has previously focused on the scheduled medicines market. However with the changes in healthcare offerings from service providers, the survey  company has widened its focus to look at all aspects of healthcare.

BLACK COHOSH SAFETY WARNING

THE HPA executive has been monitoring scientific literature and the opinions and statements of associations and regulatory authorities abroad relating to the safety of Black Cohosh (Cimicifugae racemosae rhizoma) and whether label warnings should be placed on products that contain it.

There has been evidence that Black Cohosh may, in rare instances, cause hepatitis (liver disease) – but it is not 100% conclusive.  However, since the possibility of such a risk exists, and since hepatitis is a serious condition (although usually reversible if detected early), the HPA executive has followed the lead of the UK Health Food Manufacturing Association.

It has advised Association members and non-members to include the following minimum wording on the labels and package inserts of any product that contains Black Cohosh: 

“In rare cases, Black Cohosh may cause liver problems. Consult your doctor if you already have liver disease or become unwell whilst using this product."

The fuller, UK version may also be used:
“In rare cases, Black Cohosh may cause liver problems. If you become unwell (yellowing eyes/skin, nausea, vomiting, dark urine, abdominal pain, unusual tiredness) stop taking immediately and seek medical advice. Not suitable for patients with a previous history of liver disease.”

The HPA recommends that all advertising and marketing material that includes statements about the safety of Black Cohosh, wether on paper or websites, should include the above wording.

GETTING CREATIVE ABOUT CLAIMS

THE Self Monitoring Technical Committee set up by the HPA almost two years ago as an industry watchdog-cum-advisory body is finding itself extremely busy with enquiries and concerns about product and advertising claims. So much so that it has now streamlined itself into several portfolios: marketing, technical and substances.

SMTC chairman Denise Maidment was very positive about their engagement with members. “In most instances, we’ve had magnificent responses from companies who’ve had to make changes to advertising or labelling. And we’ve noticed a lot of people are being proactive and coming to us before they commit anything to print. Ultimately, that was what we wanted.”

One of the sticking points that the SMTC encounters has to do with companies who believe the claims they’re making for products do have substantiating evidence. But she points out that such benefits cannot be applied to unregistered medicines.

“There are some disease states we simply cannot make claims for – like cancer and AIDS,” Maidment elaborated, “but even a condition like arthritis, although not life-threatening, cannot be specified. One has to use descriptions such as ‘relief for joint pain and mobility’. Get creative about wording, in other words.”

She added that some companies seemed nervous that, if they did not link products to specific medical conditions, they would lose sales. “But I reckon ‘looser phrasing’ could actually help them reach more people,” said Maidment, “and we can help them with that.”

AFRICA’S HEALING PLANTS IN SPOTLIGHT

A group of international scientists is working to produce a pharmacopoeia of African medicinal plants, a reference work that will be of vital importance in setting international standards for the therapeutic plants of this continent.

Stemming from a meeting in May 2005, when 28 experts from 14 countries met in SA to review the establishment of suitable standards for important African medicinal plants, an organisation was formed to develop such standards as well as an African Herbal Pharmacopoeia.

Africa-wide support was pledged for the preparation of African quality assurance and trading standards and the establishment of the organisation – which is known as the Association for African Medicinal Plants Standards (AAMPS). With headquarters in Mauritius, AAMPS is supported by the EU-ACP Centre for Development of Enterprise, by ProInvest and private and corporate sponsors.

AAMPS is preparing standards for the most important African plants presently traded as well as others judged of long-term importance. The profiles combine information normally contained in drug monographs with data usually found in medicinal plant trade specifications and quality control sheets. Guiding this process are Professor Kobus Eloff (Phytomedicine Programme, University of Pretoria) and Denzil Phillips (CDE Associate Expert Herbals and Pharmaceuticals), who head the project’s steering committee.

• www.aamps.org

ANNIQUE: MAXIMISING POTENTIAL

“THE core of any network marketing company is growth.” Ernest du Toit, recently appointed CEO of Annique Skin Care Products is adamant. “You can have the best products and a fantastic compensation plan, but a direct selling company won’t grow unless the network expands.” And he aims to maximise the “unexploited” potential of the South African company that helped put the healing properties of rooibos on the map.

Rooibos (Aspalathis linearis) is an indigenous herb from the Cedarberg Mountains, traditionally used by the Khoisan people to ease a range of ailments. But it was only in the 1960s that its healing properties came to the attention of the general public.

In 1968, Annique Theron discovered that the tea calmed her baby, relieving it of colic and insomnia. Intrigued, she began to investigate the plant – and in 1971 launched her line of skin care products which has developed into an extensive and respected range of skin, body and health care products.
 
For the past 37 years, Annique Skin Care Products has been primarily a family run concern. But with the appointment of du Toit, the company is breaking new ground. “Our intention is to double the turnover in the next three to four years,” said du Toit who has had similar successes in his previous executive positions with other direct selling companies. Positive results are already being achieved with sales increased by 46% in April.

Du Toit aims to expand the distributor network to be more representative of the country’s demographics and to grow the micronutrient portfolio. However, the award-winning skin care range will continue to be a primary focus. The Annique range caters for all skin types as well as teenagers, children and babies – and offers body care and sun protection.

• www.annique.co.za

A.G.M. REMINDER

HPA members are reminded that the 2008 AGM is set for 10 July in Gauteng.

This is a crucial time for the health industry so make sure you are there to have your say in voting in a new committee – and staying up to speed on the latest developments regarding:

• CAMS Regulations

• Publicity & Promotions

• IADSA & International Matters

• CAMS Training

• The work of the SMTC.

If you’ve not received your notice – or deleted it by accident! -  drop Deirdre Allen an email at: hpasa@hpasa.co.za

NEW FACES AT IADSA

APRIL this year saw the election of a new chairman and vice-chairman for IADSA. At the association’s AGM in Italy, American Byron Johnson of the Council for Responsible Nutrition took over the chair from Randy Dennin who retired. Peter van Doorn was elected as vice-chairman.

HPA honorary president, Bruce Dennison, who was IADSA Vice-Chairman for ten years, remains on the executive as representative for the Middle East, Africa and the Indian Ocean Islands.

Dennison explained that the executive committee was split geographically, with three representatives from North American and Canada, two from Europe, one from Oceania (Australia and New Zealand), one from South East Asia, two from North Asia and one from the Middle East, Africa and the Indian Ocean Islands. “Apart from me, the remainder of this committee has not been elected. But as a number of the executive members will be at the Codex meeting in Cape Town in November, the HPA has invited IADSA to hold their ExCo meeting in Cape Town on November 6.” IADSA have yet to confirm this.

GOOD-BYE TO ANDRE

Andre Roos was a man who displayed the utmost dedication and commitment to everything he tackled. Born on the Westrand on 2 November, 1942, he obtained a National Diploma in Chemistry after matriculating. Most of Andre’s career was spent in the cosmetic industry, where he worked for companies like Revlon and Justine.

A past President of the Society of Cosmetic Chemists, Andre lived for most of his life on a plot in Benoni. It gave him great pleasure to share the produce of his land with friends and colleagues. An enthusiastic microlight pilot, Andre spent many weekends flying with his daughter Celecia.

At the time of his passing, Andre was MD of Azochem laboratories, where he had been employed for 20 years. In the last few years he had been expanding Azochem into the complementary medicines arena and growing the company in to the respected operation it is today.

Andre is survived by Dale, his wife of over 40 years, his daughter Celecia and two granddaughters Gwyneth and Samantha. He will be sorely missed.

The HPA Executive extends heartfelt condolences to his family, friends and colleagues.

HEALTHY LIVING EXPO COMING UP

The Healthy Living Expo is once again on the horizon as the official HPA exhibition as well as a great promotional opportunity for stakeholders in the industry.

Exhibitors at the 2007 Sandton City event were pleased with the results of their participation. Many reported increased sales and exposure from the public traffic through the centre. An estimated 10 000-plus people visited the exhibition.

The Fountain Court has been booked again for this year’s expo – and the dates to diarise are 5, 6 and 7 September. New exhibitors so far include SA Natural Products, Lighthouse Pharma, Austell Laboratories and Swiss Herbal Remedies.

Considered a good marketing avenue in a prestige venue, the Healthy Living Expo 2008 will be promoted on Highveld Radio and posters throughout the mall. Only ten stands remain, so book yours now!

• Contact Bette McNaughton
• (021) 713-3360 / 082 472 3172
•  bettemc@iafrica.com

WELLNESS AND BEAUTY ON SHOW

Included is a programme of talks and demonstrations while tasty offerings from Durban food gurus will illustrate the pleasures of healthy eating.

Timed to coincide with the Celebrate Durban festivities, The Body Show will be backed by an extensive advertising campaign.

• For info and bookings contact Camilla Railton

• Phone (031) 572 3831or 078 339 8300

• bodyexpo@gmail.com

CODEX UPDATE

THE HPA will be one of the hosts of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) when it hold its annual meeting in Cape Town from 3 to 7 November. The venue is the Cape Sun Hotel.

As further details of the function and agenda become available, they will be published in Headlines and posted on the HPA website (www.hpasa.co.za).

MEDICINAL PLANT EXPERTS GATHER IN SA

THE fourth World Congress of Medicinal and Aromatic Plants (WOCMAP) comes to Cape Town from 9 - 14 November. It promises to be the biggest yet with over a thousand delegates expected from all the continents.

Many aspects of medicinal and aromatic plants (MAPs) will be discussed, with leading scientists serving on the Scientific Advisory Committee and presenting plenary lectures. The leader of the Phytomedicine Programme at the University of Pretoria has been invited to assist with the congress. Running concurrently will be a MAP trade fair and special exhibition, featuring African herbal products, ingredients and publications - as well as representation by international companies and organisations offering technical and financial help to the MAP sector. The WOCMAP exhibition offers local product suppliers a showcase for their products and services, and is an opportunity for organisations involved with developing our natural resources to promote themselves. Traditional herbal practitioners and plant collectors will also be able to promote their knowledge and experience.

Organised by Denzil Phillips International in association with the local WOCMAP committee and Thebe Conferences, the exhibition will be held in the Cape Town International Convention Centre.

• www.wocmap2008.co.za

• www.denzil.com

TESTING, TESTING …

NETHERLANDS: Since 2001, an off-shoot of the Dutch Association of Natural Products Manufacturers (NPN) has been running a programme that enables supplement manufacturers to have their products meet World Anti-Doping Agency (WADA) standards. The Netherlands Security System Nutritional Supplements Elite Sports (NZVT) was set up following a number of scandals where elite athletes had ingested illegal substances, with food supplements often named as the culprit. Under the scheme, products are tested in a laboratory that conforms to WADA standards. If free of contaminants, they are included on the association website’s positive list of products. A similar scheme now operates in the UK.

FOOD LAWS TIGHTENING

CANADA: Prime Minister, Stephen Harper, has announced a proposal for a safety bill intended to enhance protection for Canadian consumers with a comprehensive overhaul of food and product safety laws. The proposed changes include much more stringent penalties on negligent manufacturers, importers and retailers who knowingly endanger their customers, coupled with improved public access to information about product safety.

POTASSIUM RESTRICTION?

AUSTRALIA: Regulators are considering further restrictions on the sale of supplements (regarded as therapeutic products in Australia) containing potassium. Because of safety concerns, a label warning statement is already required for glucosamine sulphate potassium chloride complex supplements. There is also a proposal to require child resistant closure for products containing potassium salts in packs containing more than 4 000 milligrams of elemental potassium.

INTERNET CENSORSHIP

CANADA: The Canadian Competition Bureau has had a major crack-down on internet sites that present unproven claims to treat or cure diseases. While the majority of the websites have agreed to modify or remove unproven claims, some have not done so and the Bureau is considering further enforcement, including fines and/or criminal charges.

CHINESE PUZZLES

US: Officials from the U.S. Food and Drug Administration (FDA) have stated that a chemically altered substance called ‘over-sulphated’ chondroitin is probably the contaminant linked to hundreds of allergic reactions to heparin produced in China for the US market. It is not yet clear whether the compound, which is not part of the prescribed manufacturing process, was intentionally added to cut costs or whether it was a mistake. However, the dietary supplement industry has been quick to point out the difference between the suspect substance and the chondroitin used in dietary supplements: ‘over-sulphated’ chondroitin sulphate does not occur naturally, whereas the chrondroitin sulphate widely and safely used in dietary supplements for joint pain is a natural compound.

UNSAFE SUPPLEMENTS

US: More than $1 300 000 worth of dietary supplements were seized recently from a Michigan company because the products contained unapproved food additives and/or new dietary ingredients that violated the law. Labelled as dietary supplements, the products were marketed for use by body builders and were available on-line and in retail stores. When tested, the seized products were found to contain unapproved food additives and new dietary ingredients that had not been shown to be safe.

TOXIC SEED TEA?

NEW ZEALAND: THe New Zealand Food Safety Authority (NZFSA) is warning the public not to consume seeds that may be found in a Chinese herbal tea made from the plant Abrus Cantoniensis and retailed under various brand names – such as ‘Canton Love Pea’ or ‘Herba Abri’. NZFSA is advising anyone who has the product to return it to the place of purchase. The plant is not permitted to be sold as a food or food ingredient under the local Food Standards Code as the seeds, and possibly the pods, are believed to be toxic.

SELENIUM HAZARD

US: Following a warning earlier this year from the FDA about a range of liquid dietary supplement products, the Florida Health Department had provided reports on 23 individuals who experienced serious reactions, seven to 10 days after ingesting the products. A product analysis showed that certain flavours contained hazardous amounts of selenium - and chromium - at levels of up to 17 times the recommended adult daily intake.

IODINE SANDWICHES

NEW ZEALAND: Following a dietary survey that revealed the iodine levels of New Zealanders to be much lower than those of people in other countries, the New Zealand Food Safety Authority has made it mandatory for bread manufacturers to replace non-iodised salt in breads with iodised salt. Only organic and unleavened bread are exempt from this requirement.
This has come about because New Zealand’s soil iodine levels are naturally low; an increase in the popularity of sea and rock salt that has reduced consumption of iodised salt; salt consumption has general lessened; and there’s been a reduction in the use of iodine-based disinfectants in homes and industry.

HEAVY GOING FOR AYURVEDA

CANADA: Health Canada has warned consumers that consumers who use unapproved Ayurvedic medicinal products may put themselves at risk as some contain high levels of heavy metals. In a recent case, an adult male with symptoms of vomiting and diarrhoea was found to have been taking one tablet daily of an unauthorised Ayurvedic product which, on analysis, was found to contain high levels of lead, mercury and arsenic.

BOTANICALS SCRUTINISED

US: Following concerns about the adequacy of dietary botanical supplement (DBS) surveillance in the United States, a recent study looked at DBS data associated with adverse event reporting. Data from 1999 to 2003 revealed that the six most frequently-used DBS linked to adverse reporting were echinacea, ginseng, garlic, ginkgo biloba, St. John’s wort and peppermint.
Reports involving Ginseng were the most frequent and St. John’s Wort the least.. Most reports involved multiple ingredient DBS. Gastro-intestinal and neurologic problems were the most common clinical outcomes among single-ingredient DBS.

UPS AND DOWNS

US: An American company has pleaded guilty to conspiring to market and sell a prescription drug by falsely labelling it as a dietary supplement, thereby endangering those for whom the ingredient, sildenafil citrate, is contraindicated. The product was sold over the internet as a purely herbal alternative to Viagra, and was marketed as ‘certainly less expensive’ and ‘probably safer’.

EPHEDRA PRODUCTS RECALLED

US: Nine dietary supplement products containing the banned ingredient Ephedra, have been recalled on the grounds that ‘they may present a serious health hazard to consumers.’ Supplement industry associations, including the Council for Responsible Nutrition and the Natural Products Association, have been quick to express their support for the recall.

HERE’S WHY 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 for 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.

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