HPA HEADLINES DECEMBER 2018

The HPA wishes all members, colleagues, friends and family a happy and fun-filled holiday season.

THE HPA:
ACTIVELY ASSISTING THE HEALTH PRODUCTS INDUSTRY

Since its inception in 1976, the HPA has worked consistently and tirelessly to promote and protect the health products industry in South Africa – a task that has been both intense and challenging. The HPA provides information, comprehensive service and assistance to all members and the industry at large, while confronting and defusing regulatory challenges. Over the years, the HPA has worked closely with the International Alliance of Dietary / Food Supplement Associations (IADSA) and subsequently has notched up numerous achievements and positively influenced various aspects of trading, functioning and operating within the industry

Not only has the HPA worked with IADSA, but also been actively engaging (and continuing to do so) with the Department of Health, SAHPRA via the ITG, the Pharmacy Council and other regulatory bodies to ensure that the onerous regulations that have been published be amended so as to facilitate access to safe and efficacious health products for all South Africans.

Key improvements to date include:

  • The increasing of allowable levels for most vitamins and minerals [SO – as health supplements],
  • The down-scheduling of Silimarin (Milk Thistle)[S0]
  • The introduction of probiotics as health supplements [S0]
  • The down-scheduling of Methionine – 210mg limit [S0]
  • The down-scheduling of 5HTP – less than 220mg with health supplement claims [S0]

Furthermore, the HPA has and continues to influence various regulations and projects that have a negative impact on the CAMS industry. These include:

  • Engaging with SAHPRA on amending the regulations to provide for more appropriate requirements for health supplements, and to adopt a fast-track registration system
  • Working with the Pricing Committee relating to Single Exit Pricing and Bonusing issues
  • Engaging with the Pharmacy Council
  • Commissioning a workable Marketing Code and working with an appropriate body to enforce this
  • Actively participating in the CAMS Alliance
  • Liaising with Port Health
  • Providing members with assistance regarding advertising and labelling concerns via the HPA Advisory Committee and providing Certificates of Freesale

The HPA is fully aware of the challenges facing industry, and consistently and constantly ensures that all negative matters are addressed immediately. The HPA has your back!

PRESENTATIONS AND PUBLICITY
During the course of the year, HPA Chairperson Maria Ascencao delivered numerous excellent presentations to ensure that all members are updated and informed. These included “CAMS/HS Industry Trends”, “Health and Wellness Trends” and “Cannabis”. CEO of Comed, Peter Kreft, independently prepared a document outlining the difficulties of completing a CTD format for a multiple-substance product. It is well thought through, and also serves to provide a solution-based process in collaboration with SAHRPA.

The HPA also continued to present a visible face to the world. A Facebook page run by Leap Communication was launched in early 2018: it has grown exponentially and currently boasts 4466 likes and 4494 followers. The HPA website, Newsbytes and Newsletter meanwhile continue to provide relevant information: these platforms keep HPA members and other interested parties aware of industry issues both local and international.

REGULATORY PHARMACISTS
The Regulatory Pharmacist requirement presents a challenge for many HPA members. On its website, the HPA lists affiliated Regulatory Pharmacists.

LEGISLATION

REGULATIONS – INDUSTRY IMPACT & ADVERTISING REGULATORY BOARD

The South African health products industry continues to be pressurised by regulations. “For five years, from 2013 to 2017, the HPA was involved in extensive collaboration with the Department of Health (DoH), and had high expectations for a positive outcome for our industry,” explains HPA Chairperson, Maria Ascencao. “When the General Regulations to the Medicines and Related Substances Act, 101 of 1965 (Regulations, 2017) were eventually published on 25 August 2017, the industry was dismayed that our input had not been considered. These regulations effectively defined ‘complementary medicine’ and ‘health supplements’ as medicines, and the current regulatory framework is posing a major risk to the South African industry and consumers.”

Ascencao points out that the regulations make compliance for many involved in the health products industry very difficult: they rule out the understanding of food and dietary supplements according to global norms, and the classification of natural health and nutritional products as a subset of drugs will negatively impact the South African industry and consumers. “The DoH has not undertaken any impact studies to determine the risk of these regulations on the economy and an industry that provides employment and promotes health and wellness,” she stresses.

However, there is light at the end of the tunnel. “The latest regulatory challenge has inspired advocacy and drawn together several stakeholders in a united cause,” Ascencao says. “A joint strategy has been formulated and the HPA, along with the other alliance partners, will continue working hard to prepare for the challenges ahead – with a clear goal of continued constructive engagement with the DoH and Government as a whole. It is the HPA’s intention to ensure a workable system that is sustainable in developing and implementing a framework that best serves the industry, the DoH, Government Health Policies, and the South African consumer.”

ADVERTISING REGULATORY BOARD RISES FROM ASA ASHES

The Advertising Regulatory Board has risen like a phoenix from the ashes of the Advertising Standards Authority of South Africa (ASA) with Gail Schimmel at the helm. When the Advertising ASA went into liquidation in its 50th year, the marketing and advertising industries were determined that this would not mean the end of self-regulation of advertising in South Africa. Protection of the consumer is a priority of government and the marketing and advertising sectors and all parties were determined to ensure that a credible and competent organization would step in to fill the gap.

The original core members of the ASA – the Marketing Association of South Africa (MASA), the Association for Communication and Advertising (ACA) and the Internet Advertising Bureau (IAB) – all became founding members of the Advertising Regulatory Board (ARB). The Advertising Regulatory Board administers the widely-accredited Code of Advertising Practice which regulates the content of South African advertising.

For more information: http://www.arb.org.za/

SPOTLIGHT ON PROBIOTICS

Interest in probiotics is increasing globally, placing these micro-organisms in the international spotlight. According to Andrea Wong PhD, Vice President Scientific & Regulatory Affairs at CRN, increased scrutiny from the media and industry critics is to be expected. In South Africa, Saige Consultants have submitted on behalf of the HPA an application to down-schedule probiotics and expand allowable claims. In September 2018, B2B Market Research published a comprehensive industry report focusing on probiotics and entitled “South African Digestive Health (Probiotics) Industry Landscape Report”.

The 96-page report provides a dynamic synthesis of industry research, examining the local and global probiotics industry from a uniquely holistic perspective, with detailed insights into the entire value-chain, from manufacturing to retail trends and pricing analysis. The document can be found on the HPA website under ‘Presentations’. The full report order form is included in the presentation.

CRN has also published Best Practices for Probiotics Guidelines: https://www.crnusa.org/self-regulation/voluntary-guidelines-best-practices/best-practices-guidelines-probiotics

WHAT’S HAPPENING

GREEN LIGHT FOR CANNABIS

The South African Constitutional Court on 18 September 2018 delivered a landmark ruling when it legalised cannabis for personal recreational use, following in the footsteps of Canada, Georgia, Lesotho, Zimbabwe and Uruguay. Once demonised as a gateway drug, cannabis is rapidly gaining popularity worldwide for its medicinal benefits, and medical marijuana has been legalised in 29 states of the USA. HPA Chairperson, Maria Ascencao, gave a presentation on cannabis – entitled “The Most Disruptive Molecule in Medicine Today” – at the HPA Meeting of 25 October, 2018. “The current trend to reform prohibition has sparked an unprecedented bull-market in all things cannabis-related,” states Ascencao.

“Cannabis is the raw material in new innovations and delivery systems, from dietary and food supplements to nutraceuticals and cosmeceuticals, including some of today’s most cutting-edge and promising pharmaceutical agents,” continues Ascencao. “Medicines designed to combat diseases that medical science had previously dismissed as ‘untreatable’ are now opening doors to possibilities never before imagined. The potential is very real that by 2030 diseases such as Parkinson’s and Alzheimer’s will have been defeated with THC-derived medicines, medicines that would have been invalidated by legislation before their potential could be unlocked. While South Africa grapples with the grey areas around the judgement, the decision is a boon for the nascent cannabis industry in neighbouring countries which are several steps ahead of South Africa in trying to take advantage of the burgeoning global cannabis market by legalising industrial cultivation – not just private use – and they could see a profitable market open up.”

On behalf of the HPA, Afriplex Pharmacist Robert Longrigg conducted a radio interview on the subject: it can be accessed via the HPA Facebook page and website.

Ascencao’s full presentation can be obtained from the HPA.

INTERNATIONAL

THE COUNCIL FOR RESPONSIBLE NUTRITION – WORKING TO SUPPORT AND STRENGTHEN THE INDUSTRY

Founded in 1973 and based in Washington DC, the Council for Responsible Nutrition (CRN) is a leading trade association representing dietary supplement and functional food manufacturers and ingredient suppliers. The body supports and promotes industry and self-regulation, and provides informative and up-to-date news, comprehensive resources, as well as events and education facilities. Always at the forefront of industry-related matters, CRN consistently offers relevant and significant information and services to both the industry and consumers.

Supplement Owl – which was launched by CRN in April 2017 – is now expanding. With over 10 000 labels in Supplement OWL to date, the registry has become a go-to resource for regulators and other industry stakeholders. In addition to serving regulators, Supplement OWL provides retailers with an authoritative database to examine and evaluate labels of products on the market. CRN members now have the opportunity to help the OWL expand with the. Commercial Data Exchange (CDX) – a retailer-focused feature of Supplement OWL. (For more: https://www.crnusa.org/self-regulation/supplement-owl)

Consumers are equally important to CRN. The organization recently published the results of a CRN Consumer Survey revealing that the use of dietary supplements among U.S. adults increased ten percent over the past decade (https://www.crnusa.org/newsroom/new-data-reaffirm-trust-and-confidence-industry-reveal-modern-trends-and-habits-american) and also the Public Service Announcement: “Three Reminders for Consumers When Purchasing Dietary Supplements” (https://www.crnusa.org/newsroom/three-reminders-consumers-when-purchasing-dietary-supplements-public-service-announcement)

Visit CRN at: https://www.crnusa.org/

HERB CORNER

CANNABIS TAKES CENTRE STAGE

Cannabis is unquestionably the most talked-about plant on the planet right now. Touted as a revolutionary healing plant, cannabis is being manufactured, marketed and sold in many forms, shapes and guises: THC, CBD, Indica, Sativa, and their derivative strains aplenty can be found around the world. The internet is positively buzzing with articles, webinars, products and miracle stories, and the plant is being legalised in many countries. With so much publicity and such a huge demand, cannabis products can now be found everywhere. One problem, however, is the apparent lack of quality control. Do people really know what they’re getting?

Cannabis claims are made for curing a wide variety of diseases and disorders. An ever-increasing number of people are making, recommending, selling and taking cannabis oil. But what about the quality and content? Many cannabis products are homemade, untested and manufactured with limited cannabis strains via questionable extraction processes. To get the best from cannabis, one needs a product with credentials – which is why it is very important to do your homework when purchasing any cannabis product.

As stated by the New Hope Network: “Quality ingredients and products are critical across the entire supplement industry, as manufacturers and retailers fight to earn consumer trust. They’re even more important in the growing cannabis industry where consumers new to the plant and its components choose from thousands of products with varying degrees of quality. Fortunately, responsible companies are going above and beyond to bring quality products to the market and build consumer confidence.” The network has therefore published “A Retailer’s Guide to finding quality CBD products”, which can be found here: https://www.newhope.com/webinars-toolkits-and-downloads/retailers-guide-finding-quality-cbd-products

COMPANY PROFILES

LARGE AND SMALL, THE HPA REPRESENTS THEM ALL

The HPA represents over 100 companies in South Africa – from multinationals to small, privately-owned establishments. Two companies that reflect both ends of this spectrum are Chempure and Allisone. Chempure, one of sub-Saharan Africa’s largest importers of speciality, innovative ingredients, has been managing and anticipating global trends, innovations, and pricing on behalf of customers for close on 25 years. Allisone – the home of the Biochemic Institute of South Africa – was founded and is run by Alison Effting.

Based in Cape Town, Alison Effting is a bio-energetic natural health practitioner – a teacher in the modalities of Tissue Salts and Aura-Soma®. The Biochemic Institute is a branch of the Biochemischer Bund Deutschland, founded in 1885 in Oldenberg, Germany, by Dr WH Schuessler. Effting presents biochemic workshops locally and internationally, while her original, lactose-free range of AllisOne tissue salts and Synergy combinations is available in local health stores and also exported to the EU and Japan. Effting is Chair of the Association of Aura-Soma Practitioners of Southern Africa, and since 1999 served on the executive committee of the Confederation of Complementary Health Associations of South Africa. https://allisone.co.za/

Chempure sources, markets and supplies speciality ingredients to the sports nutrition, health and wellness, food and beverages, as well as personal care industries, acting as a strategic and trusted partner to some of the world’s most illustrious brands. The company endeavours to give customers a range of products that keeps abreast of the latest research, and sources speciality ingredients from world leaders. All products undergo rigorous testing and quality control. The company has a specialised technical team and boasts a proud legacy of delivering valued-added solutions and innovative ingredients to customers – from conception to final product. It carries comprehensive stocks in anticipation of customers’ needs, and is known as a reliable and inspired source of innovative ingredients backed by an agile system and service excellence.  http://www.chempure.co.za/

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