HPA HEADLINES: MARCH 2017

THE MAGIC OF MINERALS

Minerals are inorganic substances that originate in the earth. These micronutrients are absorbed from the soil by plants, and people assimilate their benefits either directly by eating vegetables and fruit, or indirectly by consuming animal products. As the human body cannot manufacture minerals, they must be derived from food or supplements.

Mineral nutrients are required for numerous biochemical and physiological functions. Vital for enzymatic processes, the composition of blood and bones, and for normal cell function, minerals also help build tissues, assist in blood-clotting, contribute to the maintenance of pH balance, and are involved in muscle contraction. They are required for the efficient functioning of the entire nervous system, and assist in the release of energy from food.

The body requires small amounts of approximately 18 different minerals. The majority of micronutrient supplements can be taken safely without input from a healthcare practitioner, but always abide by the ‘appropriate supplementation’ guideline.

LEGISLATION

NEW DRAFT REGULATIONS PUBLISHED; CALL-UP NOTICE FOR CAMS RESCINDED

On 27 January 2017 the South African Department of Health (DoH) published the new South African Health Products Authority (SAHPRA) draft regulations. “At this moment the regulations are still very fresh, but we welcome the department’s openness to comments by allowing industry a three-month comment period,” says HPA Director of Scientific & Regulatory Affairs, Wayne Robinson. “The HPA Scientific & Regulatory Committee is still reviewing these draft regulations to prepare a comment within the given period.”

According to Robinson, the comment period is very beneficial as it allows stakeholders to consider the broader implications of the draft regulations. “The initial feedback from industry has been that we expected more allowances showing the unique differences between allopathic, CAMS and Health Supplements,” he says. “It is key to apply appropriate standards and requirements to products based on their risks and claims, and we were hoping that the industry feedback submitted to the DoH on the CAMS regulations would have been applied here as well. The HPA does, however, acknowledge that these regulations afford industry a second opportunity to comment and hopefully persuade the authorities to apply a more practical approach to CAMS and Health Supplements.”

Robinson explains that the most significant changes in the draft regulations for the CAMS industry are:
1. The change in definition for Health Supplements is now more broad and “could almost cover anything”.
2. The Package Insert (PI) change to a Professional Information Leaflet, which can now be electronic and only needs to be in English.
3. The Patient Information Leaflet (PIL) change to a Consumer Information Leaflet, which can be included as part of the immediate container or outer packaging.
4. The changes to the disclaimer label to be: “This unregistered medicine has not been evaluated by the MCC for its quality, safety or intended use.” (“But it should reference South African Health Products Regulatory Authority, instead of the MCC.”)
5. The GMO warning to be added to CAMS products.

CAMS CALL-UP NOTICE RESCINDED BY MCC

On 24 February 2017 the Medicines Control Council (MCC) published Gazette No 40637 which rescinded the 2002 call-up notice for CAMS (Gazette No 23128 of 22 February 2002). “This Rescission notice has understandably caused much confusion and anxiety in the industry as to the exact reason(s) for the rescission notice and, more importantly, the full implications are not yet clear,” says Wayne Robinson. The HPA has engaged with the Registrar of Medicines, Dr Joey Gouws, for further clarification. At this point we advise all members and the CAMS industry that the Regulations of November 2013 remain binding law until such time as amended regulations are published, or further clarification of the impact of this notice can be obtained.”

FOOD AND SUPPLEMENT INDUSTRIES CAN PLAY A VITAL ROLE IN SAVING THE EARTH.

In an online article published by the New Hope Network, Nutiva CEO John Roulac emphasises that the natural products industry must play a part in saving the Earth. “Improving the health of our soils and oceans is now a matter of life and death”, he writes. “Many consumers are now seeing the link – connecting the damage done by industrial meat and dairy to soils, and how that impacts on our climate. This provides an opportunity for brands practising regenerative agriculture.”

In another article on the same theme and titled It’s Time to Lead on Climate Issues, Lara Dickinson writes, “The natural products industry can leverage its power to reverse climate change. It’s one of the greatest opportunities we’ve ever had to innovate and make change. By joining forces, we can unleash a new wave of innovation that will help slow and ultimately reverse climate change, while improving our quality of life and making our businesses stronger.”

For the full articles go to:
http://www.newhope.com/news/will-food-industry-be-climate-savior?NL=NP-05&Issue=NP-05_20170222_NP-05_249&sfvc4enews=42&cl=article_1_1&utm_rid=CNHNM000000584083&utm_campaign=20165&utm_medium=email

http://www.newhope.com/news/its-time-lead-climate-issues

WHAT’S ON

HPA WORKSHOP: A PRACTICAL GUIDE TO GMP FOR CAMS AND AN INSIGHT INTO STABILITY

The HPA is to host a valuable workshop to assist industry stakeholders in understanding the GMP procedures required for CAMS, focusing on Requirements and Stability related to herbals and other complementary ingredients and products. The workshops will take place in Johannesburg on 23 March and Cape Town on 6 April.

The three reputable speakers who will deliver presentations are authorities in the GMP arena. Debbie Flandorp, a QA Manager and Responsible Pharmacist with many years’ experience in the CAMS field, will discuss Principles of a GMP Environment as it relates to both local and international certification and Stability from a quality compliance and regulatory perspective. GMP Technical Advisor, Deryck Smith, will speak on Pharma Facility Services Self-Inspections. A guide to a self-inspection as it relates to the manufacturing process, equipment with special focus on HVAC and facility layout. And the Operational Director of Stabil Labs, Dr Herman Julsing, will talk on Insight into StabilityTesting from a storage perspective and simplified requirements.

This workshop is for all CAMS company personnel – marketing, sales, procurement, and manufacturers/raw material importers. The workshop will de-mystify many GMP concerns and ensure that companies have the appropriate information on GMP approval for products, as well as how to make sure that contractors are GMP compliant.

For more information visit the HPA website: http://www.hpasa.co.za/
Or contact Deirdre Allen at hpasa@hpasa.co.za

INTERNATIONAL

SUPPLEMENTS COULD SAVE SWEDISH HEALTHCARE MILLIONS

The value of dietary supplements in health maintenance, disease prevention and helping to decrease healthcare costs is gaining increasing recognition. According to a new study conducted by Frost & Sullivan, Swedish health services could save 850 million Swedish Kronor per year if people over 55 with osteoporosis started taking supplements containing 1000mg calcium and 15mcg D-vitamins.

“This is another clear sign that supplements can reduce healthcare costs and increase the quality of life for many elderly”, says Ingrid Atteryd Heiman, Chairman of Svensk Egenvård. Food Supplements Europe have commissioned economic consultants to evaluate the potential savings.Download the reports and infographics here: http://www.foodsupplementseurope.org/value-of-supplementation/?utm_campaign=Nordic+Natural+Newsletter+February+17&utm_source=emailCampaign&utm_medium=email&utm_content=

A recent story in Nutraingredients also reveals that supplementing with Calcium and Vit D could save European Healthcare four billion euros: http://www.nutraingredients.com/Regulation-Policy/Calcium-plus-vitamin-D-could-save-European-healthcare-nearly-4-billion?utm_source=newsletter_daily&utm_medium=email&utm_campaign=22-Feb-2017&c=SAsOqIf01s375fVNc%2BqbMA%3D%3D&p2

 INDIGENOUS CORNER

STRESS-BUSTING SCELETIUM

Sceletium tortuosum, an indigenous South African succulent plant also known as kougoed or kanna, has been used as a medicine by the Bushmen and Khoikhoi people for hundreds of years. This impressive plant has now gained international recognition for its ability to assist in alleviating stress, tension, anxiety, depression and addiction.

There are a number of sceletium products on the market and numerous producers in South Africa. One of the most prominent is HG&H Pharmaceuticals, the company that developed Zembrin®. The company was founded by South African medical practitioner, botanist and ethnopharmacologist, Dr Nigel Gericke. Gericke has been researching the ethnobotany, chemistry and pharmacology of sceletium since 1991. He was joined by Deon Hofmeyr in 2002, and they were joined by Halls Investments in 2006 to form HG&H Pharmaceuticals (Pty) Ltd.

In 2010, the company was granted the first ever Integrated Export and Bioprospecting Permit issued by the South African Government Department of Water and Environmental Affairs, and which allows the company to research, export and commercialise this indigenous product, and incorporates a benefit-sharing agreement with the San Council.

HG&H have completed the following three rigorous, randomised, double-blind placebo-controlled clinical trials, the first clinical trials ever to be done on a sceletium product: http://www.zembrin.com/clinical-studies-page/

HELPFUL HINTS

CRN’S SUPPLEMENTS ONLINE PRODUCT REGISTRY TAKES OFF

The vast range of dietary supplements on the market can be confusing to consumers. CRN has come to the rescue in the US by publishing an online products registry. The Supplement OWL (Online Wellness Library) – the dietary supplement product registry – is an industry-wide, self-regulatory initiative that will help create a rich and more complete picture of the marketplace for regulators, retailers, industry and ultimately, consumers. It will serve as a resource to examine, evaluate and compare product labels.

Individual companies and their trade associations in the industry are working together to create a product registry that will help increase transparency and accountability in the marketplace. The Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement industry, is spearheading the effort by providing the initial funding and conceptual project management. UL, a global independent safety science company, is investing funding in the development and administration of the registry and the technology that will drive this database.

For more information visit: http://www.supplementowl.org/

 

HOW TO BECOME A MEMBER

To experience the many advantages of being an HPA member, simply click on the button below.

DOWNLOAD FORMS

SIGN-UP FOR UPDATES

Get all the latest news and our exclusive content straight to your email inbox.

7cdc3873e5ea0eb59d243d7af8628087]]]]]]]]]]]]]]]