HPA Headlines: August 2016

VITAMINS SUPPORT LIFE

Vitamins provide the foundation for health. They maintain the balance of cells, tissues and organs, regulate biochemical processes, act as antioxidants and enable the body to process proteins, carbohydrates and fats. Vitamins support life and we could not survive without them.

There are 13 vitamins in the life-support arsenal – Vitamin A, eight B Vitamins, Vitamin C, Vitamin D, Vitamin E and Vitamin K. Multivitamin supplements contain multiple micronutrients and are designed to supply sufficient daily amounts to sustain health when these are not obtained through a varied diet.

The Journal of the American Medical Association recommends that every adult take a multivitamin/mineral daily for health maintenance and to assist in the prevention of a wide range of lifestyle disorders. Supplementing with vitamins can help lighten the burden on healthcare systems: for example, a recent Harvard study shows that long-term vitamin use is linked to fewer heart problems: http://jn.nutrition.org/content/early/2016/04/26/jn.115.227884.abstract.

The safety of vitamin supplements is supported by the following current report that claims: ZERO DEATHS FROM VITAMINS IN THE USA IN 2014, DESPITE 6 BILLION DAILY DOSES. To view the full report, click here: http://www.tandfonline.com/doi/abs/10.3109/15563650.2015.1102927

LEGISLATION

WHEN DOES A VITAMIN BECOME AN ALLOPATHIC MEDICINE?

On 13 June 2016, the South African Department of Health (DoH) published amended Guidelines to the November 2013 CAMS Regulations which supports the latest published schedules for vitamin levels as relevant to South Africa.  The following table charts out the levels below which vitamins will be classified as health supplements – providing only health supplement claims are being made. Above these levels the vitamins will be classified as medicines.

If the vitamin content in a supplement is below the levels now stipulated in the new Guidelines, the product falls under CAMS, Category D Regulations. But if the content surges to highs that are considered therapeutic, the product is then regarded as Category A and must be registered as an allopathic medicine – a ruling that has potentially adverse effects on many CAMS products.

Research commissioned by the Alliance for Natural Health has proposed an improved approach to determine optimal intake levels for vitamins and minerals. This approach helps customise micronutrient intake recommendations for different consumer groups according to their specific needs. http://anhinternational.org/2016/06/01/dosing-vitamins-minerals/

 Vitamin chart

Download: RSA Allowable Levels for Health Supplements

VITAMINS – THE DOMINANT PRODUCT CATEGORY

The South African CAMS industry survey commissioned by the HPA and conducted by Health Eye reveals that “Vitamins are the dominant category and continue to grow faster than the other categories, with this growth supported by strategies adopted by manufacturers and retailers.” This trend is supported by similar research carried out by Euromonitor International.

Published in November 2015, the Euromonitor report, Vitamins and Dietary Supplements in South Africa, established that “Vitamins continue to grow and dominate the overall category, with a share of 58% in current value terms in 2015. Multivitamins accounted for 79% of value sales of vitamins, and vitamin C recorded the most dynamic current value growth of 16%.”

According to the report, vitamins and dietary supplements increased by 14%, attributed to consumers turning to vitamins and dietary supplements as a viable option for the intake of various nutrients which may not be sufficiently available in the foods consumed.

It predicts that “Vitamins are anticipated to continue dominating the category over the forecast period. Multivitamins are expected to help drive growth as these products tend to be perceived by South Africans as value-for-money, due to the multiple benefits they provide.”

 

WHAT’S ON – FEEDBACK

DEPARTMENT OF HEALTH PRESENTS WORKSHOP FOR CAMS INDUSTRY

On Monday 13 June, a CAMS industry workshop structured to assist with Navigating the Current Regulatory Framework took place in Johannesburg. Hosted by the HPA and SMASA, the workshop featured presentations by some of the most prominent people in the South African health arena.

CEO of the Innovative Pharmaceutical Association (IPASA), Dr Konji Sebati, opened the workshop. This was followed by a presentation on MCC Structure and Protocol by the Registrar of Medicines, Dr Joey Gouws. Senior Pharmacology lecturer at UKZN and Member of the South African Medicines Control Council (MCC), Andy Gray, spoke on The Missing Link for CAMS: Various Acts and Regulations; Chairperson of the Complementary Medicines Committee (CMC), Dr Neil Gower,  discussed When is a Product a Medicine, and Pharmacist and Regulatory Consultant, Leneri du Toit, gave insights into Licensing and Responsible Pharmacists.

Clarification on What is Required for Regulatory Compliance was also on the agenda, with presentations on Principles and Requirements of GMP for CAMS and Health Supplements by Medicines Control Officer at the National Department of Health Inspectorate and Law Enforcement Unit, Andrea Julsing, and The Registration Process and Dossiers – CTD & eCTD as it pertains to CAMS by PR of the National Department of Health, Estelle Taute. The presentations can all be viewed on the HPA website.

IADSA MEETS WITH THE DEPARTMENT OF HEALTH

IADSA Executive Director, Simon Pettman, together with IADSA Technical Director, Cynthia Rousellot, paid a visit to South Africa in June 2016. They met with the HPA Executive Committee as well as members of the South African Medicines Control Council (MCC) to discuss the state of CAMS regulations worldwide.

IADSA is the leading international expert association regarding the globalisation of food supplement markets and increasing regulatory challenges. Bringing together food supplement associations from six continents, IADSA aims to build an international platform for debate and a sound legislative and political environment for the development of the food supplement sector worldwide. The HPA is a founding member of this organization, and maintains strong working relationships with it.

INTERNATIONAL

HEALTH SUPPLEMENTS SUPPORT ECONOMY

The dietary supplement industry in the United States contributes a healthy $122 billion to the economy, creates over 750 000 jobs and pays $38.4 billion in wages. These figures were established by an economic impact report produced by John Dunham and Associates for the Council for Responsible Nutrition (CRN).

In a press release issued by CRN on 8 June 2016, CRN President & CEO, Steve Mister, states: “The dietary supplement industry is a robust industry, and this new economic analysis further demonstrates the important and positive impact that our industry has on people’s lives.”

For more on the impact survey: http://www.crnusa.org/economicimpact/.

For the full press release: http://www.crnusa.org/CRNPR16-HealthyProductsSupportHealthyEconomy060816.html

INDIGENOUS CORNER

MORINGA – SUPERFOOD FOR AFRICA

The moringa tree – Moringa oleifera – is now successfully naturalised and cultivated in South Africa. Also referred to as The Miracle Tree, moringa is considered to be a powerhouse of nutrition as it is rich in vitamins, minerals, antioxidants and essential amino acids.

Included in the PDF Medicinal Plants of South Africa produced by the Department of Agriculture, Forestry and Fisheries (http://www.nda.agric.za/docs/Brochures/Medicin.pdf), moringa is an ideal crop for the African landscape. Often referred to as a nutritional miracle, it contains almost all of the nutrients required for perfect health.

The leaves are 27% protein and, gram for gram, have two times the protein of plain yogurt, four times the calcium of milk, 25 times the iron of spinach, four times the vitamin A of carrots,  three times the potassium of bananas and seven times the vitamin C of oranges.

Health benefits from consuming this plant are being experienced by many malnourished communities in South Africa, as well as by health-conscious people around the world. Another benefit is financial: growing and processing moringa has become a sustainable business for many people in this country. Moringa is also used for livestock fodder, and researchers have discovered that the drought-tolerant moringa tree can even clean water. http://www.takepart.com/article/2014/08/10/tree-can-purify-dirty-water-kills-millions-people-year.

 

HELPFUL HINTS

# SUPPLEMENT FACTS

Supplement Facts is a new insert that will be published every Friday on the CRN website. Committed to promoting the CAMS industry and products, CRN has initiated this simple, visual, fact-based approach to create awareness of positive facts relating to these sectors.

Every Friday, CRN will be issuing a Supplement Facts box that will feature a short, easy-to-understand fact about either dietary supplement science, regulations, healthcare cost savings, consumer usage, or the industry’s economic impact. The weekly Supplement Facts box will be on CRN’s social media channels (along with #SupplementFacts), featured on its website, promoted in its newsletter and distributed to member companies and retailer contacts. For more: http://www.crnusa.org/supplementfacts/

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