Regulatory Update

By: Penny Viner International Regulatory Affairs Adviser

COUNTRY & REGIONAL REPORT

AFRICA

NORTH AMERICA

LATIN AMERICA

ASIA

AUSTRALIA

INTERNATIONAL

Quarterly International

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European Federation of Associationsof Health Product Manufacturers

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MIDDLE EAST

SOUTH AFRICAN CAMS REGULATION: THE CANADIAN MODEL?

The South African complementary and alternative medicines (CAMS) industry has been facing extremely challenging times because, as reported in previous issues of the Newsflash, the South African health authorities had been seeking to publish new regulations for CAMS products that would closely align them to pharmaceutical drugs.

The trade association, Health Products Africa (HPA) has been actively seeking the establishment of more appropriate regulation. One of its major breakthroughs was the suspension of its litigation against the Department of Health (DoH) and the Medicines Control Council (MCC) because the legal action succeeded in exerting sufficient pressure on the Regulators to encourage them to agree to discussions with CAMS stakeholders regarding modifications to the proposed inappropriate Regulations.

In May 2015 the HPA held a positive meeting with the South African health authorities where the Medicines Registrar conceded that the current regulatory Road Map was not working, that CAMS had to be regulated differently from allopathic medicines, and that ‘out-of-the-box’ thinking was required. She advised that the Complementary Medicines Council (CMC) had completed its assessments of the various submissions made by industry on Regulations and Guidelines, and said that the definition of CAMS would be changed. She said that a streamlined registration system for CAMS is a priority and will probably follow the Canadian system.

In a subsequent meeting MCC Chairperson, Professor Helen Reece, stated that the CMC has been “energised” and is working on Amended CAMS Regulations, Guidelines and a Roadmap. Discussions have continued throughout the year, with the active involvement of the HPA, and the industry has been told that that new CAMS regulations and Guidelines are now imminent.

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REPORT SHOWS HEALTHY GROWTH FOR NUTRACEUTICALS

In a global nutraceuticals market estimated at $35bn, a report by Future Market Insights (FMI) forecasts 7.1% yearly growth for the nutraceuticals market in the Middle East and North Africa regions between now and 2020.

Food supplements account for the 37% of the market, with vitamins, minerals and proteins accounting for 75% of sales. Protein supplements were worth about €1bn in 2014, with functional beverages the next biggest segment at 27.9%.

North Africa is expected to grow at a 'healthy single digit' rate until 2020, and the six nations of the Gulf Cooperation Council (GCC) – Saudi Arabia, Kuwait, the United Arab Emirates, Qatar, Bahrain, and Oman – represent the biggest market, at €3.25bn in 2014 and expected to reach €4.86bn by 2020. The remainder of the Middle Eastern market was estimated to be worth €1.88bn in 2014.

NORTH AFRICA AND MIDDLE EAST

ACTION ON HALLUCINOGENIC HERB

The Honourable Rona Ambrose, Canadian Minister of Health, has announced regulatory amendments to protect Canadian youth from Salvia divinorum (also known as salvia), and its preparations and derivatives.

Salvia divinorum is a plant known to be chewed or smoked to obtain hallucinogenic effects. Salvinorin A, the main psychoactive ingredient, is found primarily in the leaves. Products are typically found in a number of forms, including fresh or dried leaves, liquids or seeds and plant cuttings for growing purposes.

A recent Youth Smoking survey found that around 2% of Canadian teenagers had used Salvia divinorum. Adverse drug reactions to salvia include, disorientation, confusion, hallucination, aggression and/or self-harming.

CHANGES TO NATURAL PRODUCT REGULATIONS

121 homoeopathic nosode products – made from diseased or pathological material in high dilution – are currently authorised by the Canadian Health Authority, Health Canada. As from January 2016, such products must carry the following statement on their labels: ‘This product is neither a vaccine nor an alternative to vaccination. This product has not been proved to prevent infection. Health Canada does not recommend its use in children and advises that your child receive all routine vaccinations.’

A further 139 homeopathic products for coughs, colds and flu for children under 12 are also currently authorised for sale, but from July 2016 Health Canada will no longer approve specific health claims on homeopathic products for these conditions for children of 12 and under, unless those claims are supported by scientific evidence.

VITAMIN D3 PRODUCT RECALL

Health Canada, in consultation with the manufacturer, has recently arranged the voluntary recall of a children’s Vitamin D3 product which contained almost four times the level of vitamin D indicated on the label. Excessive intake of vitamin D for children under 8 years of age can lead to vitamin D "intoxication," which can cause headache, nausea, vomiting, constipation, lack of appetite, irritability, dehydration, fatigue and weight loss.

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CANADA

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NUTRIENT DEFICIENCIES IN THE US POPULATION According to data from the Centres on Disease Control and Prevention (CDC), nearly 90 million Americans have a vitamin D deficiency, 30 million are deficient in vitamin B6, 18 million are deficient in vitamin B12 and nearly 16 million have a vitamin C deficiency.

The CDC data was presented by Dr. Tieraona Low Dog, a nationally recognised physician, author and speaker, at an educational briefing, "Life Fortified: A Physician's Case for Dietary Supplements," held by the Congressional Dietary Supplement Caucus (DSC) in cooperation with the leading trade associations representing the dietary supplement industry.

Dr. Low Dog pointed out that,”The mantra that Americans get all the nutrients they need from food is simply not true and the data demonstrates it is false”. As example, she said that to get the recommended 18 milligrams of iron per day through food alone, you would need to eat four cups of raisins, 15 cups of broccoli, three cups of cooked spinach, 10 ounces of beef liver, or 45 ounces of chicken breast. As she pointed out, many people’s diets, particularly those of people on low incomes, do not provide this amount of iron.

UNITED STATES

CONSUMER UNDERSTANDING OF THE ROLE OF MULTIVITAMINS

The vast majority of consumers recognize that multivitamins, calcium and/or vitamin D supplements can help fill nutrient gaps, but should not be viewed as replacements for a healthy diet, according to a new survey conducted on behalf of the Council for Responsible Nutrition (CRN), and published in Nutrition Journal, “Consumer attitudes about the role of multivitamins and other dietary supplements: report of a survey,”

The survey asked 2,159 U.S. adults key questions to measure consumer attitudes about the role of multivitamins, calcium and/or vitamin D supplements, in improving dietary intakes. Nearly 90% of respondents said that calcium and vitamin D supplements can help support bone health when dietary intake is not sufficient and 87% reported that multivitamin and mineral supplements can help meet nutrient needs when people do not get enough from food alone.

Responses indicated consumers hold balanced perspectives about the role supplementation plays in overall health, with 80% in agreement that multivitamins should not replace healthy eating or lifestyle habits and 81% concluding that multivitamins should be considered as just one part of a healthy diet.

THE BENEFITS OF IODINE SUPPLEMENTATION

According to a recent article published in Natural Medicine Journal, all pregnant and lactating women should supplement their diet with a daily multivitamin that contains 150 mcg of iodine.

Similarly, new research data published in The Lancet Diabetes & Endocrinology Journal reveals enormous societal cost savings (in iodine deficient countries such as the UK) and health benefits of iodine supplements for pregnant and lactating women. To quote Kate Jolly, a co-author of the article, “Iodine deficiency in pregnancy remains the leading cause of preventable retardation worldwide. Even mild iodine deficiency during pregnancy is associated with children with lower IQs. It’s time for all women living in iodine deficient countries without universal supplementation of iodine, who are pregnant, breastfeeding, or planning a pregnancy to be advised to take a daily supplement containing iodine.”

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THE ON-GOING SAGA OF THE NY AG AND HERBAL QUALITY

In February of this year, the New York Attorney General, (NY AG) Eric Schneiderman, wrote to 4 major retailers asking them to cease & desist marketing, distributing or selling their herbal products because DNA tests had found that 79% of tested herbal products did not contain the labelled substance or contained other non-listed ingredients.

Industry and analytical experts responded rapidly, questioning the adequacy DNA testing alone for botanical extracts, and since then the debate has rumbled on, with many companies introducing new ingredient/product testing methodology, and all the major trade associations emphasising the importance of quality throughout the supply chain. Most recently a new association has come into being with a mission devoted to solving supply chain issues – see below.

However, in early September, the office of the New York Attorney General (NY AG) took action again, this time issuing demands for thirteen supplement companies to cease and desist from marketing, distribution, and sale of products labelled as "devil's claw", on the grounds that the products fraudulently mixed one species of devil’s claw with another closely related species.

Herbal experts have again reacted promptly, denying that this is an issue of fraud, and pointing that it has long been officially accepted practice that Harpagophytum procumbens and Harpagophytum zeyheri are used interchangeably.

But while the supplement industry is clear that this time the NG AG has targeted a ‘non-issue’, it is thought unlikely that he will ‘cease and desist’ activity on botanical food supplements, and concern remains as to where he may direct his attention next…..

DESPITE THE NY AG, HERBAL SUPPLEMENT GROWTH CONTINUES

Sales of herbal dietary supplements in the United States increased by 6.8% in 2014, for the eleventh consecutive year, reaching an estimated total of more than $6.4 billion. These statistics and other herbal sales figures are included in a new market report* published in the current issue of HerbalGram, the peer-reviewed quarterly journal of the American Botanical Council (ABC).

Sales in the mainstream market channel — which includes retail outlets such as food, drug, and mass-market stores, plus club and convenience stores — continued to grow, increasing an estimated 2.1% over 2013 sales, while sales in natural and health food stores rose by a stronger estimated growth of 5.2%.

The top-sellers were horehound (Marrubium vulgare), a key ingredient in throat lozenges; cranberry (Vaccinium macrocarpon), for urinary tract health; echinacea (Echinacea spp.), popular in the cold and flu season; black cohosh (Actaea racemosa), for menopausal symptoms; and flax or flaxseed oil (Linum usitatissimum), a source of plant-based omega-3 fatty acids used against high cholesterol and heart disease. Other top sellers included turmeric (Curcuma longa), wheatgrass and barley grass (Triticum aestivum and Hordeum vulgare, respectively); flaxseed and/or flax oil; aloe vera (Aloe vera); and spirulina/blue-green algae (Arthrospira spp.).

There had been speculation that sales in 2015 would be negatively impacted by press reports resulting from the action of the New York Attorney General’s investigation of herbal supplements that began in early 2015. However, on the contrary, recent data demonstrates that sales of herbal combination supplements have increased by 12.6% over the same period in the previous year.

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ASSOCIATIONS SEEK NEW STATUS FOR SUPPLEMENT DIVISION

Several of the major US Supplement Trade associations, including the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA), and the American Herbal Products Association (AHA) have written jointly to the Food and Drug Administration (FDA) seeking the elevation of the Division of Dietary Supplement Programmes (DDSP) to the status of an ‘Office’ within the Centre for Food Safety and Nutrition at the FDA.

The DDSP, established soon after the Dietary Supplement Health and Education Act of l994 came into force, advises the FDA on policy issues involving dietary supplements, including the safety of new dietary ingredients and good manufacturing practices,

In their letter, the Associations say that ‘Office’ status would ‘provide appropriate regulatory attention to the rapidly growing supplement industry and would ‘increase FDA’s enforcement activities and priorities’. The re-organisation would thus ‘enhance the effectiveness’ of the new Office, thereby ‘helping FDA achieve its current and long-term goals for supplements’.

FTC SEEKS SCIENTIFIC PROOF FOR HOMOEOPATHIC CLAIMS

Health Canada is not alone in seeking tighter recommendation of homoeopathic products. In comments recently submitted to the US Food and Drug Administration (FDA), the US Federal Trade Commission (FTC) has asserted that claims for homeopathic drugs must be supported by competent and reliable scientific evidence, thus putting this class of products on the same standard as conventional drug products.

FTC notes that FDA’s advertising substantiation policy (that health claims must be substantiated by evidence) is in conflict with the FDA's current regulatory framework for homeopathic drugs that allows marketing of homeopathic drug products without proof of efficacy. FTC is concerned that these conflicting policies may harm consumers and confuse advertisers.

FTC also expresses concern that FDA's current framework may allow some companies to skirt more stringent regulations for OTC drug products or dietary supplements by labelling them as homeopathic or combining homeopathic ingredients with dietary supplements or other non-homeopathic ingredients.

NEW ASSOCIATION WILL MONITOR THE SUPPLY CHAIN

Following the furore caused by the New York Attorney General’s ongoing attack on supplement quality, a new supplement association has been formed in the USA, The Coalition for Supplement Sustainability (CSS).

CSS describes itself as a member-driven trade association of the dietary supplement industry, established to maintain sustainable, independently verifiable and transparent standards across the entire supplement supply chain. Members collaborate to review proposed third-party verification standards across all aspects of the supply chain, with the goal of creating a common consensus rooted in application of international best-practices, validated testing and reliable scientific evidence.

For further detail, see: http://www.supplementsustainability.org/

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CRIMINAL ACTION SOUGHT AGAINST SUPPLEMENT MANUFACTURER

The US Department of Justice (DOJ) is seeking criminal contempt sanctions against a man for selling dietary supplements and drugs in violation of two court orders. The man allegedly violated a 2010 court order and a 2013 order of civil contempt that prohibited him from selling dietary supplements and drugs. The DOJ alleges that the man failed to shut down businesses on Amazon.com, websites and a promotional Facebook page.

According to court documents, the man sold misbranded and adulterated dietary supplements and drugs that made unsupported claims to cure cancer, ADD/ADHD, epilepsy and intestinal parasites, among other things.

PRISON SENTENCE FOR SUPPLEMENT MANUFACTURER The president and owner of a dietary supplement manufacturing company was recently sentenced to serve 40 months in prison and one year of supervised release, and was also ordered to forfeit $1 million in profits for the sale of diluted and adulterated dietary ingredients and supplements.

In pleading guilty, the owner admitted that he instructed employees to add "fillers" to the dietary ingredients and supplements. These "fillers" were added without customer consent or knowledge. He also directed employees not to list the "fillers" as ingredients on certificates of analysis issued to its customers as proof of the identity of the ingredients contained in the products.

UNITED STATES

PERMANENT INJUNCTION AGAINST 3 SUPPLEMENT MANUFACTURERS

Three dietary supplement companies in Wisconsin, USA, have agreed to be bound by a consent decree of permanent injunction that requires them to cease all operations until FDA determines their manufacturing practices have come into compliance with the law.

The complaint lists several alleged cGMP violations, including failing to:

• establish identity specifications for each component • set product specifications for the identity, purity, strength, and composition of the finished

dietary supplement and limits on contaminants • establish the reliability of a supplier's certificate of analysis (COA) by confirming results of

supplier's tests or examinations • establish or follow written procedures for the responsibilities of the quality control

operations • develop and use complete master manufacturing records (MMRs) • examine if packaging and labels conform to the MMR. In addition, the complaint includes several alleged labelling violations, including failing to identify the part of the plant from which the ingredient was derived or failing to declare the serving size and the number of servings per container.

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BAYER AG WIN CONTEMPT CASE

In a case closely followed by the supplement industry, a U.S. District judge has refused to hold the company Bayer AG in contempt for allegedly violating a 2007 court order that prohibited the company from making unsubstantiated claims for any dietary supplement it promotes or sells.

The industry’s particular concern was that the Federal Trade Commission (FTC) had been seeking to subject Bayer's dietary supplements to the same standard for testing as prescription drugs. In response, Bayer maintained it followed the law, including the FTC's previous guidance and claimed the products were "fully substantiated" by "numerous" clinical, animal and genetic studies.

In the event, despite FTC's assertion that Bayer must possess two randomized, placebo-controlled, double-blind human clinical trials for the exact combination of strains of bacteria used in the supplement, the Bayer Corporation’s arguments prevailed.

FDA ACTION ON BULK PURE CAFFEINE PRODUCTS

The US Food and Drug Administration (FDA) has issued warning letters to five distributors of pure powdered caffeine, stating its position that these products are dangerous and present a significant or unreasonable risk of illness or injury to consumers. The agency states that the difference between a safe amount and a toxic dose of caffeine in these pure powdered products is very small and safe quantities can be nearly impossible to measure accurately with common kitchen measuring tools.

FDA says it will continue to aggressively monitor the marketplace for pure powdered caffeine products and take enforcement action, including seizure or an injunction to prevent the manufacture or marketing of pure caffeine.

UNITED STATES

BOLIVIA

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BOLIVIA TO HARMONISE FOOD REGULATION

Bolivia has now signed official adherence to Mercosur and, within four years, must harmonise its regulations, which include areas of food regulation such as additive lists, plus general food and nutritional food labelling

The full members of Mercosur are Argentina, Bolivia, Paraguay, Uruguay and Venezuela, with Chile, Peru, Columbia and Ecuador as associates. Founded in 1991, Mercosur’s purpose is to promote free trade and the fluid movement of goods. It is now a full customs union (a free trade area with a common external tariff), and a trading bloc – an area where regional barriers to trade are reduced or eliminated among the participating states.

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NEW STANDARDS FOR SUPPLEMENT MANUFACTURE/MARKETING

Paraguay’s National Direction of Sanitary Surveillance (DINAVISA), has notified a Decree that establishes standards for the manufacture, a system for obtaining and renewing sanitary registration, quality control, sanitary control and marketing of dietary supplements, with a view to protecting human health and safety and preventing practices likely to mislead consumers. The regulation encompasses maximum levels for vitamins and minerals, sales conditions, labelling rules, and specifies the technical documentation required.

PARAGUAY

NEW CONSUMER-FRIENDLY ADVERTISING REGULATION

The Chinese Food and Drug Authority (CFDA) has banned health food products from carrying names that indicate the function of the product. Companies with health products bearing names that indicate the product function which are already registered with the state regulator must change the product’s name and re-apply for registration by end 2015, and by May 2016, the production of health foods with names indicating the product function must cease. (Products manufactured before that date can sell through to the expiry date).

Health food advertisements should be censored before release and must state that “this product cannot replace medicinal drugs.” Additionally, health product endorsements by celebrities are forbidden because they may mislead - and consumers who may have been misled by such advertising can ask for compensation from the advertiser as well as from the celebrity who endorses the product.

Also, advertisements for medical services, drugs, health foods and cosmetics must not be promoted via media outlets that target children. Thus, companies are not allowed to endorse school events or send out advertising material via the textbooks of primary and middle school students.

Those who do not comply with the new regulations will be subject to financial penalties.

CHINA

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ADULTERATED WINE MASQUERADING AS ‘HEALTH PRODUCTS’

In the absence of official definitions of wines, health products or liquor, some Chinese health liquor production companies have been adding medicinal substances so as to claim that the products are health products. Most recently, several well-established local Chinese wine brands have been found to contain Viagra. The problem is compounded by lack of proper regulation: in 2013, food production came under the supervision of the CFDA, but the transfer of responsibility from local to state level has not been fully implemented, leading to the exploitation of regulatory loopholes.

SUB-STANDARD GINKGO PRODUCTS RECALLED

The Chinese Food and Drug Administration (CFDA) has taken action against local suppliers found to be engaged in supplying substandard versions of the botanical Ginkgo biloba to 24 Chinese food supplement and pharmaceutical manufacturers. The agency issued a recall on all products using the extracts at the end of May and called for all products to be destroyed.

The CFDA’s action was prompted by a change in the extraction process used - from alcohol to hydrochloric acid. Local authorities have been instructed to target ginkgo products and have them tested for unauthorised manufacturing processes..It is estimated more than 200 million tablets have been recalled, but to date, no adverse health effects have been reported.

CHINA

REGULATIONS STOPPING PRODUCTS REACHING THE MARKET

As many as 700 new food and beverage products are currently awaiting approval by the Food Safety and Standards Authority of India (FSSAI) and imported goods are being help up at the ports. Thus it is hoped that India’s long-awaited decision to move from checks for every consignment to a system of random and risk-based inspections will improve matters..In practice, the growth of regional trade pacts in the Asia-Pacific region which operate according to their own private standards, is forcing change in India towards the adoption of international standards, and the Indian government is to create a nation platform for private standards that will deal with evolving trade rules, which will be developed under the guidance of India’s commerce ministry, supported by the United Nations Forum on Sustainability Standards (UNFSS).

The Indian cabinet has also recently approved the Bureau of Indian Standards Bill, 2015, which aims to establish the new national standards body of India.

The new bill is expected to bring in a mandatory certification system aimed at improving the quality/practices of domestic suppliers and reducing sub-standard imports.

INDIA

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FOODS WITH FUNCTIONAL CLAIMS

As of September 2015, 93 Food with Functional Claim (FFC) products have been accepted by the Japanese Consumer Affairs Agency (CAA), including two perishable foods.

One of the foods is a tangerine-type fruit, Citrus unshiu Marcow, specially produced in Mikkabi city in Japan, and the other is a vegetable, ‘soybean sprout’. The active components of the tangerine and the soybean sprout are Beta-cryptoxanthin and soybean isoflavone, respectively. The health claims for both products are the same: “Good for bone health”, and the daily recommended dosages are 3 oranges for 3 mg of beta-cryptoxanthin and 200g soybean sprout for 56mg of isoflavone (36 mg of soybean isoflavone agricone)

JAPAN

NON-CONFORMING SUPPLEMENTS RECALLED.

India’s food safety authority, FSSAI, has recently ordered the recall of four protein supplements on the grounds that, ‘on the basis of recommendations by an official scientific panel for functional foods’, they allegedly do not conform with regulations, and that therefore, ‘the authority does not recommend approval for the product’..FSSAI has recently decreed that all food companies must have a detailed written recall plan, available to the food authority on request.

SUPPLEMENTS WITH DISEASE CLAIMS TO BE RE-CLASSIFIED?

Based on the recommendation of its Drugs Technical Advisory Board, which includes regulators and industry representatives, the Central Drugs Standard Control Organization (CDSCO), the national regulatory body for Indian pharmaceuticals and medical devices, has proposed that vitamin supplements that claim to treat or prevent disease should be classified as drugs rather than foods.

They have also concluded that supplements containing vitamins already found in medicinal products should be labelled as drugs, even if the ingredient is below recommended daily allowance (RDA) limits. Additionally, the Committee has recommended that products should not be considered as food if the label of the product indicates the name of a disease.

Industry feedback on these recommendations is currently being sought.

INDIA

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JAPAN’S HEALTH MINISTRY TAKES ACTION ON GMP

The Japanese Ministry of Health, Labour and Welfare (MHLW) is to introduce a quality scheme encompassing HACCP plus general hygiene practices (Food GMP), for all foods, including supplement-type processed foods.

MHLW’s decision was made in accordance with the Codex decision of 1997 on the general principles of food hygiene, and they intend to make the scheme compulsory for the food industry by 2020 (when the Olympic Games will be held in Tokyo).

MHLW had already realized that a particular level of quality control is necessary for health foods such as food supplements and in 2005 had published GMP guidance for these products. Now, on November 1st, 2015, MHLW will publish a comparison of HACCP+Food GMP standards, covering MHLW’s GMP guidance for food products, two Japanese third-party GMP standards, FDA’s cGMP for dietary supplements, and Korea’s GMP for Health Functional Foods.

MHLW has also introduced the EHPM Quality Guide and IADSA GMP Guide, in translation, as internationally known guidance for supplement products.

The MHLW’s report and the reference materials including the translation of EHPM Guide can be seen at the website of the MHLW.

- Main report (Japanese only): http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000096358.pdf

- Reference materials: http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000096359.pdf

JAPAN

ASSOCIATION SUPPORTS INNOVATIVE ENVIRONMENT Complementary Medicines Australia (CMA) has recently reiterated its support of the Government’s commitment to foster a regulatory environment that is more supportive of innovation and competitiveness. “To achieve an appropriate regulatory regime – one that is supportive of innovation and competitiveness but that doesn’t undermine the current high standards for Australian complementary medicines – CMA recommendations are focused on those areas where the system could be simplified without risking product safety and quality,” said Mr Carl Gibson, chief executive officer of CMA. “Removal of excessive regulatory burden, and a greater focus on international harmonisation, will assist the complementary medicines industry to bring innovative new products to the Australian market.”

“The complementary medicines industry also holds enormous potential to contribute to a sustainable healthcare system, one that focuses on prevention of chronic disease and on keeping people healthy”, Mr Gibson added.

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CM EXPORTS TO ASIA SEE RAPID GROWTH

Complementary Medicines Australia (CMA) has welcomed the latest AusTrade data that shows Australian complementary medicines (CM) exports to Asia have more than doubled in the last year. “Over the last two years we have seen exports of Australian complementary medicines grow 36%. South Korea has now overtaken New Zealand as our top export market. Over half the counties in the top ten list of exports are in the Asian Region – and there is continued healthy demand for Australian products”, said Mr Carl Gibson, chief executive officer of CMA.

“This demand for Australian complementary medicines by Asian consumers can be attributed to several factors, including our industry’s reputation for quality products that meet the highest standards of safety and efficacy. This is coupled with the demographic changes in the Asian region, such as ageing populations, and a rapidly developing middle class that embraces complementary medicines, “

It has been projected that by 2030, there could be close to 3.2 billion middle-class consumers in the Asia Pacific region. A large demand is expected in the areas of health and aged care, natural preventive care and high-quality food products.

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BOTANICALS - THE FASTEST GROWING INGREDIENT SECTOR?

Recent market reports have found botanicals to be the fastest growing class of ingredient globally, with an anticipated growth rate of 7% per annum until 2020, when market size is estimated at $35bn.

The Asia-Pacific region – particularly Japan, India and China - is considered to be the area of fastest growth, with Japan leading the way due to its rapidly aging population.

GLOBAL CONGRESS BACKS FOOD FORTIFICATION

A recent three day congress, ‘The Fortified Futures summit’ , was attended by 450 delegates from 57 countries. Stakeholders at the event included the Global Alliance for Improved Nutrition (GAIN), the African Union (AU), the Bill & Melinda Gates Foundation (BMGF),UNICEF, USAID, WFP and WHO, Food and Agriculture Organization (FAO), the Food Fortification Initiative (FFI), the Micronutrient Forum, and the Micronutrient Initiative (MI).

The main outcome from the event was that stakeholders were strongly in favour of food fortification as a “simple, scaleable and inexpensive solution” to tackle widespread micronutrient deficiencies that affect 2bn people and accounts for 11% of the global public health burden.

To quote H.E. Tumusiime Rhoda Peace, African Union Commissioner for Rural Economy and Agriculture, “Preventable deficiencies of critical vitamins and minerals such as Vitamin A, D, iron,iodine, folic acid and zinc contribute to up to 3m child deaths annually. We have the tools, we need to finish the job started a hundred years ago and make the benefits of this simple and cost effective approach to an improved diet .” to up to 3m child deaths annually. We have the tools, we need to finish thejob started a hundred years ago and make the benefits of this simple and cost effective approach to an improved diet available to all”.

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