Nutraconsensus Emerging Insights on Nutraceuticals - Players and Policy Makers

Nutraconsensus Emerging insights on Nutraceuticals - players and policy makers

A whitepaper prepared by Grant Thornton and FICCI FICCI-HADSA Nutraceuticals 2012 “Regulation, Categorisation and Commercialisation” 6 November 2012, Mumbai

Nutraconsensus 1

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Contents

Page

Foreword – FICCI 3

Foreword – Grant Thornton 4

A framework of definition 5

A framework of operation 10

A framework of regulation 31

Recommendations 42

© Grant Thornton India LLP. All rights reserved. Member firm of Grant Thornton International Ltd Offices in Bengaluru, Chandigarh, Chennai, Gurgaon, Hyderabad, Kolkata, Mumbai, New Delhi and Pune Nutraconsensus 3

Foreword: FICCI

Mr Ajit Singh Chairman-FICCI Task Force on Nutraceuticals Chairman-ACG Worldwide President-Health Foods & Dietary Supplements Association (HADSA)

As we enter our fourth successive year, FICCI and HADSA are delighted to bring together another edition of the developments in the Nutraceuticals sector.

This whitepaper attempts to bring out the key trends in the developments of the nutraceuticals segment in the BRIC regions over the last few years. It further benchmarks the regulatory aspects and challenges in operation, quality, control and market dynamics. While strategies adopted by key market players are often specific to countries, they often serve as an effective medium of learning for other regions with similar demographic profiles and population characteristics.

Increased consumer awareness, changing lifestyles and a marginal degree of under-satisfaction from traditional drugs has given adequate impetus to this industry to expand its presence and visibility through innovative marketing channels and riding the retail boom in countries like India.

The year 2012 is being envisioned as the year of nutraceuticals in India with a positive beginning in the form of crystallisation of licensing, registration and quality control standards by the Food and Safety Standards of India. Although much needs to be done to strengthen the mechanism of implementation and application of these guidelines, this has been a move which has been welcomed by the industry and other users alike.

Foreword: Grant Thornton

Mahadevan Narayanamoni Practice Leader, Healthcare and Life Sciences Advisory Partner, Corporate Finance Grant Thornton India LLP

It gives us immense pleasure to participate as Knowledge Partners with FICCI and HADSA for the 4th International Nutraceutical Conference on Regulation, categorisation and commercialisation of Nutraceuticals.

As the world celebrates a 100 years of Vitamins, India continues to remain a leader as one of the most undernourished populations in the world. Past efforts for removal of malnutrition have been ad- dressed through some national efforts by the government and global aid agencies in the form of fortification and specific eradication measures. India can now be viewed both as a developer and manufacturer of nutraceutical ingredients and products, and also as one of the strongest emerging market for nutraceuticals. Players, domestic and international, have expressed a high degree of satisfaction with the country moving towards a more regulated environment and see this as an enabler for weeding out unproven and unapproved products which find a place on the retail shelf and are often administered/ used without appropriate medical advice/ knowledge.

This whitepaper attempts to bring out issues and concerns in the emerging markets and undertakes a benchmarking of the cultural issues, operating and regulatory dynamics across these regions and includes recommendations for a multi-pronged strategy to address the nutritional needs of a vastly growing, ageing and unhealthy population.

Nutraceuticals and functional foods combine traditional nutri- tive with drug-like functions of prevention

Clarity in Definition

Although not clearly defined as such in regulatory parlance, the term “Nutraceuticals” has been a part of our medical history, knowingly or unknowingly, for the last several decades. Formally christened as “Nutraceuticals” in 1989 by Dr. Stephen De Felice (Foundation of Innovation in Medicine), they can be defined as “a food or part of a food that provides medical or health benefits, including the prevention and treatment of a disease”. While this definition has seen a contin- uous evolution over the years, nutraceuticals are now broadly defined “as natural, bioactive chem- ical compounds which have a health promoting, disease preventing or medicinal properties”.

The food versus drug debate…… Often regarded as synonymous to a drug, the key differentiator between a drug and a nutraceutical is the ability of the drug to act as a “treatment” for a disease whereas nutraceuticals simply have a supportive function and are often just used as “supplements”. Drugs (which are patent protected for the first few years) also need to confirm to stringent compliances (including clinical and animal trials) prescribed by regulators in respective countries. Nutraceuticals on the other hand are not subject to independent guidelines (more stringent in the US and Europe) and have a comparative-

ly shorter approval process without the need for conducting clinical/ animal trials. Accordingly, nutraceuticals lie somewhere between a food and a drug.

NUTRITION plus PHARMACEUTICAL equals NUTRACEUTICAL

DRUGS HEALTH AND WELLNESS COSMECEUTICAL

PHARMACEUTICAL NATURAL/ ARTIFICAL SUPPLEMENT

PRESCRIPTION THERAPEUTIC CLAIMS REGULATION BABY BOOMERS

SAFETY PROBIOTICS AND PREBIOTICS MEDICINE FUNCTIONAL FOODS

Celebrating a hundred years of Vitamins - 2012

1980’s – 1990’s Emerging physician acceptance Awareness through numerous journals and articles on benefits

1912 1934-1987 “Vitamin” coined by Industrial Casimir Funk production of 1910 vitamins Umetaro 1912-1913 Suzuki dis- 13 Vitamins identified 2000 onwards covers prod- and characterised Deficiencies uct, later identified in identified as several indus- Vit B1 trialised countries 1924-2000 Mandatory fortification of salt, flour, cereals, sugar, wheat, maize, dairy in many countries.

Control over deficiencies such as iodine, iron, vitamin A,D, B

1900 1950 2000

Vitamins are organic nutrients which are essential Unlike micronutrients such as vitamins and miner- for life. The human body requires very small als, macronutrients are required by the body in larger amounts of these nutrients to ensure normal me- amounts and include proteins, carbohydrates, and tabolism, growth and physical well-being. Most fats. They, too, are indispensable for our health and vitamins are not made in the body or only in insuf- well-being. ficient amounts to meet our needs. They therefore have to be obtained primarily through the food we Each of the 13 vitamins known today has specific eat in which they are present in minute quantities. functions in the body, which makes each of them unique and irreplaceable. No single food contains Minerals, as with vitamins, are indispensable (essen- the full range of vitamins, and inadequate vitamin tial) in small amounts to ensure that the body intake results in vitamin deficiency disorders. A bal- grows, develops, and stays healthy. Minerals are anced and varied diet is therefore vital to meet the found in wide range of foods. The body uses min- body’s vitamin requirements. Of the 13 known vit- erals to perform many different functions — from amins, four are fat-soluble, namely vitamins A, D, E building blood and strong bones to transmitting and K. The others are water-soluble: vitamin C and nerve pulses and maintaining a normal heartbeat. the B-complex, consisting of vitamins B1, B2, B6, B12, niacin, folic acid, biotin and pantothenic acid.

Segmentation Dynamics

Nutrition is needed not only for sustaining growth but also for combating diseases in the human life cycle. They can be classified on the basis of the form in which they are consumed, on the basis of their possible health benefits or even on the basis of the type of the user. Regula- tions in each country differ not only in terms of the definition of a nutraceutical but also in terms of the inclusion/ exclusions therefrom.

Functional foods Dietary Supplements Functional Beverages Foods having specific psycho- Foods providing nutrients that Liquids quenching thirst as logical benefits or reduce the are not consumed in sufficient well as replenishing miner- risk of chronic diseases quantity in a person's diet als, provide energy, prevent ailments, and promote  Nutrition Fortified Foods • Vitamin & mineral supple- healthy lifestyle  Probiotic food like yogurt ments • Sports and energy drinks • Amino acids  Protein powder • Fortified juices • Antioxidants  Paediatric nutrition • Glucose powder • Herbal and non-herbal ex- • Malted beverages tracts

Micronutrient deficiencies in developed and developing countries are some of the key drivers of age related ailments, lifestyle diseases, cognitive development, infant and women health issues and overall immunity of individuals. Nutraceuticals, largely for their role in health enhancement, are often also categorised on the basis of their end use • Disease prevention • Immunity Enhancement • Health foods and supplements, and • Personalised Nutrition (including sports nutrition)

Emerging trends

Multiple micronutrient intervention approach could act as an effective means for large studies scale intervention. On-going research in various corners of the world aims to establish a link between single and multiple Food, Water and Sanitation – underpinning micronutrient intervention studies and diseases of the success of Nutrition the human body to arrive at a holistic nutritional Food and Nutrition is being defined as “a situation approach for combat. The evidence supporting when all people at all times have physical, social the role of interventions in the prevention of vari- and economical access to food, which is consumed ous diseases however is still evolving. As an ex- in sufficient quantity and quality to meet their die- ample, food fortification with folic acid is being tary needs and food preferences and is supported researched for NTD reduction whereas food forti- by an environment of adequate sanitation, health fication with Iodine for goitre reduction is already services and care, allowing for a healthy and active an established and implemented area of scientific life.” research. The effectiveness of multiple interventions depends on their appropriate combination New Dimensions and sequencing. In addition to the sectors men- The usage of nutrients has increased from tradi- tioned, water and sanitation which are also closely tional forms (foods, supplements and beverages) to interlinked are also being examined in parallel. new markets such as cosmetics, pet care, marine life, sports, etc. Partnering in Nutrition Nutrition now plays a prominent role in the global • Antioxidants for longevity, immunity and vitali- public health agenda and has also been identified ty as the top investment priority at the recent Copen- • Increased demand from the highest risk categories of baby boomers hagen Consensus 2012. There are several players • non-prescription based cosmetics with medici- in the nutrition space, each with its own agenda, nal (including anti-ageing) properties structure and approach strategy. There is a need to • Functional and medicated confectionary foods move away from multiple pilot scale programs and and snack bars launch large scale interventions and engage players, • Fatty Acids (CLA and omega 3, 6 and 9) and policy makers and global agencies with govern- Proteins and clinical evidence of their health ment support. benefits • Pet Nutraceuticals • Sports Nutraceuticals In home fortification • Functional Additives - Vitamins, proteins, fi- A promising approach (which finds mention in a bres WHO report 2011), in- home fortification of food Naturally derived substances, consisting of herbal was suggested to improve iron status and reduce and botanical extracts and animal- and marine- anaemia in infants, children and women. If com- based derivatives. bined with commercial distribution schemes, this

The largest market for nutraceuticals is US, followed by Europe and Japan. The global market for Nutraceuticals is projected to reach US$250 billion by 2018 largely driven by the need for a disease free lifestyle. Growth is also seen in emerging countries like BRIC nations (Brazil, Rus- sia, India, and China), Mexico,

Poland, and South East Asian countries including Taiwan,

Thailand, Philippines, Vietnam,

Malaysia, Singapore, North and South Korea. This white paper emphasises on growth trends in the BRIC countries and com- pares them to our most nourished counterpart – the US

Global landscape

Distribution Network

Nutra Material Companies Supplies

Customer

Regulator Nutrition Support Groups

Research Agencies

The Consumer Consumers of nutraceuticals are demographically regulations are closely linked to cultural attitudes, diverse: a malnourished child in a developing coun- population and other demographic profiles of each try, a young mother and her infant, an aged man/ region. Contents of regulation also differ significant- woman with prostate issues/ severe osteoporosis, an ly in terms of coverage, acceptance of claims, label- aging baby boomer who is willing to experiment with ling and quality rules. her food/ vitamin basket. The Suppliers The Regulator These are primary producers of the raw materials in An evolving regulatory environment for nutrition the world - an agricultural producer, a processor or products with marketing and labelling guidelines has specialised ingredient/ formulation suppliers. made science based efficacy as an essential parameter for judging the success of nutraceuticals. Regulations The Channel vary as per the country of sale - DSHEA and FDA in A Nutraceutical company could either follow a direct the US, Health Canada in Canada and FHC, FNFC, B2C channel (direct marketing by Amway and Herb- FOSHU in Japan, EC directives in the EU, ANVISA alife), or have a direct distribution network (sold at a in Brazil, FSSAI in India and SFDA in China. While pharmacy/ retail stores) or enter into JVs with mar- a comparative benchmarking of these regulators has keting partners. been discussed later in this whitepaper, national

Learning from a nourished counterpart

USA Key players One of the earliest adopters of the fortified foods Competition is intensifying with growing sales, re- regime, functional foods already represent around sulting in excessive advertising, new (often hurried) 5% of the overall US food market. While early forti- product introductions, the emphasis on quality and fication was mostly done under public support (flour efficacy have assumed significant importance in the fortified with Vit B, salt fortified with iodine, milk consumers mind. enriched with Vit D), developments in the last few decades have been driven largely through private Food and beverage conglomerates such as Danone, initiatives. The market today is dominated by many Unilever, Nestle, Kellogg, Kraft and Coca Cola large multinationals in collaboration with specialised have introduced tailored healthy foods and adopted ingredient makers. Soft drinks and dairy are the key health, nutrition and wellness as much as possible functional foods currently being sold in the US mar- in their product baskets. Every major food corpo- kets. ration from Nestle to Kraft is involved in nutraceuticals including Johnson & Johnson which has Completely impervious to the financial crisis, this launched a new supplement brand. Some of the segment continued to display healthy growth pat- recent acquisitions in this arena by these players in terns, factors fuelling which include: the US include - Kraft acquisition of $140 million (Balance Bar and Boca Burger), Nestle acquisition  A proactive adult population who understands of the competing PowerBar ($130 million sales), the need for nutrition Quaker JV with Novartis.  An ageing baby boomer population  Increased awareness about quality and safety  Solving the equation of diet and disease  An evolving labelling and marketing regulation  Brand evolution through some direct channels  An early maturity for most products and availability of newer products and newer brands

The Yakult Story A single niche brand displacing generalist brands and market leaders!

Illustrative list of players in the US region

US Company Nutrition Deal History Operating dynamics and differen- Key brands Name (2011/2012) tiators

Nutraceutical

Companies

Pfizer Nutrition sold to Pfizer Nutrition Nestle for $11.85bn (2012) More than 80% of Pfizer Nutrition S-26 Gold, SMA and Promil sales were in emerging markets.

Focus – “Infant Nutrition “ Acquires Emergen C (Sup-

plement) Dietary Supplements is the key Pfizer Consumer focus area within Nutraceuticals. Healthcare Acquires Ferrosan’s Con- sumer Healthcare Business

Infant Nutrition - Nan, Gerber, Lac- Nestlé Health Science to Pfizer Nutrition acquisition to com- togen, Nestogen and Cerelac infant acquire a stake in Accera Nestle plement existing Infant Nutrition cereal Nestle acquisition of Pow- Portfolio. erBar ($130 million sales)

Abbott Glucerna Child Health and Nutrition Long term supply agree- Pediasure Working towards probiotics and ment with Martek for infant Ensure Muscle Health prebiotics - Nutrition shakes. nutrition (Martek acquired Immune Balance by DSM) NutriPals

Subsidiaries of

Indian Companies EID Parry Ltd acquired Saw Palmetto, Zanthin, Cranberol Valensa Interna- stake US Nutraceuticals Targets Baby Boomer Population t, AstaCran, Valerex, Z-Omega, tional (EID Parry) (Valensa) (2008) Botanical Solutions Provider. Amaranthol

Key focus areas - nutritional sup- Natrol, Laci Le Beau, Trinovin, plements, herbal teas and sports No history of recent acqui- Natrol (Plethico) Prolab, Vedic Mantra, NuHair, nutrition (through acquisition of Pro- sitions Shen Min, Promensil lab Nutrition and Medical Research Institute).

US Company Nutrition Deal History Operating dynamics and differentia- Key brands Name (2011/2012) tors

Ingredient

Supplier Acquires Cargill’s Cultures and Enzymes Business for Global supplier of nutritional and spe- Quali blends, Carotenoids Euro 85bn (2012) cialty ingredients to food, beverage (Carocare, Actilease), Life’sDHA, DSM Nutritional Acquires Martek, Microbia and dietary supplement manufacturers. Resvida, GeniVida, fabuless, Pep- Products and Vitatene (2010-11) topro, Alliances with Kemrock and Focus is on production of vitamins,

Sinochem in India (2011) minerals and micronutrients.

Direct Marketing

Direct selling companies with a multi- level marketing system Plans to spend $185 million Grows, harvests and processes at its on U.S. manufacturing ex- Nutrilite, XS Energy Drinks, per- own organic farms. pansion to meet growing Amway sonal care, home care, air and global demand Nutrilite Early China entry in 1995 water purifiers, Artistry cosmetics brands. Despite regulatory (direct selling related) changes, China remains its largest contributor of sales.

Weight Management, Digestive Health, Formula 1, Active Fiber l, Herbal- No history of recent acquisi- Energy & Fitness, Targeted Nutrition, Herbalife ife24, Prolessa™ Duo, Herbal- tions Personal Care. ifeKids

*Neither Grant Thornton nor FICCI express any personal views on the performance or market standing of any of the above companies and the same have only been presented as a segment illustrative.

Quick Brick fact-files CHINA

Brazil Russia India China

2011 $trillion 2.48 1.85 1.86 7.31 US GDP GDP growth 3% 4% 7% 9% (Annual)

Area (Mn 8.52 17.08 3.29 9.60 Sq. Kms)

Population 197 142 1241 1344 (Mn)

Ages 0-14 25% 15% 30% 19% (% of total)

Ages 15-64 68% 72% 65% 73% (% of total

Ages 65 and above (% of 7% 13% 5% 8% total)

Population 1% 0% 1% 0.5% growth

Life 73 years 69 years 65 years 73 years expectancy

Emerging trends

BRAZIL RUSSIA

Number of people Prevalence of Prevalence of Underweight (un- who are under- overweight (above overweight (% der-five, 000) nourished 15 years) above 15 years)

11.7 million 2008 57%2010 49% 2010 2222008

Prevalence of un- GNI per capita Infant Mortality GNI per capita dernourishment (current US$) Rate (per 1000 live (current US$) (%of population) births)

6%2008 $10720 2011 12 2008 $10400 2011

Health expenditure Maternal mortality Health expenditure Maternal mortality per capita (current ratio (per 100,000 per capita (current ratio (per 100,000 US$) live births) US$) live births)

$990 2010 $525 2010 56 2010 342010

INDIA CHINA

Prevalence of un- Lifetime risk of Number of people Under-five mortali- der nourishment maternal death who are under- ty rate: (% of population) nourished 21 per 1,000 live 19% 2008 1 in 702009 129 million 2008 births 2008

Under-five mortali- GNI per capita Malnutrition – Maternal Mortality ty rate: (current US$) Height for age (be- Ratio (per 100,000 69 per 1000 live low five years) live births) 2010 births 2009 $1410 2011 9.4%2010 37

Health expenditure Infant Mortality Health expenditure GNI per18 capita2008 per capita (current Rate (per 1000 live per capita (current (current US$) US$) births) US$) 2010 2008 2010 $54 52 $221 $4940 2011

Building Nutra – BRIC by BRIC

Nutraceuticals have entered the world food market and have gained tremendous importance in the last few years in most developed companies. Such functional food and beverages are priced higher (result- ant higher profits) and provide additional economic benefits to players when compared to traditional foods.

Globally, the US and Japan are the most developed markets for nutraceuticals, due to the consumer acceptability achieved in these regions. India, China and Brazil are developing nations which show huge potential for the nutraceuticals market. Also, India and China have emerged as a key sourcing destination for natural ingredients. Each of the countries in the BRIC region is in different evolution- ary stages of development and nutraceuticals are subject to differences in regulation, nutrition awareness, consumer demand, biological support and affordability. China and Brazil have an advanced regulatory framework for the approval of nutraceuticals and their advertising, although these differ some- what in the specifics.

Copenhagen Consensus 2012 The Copenhagen Consensus 2012 Expert Panel finds that fighting malnourishment should be the top priority for policy-makers and philanthropists. For just $100 per child, interventions including micronutrient provision, complementary foods, treatments for worms and diarrheal diseases, and behav- iour change programs, could reduce chronic under-nutrition by 36 per cent in developing countries. While a $100 per child may mean a significant sum for a developing country, this only constitutes a 15% increase in the current aid spending indicating a need for re-channelising some of our existing resources. The key investment priorities for advancing global welfare (especially in the developing countries) are:  BUNDLED MICRONUTRIENT IN-  Hepatitis B Immunisation (Health/ Dis- TERVENTIONS to fight hunger and ease related) improve education (Health/ Disease re-  Low‐Cost Drugs for Acute Heart Attacks lated) (Health/ Disease related)  Malaria Combination Treatment  Salt Reduction Campaign (Health/ Dis- (Health/ Disease related) ease related)  Childhood Immunisation Coverage  Solar radiation management (Health/ Disease related)  Conditional Cash Transfers  Deworming (Health/ Disease related)  HIV Vaccine R&D (Health/ Disease re-  TB treatment (Health/ Disease related) lated)  R&D to Increase Yield Enhancement to  Information Campaigns on Schooling fight hunger Benefits  Effective Early Warning Systems  Borehole and Public Hand Pump Inter-  Strengthening Surgical Capacity (Health/ vention Disease related)

Nutraceutical trends in Brazil

Country specific developments and challenges With a rich natural resources profile, a large domestic market and an exploding middle class (though small in number but high in value) segment, the demand for nutraceuticals in this region has indicated healthy growth rates over the last few years. Guidelines in Brazil are often comparable to several developed countries although it has significant dependencies in the form of imported ingredients.

An aging population, improved economy, improved personal wealth, more educated and savvy youth, as well as consciousness for health(with awareness of linking diet to chronic diseases), are all encourag- ing factors for growth in Brazil. The nutraceuticals industry in Brazil is roughly divided into two major industry sectors: the over-the-counter (OTC) market, and the health and wellness foods market. Nei- ther market is believed to have reached maturity, which indicates there is good potential for future growth. Current supply chain vulnerabilities in nutraceuticals are evident through its reliance on imported ingredients for processing foods (despites its own rich botanical heritage) and limited processing capabilities.

Regulations are stringent (ANVISA), although need to be strengthened to provide impetus to research- ing its natural botanical heritage. The trend across the globe, including across Latin America, is toward more rather than less regulation - a more demanding legislation, and a greater need for high quality, scientific, technical, regulatory guidance for decision-makers. A few other notable nutraceutical trends in this country include:  A nutrition transformation from an under nourished to an over nourished (read obese) population  Pharmacies being the primary mode of distribution for OTC products  Vitamins and dietary supplements and herbal and traditional products also being the key drivers of the OTC segment sales.  An aging population that is concerned about the increased risk of diseases like diabetes, heart disease and cancer.  ‘Organic is healthy’ mantra - Healthy lifestyles, including diet, are becoming part of mainstream awareness leading to a growth in ‘less sugar’, ‘slimming food’, ‘light food’, fortified foods. ‘fresh organic food’ (sugar, coffee, soya being chief crops)

BRAZIL

Key consolidation activity (involving Brazil as a target) in 2011 and 2012 Month Target name Acquirer Transaction Details

Deal Size: $86.3 Mn Probiótica Laboratórios Valeant Pharma- Probiotica currently markets a full line of over-the- Feb 2012 (Brazil) ceuticals counter sports nutrition products and other food supplements.

Enterprise Valuation: is € 465 mn. Tortuga deals in Tortuga Companhia Zootéc- August 2012 Royal DSM nutritional supplements with a focus on pasture raised nica Agrária beef and dairy cattle.

Deal Size: $ 15.7 Mn. Mylner develops manufactures Mylner Indústria E Comércio Frutarom Indus- and markets flavour solutions, focusing mainly on February 2012 Ltda tries Ltd sweet flavours for beverages and baked goods, natural plant extracts and natural flavours products.

Deal size: $ 1160 Mn August 2012 Yoki General Mills Privately-held food company headquartered in São Bernardo do Campo, Brazil.

Nutraceutical trends in Russia

Country specific developments and challenges Russia’s evolution in the nutraceutical space has been marred by the presence of an equal number of unregu- lated products as the number of regulated products. An illegal sales network of low quality (often dangerous products) has forced policy makers to review regulation around nutraceuticals. In addition, most of the business still stems from two or three key cities usually identifiable by population size, superior distribution network and appropriate advertising impetus. Russian Nutraceutical sales largely include Vitamins, combination dietary supplements and probiotic supplements.

Significant limitations have been imposed on the nutraceutical market with regard to advertising, promotion and distribution, especially in “official” sales channels. Before such anti-dietary supplement regulations were put, it was easy to unscrupulously obtain Traditional Chinese Medicine and minor brands from Eastern Eu- rope without any significant constraints. Post introduction of stringent guidelines and new product registration procedures, global players can now penetrate the region by securing relationships with existing reputable local players that understand the space and can navigate through the regulatory and product launch stages. Existing multinational players who are already in the nutraceutical market include Amway, Herbalife, Nu Skin and Sunrider (Direct Sales); and Nycomed, Ferrosan and Unipharm (Pharmacy channel). Some of the top- most local Russian brands and the operating Companies are set out in exhibit in the following page:

RUSSIA

Key local Russian Players and their Brands

Name Brand Differentiator

Market leader Cultivation of medicinal herbs and their CardioActiv, Ginkgo Biloba, Everyday processing extracts to packaging of fin- Calm, Stress free, Slim by nature, Brome- ished products Evalar lain Strategic direction of the company is the transfer of dietary supplements with proven clinical efficacy in the category of drugs done in collaboration with an established clinical trials outfit.

Development and production of natural non-drug and drug treatment of active cosmetics, medical and environmental Capilar, Viardo, Iod-Active, Phase 2, arthro- technology, innovative substances for the Active, optometrist , Orvirem, Hypoxen – Diod prevention and treatment of socially signif- Pharmaceuticals, icant diseases. Mir ekologii' - Retail Chain Also manufactures healthcare equipment, healthcare cosmetics, pharmaceuticals, and has its own retail chain.

Develops, produces and promotes vitamin and vitamin-mineral complexes – supplied ABC (Vitamins) to several Russian companies for fortifica- Akvion Vetoron (beta-carotene) tion Qudesan (co-enzyme) Kardiosredstva, tools for vision correction, Energotropic drugs.

Nutraceutical trends in India

Country specifications and challenges Even with the lowest per capita GDP in the BRIC regions, India is poised to overtake China as the most populous country (also with the largest number of undernourished children in the world), and represents an extremely favourable market for the growth of nutraceuticals. At population levels like ours combined with income disparities, the need for nutrition arises in each strata of our society. While approximately 42% of all Indian children under age 5 suffer from malnutrition, nearly 300 million people are part of an expanding middle class. The middle class level, with increased disposable incomes has become aware of the importance of diet and nutrition for long term good health. “Healthy habits need to start young. Only an appropriate blend of micro/ macro nutrients in our diet can help us break through the health deficit” feels Rajiv Chopra, Presi- dent, DSM India. An increasing working age population presents a market opportunity for development and marketing of Nutraceuticals. Some key emerging trends in the Indian Nutraceutical space are set out below:

 Focus on wellness and preventive care  Increased awareness and health consciousness  Growth currently driven by the functional food and beverages segment.  Health and wellness yet to reach the fat and oils segment  Increased accessibility through new distribution channels and greater visibility (example infant and sports nutrition)  A large diabetic population (similar to Brazil and China)  Vitamins used in several food fortifications  Mass market retailing is just getting off ground in India with FDI approvals and can represent a great way to market the nutraceuticals.  One third of the population being vegetarian, protein supplements in the form of soya/ rice/ others can assume great significance.  Flavoured powdered milk fortified with vitamins and minerals is a recent trend. In other parts of the country, milk scarcity drives soya and skimmed milk demand

Both India and China have traditional remedies and healing systems such as Ayurveda and TCM which form the centre stage in terms of a tried and tested from of medicine with identifiable herb compounds. Dietary supplement regulations in India continue to evolve leaving many wondering how emerging legislation will rec- oncile modern, corporate research and regulations with ancient traditions.

Because nutraceuticals are not a part of pharmaceuticals and drugs formulation, rules and regulations also tend to be different for this segment. Indian government has recently implemented the FSSAI regulations (Food Safety and Standards Authority of India) although implementation parameters are not clearly understood by all in the industry and are being explored.

But challenges remain, as poor infrastructure, lack of adequate facilities for storage, transportation and cold storage facilities continue to hinder growth. And while the Indian regulators have worked to improve the regulatory framework, there is still plenty of confusion around rules, regulations and licensing for a variety of different commodities.

India can be viewed both as a developer and manufacturer of nutraceutical ingredients and products, and as a strong emerging market for nutraceuticals. .We now analyse some of the key players in India (without relying on any specific selection criteria) and the marketing strategies adopted by them:

ZYDUS PLETHICO/ (including subsidiary NATROL) Zydus Wellness and Zydus Nutriva are the key drivers Dominant player in the herbal and nutraceutical seg- of the consumer, wellness and nutraceuticals division ment with a focus on of this pharma major. Market strategy includes “Third - Sports Nutrition and Women’s Health. The Generation Nutraceuticals” Company aims to bridge the gap demand supply gap in the country to reduce dependencies Segment presence on high cost and duty laden imports. Protein formulae for all ages, diabetics and pregnancy and lactation, haematinics, tonics, calcium supple- Alliance History ments, osteoporosis, osteoarthritis, menopause, male Acquired Natrol in 2007 – a leading manufacturer and subfertility, obesity, specialized pregnancy care range, marketer of branded nutritional products in the United animal health products States. Several acquisitions in the CIS regions to Cosmeceuticals. obtain retail reach.

Key brands Key brands GRD (protein supplement), Fol-5 (folic acid), Globac Sports Nutrition - Natrol, MRI, Laci Le Beau, NuHair, Activ (iron), C-yum (calcium), Sugar Free D’lite (health ShenMin, Promensil, and Prolab drink), Nutralite (cholesterol free spread), Actilife (nu- Herbal - Mountain Herbz (herbal medicines and sup- tritional milk additive), Globac-Z. plements), Travisil (herbal cough syrup & lozenges).

Key differentiators Marketing Strategy - Formed an Indian advisory board for rational use of India - Prescription by Doctors, Nutritionists and nutraceuticals availability of products on the retail shelf supplement- - Dedicated nutraceutical range with emphasis on ed through brand awareness campaigns. women health, infant and child nutrition. Natrol - distributes products in the US through more than 54,000 retailers.

PIRAMAL HEALTHCARE Established the consumer product division in 2007, Piramal Healthcare’s OTC range includes product categories like Vitamins & Nutrition, Analgesics, Der- matological, Antacids and Cough & Cold.

Segment presence It entered nutraceuticals market in 2009 with Suprac- tiv Complete, a vitamin and mineral supplement for daily consumption. The product, a Rs 12 crore brand is the second biggest brand in the nutrition segment after Revital.

Key brands Lacto Calamine, Saridon, Supractiv Complete, Triac- tiv, Itchmosol, i-Pill, Workz, Jungle Magic.

Key differentiators Global presence in over 100 countries including manufacturing bases in USA, Great Britain, Sri Lanka, China and Canada.

“The recent FSSAI guidelines are a welcome move for the nutraceutical industry in India. It represents a concrete idea which gives assurance on safety of food, safety of customer and the promise of a good product. The implementation mechanism and guidelines need strengthening and we feel that if the approvals were made for a formulation (rather than the product itself), this would help improve timelines for approval in a significant manner. We, as industry players, are willing to provide manpower and other form of implementation support to FSSAI that may be needed.”

- Sanjay Singh, Head F&D (Nutraceuticals and Herbals), Plethico Pharmaceuticals

ELDER PHARMA UNIVERSAL MEDICARE (SANOFI) A Mumbai based pharmaceutical manufacturing & Sanofi, a global healthcare company operates in 7 marketing organisation, Elder entered the nutraceu- core areas which are diabetes solutions, human ticals segment in 2010 with launch of 'Coenzyme vaccines, innovative drugs, consumer healthcare, Q10' which helps to build immunity against cardio- emerging markets, animal health and the new Gen- vascular diseases, neuro-generative diseases. zyme.

SEGMENT PRESENCE ALLIANCE HISTORY Presence across 5 therapeutic segments – women Aventis Pharma (part of the Sanofi Group) acquired healthcare, anti-infective, wound & pain manage- Universal Medicare business of marketing and dis- ment, nutraceuticals, and life care products. tribution of branded nutraceutical formulations in India in November 2011. KEY BRANDS Shelcal, Eldervit Range, Elmecob, I-Vit, Phytomega, KEY BRANDS Carnisure, Somazina (in-licensed brand), Amifru The portfolio of nutraceuticals and lifestyle man- group, Nephrocaps and I-Vit group. Launched 3 agement products includes brands like Sea Cod®, nutraceutical products during 2011-12 - I-Vit, I-Vit Primosa, Multivite and Freeflex Plus and D-360. MARKETING STRATEGY KEY DIFFERENTIATORS Part of Sanofi’s Global marketing network and OTC Prescription based marketing and prescription based sales. Wide range of nutraceutical products with focus on women healthcare R&D division develops novel drug delivery system (NDDS) for a nutraceutical formulation called Coen- zyme Q (10) CO Q10, first of its kinds globally.

NANDAN TABLETS INDIA LIMITED Established in December 1999, NBL is a sustainable A part of Jhaver group, TIL’s therapeutic range in- energy provider and herbal nutraceutical company cludes nutritional supplements, haematinics, hepa- headquartered in Hyderabad and listed overseas. toprotectives, novel antipyretic, Osteoporotic Formu- KEY BRANDS la, Respiratory Medicine. NBL offers herbal and by- herbal products with focus KEY BRANDS on therapeutic value. Key products include Safed Bifilac, Hapenz, BioRS, Ecoflora, Astymin, Astyvit, Musli Standardised Root Extract, Bio-Rhythm Cap- Astyfer, Aminocal, Tilvit, Antoxyl Forte, Cefobeta, sules, Sorgasm Capsules, AloeActiv Beverage. Ambrolite, Peglec, Glutazene, Neutrosec, Apetamin.

HEXAGON NUTRITION NATURAL REMEDIES Hexagon Nutrition entered the nutrition industry in It manufactures and supplies standardized herbal 1991. The broad segments are Food Fortification, extracts, phytochemicals and herbal veterinary clinical nutrition and Animal Nutrition. healthcare products. Broad segments are Human KEY BRANDS Healthcare, Animal Health care and Phytocom- Clinical nutrition –Penta sure range, Meta Gluta Zs pounds. (Immunity), Obesi Go BLCD (Weight management), KEY BRANDS Geria Gold, Proactiv (Wellness nutrition). Human Healthcare-Allerease, Bacomind, Kalmcold, Gutgard, Ocibest.

DABUR ADVANCED ENZYMES Dabur is an Ayurvedic and Natural Health Care Deals in the production of plant, microbial and ani- Company. It entered the nutrition supplements seg- mal-based enzymes. Product categories include ment with the launch of Dabur NUTRiGO in 2010. Human Nutrition, Animal Nutrition, Food Processing, Products categories include Hair Care, Oral Care, Bio Fuels, Bio Catalyst, Biologicals and Industrial Health Care and Skin Care. Processing. KEY BRANDS KEY BRANDS Dabur Chyawanprash, Dabur Honey and Dabur Human Nutrition (Active ingredients) –Nattokinase, Glucose. fungal Lactase, Peptizyme SP, Fungal Lipase.

“Women and child health continues to remain our primary focus area; we also believe that ad-

dressing the wellness needs of the country’s growing geriatric population by ensuring a disease free life presents an excellent opportunity of growth. Our SHELCAL brand for example targets the nutrition needs (especially of calcium and vitamin D) of a broad based population segment – from the paediatric to the geriatric population.” - Himanshoo Nayak, Head - Business Development, Elder Pharma

INTERNATIONAL PRESENCE

DSM Nutritional Products DSM is a global supplier of nutritional and specialty ingredients to food, beverage and dietary supplement manufacturers. Providing ingredients and ‘Health benefit Solutions’ globally, DSM focuses on the production of vitamins, minerals and micronutrients that enhance the health profile of products, as well as areas where end consumers are looking for answers and support. Health Benefit Solutions Eye Health, Bone Health, Essentials for women, Essentials for men, Essentials for kids and teens, Essentials for vege- tarians, Mind health, Hearty health, Beauty from within, Weight nutrition, Sports nutrition, Joint health, Immunity, Essen- tial nutrition and Healthy ageing.

ABBOTT NUTRITION Abbott Nutrition, a division of Abbott is a healthcare company to develop nutritional and related health care products .It offers a wide range of nutritional supplements in segments of infant and mother care, child, adult, sports and active living, therapeutic nutrition.

Key Brands Similac, Advance, Similac Expert Care, Alimentum, Soy Isomil in infant formulas PediaSure and Pedialyte for children, Ensure and ZonePerfect for active adults, EAS for elite athletes and fitness en- thusiasts and Glucerna for people with diabetes.

GSK

GSK consumer healthcare business operates in three areas - Over-the-counter (OTC) medicines, Oral healthcare and Nutritional healthcare. In 2010, GSK acquired Europe’s leading sports nutrition brand, Maxinutrition. GSK portfolio includes a number of well-known brands such as Panadol, Sensodyne, Lucozade and Horlicks. Revenue from Consumer Healthcare is Euro 5.2 billion in 2011 (19% of the group revenue).

Key Brands Lucozade and Ribena – energy and sports drink, Horlicks, Boost and Maltova - malted, milk-based drinks and foods and Viva, a vitamin supplement.

AMWAY HERBALIFE A global direct selling company, Amway markets Herbalife International is a direct selling company product primarily dealing in the health, beauty, and which deals in nutrition and weight management. It home care segments. has over 2 million independent distributors. SEGMENT PRESENCE Presence in more than 80 countries including SEGMENT PRESENCE Americas, Europe, greater China, Japan and Korea, Herbalife operates in more than 80 countries. Prod- and SE Asia/Australia. uct segment includes Targeted nutrition, personalised weight management, Essential nutrition, Energy KEY BRANDS and Fitness, Skin care and Fragrances. Nutrilite, Artistry, XS Energy KEY BRANDS KEY DIFFERENTIATORS Formula 1, Active Fiber l and Herbalife24, Shape Amway’s business model is based on multi- Works. level/networking marketing and distributes products globally through more than 200,000 distributors MARKETING STRATEGY Also, Nutralitie is the only global vitamin and mineral Partnered with the Global Alliance for Improved brand to grow, harvest, and process plants on its Nutrition (GAIN) and DSM, nutrient suppliers, to own certified organic farms. distribute 20 million micronutrient sachets to those in needs in Ethiopia and Kenya The company has also opened five new markets in 2011.

“Key stakeholders in the Indian Nutraceutical landscape need to focus on the following Critical Success Factors – providing access to food in the first place, ensuring the right quality and mix of food, weeding out adulteration, improving the general environment and ensuring the availability of clean drinking water for all.”

RAJIV CHOPRA President, DSM Nutritional Products

Deals, alliances and expansion strategies The Nutraceutical industry has shown strong growth potential and much of the early stage commercial/regulatory risk has been reduced as international nutraceutical companies establish a record of doing business in the market.

Whether one views the country as a developer and manufacturer of nutraceutical ingredients or as a strong emerging market for nutraceuticals, the country is poised for unprecedented growth from domestic players and already established international companies. Devising a strategy for deeper penetration into the Indian Nutraceutical market will be foremost in the minds of large global players.

Nutraconsensus 27

INDIA

Key consolidation and M&A activities (involving India) in 2011 and 2012 Month Target Name Investor Transaction Details Aventis Pharma Ltd. acquired nutraceutical business of Universal Medicare Pvt. Ltd. for a total consideration of $114.22 million (INR 5.67 Universal Medicare- August 2011 Sanofi India billion). Under the agreement, Universal Medicare will manufacture the Nutraceutical Business products that Sanofi/ Aventis will be acquiring on mutually agreed terms. Innoves Animal Health Innoves Animal Health Pvt. is engaged in the marketing of large animal October 2012 Hester Biosciences Pvt. health products. Octtantis Nobel Labs Octtantis Nobel Labs Pvt. is engaged in trading, manufacturing and September 2011 Vivimed Labs Pvt. marketing of pharmaceuticals and nutraceuticals formulations. 30 plus brand from Ajanta Pharma is a Mumbai based company. 30 plus is an energiser May 2011 Dabur India Ajanta Pharma brand. Johnson & Johnson , Raricap is the trademark for manufacturing tablets for iron deficiency April 2011 Bafna Pharmaceuticals Raricap anaemia used in pregnancy of Johnson & Johnson Full Fit is an anti-obesity brand. The brand Full Fit is a formulation con- September 2010 Full Fit Socrus Bio Sciences Ltd tains the herbal ingredients which have no side effects.

The company offers various products in the fields of women’s NA Elder Pharmaceuticals Private Placement healthcare, wound care and pain management, nutraceuticals, cardiovascular, central nervous system, neuro drugs, and anti-infective.

Relying heavily on imports to meet its nutritional demands, activity in the domestic space has seen the mushrooming of smaller (but focussed companies), increased visibility of some domestic companies, and select brand oriented. With clarity in regulation, it is however expected that the more and more international and domestic nutrition players will now be seen on an expanding retail shelf. While some traditional players may still want to go the prescription route, it is expected that in the post regulation scenario and retail-boom, nutrition products will find an entry into more and more households in the next ten years. Already established as one of the leading ingredient suppliers, In- dia will remain an attractive destination for significant consolidation activities in the near term.

Nutraconsensus 28

Nutraceutical trends in China

Country specifications and challenges Although still heavily influenced by Traditional Chinese Medicine, all types of functional foods and supplements are gaining acceptance in China. Traditionally dietary supplements were sold in small grocery stores; however, a change in retail structure has led to the emergence of large format outlets such as hypermarkets and convenience stores. Factors such as rising healthcare costs and an ageing population and diseases such as an unhealthy immune system, fatigue and cholesterol regulation are expected to be key drivers for the development of this sector in the future. High costs of insurance and healthcare have prompted the Chinese population to resort to preventive medicine. Imported supplements are often associated with better quality and with a burgeoning middle class population, the demand for nutraceuticals (considering approved TCM as a part of the group) is expected to multiply four times the present.

China is one of the leading suppliers of nutraceutical ingredients to almost all of the leading players worldwide. According to a recent study, China will evolve into the largest global producer and consumer of nutraceutical ingredients by 2020, surpassing the U.S. and Western Europe. A survey indicates that consumers in China are ready to switch to healthier alternatives of carbonated soft drinks and that brands are yet to offer the product op- tions to fulfil this demand signalling a need for large players to respond to this demand and penetrate the market. Launches of “Natural”, “Diet”, “Low calorie claims” are penetrating deeper into the natural beverages market indicating an “On the move” consumption opportunity at convenience stores.

Nutraconsensus 29

CHINA

Key expansion activities (involving China) in 2011 and 2012

Month Target Name Transaction Details

Deal Size: $201 Mn The Company offers synthetic vitamin E, natural vitamin E June 2011 Zhejiang Medicine Private Placement soft capsules, levofloxacin lactate tablets, vitamin A tablets etc. Raising capital on the Securities Exchange.

Deal Size: $ 62.15 Mn USANA Health Sci- June 2010 Baby Care Develops, manufactures and sells nutritional products for ences Inc. the entire family, with an emphasis on infant nutrition. Deal Size: $ 5.71 Mn Guangdong Jiuji Xiangxue Pharma- March 2011 Seller of healthcare equipment, chemicals, and Biotech ceutical cosmetics.

Guangming Phar- Shenzhen Kangzhe Producer of health supplements, biological diagnostic May 2011 maceutical Pharmaceutical reagent and bioengineering fields.

Deal Size: $43.79 Mn Northeast Pharma- Liaoning Fangda Vitamin Series, Antibiotics, Anti-AIDS, Digestives, Narcot- June 2012 ceutical Group Co. Group Industrial ic medicines, Cardiovascular and Cerebrovascular medicines.

Jiangsu Spring Fruit Yihai Kerry Invest- June 2011 Vitamin E oil manufacturer. Biological Products ments

2011-12 Lonza Facility Set Up For Vitamin B3 – Niacin.

Nutraconsensus 30

Regulatory standards and legislative practices are changing and constantly evolving across the globe. With globalisation of nutritional supplements market and increasing challenges, it becomes imperative to have a sound regulatory framework for safety of consumer health and ensure fair practices in international trade

Nutraconsensus 31

Regulation and Standardisation

Legal status, the world over The regulatory environment in developed countries is often governed or controlled by government agencies which look into regulatory matters on nutrition related scientific health claims and also other aspects such as manufacturing, packaging, labeling, and marketing of functional foods and dietary supplements. The regulatory regime ensures the safety of consumer health and encourages fair practice in international trade through the development of guidelines on food standards, codes of practice and other recommendations. The FAO and WHO have developed together the Codex Alimentarius Commission which aims to integrate, harmonise global food standards and create coordination amongst non-governmental and international agencies. In practice, however, most countries follow their own established regulatory system as it still remains unclear about the approach used in setting guidelines for the Safe Upper Limit (SUL) of vitamins and minerals and consensus on matters like the reduction of disease risk claims and scientific substantiation are yet to be reached.

Regulations in the US In the USA, the FDA through the DSHEA has a separate set of regulations for dietary supplements and dietary ingredients and does not cover food additives and medicines. All companies, domestic and foreign engaged in the manufacturing, packaging, labeling etc. of dietary supplements must comply with good manufacturing practice (GMP) for quality control. Under DSHEA, manufacturers are responsible for product safety and labeling, however, the FDA bears the burden of proving that a product is unsafe or improperly labeled. Also, in general, registration and product approval is not required for dietary supplements.

Three types of claims are allowed in the U.S. The first two are allowed without FDA premarket approval, provided they are not false or misleading:

1) Nutrient content claims: Claims relating to the level of nutrient in the food. For example, the product is “low fat”, or “contains 60 calories” or “contains no added sugar”

2) Structure/function claims: The role of a nutrient or an ingredient likely to affect the structure or function of a human body. For example, calcium is good for bones, fibre for digestive health, vitamins A/C/E for natural defenses, vitamin A for eyes, etc.

3) Health claims describe the relationship between a substance and a health related condition or disease. They are often written statements but also include symbols, specific labeling and any other form of communication that establish a relation. Evaluation and review by the FDA is a must prior to use. As per FDA, an example of an authorised health claim is “Three grams of soluble fiber from oatmeal daily in a diet low in saturated fat and cholesterol may reduce the risk of heart disease.”

Nutraconsensus 32

Federal Trade Commission (FTC) is an independent agency responsible for consumer protection as well as regulating the advertisement related to dietary supplements and the DSHEA is responsible for product claims, product labeling and promotional activities undertaken at the point of sale. In order to be compliant with the FTC law, the advertiser must identify claims and interpret ad meaning then veri- fy by having substantiate claims and also validate claims based on traditional sues and consumer expe- riences. Also, under DSHEA, all statements must have a disclaimer that the statement has not been evaluated by FDA and that the product is not intended to "diagnose, treat, cure or prevent any disease."

Cosmetics: FDA's Center for Food Safety and Applied Nutrition (CFSAN) is responsible for regulating the cosmetic products. Pre-market approval of the FDA is not required for most cosmetic products (except those containing colour additives). Like DSHEA, here also manufacturer is responsible for the ingredients and safety of the product before it reaches the market. Other major enactments of law governing cosmetics are the Federal Food Drug and Cosmetic Act and the Fair Packaging and Labeling Act which require consumer products to be labeled with proper disclosure and honesty. The FDA also maintains a Voluntary Cosmetic Registration Program (VCRP) for post market reporting for use by manufacturers. It applies to only cosmetic products sold in the US and does not include skin care clin- ics or spa. The FDA does not formally recognise a classification for “cosmeceuticals”, for the agency, a product is either a cosmetic or a drug depending on its intended use.

Veterinary Products: Federal Food Drug and Cosmetic Act (FFDCA) set the regulatory framework for animal feed including pet food. The provisions of DSHEA are not applicable for veterinary products.

European Union The regulatory status of dietary supplements in the EU is diversified and complex due to the presence of different legislations and practices within member states. The European Food Safety Authority (EFSA) is the risk assessment regulatory body that also governs matters related to nutraceuticals. Di- rectives have been issued by EFSA in the nutraceutical segment on matters such as food supplements, nutrition and health claims, botanicals, novel food and novel food ingredients, the traditional herbal medicinal products and foods for particular nutritional purposes. Set out below is a brief of some of the directives issued.

 Nutrition and Health claims Regulation 1924/2006 sets out framework to ensure that labeling claims in the EU are validated by scientific evidence and contains guidelines which protect consumers from misleading or false claims  Food Supplements Directive 2002/46/EC has guidelines for labeling requirement and also sets the maximum level of intake of vitamins and minerals that can be added to a food supplement. Apart from this, it contains the list of vitamins and minerals that can be added for specific nutritional purposes in food supplements  Botanicals: Food supplements prepared from plants, algae have become available in the EU market. Use of botanicals in food supplements are regulated by EFSA. The main purpose use scientific based approach to assess the safety of botanicals used in food and supplements  Foods for Particular Nutritional Purposes Directive 89/398/EEC, which sets up specific directives and rules for several areas such as infant or young children, weight management foods and other specific areas.  Cosmetics: The Cosmetics Directive includes rules and procedures on what constitutes as safe cosmetics and also guidance on restrictions on ingredients and monitoring labeling, packaging and marketing requirements

Nutraconsensus 33

 Vet Products: Committee for Medicinal Products for Veterinary Use governs the technical as- sessments and the European Medicines Agency which governs the drugs and pharmaceuticals in EU region look after the Marketing rules. Marketing authorisation is required for veterinary products in EU.

United Kingdom Products categorised as dietary supplements are mostly classified as food and are not regulated as a therapeutic product under the Medicines Act. Also, stringent guidelines and product approvals applicable for medicines in terms of dosage, ingredients, labelling and purity are not required for dietary supplements. The Food Standards Agency (FSA) Expert Group on Vitamins and Minerals (EVM) has published recommendations on what constitutes as a safe levels of intake for vitamins and minerals. The food law and European level regulate the claims made for supplements. The Advertising Stand- ards Authority (ASA), a self-regulatory body set up by the advertising industry has established codes for the broadcast media (TV and radio advertising standards codes) to ensure marketing communication of dietary supplements is legal and honest.

Japan In Japan, Foods for Specified Health Use (FOSHU) look into the food regulation, registration process and labeling guidelines for food products that contain functional ingredients which affect the structure/function of the body. FOSHU approval is determined on a case-by-case basis while nutrient- health claims are generic for any product, meeting the stipulated requirements.

Nutraconsensus 34

Regulatory Framework in developed countries – USA, European Union, and Japan

Defined Labelling & Mar- Regulatory/Non- Role of Regulatory Regulatory Acts Nutraceutical keting Regula- Regulatory Body Segments tions USA Regulatory body – Food & Drug Ad- Functional Foods Provide pre-approval The food labelling Food & Drug Ad- ministration (FDA), and Dietary Sup- to health claims; regulations are ministration Dietary Supple- plements. Defines dietary sup- complex and con- ment Health and plements; stantly developing. Education Act Regulates all foods Monitors safety (DSHEA), Federal and measures in case Food Drug and food additives; of any adverse Cosmetic Act Regulates good reporting related to (FDCA), CODEX manufacturing prac- foods and product (Codex Alimentari- tices for supple- information such as us Commission). ments; labelling, health or Develops standards functional claims, and guidelines for and package in- foods for special serts. dietary uses.

Europe Regulatory body – General Food Law Dietetic foods, Approves the health Mutual legislation European Food Regulation, EC food supplements, claims. regarding labelling Safety Authority 178/2002, Europe- novel foods, herb- Assess the laws of is missing among an Food Safety al medicines, etc. EU countries relating EU countries. Authority (EFSA), to supplements. EFSA ensures that Directive Allows the registra- products sold are 2002/46/EC (food tion of products as safe and prevents supplements), medicines by devel- the miscommunica- Directive opers providing tion of information 2004/27/EC (me- good quality herbal to consumers. dicinal products), products. Directive Classifies novel 2001/83/EC, Novel foods. Food Regulation Defines the claims EC 258/97, The made for products Traditional Herbal based on which a Medicinal Products product can be de- Directive fined as medicinal. 2004/24/EC. Establishes a science-based approach for theories relating to functional foods.

Nutraconsensus 35

Defined Regulatory/Non- Role of Regulatory Labelling & Market- Regulatory Acts Nutraceutical Regulatory Body ing Regulations Segments Japan Regulatory Foods for Specific Functional foods Focuses on health Japan has a well- (FOSHU) as well Health Use claims for specific defined product cate- as non-regulatory (FOSHU), Japan products. gory and labelling (non-FOSHU) Health Food As- Approves health system which helps in sociation (JHFA) - claims. controlling the market- purposeful gov- FOSHU approval ing of non-approved ernment involve- process of 1 year to products. ment that regu- be followed by man- Functional foods in lates the field, but ufacturing compa- Japan are a highly does not overly nies for their prod- profitable business and restrict it. ucts and a further generate further big short period required profits as the FOSHU for review by the label allows for higher local authorities and pricing of products. the Ministry of Health and Welfare (MHW).

Canada Regulatory body – Natural Health Functional foods, Define requirements Define the require- Health Canada Product Regula- Probiotics, natural for quality, efficiency ments for labelling, tions, Food and health products and safety of prod- packaging, clinical Drug Act, Canadi- (NHPs) ucts. trials, Gmp, site in- an Food Inspec- Manage health food spection, and also tion Agency claims for functional reporting of adverse foods. events. Defines natural health products. Approve specific claims post review- ing the products in detail (processing method and nutrition content, etc.)

Nutraconsensus 36

Regulations in the BRIC regions

Factors fuelling the growth of the Nutraceutical Industry The demographic, economic, and cultural changes that have driven the development of functional food markets Consumer Awareness in developed countries are also fuelling the growth in the BRIC regions. While the domestic market environment Changing lifestyles and demand factors in the opportunities available for companies in developing countries, export markets may offer profitable opportunities to overcome their limited Increase in disposable income domestic demand of functional foods. Commercial export opportunities exist in value-added raw materials, Retail growth functional ingredients, and even in consumer products for the functional food sector in the more mature markets. The following section examines the functional Ageing population foods sector in three of the emerging economies in the BRIC regions – Brazil, Russia, China and followed by Certain degree of dissatisfaction of developments in India. modern medicine

Nutraconsensus 37

Regulatory Framework in developing countries – Brazil, Russia, and China

Defined Regulatory/Non- Regulatory Role of Regulatory Labelling & Market- Nutraceutical Regulatory Acts Body ing Regulations Segments Brazil Health claims ‐ National Health Functional Coordinates, supervises, reference Surveillance Foods and controls activities to the cure or Agency (ANVI- regarding registration, prevention of SA), State information, inspection, disease ‐ are not Food and Drug risk control, and rulemak- allowed Administration ing to assure health sur- (SFDA) veillance over food, beverages, water, ingredients, packages, technologies, contamination limits, and veterinary residues, Check natural or synthetic substances having a demonstrated and physiologic activity, Regulates foods that have a functional or health claim associated with their use

Russia Non regulatory Russian Minis- Dietary sup- The process for register- Significant limitations try of Health plements ing dietary supplements have been imposed takes around 6 months on the nutraceutical and once all the require- market with regard to ments are fulfilled, there advertising, promotion is a short period required and distribution, espe- for issuing and register- cially in “official” sales ing the certificates. channels

Among the BRIC countries Brazil leads the vitamins and minerals market. China is home to the second largest vitamins and minerals market, led by multi‐vitamins, while its single minerals category displays rapid growth. Among the developed country manufacturing packaging labelling and marketing of nutraceuticals and dietary supplements are regulated by the well-furnished and managed government regulatory body. But in the developing country like India, regulations have been evolving over the last decade with a formalisation of the policy in 2011-12.

Nutraconsensus 38

Evolution of the Nutraceutical Regulation in India

The Food Safety and Standards Regulations, 2011. How is it different from the previous (multiple) law/s? Prior to the FSSA, there were multiple laws and regulations governing food safety and standards. Nutraceuti- cals were clubbed under Prevention of Food Adulteration Act and Rules (PFA). Food was classified as either fortified or propriety. Later in 2006, all the existing laws were consolidated to form one single statute in order to ensure systematic and scientific development of the food processing industry. Food was classified under the following heads:  Novel foods  Genetically modified food  Propriety Food  Standardised Food  Foods for special dietary use  Functional foods/Nutraceuticals/Health Supplements

The Food Safety and Standards Regulations, 2011 notified in the Gazette of India came into force on 5th Aug 2011 to regulate manufacture, distribution and sale of nutraceuticals, functional foods and dietary supplements in India.

Licensing and Registration requirements  Every Food Business Operator(FBO) in the country will have to obtain registration and license in accordance with the procedure laid down in FSSAI (Licensing and Registration of Food Business)Regulation 2011  A manufacturer cannot commence business unless he is registered or has a valid license.  Petty food manufacturers(annual turnover less than Rs.12 lakh) have to register with the Commissioner- ate and manufacturers whose turnover is greater than 12 lakhs to obtain PA or food licence from FSSA office  Existing licenses/registration should be converted into FSSAI license/registration before 5 August 2012 (now extended by a few months)  An application for the grant of a license shall be made in Form B of Schedule 2 to the concerned Licens- ing Authority. The license shall be issued within 60 days from the date of issue of an application ID number  After the issue of Application ID number the Licensing Authority may direct the Food Safety Officer to inspect the premises in the manner prescribed by the FSSAI in accordance with these Regulations.  The Licensing Authority shall issue a License in Format C under Schedule 2 of these Regulations  Registration or license granted under these Regulations shall be valid and subsisting, unless otherwise specified, for a period of 1 to 5 years.

Increased regulation should encourage manufacturers to devise long-term market strategies…..and weed out unscrupulous players and products from the market.

Nutraconsensus 39

FSSAI regulations 2011 at a glance

Food Business Operator (FBO)

Registration/license is mandatory

YES

Check criteria  Fill application Form B for for Central Meets license license or State eligibility?  Submit documents license  Licensing authority may seek additional information  Issue of Unique Application number YES

NO  Fill application Form A for Inspection Grant registration/ FBO can now license within the commence business registration required?  stipulated time Submit documents  Attach self-declaration form YES

Appoint Food Security Officer (FSO)

Send notice of inspection to FBO

FBO to comply with the required alterations

FSO to submit inspection report

Challenges faced by the Supplier/Manufacturer with the introduction of the new law Product Approval Prior to FSSAI, a company could manufacture a product if it had the license of Prevention of Food Adultera- tion (PFA). But now, product approval certificate is mandatory to obtain a FSSAI license. An applicant has to apply for each ingredient separately for New Product/Ingredient. For obtaining product approval the food business operator will make an application in the prescribed format with an initial payment of non-refundable INR 25,000. This tends to create technical hurdles as well as increase the cost incurred by the manufacturer/supplier. In a recent case, Tamil Nadu Food Supplement Manufacturers and Traders Association (TFSM- TA) has decided to move court seeking amendment to FSSA rules.

Nutraconsensus 40

Separate Food License for packed food items In order to prevent misrepresentation of claims on labels, the FSSAI has recently sent notices to manufacturers of food supplements like Pediasure, Bournvita, NutriChoice asking them to provide scientific basis of their claims. The act has made it mandatory to have separate licenses for these items.

Timelines While specific timelines have been mentioned in the guidelines actual implementation of some of the above process steps may take longer than prescribed timelines as the procedures, implementation agencies and their operations are in the process of formalisation. Considering the fact that an approval process lasts for only a period of one year, companies with a larger portfolio would be involved in the approval process for significant time periods every year. While these appear to be teething issues in the implementation of the regulation, interim relief through specific approvals) is being awarded in terms of temporary licenses for products which are already being sold in the market. Foreign players, however, disagree on selling products until final confirmed approvals for all products are in place.

Facility Approvals Operators also feel that a certain level of facility based approvals should also be added to the current regime (like pharma) so as to save timelines for process based formalities which may be common for a basket of products that are being manufactured at a facility.

Documentary evidence There does not appear to be complete clarity on the documents required to be submitted during the approval process and monitoring agencies seem to be taking time before responding with specific pending requirements. Also clarity is required in terms of products which are manufactured outside India (to prevent dumping of re- jected overseas products in the country).

Labelling/ Advertising Legislation on product quality and standards (included in the FSS (Packaging and Labelling) Regulations, 2001) need to be adequately supported by a claims monitoring agency for product labels and advertisements directed at attracting the consumer to the product. Regulations currently prohibit the making of any health claim on proprietary/ functional/ novel foods without FSSAI approval and no claims should be made which are false, misleading or deceptive. What is a correct/ misleading health claim is it proven, what the process of approval is and associated timelines are some of the questions which still remain unanswered.

Marred by issues around ambiguity and multiplicity for the last decade, guidelines for Nutraceutical regulations have made a hurried but long awaited debut in the Indian market in 2011-12. Welcomed by all, these guidelines appear to face teething issues in terms of actual implementation and transition of old, existing products into the new regime. While nodal and monitoring agencies have been framed for the effective implementation of these rules, still much needs to be done to supplement the manpower to handle the volume of applications in a country, which is poised to become one of the largest consumers of Nutraceuticals in this decade.

Nutraconsensus 41

Growing market sizes, heightened attention to product safety and the continuing harmonisation of food

supplemen t regulations show a

global trend toward more regula-

tion and India, although a late en-

trant, has emulated these guiding

principles of Nutrition Regulation

across the globe

Nutraconsensus 42

Recommendations and way forward

Some of our recommendations for growth of this sector in a regulated environment are included in the paragraphs below:

Transformational Partnerships  technical assistance on potential technologies The National Health Agenda, though currently  evaluation of scientific benefits and evaluation viewed from the lens of ‘public’ health only, needs to of claims be viewed through experienced industry players and  best practices in quality standards including institutional agencies as well. A key learning from learning from products which are already ap- the Copenhagen Consensus 2012 for our policy proved in other regulated markets makers is to ensure that Bundled Micro-Nutrient  manpower support with experienced specialists Intervention should form a core area of fund alloca- for speedy transition and redressal of issues and tion in our Budget. Independent pilot plans for avoidance of delays meeting the nutrition needs of the country need to  change enablement support for smaller and be supplemented with large scale alliances of public newer entrants in the market and private partners to increase access to the missing nutrients necessary for the growth of health of peo- Continued research and innovation ple, communities and economies. These alliances There has been a continued scientific evaluation in can then be supported by public and private sector the areas of biodiversity and the beneficial health donors and participation from domestic and interna- effects on functional food and nutritional uses in the tional players (who may have experience of imple- markets. Scientific evidence for safety and functional menting these in other developing economies). effectiveness of these compounds is essential in or- Some examples for the kind of alliances which can der to realise their potential in the production of high be layered under one another to address a collective market valued products. agenda of malnutrition include: New value-added components could also come from  National multi-stakeholder PPP model local food crops, medicinal plants or non-food  Sectoral partnerships sources.  Private sector led initiatives (by experienced global players) Economics of Nutrition Providing information and support for strategic Building institutional capacity with industry decision-making: representation To a supplier of raw material ingredients, the target The improved and stringent regulatory environment markets for food supplements, traditional medicine should be augmented with institutional capacity and and functional food all appear to be interlinked. In include member representatives such as producers, order to strengthen the functional food programs, it processors as well as the government regulatory bod- becomes imperative to identify the potential sectors ies, as necessary for addressing matters around: on a case by case basis and assess their profitability. . Before a product decision is made, it is helpful to

Nutraconsensus 43

understand the likelihood of market acceptance by norms for packaging and labeling urgent attention of studying each market segment in depth. Each mem- the government or the regulatory body in this direc- ber of the supply chain must be given an opportunity tion which covers all aspects of Advertising, Packag- to make rational and informed choices. This can ing and Labeling and evaluate all products before happen only if the market and regulatory information they enter the market (and not in the form of post is made available to them. facto approvals/ withdrawals, as is currently the case). Strengthening mass communication for specific health nutrition factors Child and women’s health and sports nutrition appear to be the focus areas of almost all industry players in the developing regions. A national emphasis on such matters, which is already present in case of infant and women nutrition to an extent, needs to be extended to emphasising on the importance of sports activities in school curriculum as well as in the younger and middle aged population.

Change enablement The FSSAI regulations include the set-up of nodal agencies for the immediate implementation of the guidelines. Industry representatives feel that several time limits are currently not being complied with for existing product applications and there have been significant delays resulting in financial losses for the cautious players. Interim, temporary approvals need to be allowed for players and products which have a long history of having sold these products in the domestic and international market.

A formulation or a facility based approval Current approval processes designed for each and every product (whether new or already being marketed) is a lengthy process and also holds validity only for a defined time period. This may be streamlined with practices in the pharma industry where both product and facility approvals can co-exist and re- newals are less stringent and less time-consuming process.

Labelling and Claim Evaluation In a vastly illiterate and scientifically ill-informed population like India, any misleading information (through advertising/ packaging/ labeling) that has been printed on to the label of the dietary supplements meant for mass consumption may cause a major national crisis. Though National institute of Nu- trition and the FSSAI have issued guidelines and

Nutraconsensus 44

References

1. Micronutrients, Macro Impact:- The story of vitamins and a hungry world (www.sightandLife.com) 2. Nutrition Business Journal, S&P 3. International Journal of Pharmacy and Pharmaceutical Sciences - DIETARY SUPPLEMENTS: A LE- GAL STATUS IN INDIA & IN FOREIGN COUNTRIES 4. Health Enhancing Foods Country Case Studies of China and India – The World Bank 5. Expert Panel Findings, Copenhagen Consensus 2012 6. Next-Generation Nutraceuticals, Business Insights 7. Nutraceuticals as therapeutic agents: A Review, Research J. Pharm. and Tech 8. An Overview Of Nutraceuticals Current Scenario, Journal of Basic and Clinical Pharmacy 9. Advanced analysis of nutraceuticals , Journal of Pharmaceutical and Biomedical Analysis 10. Hunger And Malnutrition, Challenge paper, Copenhagen Consensus 2012 11. Regulatory environment for nutraceuticals and functional foods, National Research Council of Canada 12. Nutraceuticals: What Are They And Do They Work? Kentucky Equine Research, Inc.,Versailles, KY 13. East Meets West: Bridging the Cultures with Innovative Food Solutions - Dr. Sharon Shoemaker + Dr. Karen Lapsley, Moderators 14. Nobel Laureates: More Should Be Spent On Hunger, Health 15. Classification, Regulatory Acts And Applications Of Nutraceuticals For Health and Dietary Supple- ments: A Legal Status In India & In Foreign Countries, International Journal of Pharmacy and Biological Sciences 16. Regulatory Perspective of Nutraceuticals in India, Interlinker 17. Health Enhancing Foods Opportunities for Strengthening the Sector in Developing Countries, The World Bank 18. Multiple articles and references from www.nutraworld.com 19. Multiple articles and references from www.sightandlife.org 20. Food and Nutraceutical Regulations - Global Snapshot, www.fnbnews.com 21. Food-and-Nutraceutical-Regulations, foodsafetyauthorityindia.blogspot.in 22. NRC Publications Archive – Archives des publications du CNRC Regulations and standards – 23. http://www.fda.gov/ 24. http://www.fda.gov/food/dietarysupplements/default.htm, http://ods.od.nih.gov/About/DSHEA_Wording.aspx 25. FTC - http://www.ftc.gov/ 26. FDCA - http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/default.ht m 27. CODEX - http://www.codexalimentarius.org/ 28. Health Canada - http://www.hc-sc.gc.ca/index-eng.php 29. FSSAI - http://www.fssai.gov.in/ 30. ANVISA - http://www.anvisa.gov.br/eng/index.htm 31. SFDA - http://eng.sfda.gov.cn/WS03/CL0755/ 32. EFSA - http://www.efsa.europa.eu/ 33. EU Directives: http://ec.europa.eu/eu_law/introduction/what_directive_en.htm 34. FSA - http://www.food.gov.uk/

Nutraconsensus 45

35. FOSHU - http://www.foshu.com/ 36. FNFC - http://www.mhlw.go.jp/english/topics/foodsafety/fhc/01.html 37. FHC - http://www.mhlw.go.jp/english/topics/foodsafety/fhc/index.html 38. Russian Ministry of Health - http://government.ru/eng/power/23/ 39. http://pharmabiz.com/NewsDetails.aspx?aid=70232&sid=1 40. www.slideshare.net/Overview of FSS Act Rules Regulation2012

Deal References 41. Capital IQ 42. VCC Edge: http://www.vccedge.com/index_new.php 43. Nutritional Capital: http://www.nutritioncapital.com/ 44. http://www.business-standard.com/india/news/sanofi-arm-to-buy-universal-medicare%5Cs- nutraceuticals-biz/446976/ 45. http://www.business-standard.com/india/news/hester-biosciences-acquires-innoves-animal- health/489900/ 46. http://www.vivimedlabs.com/news/2011/vivimed-labs-acquires-octtantis-nobel-pvt-ltd/ 47. http://www.business-standard.com/india/news/dabur-buys-ajanta-pharma-capsule-brand-focusotc- healthcare/434431/ 48. http://www.indiainfoline.com/Markets/News/Bafna-Pharma-to-acquire-Johnson-and-Johnson- report/5111036623 49. http://profit.ndtv.com/news/market/article-socrus-bio-sciences-ltd-socrus-bio-acquires-anti-obesity- brand-34-full-fit-34-19513

Emerging Trends 50. http://www.worldbank.org/ 51. http://www.who.int/en/ 52. http://www.wfp.org/nutrition

Nutraconsensus 46

Appendix

Regulation The National Health Ministry of Health and The Food Safety and State Food and Drug Surveillance Agency Social Development Standards Authority of Administration (SFDA) (ANVISA) India (FSSAI)

Effective 1999 1997 2006 2003 from

Vitamin/Mineral Biologically Active Foods for Special Die- Special Dietary Definition supplements Food Supplements- tary Use/Medical use Food/Functional Food

Supplements fall with- According to the Minis- Foods for special dietary Health Foods require in the food category try of Health, BAS use are specially pro- pre market registration when their levels do (nutraceuticals and cessed or formulated to and approval by SDFA. not exceed the Rec- parapharmaceuticals), satisfy particular dietary Special Dietary food: ommended Daily Al- are concentrates in- requirements that exist food which is used to lowance (RDA) if extended for internal because of a particular fulfil the specific dietary ceeded; these are consumption or inclu- physical or physiological requirements of con- then treated as medi- sion in products to condition and/or specific sumers. Special dietary cines. Supplements enrich the diet with disease and disorder. The food cannot make func- are referred to as biologically active sub- composition of these tional claims with re- “Vitamin and /or min- stances or their com- foods must differ signifi- gards to the product eral supplements. plexes. According to cantly from the composi- itself, but claims can be Other ingredients, the above definition, tion of ordinary foods of made with regards to such probiotics or the following products comparable nature, if such the ingredients of the herbs, are not allowed can be identified as food exists. product itself, but claims in supplements and biologically active sup- Health Supplements in- can be made with re- might be regulated plements: clude Vitamins, minerals, gards to the ingredients under specific stand-  Polysaturated ac- proteins, fatty acids, ami- of the product ards in the food and/or ids no acids, plants or botani- medicine  Mineral substanc- cals, other dietary sub- category. es, micro and stances, substances from macro elements. animal origin with known  Some aminoacids or established physiologi-  Some mono and cal effect, intended to disaccharides supplement normal diet  Food fibres and usually marketed in  Microorganisms unit dose or other dosage present in human forms such as capsules, body tablets, powders, solu-  Vitamins, whose tions. daily dose does Products with reduced not exceed the calorie content as a formu- one needed for la for losing the human body. weight/slimming etc. Dieting foods are products of high nutritional content to satisfy particular dietary requirements which exist because of certain physiological conditions or specific diseases/disorders usually without medical advice. Foods specially processed for Infants

Nutraconsensus 47

Emergence of Nutraceuticals and their Health Benefits Lipids (except fatty acids)

Nutraceutical Matrix Possible Health Benefit Phytosterols decrease cholesterol associated with Vegetable oils (olive, Plant sterols (Phytosterols) LDL, have anti-cancer activity and modulate the sunflower, rice bran, seeds) immune function and inflammation. Glycerolipids Seed oils Skin care and source of fatty acids Phytosterols, γ-oryzanol and Antioxidant, decrease cholesterol absorption, pro- steryl ferulates octacosanol, Rice tect against atherosclerosis, nerve imbalance and and squalene. disorders of menopause Mediterranean mussel and Sterols Rapana venosa Skin-care (hard-shellclam) Glycerolipids Microalga Antimicrobial and anti- inflammatory activities Decrease cholesterol and reduce the risk of coro- Sterols Italian walnut nary heart disease Phytosterols and phytostanols Milk and yoghurt Decrease cholesterol levels Tetraploid and hexaploid Phytosterols Decrease cholesterol levels wheats Squalene Vegetable oil Decrease cholesterol and anti-cancer activity Antiseptic, carminative, antimicrobial, and antioxida- Terpenes and terpenoids Essential oils tive effects. Antibacterial and antineoplastic Terpenoids Quinoa flour (pseudo-cereal) properties. Milk lipids (triglycerides, Immuno-suppressive, anti-inflammatory, andantimi- diacylglycerides, saturated Milk crobial fatty acids and PUFAs). properties. Protect against enteric pathogens, and prebiotic Gangliosides Dairy products (milk) functions.

Carotenoid nutraceuticals

Nutraceutical Matrix Possible Health Benefit β-carotene, β-cryptoxanthin, Mandarin, Orange juices Antioxidant, inmunomodulation and cancer preven- mutatoxanthin, antheraxanthin, tion luteoxanthin, epoxycarotenoids esters. . . β-carotene, lycopene Thai fruits Antioxidant, anti-cancer, prevent degenerative diseases β-carotene, lutein, lycopene Chestnut Antioxidant, inmunomodulation and cancer prevention β-carotene Tea seed oils Antioxidant effects Astaxanthin, β-carotene, lutein, Alga Antioxidant, inmunomodulation and cancer preven- cantaxanthin, violaxanthin, tion. neoxanthin Lycopene Tomato products, nutritional Antioxidant, anti-cancer supplements

Nutraconsensus 48

Vitamins

Nutraceutical Matrix Possible Health Benefit Tocopherols (Vitamin E) Vegetable and vegetable oils Antioxidant, antitumor, hypocholesterolemic potential and for the treatment of cardiovascular disease and angiogenic disorders Tocopherols (Vitamin E) Microalga Antioxidant and prevents degenerative disorders Vitamin B1 and B2 Mushrooms Antioxidant Water-soluble vitamins (B1, Maize flour, green and golden Antioxidant and co-enzymes B2, two B3 vitamers, B5, five kiwi and tomato pulp. B6 vitamers, B8, B9, B12 and C). Vitamins B2, B3 and B6 Energy drinks Antioxidant and co-enzymes Vitamin C (L-ascorbic acid) Fruits Antioxidant L-ascorbic acid dehydroascorbic Buckwheats Antioxidant acid) S-methyl-L-methionine Centella asiatica Wound healing (vitamin U) Fat and water soluble vitamins Beer and bioactive drinks Antioxidant and co-enzymes

Proteins, peptides and aminoacids

Nutraceutical Matrix Possible Health Benefit Milk proteins, peptides Milk and derived products Antihypertensive, antimicrobial, Lactoferrin and anti-inflammatory and immunoglobulin G. inmunostimulating activities. Important source of amino acids Amino acids Sprouts, alga and sport drinks Effect on the nervous system, and tablets antioxidant, anti-cancer and source of muscle energy Peptide Fishes Antihypertensive, antioxidant and anticoagulant activities Type II collagen Chick Can suppress Rheumatoid arthritis (RA) and promote healthy joints. ∼35 kDa antioxidant protein Curry leaves Antioxidant properties Immunomodulatoryproteins Garlic (Allium sativum) Immunomodulation activity Total proteins Ganoderma lucidum (fungi) Prevention and treatment of hypertension, diabetes, hepatitis, cancers and AIDS Lysozyme-derivedpeptides Hen’s egg Antimicrobial activity Cyclopeptides Cow cockle seed Estrogen like activity in vivo Phaseolamin Kidney bean (Phaseolus vulg.) May reduce calorie absorbance, thereby promoting weight loss. Selenopeptides Nuts Antioxidant, anti-cancer, anti-heart disease

Nutraconsensus 49

Glycosides

Nutraceutical Matrix Possible Health Benefit Stimulate muscle growth and raise Testosterone levels. Antidiabetic or Saponins Vegetables anti-obese effects, antibacterial and antineoplastic properties Raw materials, formulations Treatment of osteoarthritis and some Chondroitin sulfate and dietary supplements. ophthalmologic diseases. Polysaccharide Poria cocos (fungus) Anti-inflammatory effects (1,3-α-galactan) Saccharides Black currant pomace Antioxidant properties Increased absorption of calcium and Dairy-based prebiotic Galactooligosaccharides magnesium, and improved elimination Ingredient. of toxic compounds Nutraceutical preparations and Glucosamine Treatment of osteoarthritis Tablets Glycosides (glucosinolates, Choleretic, anti-inflammatory, glycyrrhetic acid, glycyrrzhin, Plants anti-cancer, antioxidant, anorexant liquiritin, steroidal glycosides) and diuretic properties

Phenolic compounds

Nutraceutical Matrix Possible Health Benefit Phenolic acids Seed-oil Antioxidant Phenolics Fruits, Mushrooms, Antioxidant legumes Anthocyanins Fruits, Nutraceutical Antioxidant Capsules Anthocyanins Fruits, tubers Antioxidant Phenolics Marula (Sclerocarrya birrea) Antioxidants and Antiatherogenic Catecholamines Banana peel Antioxidant Rutin Buckwheats Antioxidant Flavone isomers lemon juice Antioxidant Phenolics Potatoe Antioxidant Phenolic acids Cooked meat Antioxidant Flavonol Bean Antioxidant Phenolics Moscatel sweet wines Antioxidant Phenolics Carex distachya roots Antioxidant Curcuminoids Curcuma longa Antioxidant Lignans Flaxseed Antioxidant Phenolic acids, proanthocya- Triticale Antioxidant nidins, and lignans Flavonoids Ulmus davidiana Antioxidant Demethyloleuropein Olive fruit Antioxidant Alkil phenols Anacardum Antioxidant Flavonoids Hypericum perforatum Antioxidant Phenolic acids, isoflavones Black Soybeans Antioxidant Phenolics Pepper Antioxidant Phenolic acids Malt Antioxidant Catechins and condensed Green Tea Antioxidant tannins Phenolic acids Mangosteen Antioxidant Phenolics Bergenia ciliate Antioxidant

Nutraconsensus 50

Nutraceutical Matrix Possible Health Benefit Phenolics Vanilla planifolia Antioxidant Phenolics Grape Antioxidant Flavonoids and phenolic acids Chinese herbal tea Antioxidant Resveratrol Nutraceutical capsules Prevention of atherosclerosis Phenolics Grape skin Antioxidant Lignans Myristica fragrans (nutmeg) Anticariogenic Prunate Prunus Anticarcinogenic Polymethoxilated Flavones Orange Oil Antioxidant Carnosic Rosemary Antioxidant Licochalcone A Glycyrrhiza uralensis Lipase inhibition Phlorotannins Alga (Ishige okamurae) Cholinesterase inhibition Phytoestrogens Dietary supplements Estrogenic activity Flavonol glycosides Ginkgo biloba Memory enhancing Isoflavones Soy milk Estrogenic activity Isoflavones Soy supplements Antimenopausial sympthoms Phenolics Tamarix gallica Antioxidant and antimicrobial Flavonoids Citrus peel Antiinflammatory, anticarcinogenic and antiatherogenic Resveratrol Oligomers and Carex folliculata Seeds Antioxidant, cytotoxicity and antibacterial Flavonoids Phenolic acids Infant cereals Antioxidant & aroma O-glucoside phenolic Olive by-products Antioxidant, maturity indicators compounds Isoflavones Soybean seeds Antimenopausial sympthoms Isoflavones Red clover Antifungal activity Isoflavones Nutritional supplements Estrogenic activity

Other potential nutraceuticals

Nutraceutical Matrix Possible Health Benefit Sulforaphane Crucifer vegetables Anticarcinogenic properties (Brassica species) Phenylpropanoid amide Transgenic tomato Antioxidant and chemotherapeutic effects Phaeophytines Amaranthus tricolor Antioxidant, cancer prevention (Amaranthaceae) Monacolins Rice Cholesterol lowering and anticancer agent Capsaicinoids Peppers Antioxidants, anti-mutagenic, anti-inflammatory and anti-tumoral properties Acids (bitter acids, asiatic Plants (Centella asiatica, Anticarcinogenic properties acid and asiaticoside) hop)

Nutraconsensus 51

About FICCI

Established in 1927, FICCI is a not for profit organisation and is the largest and oldest apex business organisation in India.

FICCI has direct membership from the private as well as public sectors, including SMEs and MNCs, and an indirect membership of over 83,000 companies from regional chambers of commerce. With a Membership of over 500 Chambers of Commerce, Trade Associations Industry bodies, the Chamber speaks directly and indirectly for over 2, 50,000 small, medium and large business units employing around 20 million people.

The Head Office is located in Delhi. It has 8 State offices and 6 International Offices. FICCI-Western Regional Council is the western regional arm of the Federation of Indian Chambers of Commerce & Industry. In addition to supporting FICCI, New Delhi, FICCI-WRC organises its own conferences, seminars, workshops and networks with visiting delegations from several developed and developing countries.

FICCI-WRC actively provides sectoral services in Business Matching, Gems and Jewellery, Nutraceuti- cals, Progressive Maharashtra, Textiles, Technical Textiles and Wellness.

About HADSA

The Health Foods and Dietary Supplements Association (HADSA), was founded in April 2002, keeping the consumer benefits in mind, and represents the interests of manufacturers and suppliers of healthcare products including vitamin, mineral and botanical (including organic, GMO, non-GMO), Health Food, Natural Ingredient, Cosmeceuticals, Sports Nutrition Products, herbs and other Dietary Supplements.

HADSA is a National, non-profit trade association committed to providing consumers with safe and effective products made to quality standards. Further, the association supports a science-based environment for responsible marketing of Nutritional Supplements and ensures that consumers are provided with accurate information required to make informed choice.

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