GT FICCI Nutraconsensus Whitepaper

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
Disclaimer: The information and opinions contained in this document have been compiled or arrived at from published sources believed to be reliable, but no representation or warranty is made to their accuracy, completeness or correctness. This document is for information purposes only. The information contained in this document is published for the assistance of the recipient but is not to be relied upon as authoritative or taken in substitution for the exercise of judgment by any recipient. This document is not intended to be a substitute for professional, technical or legal advice. All opinions expressed in this document are subject to change without notice. Whilst due care has been taken in the preparation of this document and information contained herein, neither Grant Thornton nor FICCI nor other legal entities in the group to which they belong, accept any liability whatsoever, for any direct Grant Thornton India LLP. All rights reserved. Member firm of Grant Thornton International Ltd or consequential loss howsoever arising from any use of this document or its conOffices in Bengaluru, Chandigarh, Chennai, Gurgaon, Hyderabad, Kolkata, Mumbai, New Delhi and Pune tents or otherwise arising in connection herewith.
Nutraconsensus
Contents
Page
Foreword FICCI Foreword Grant Thornton A framework of definition A framework of operation A framework of regulation Recommendations
3 4 5 10 31 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
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.
Grant Thornton India LLP. All rights reserved.
Nutraconsensus
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 addressed 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.
Nutraconsensus
Nutraceuticals and functional foods combine traditional nutritive with drug-like functions of prevention
Nutraconsensus
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 continuous evolution over the years, nutraceuticals are now broadly defined as natural, bioactive chemical 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 comparatively 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
Nutraconsensus
Celebrating a hundred years of Vitamins - 2012
1980s 1990s Emerging physician acceptance Awareness through numerous journals and articles on benefits 1912 Vitamin coined by Casimir Funk 1912-1913 13 Vitamins identified and characterised 1934-1987 Industrial production of vitamins 2000 onwards Deficiencies identified in several industrialised 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
1910 Umetaro Suzuki discovers product, later identified as Vit B1
1900
1950
2000
Vitamins are organic nutrients which are essential for life. The human body requires very small amounts of these nutrients to ensure normal metabolism, growth and physical well-being. Most vitamins are not made in the body or only in insufficient amounts to meet our needs. They therefore have to be obtained primarily through the food we eat in which they are present in minute quantities. Minerals, as with vitamins, are indispensable (essential) in small amounts to ensure that the body grows, develops, and stays healthy. Minerals are found in wide range of foods. The body uses minerals to perform many different functions from building blood and strong bones to transmitting nerve pulses and maintaining a normal heartbeat.
Unlike micronutrients such as vitamins and minerals, macronutrients are required by the body in larger amounts and include proteins, carbohydrates, and fats. They, too, are indispensable for our health and well-being. Each of the 13 vitamins known today has specific functions in the body, which makes each of them unique and irreplaceable. No single food contains the full range of vitamins, and inadequate vitamin intake results in vitamin deficiency disorders. A balanced and varied diet is therefore vital to meet the bodys vitamin requirements. Of the 13 known vitamins, four are fat-soluble, namely vitamins A, D, E and K. The others are water-soluble: vitamin C and the B-complex, consisting of vitamins B1, B2, B6, B12, niacin, folic acid, biotin and pantothenic acid.
Nutraconsensus
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. Regulations 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 psychological benefits or reduce the risk of chronic diseases Nutrition Fortified Foods Probiotic food like yogurt Protein powder Paediatric nutrition
Foods providing nutrients that are not consumed in sufficient quantity in a person's diet Vitamin & mineral supplements Amino acids Antioxidants Herbal and non-herbal extracts
Liquids quenching thirst as well as replenishing minerals, provide energy, prevent ailments, and promote healthy lifestyle Sports and energy drinks Fortified juices Glucose powder Malted beverages
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)
Nutraconsensus
Emerging trends
Multiple micronutrient intervention studies
approach could act as an effective means for large scale intervention.

Food, Water and Sanitation underpinning the success of Nutrition
On-going research in various corners of the world aims to establish a link between single and multiple micronutrient intervention studies and diseases of the human body to arrive at a holistic nutritional approach for combat. The evidence supporting the role of interventions in the prevention of various diseases however is still evolving. As an example, food fortification with folic acid is being researched for NTD reduction whereas food fortification with Iodine for goitre reduction is already an established and implemented area of scientific research. The effectiveness of multiple interventions depends on their appropriate combination and sequencing. In addition to the sectors mentioned, water and sanitation which are also closely interlinked are also being examined in parallel.
Partnering in Nutrition
Food and Nutrition is being defined as a situation when all people at all times have physical, social and economical access to food, which is consumed in sufficient quantity and quality to meet their dietary needs and food preferences and is supported by an environment of adequate sanitation, health services and care, allowing for a healthy and active life.
New Dimensions
The usage of nutrients has increased from traditional forms (foods, supplements and beverages) to new markets such as cosmetics, pet care, marine life, sports, etc. Antioxidants for longevity, immunity and vitality Increased demand from the highest risk categories of baby boomers non-prescription based cosmetics with medicinal (including anti-ageing) properties Functional and medicated confectionary foods and snack bars Fatty Acids (CLA and omega 3, 6 and 9) and Proteins and clinical evidence of their health benefits Pet Nutraceuticals Sports Nutraceuticals Functional Additives - Vitamins, proteins, fibres Naturally derived substances, consisting of herbal and botanical extracts and animal- and marinebased derivatives.
Nutrition now plays a prominent role in the global public health agenda and has also been identified as the top investment priority at the recent Copenhagen Consensus 2012. There are several players in the nutrition space, each with its own agenda, structure and approach strategy. There is a need to move away from multiple pilot scale programs and launch large scale interventions and engage players, policy makers and global agencies with government support.
In home fortification
A promising approach (which finds mention in a WHO report 2011), in- home fortification of food was suggested to improve iron status and reduce anaemia in infants, children and women. If combined with commercial distribution schemes, this
Nutraconsensus
10
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, Russia, 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 compares them to our most nourished counterpart the US
Nutraconsensus
11
Global landscape
Distribution Network
Material Supplies
Nutra Companies
Customer
Regulator
Nutrition Support Groups
Research Agencies
The Consumer
Consumers of nutraceuticals are demographically diverse: a malnourished child in a developing country, a young mother and her infant, an aged man/ woman with prostate issues/ severe osteoporosis, an aging baby boomer who is willing to experiment with her food/ vitamin basket.
The Regulator
regulations are closely linked to cultural attitudes, population and other demographic profiles of each region. Contents of regulation also differ significantly in terms of coverage, acceptance of claims, labelling and quality rules.
The Suppliers
An evolving regulatory environment for nutrition products with marketing and labelling guidelines has made science based efficacy as an essential parameter for judging the success of nutraceuticals. Regulations vary as per the country of sale - DSHEA and FDA in the US, Health Canada in Canada and FHC, FNFC, FOSHU in Japan, EC directives in the EU, ANVISA in Brazil, FSSAI in India and SFDA in China. While a comparative benchmarking of these regulators has been discussed later in this whitepaper, national
These are primary producers of the raw materials in the world - an agricultural producer, a processor or specialised ingredient/ formulation suppliers.
The Channel
A Nutraceutical company could either follow a direct B2C channel (direct marketing by Amway and Herbalife), or have a direct distribution network (sold at a pharmacy/ retail stores) or enter into JVs with marketing partners.
Nutraconsensus
12
Learning from a nourished counterpart
USA
Key players
One of the earliest adopters of the fortified foods regime, functional foods already represent around 5% of the overall US food market. While early fortification was mostly done under public support (flour fortified with Vit B, salt fortified with iodine, milk enriched with Vit D), developments in the last few decades have been driven largely through private initiatives. The market today is dominated by many large multinationals in collaboration with specialised ingredient makers. Soft drinks and dairy are the key functional foods currently being sold in the US markets. Completely impervious to the financial crisis, this segment continued to display healthy growth patterns, factors fuelling which include: A proactive adult population who understands the need for nutrition 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
Competition is intensifying with growing sales, resulting in excessive advertising, new (often hurried) product introductions, the emphasis on quality and efficacy have assumed significant importance in the consumers mind. Food and beverage conglomerates such as Danone, Unilever, Nestle, Kellogg, Kraft and Coca Cola have introduced tailored healthy foods and adopted health, nutrition and wellness as much as possible in their product baskets. Every major food corporation from Nestle to Kraft is involved in nutraceuticals including Johnson & Johnson which has launched a new supplement brand. Some of the recent acquisitions in this arena by these players in the US include - Kraft acquisition of $140 million (Balance Bar and Boca Burger), Nestle acquisition of the competing PowerBar ($130 million sales), Quaker JV with Novartis.
The Yakult Story A single niche brand displacing generalist brands and market leaders!
Nutraconsensus
13
Illustrative list of players in the US region
US Company Name Nutraceutical Companies
Key brands
Nutrition Deal History (2011/2012)
Operating dynamics and differentiators
Pfizer Nutrition S-26 Gold, SMA and Promil
Pfizer Nutrition sold to Nestle for $11.85bn (2012)
Acquires Emergen C (Supplement) Pfizer Consumer Healthcare Acquires Ferrosans Consumer Healthcare Business
More than 80% of Pfizer Nutrition sales were in emerging markets. Focus Infant Nutrition Dietary Supplements is the key focus area within Nutraceuticals.
Nestle
Infant Nutrition - Nan, Gerber, Lactogen, Nestogen and Cerelac infant cereal
Nestl Health Science to acquire a stake in Accera Nestle acquisition of PowerBar ($130 million sales)
Pfizer Nutrition acquisition to complement existing Infant Nutrition Portfolio.
Abbott
Glucerna Pediasure Ensure Muscle Health Immune Balance NutriPals
Long term supply agreement with Martek for infant nutrition (Martek acquired by DSM)
Child Health and Nutrition Working towards probiotics and prebiotics - Nutrition shakes.
Subsidiaries of Indian Companies Valensa International (EID Parry) Saw Palmetto, Zanthin, Cranberol t, AstaCran, Valerex, Z-Omega, Amaranthol Natrol, Laci Le Beau, Trinovin, Prolab, Vedic Mantra, NuHair, Shen Min, Promensil EID Parry Ltd acquired stake US Nutraceuticals (Valensa) (2008) Targets Baby Boomer Population Botanical Solutions Provider. Key focus areas - nutritional supplements, herbal teas and sports nutrition (through acquisition of Prolab Nutrition and Medical Research Institute).
Natrol (Plethico)
No history of recent acquisitions
Nutraconsensus
14
US Company Name Ingredient Supplier
Key brands
Nutrition Deal History (2011/2012)
Operating dynamics and differentiators
DSM Nutritional Products
Quali blends, Carotenoids (Carocare, Actilease), LifesDHA, Resvida, GeniVida, fabuless, Peptopro,
Acquires Cargills Cultures and Enzymes Business for Euro 85bn (2012) Acquires Martek, Microbia and Vitatene (2010-11) Alliances with Kemrock and Sinochem in India (2011)
Global supplier of nutritional and specialty ingredients to food, beverage and dietary supplement manufacturers. Focus is on production of vitamins, minerals and micronutrients.
Direct Marketing Direct selling companies with a multilevel marketing system Nutrilite, XS Energy Drinks, personal care, home care, air and water purifiers, Artistry cosmetics Plans to spend $185 million on U.S. manufacturing expansion to meet growing global demand Nutrilite brands. Grows, harvests and processes at its own organic farms. Early China entry in 1995 Despite regulatory (direct selling related) changes, China remains its largest contributor of sales.
Amway
Herbalife
Formula 1, Active Fiber l, Herbalife24, Prolessa Duo, HerbalifeKids
No history of recent acquisitions
Weight Management, Digestive Health, Energy & Fitness, Targeted Nutrition, Personal Care.
*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.
Nutraconsensus
15
Quick Brick fact-files
Brazil 2011 $trillion US GDP GDP growth (Annual) Area (Mn Sq. Kms) Population (Mn) Ages 0-14 (% of total) Ages 15-64 (% of total Ages 65 and above (% of total) Population growth Life expectancy 2.48
Russia 1.85
India 1.86
China 7.31
3%
4%
7%
9%
8.52
17.08
3.29
9.60
197
142
1241
1344
25%
15%
30%
19%
68%
72%
65%
73%
7%
13%
5%
8%
1%
0%
1%
0.5%
73 years
69 years
65 years
73 years
Nutraconsensus
16
Emerging trends
BRAZIL
Number of people who are undernourished 11.7 million 2008 Prevalence of undernourishment (%of population) Prevalence of overweight (above 15 years)
RUSSIA
Prevalence of overweight (% above 15 years) Underweight (under-five, 000)
57%2010
GNI per capita (current US$)
49% 2010
Infant Mortality Rate (per 1000 live births)
2222008
6%2008
Health expenditure per capita (current US$)
$10720 2011
Maternal mortality ratio (per 100,000 live births)
12 2008
$10400 2011
Maternal mortality ratio (per 100,000 live births)
$990 2010
56 2010
$525 2010
342010
INDIA
Prevalence of under nourishment (% of population) Lifetime risk of maternal death
CHINA
Number of people who are undernourished 129 million 2008 Malnutrition Height for age (below five years) Under-five mortality rate: 21 per 1,000 live births 2008 Maternal Mortality Ratio (per 100,000 live births)
19% 2008
Under-five mortality rate: 69 per 1000 live births 2009 Health expenditure per capita (current US$)
1 in 702009
$1410 2011
Infant Mortality Rate (per 1000 live births)
9.4%2010
372010 18capita 2008 GNI per (current US$) $4940 2011
$542010
522008
$2212010
Nutraconsensus
17
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 (resultant 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 evolutionary 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 somewhat 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 behaviour 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/ DisTERVENTIONS to fight hunger and ease related) improve education (Health/ Disease re LowCost 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)
Nutraconsensus
18
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 encouraging 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. Neither 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 researching 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)
Nutraconsensus
19
BRAZIL
Key consolidation activity (involving Brazil as a target) in 2011 and 2012 Month Target name Acquirer Transaction Details Deal Size: $86.3 Mn Probiotica currently markets a full line of over-thecounter sports nutrition products and other food supplements. Enterprise Valuation: is 465 mn. Tortuga deals in nutritional supplements with a focus on pasture raised beef and dairy cattle. Deal Size: $ 15.7 Mn. Mylner develops manufactures and markets flavour solutions, focusing mainly on sweet flavours for beverages and baked goods, natural plant extracts and natural flavours products. Deal size: $ 1160 Mn Privately-held food company headquartered in So Bernardo do Campo, Brazil.
Feb 2012
Probitica Laboratrios (Brazil)
Valeant Pharmaceuticals
August 2012
Tortuga Companhia Zootcnica Agrria
Royal DSM
February 2012
Mylner Indstria E Comrcio Ltda
Frutarom Industries Ltd
August 2012
Yoki
General Mills
Nutraconsensus
20
Nutraceutical trends in Russia
Country specific developments and challenges
Russias evolution in the nutraceutical space has been marred by the presence of an equal number of unregulated 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 Europe 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 topmost local Russian brands and the operating Companies are set out in exhibit in the following page:
Nutraconsensus
21
RUSSIA
Key local Russian Players and their Brands Name Brand Differentiator Market leader Cultivation of medicinal herbs and their processing extracts to packaging of finished products 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 technology, innovative substances for the prevention and treatment of socially significant diseases. Also manufactures healthcare equipment, healthcare cosmetics, pharmaceuticals, and has its own retail chain. Develops, produces and promotes vitamin and vitamin-mineral complexes supplied to several Russian companies for fortification Kardiosredstva, tools for vision correction, Energotropic drugs.
Evalar
CardioActiv, Ginkgo Biloba, Everyday Calm, Stress free, Slim by nature, Bromelain
Diod
Capilar, Viardo, Iod-Active, Phase 2, arthroActive, optometrist , Orvirem, Hypoxen Pharmaceuticals, Mir ekologii' - Retail Chain
Akvion
ABC (Vitamins) Vetoron (beta-carotene) Qudesan (co-enzyme)
Nutraconsensus
22
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, President, 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 reconcile 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.
Nutraconsensus
23
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 Zydus Wellness and Zydus Nutriva are the key drivers of the consumer, wellness and nutraceuticals division of this pharma major. Market strategy includes Third Generation Nutraceuticals Segment presence Protein formulae for all ages, diabetics and pregnancy and lactation, haematinics, tonics, calcium supplements, osteoporosis, osteoarthritis, menopause, male subfertility, obesity, specialized pregnancy care range, animal health products Cosmeceuticals. Key brands GRD (protein supplement), Fol-5 (folic acid), Globac Activ (iron), C-yum (calcium), Sugar Free Dlite (health drink), Nutralite (cholesterol free spread), Actilife (nutritional milk additive), Globac-Z. Key differentiators - Formed an Indian advisory board for rational use of nutraceuticals - Dedicated nutraceutical range with emphasis on women health, infant and child nutrition. PLETHICO/ (including subsidiary NATROL) Dominant player in the herbal and nutraceutical segment with a focus on Sports Nutrition and Womens Health. The Company aims to bridge the gap demand supply gap in the country to reduce dependencies on high cost and duty laden imports. Alliance History Acquired Natrol in 2007 a leading manufacturer and marketer of branded nutritional products in the United States. Several acquisitions in the CIS regions to obtain retail reach. Key brands Sports Nutrition - Natrol, MRI, Laci Le Beau, NuHair, ShenMin, Promensil, and Prolab Herbal - Mountain Herbz (herbal medicines and supplements), Travisil (herbal cough syrup & lozenges). Marketing Strategy India - Prescription by Doctors, Nutritionists and availability of products on the retail shelf supplemented through brand awareness campaigns. Natrol - distributes products in the US through more than 54,000 retailers.
PIRAMAL HEALTHCARE Established the consumer product division in 2007, Piramal Healthcares OTC range includes product categories like Vitamins & Nutrition, Analgesics, Dermatological, Antacids and Cough & Cold. Segment presence It entered nutraceuticals market in 2009 with Supractiv 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, Triactiv, 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.
Nutraconsensus
24
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 A Mumbai based pharmaceutical manufacturing & marketing organisation, Elder entered the nutraceuticals segment in 2010 with launch of 'Coenzyme Q10' which helps to build immunity against cardiovascular diseases, neuro-generative diseases. SEGMENT PRESENCE Presence across 5 therapeutic segments women healthcare, anti-infective, wound & pain management, nutraceuticals, and life care products. KEY BRANDS Shelcal, Eldervit Range, Elmecob, I-Vit, Phytomega, Carnisure, Somazina (in-licensed brand), Amifru group, Nephrocaps and I-Vit group. Launched 3 nutraceutical products during 2011-12 - I-Vit, I-Vit Plus and D-360. KEY DIFFERENTIATORS Prescription based marketing Wide range of nutraceutical products with focus on women healthcare R&D division develops novel drug delivery system (NDDS) for a nutraceutical formulation called Coenzyme Q (10) CO Q10, first of its kinds globally.
UNIVERSAL MEDICARE (SANOFI) Sanofi, a global healthcare company operates in 7 core areas which are diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. ALLIANCE HISTORY Aventis Pharma (part of the Sanofi Group) acquired Universal Medicare business of marketing and distribution of branded nutraceutical formulations in India in November 2011. KEY BRANDS The portfolio of nutraceuticals and lifestyle management products includes brands like Sea Cod, Primosa, Multivite and Freeflex MARKETING STRATEGY Part of Sanofis Global marketing network and OTC and prescription based sales.
NANDAN Established in December 1999, NBL is a sustainable energy provider and herbal nutraceutical company headquartered in Hyderabad and listed overseas. KEY BRANDS NBL offers herbal and by- herbal products with focus on therapeutic value. Key products include Safed Musli Standardised Root Extract, Bio-Rhythm Capsules, Sorgasm Capsules, AloeActiv Beverage.
TABLETS INDIA LIMITED A part of Jhaver group, TILs therapeutic range includes nutritional supplements, haematinics, hepatoprotectives, novel antipyretic, Osteoporotic Formula, Respiratory Medicine. KEY BRANDS Bifilac, Hapenz, BioRS, Ecoflora, Astymin, Astyvit, Astyfer, Aminocal, Tilvit, Antoxyl Forte, Cefobeta, Ambrolite, Peglec, Glutazene, Neutrosec, Apetamin.
HEXAGON NUTRITION Hexagon Nutrition entered the nutrition industry in 1991. The broad segments are Food Fortification, clinical nutrition and Animal Nutrition. KEY BRANDS Clinical nutrition Penta sure range, Meta Gluta Zs (Immunity), Obesi Go BLCD (Weight management), Geria Gold, Proactiv (Wellness nutrition).
NATURAL REMEDIES It manufactures and supplies standardized herbal extracts, phytochemicals and herbal veterinary healthcare products. Broad segments are Human Healthcare, Animal Health care and Phytocompounds. KEY BRANDS Human Healthcare-Allerease, Bacomind, Kalmcold, Gutgard, Ocibest.
Nutraconsensus
25
DABUR Dabur is an Ayurvedic and Natural Health Care Company. It entered the nutrition supplements segment with the launch of Dabur NUTRiGO in 2010. Products categories include Hair Care, Oral Care, Health Care and Skin Care. KEY BRANDS Dabur Chyawanprash, Dabur Honey and Dabur Glucose.
ADVANCED ENZYMES Deals in the production of plant, microbial and animal-based enzymes. Product categories include Human Nutrition, Animal Nutrition, Food Processing, Bio Fuels, Bio Catalyst, Biologicals and Industrial Processing. KEY BRANDS Human Nutrition (Active ingredients) Nattokinase, fungal Lactase, Peptizyme SP, Fungal Lipase.
Women and child health continues to remain our primary focus area; we also believe that addressing the wellness needs of the countrys 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, minera ls 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 vegetarians, Mind health, Hearty health, Beauty from within, Weight nutrition, Sports nutrition, Joint health, Immunity, Essential 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 enthusiasts 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 Europes leading sports nutrition brand, Maxinutrition. GSK portfolio i ncludes 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.
Nutraconsensus
26
AMWAY A global direct selling company, Amway markets product primarily dealing in the health, beauty, and home care segments. SEGMENT PRESENCE Presence in more than 80 countries including Americas, Europe, greater China, Japan and Korea, and SE Asia/Australia. KEY BRANDS Nutrilite, Artistry, XS Energy KEY DIFFERENTIATORS Amways business model is based on multilevel/networking marketing and distributes products globally through more than 200,000 distributors Also, Nutralitie is the only global vitamin and mineral brand to grow, harvest, and process plants on its own certified organic farms.
HERBALIFE Herbalife International is a direct selling company which deals in nutrition and weight management. It has over 2 million independent distributors. SEGMENT PRESENCE Herbalife operates in more than 80 countries. Product segment includes Targeted nutrition, personalised weight management, Essential nutrition, Energy and Fitness, Skin care and Fragrances. KEY BRANDS Formula 1, Active Fiber l and Herbalife24, Shape Works. MARKETING STRATEGY Partnered with the Global Alliance for Improved Nutrition (GAIN) and DSM, nutrient suppliers, to 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 Universal MedicareNutraceutical Business Innoves Animal Health Pvt. Octtantis Nobel Labs Pvt. 30 plus brand from Ajanta Pharma Johnson & Johnson , Raricap Full Fit 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 billion). Under the agreement, Universal Medicare will manufacture the products that Sanofi/ Aventis will be acquiring on mutually agreed terms. Innoves Animal Health Pvt. is engaged in the marketing of large animal health products. Octtantis Nobel Labs Pvt. is engaged in trading, manufacturing and marketing of pharmaceuticals and nutraceuticals formulations. Ajanta Pharma is a Mumbai based company. 30 plus is an energiser brand. Raricap is the trademark for manufacturing tablets for iron deficiency anaemia used in pregnancy of Johnson & Johnson Full Fit is an anti-obesity brand. The brand Full Fit is a formulation contains the herbal ingredients which have no side effects. The company offers various products in the fields of womens healthcare, wound care and pain management, nutraceuticals, cardiovascular, central nervous system, neuro drugs, and anti-infective.
August 2011
Sanofi India
October 2012 September 2011 May 2011 April 2011 September 2010
Hester Biosciences Vivimed Labs Dabur India Bafna Pharmaceuticals Socrus Bio Sciences Ltd
NA
Elder Pharmaceuticals
Private Placement
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, India 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 options 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 soft capsules, levofloxacin lactate tablets, vitamin A tablets etc. Raising capital on the Securities Exchange. Deal Size: $ 62.15 Mn Develops, manufactures and sells nutritional products for the entire family, with an emphasis on infant nutrition. Deal Size: $ 5.71 Mn Seller of healthcare equipment, chemicals, and cosmetics. Producer of health supplements, biological diagnostic reagent and bioengineering fields. Deal Size: $43.79 Mn Vitamin Series, Antibiotics, Anti-AIDS, Digestives, Narcotic medicines, Cardiovascular and Cerebrovascular medicines. Vitamin E oil manufacturer. For Vitamin B3 Niacin.
June 2011
Zhejiang Medicine
Private Placement
June 2010
Baby Care
USANA Health Sciences Inc. Xiangxue Pharmaceutical Shenzhen Kangzhe Pharmaceutical
March 2011
Guangdong Jiuji Biotech Guangming Pharmaceutical
May 2011
June 2012
Northeast Pharmaceutical Group Co.
Liaoning Fangda Group Industrial
June 2011 2011-12
Jiangsu Spring Fruit Biological Products Lonza
Yihai Kerry Investments Facility Set Up
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 verify by having substantiate claims and also validate claims based on traditional sues and consumer experiences. 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 clinics 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. Directives 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 assessments 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 Standards 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 nutrienthealth claims are generic for any product, meeting the stipulated requirements.
Nutraconsensus
34
Regulatory Framework in developed countries USA, European Union, and Japan
Regulatory/NonRegulatory USA Regulatory body Food & Drug Administration
Regulatory Acts Food & Drug Administration (FDA), Dietary Supplement Health and Education Act (DSHEA), Federal Food Drug and Cosmetic Act (FDCA), CODEX (Codex Alimentarius Commission).
Defined Nutraceutical Segments Functional Foods and Dietary Supplements.
Role of Regulatory Body Provide pre-approval to health claims; Defines dietary supplements; Regulates all foods and food additives; Regulates good manufacturing practices for supplements; Develops standards and guidelines for foods for special dietary uses.
Labelling & Marketing Regulations The food labelling regulations are complex and constantly developing. Monitors safety measures in case of any adverse reporting related to foods and product information such as labelling, health or functional claims, and package inserts.
Europe
Regulatory body European Food Safety Authority
General Food Law Regulation, EC 178/2002, European Food Safety Authority (EFSA), Directive 2002/46/EC (food supplements), Directive 2004/27/EC (medicinal products), Directive 2001/83/EC, Novel Food Regulation EC 258/97, The Traditional Herbal Medicinal Products Directive 2004/24/EC.
Dietetic foods, food supplements, novel foods, herbal medicines, etc.
Approves the health claims. Assess the laws of EU countries relating to supplements. Allows the registration of products as medicines by developers providing good quality herbal products. Classifies novel foods. Defines the claims made for products based on which a product can be defined as medicinal. Establishes a science-based approach for theories relating to functional foods.
Mutual legislation regarding labelling is missing among EU countries. EFSA ensures that products sold are safe and prevents the miscommunication of information to consumers.
Nutraconsensus
35
Regulatory/NonRegulatory Japan Regulatory (FOSHU) as well as non-regulatory (non-FOSHU)
Regulatory Acts Foods for Specific Health Use (FOSHU), Japan Health Food Association (JHFA) purposeful government involvement that regulates the field, but does not overly restrict it.
Defined Nutraceutical Segments Functional foods
Role of Regulatory Body Focuses on health claims for specific products. Approves health claims. FOSHU approval process of 1 year to be followed by manufacturing companies for their products and a further short period required for review by the local authorities and the Ministry of Health and Welfare (MHW).
Labelling & Marketing Regulations Japan has a welldefined product category and labelling system which helps in controlling the marketing of non-approved products. Functional foods in Japan are a highly profitable business and generate further big profits as the FOSHU label allows for higher pricing of products.
Canada
Regulatory body Health Canada
Natural Health Product Regulations, Food and Drug Act, Canadian Food Inspection Agency
Functional foods, Probiotics, natural health products (NHPs)
Define requirements for quality, efficiency and safety of products. Manage health food claims for functional foods. Defines natural health products. Approve specific claims post reviewing the products in detail (processing method and nutrition content, etc.)
Define the requirements for labelling, packaging, clinical trials, Gmp, site inspection, and also reporting of adverse events.
Nutraconsensus
36
Regulations in the BRIC regions
The demographic, economic, and cultural changes that have driven the development of functional food markets in developed countries are also fuelling the growth in the BRIC regions. While the domestic market environment and demand factors in the opportunities available for companies in developing countries, export markets may offer profitable opportunities to overcome their limited domestic demand of functional foods. Commercial export opportunities exist in value-added raw materials, functional ingredients, and even in consumer products for the functional food sector in the more mature markets. The following section examines the functional foods sector in three of the emerging economies in the BRIC regions Brazil, Russia, China and followed by developments in India.
Factors fuelling the growth of the Nutraceutical Industry
Consumer Awareness Changing lifestyles Increase in disposable income Retail growth Ageing population Certain degree of dissatisfaction of modern medicine
Nutraconsensus
37
Regulatory Framework in developing countries Brazil, Russia, and China
Regulatory/NonRegulatory Brazil Health claims reference to the cure or prevention of disease are not allowed
Regulatory Acts National Health Surveillance Agency (ANVISA), State Food and Drug Administration (SFDA)
Defined Nutraceutical Segments Functional Foods
Role of Regulatory Body Coordinates, supervises, and controls activities regarding registration, information, inspection, risk control, and rulemaking to assure health surveillance 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
Labelling & Marketing Regulations
Russia
Non regulatory
Russian Ministry of Health
Dietary supplements
The process for registering dietary supplements takes around 6 months and once all the requirements are fulfilled, there is a short period required for issuing and registering the certificates.
Significant limitations have been imposed on the nutraceutical market with regard to advertising, promotion and distribution, especially in official sales 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 multivitamins, 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. Nutraceuticals 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 Commissionerate 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 Licensing 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
Meets eligibility?
Check criteria for Central license or State license
Fill application Form B for license Submit documents Licensing authority may seek additional information Issue of Unique Application number
YES
NO
Fill application Form A for registration Submit documents Attach self-declaration form
Inspection required?
Grant registration/ license within the stipulated time
FBO can now commence business
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 Adulteration (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 (TFSMTA) 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 rejected 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 supplement regulations show a global trend toward more regulation and India, although a late entrant, 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
The National Health Agenda, though currently viewed from the lens of public health only, needs to be viewed through experienced industry players and institutional agencies as well. A key learning from the Copenhagen Consensus 2012 for our policy makers is to ensure that Bundled Micro-Nutrient Intervention should form a core area of fund allocation in our Budget. Independent pilot plans for meeting the nutrition needs of the country need to be supplemented with large scale alliances of public and private partners to increase access to the missing nutrients necessary for the growth of health of people, communities and economies. These alliances can then be supported by public and private sector donors and participation from domestic and international players (who may have experience of implementing these in other developing economies). Some examples for the kind of alliances which can be layered under one another to address a collective agenda of malnutrition include: National multi-stakeholder PPP model Sectoral partnerships Private sector led initiatives (by experienced global players)
Building institutional capacity with industry representation
technical assistance on potential technologies evaluation of scientific benefits and evaluation of claims best practices in quality standards including learning from products which are already approved in other regulated markets manpower support with experienced specialists for speedy transition and redressal of issues and avoidance of delays change enablement support for smaller and newer entrants in the market
Continued research and innovation
There has been a continued scientific evaluation in the areas of biodiversity and the beneficial health effects on functional food and nutritional uses in the markets. Scientific evidence for safety and functional effectiveness of these compounds is essential in order to realise their potential in the production of high market valued products. New value-added components could also come from local food crops, medicinal plants or non-food sources.
Economics of Nutrition
The improved and stringent regulatory environment should be augmented with institutional capacity and include member representatives such as producers, processors as well as the government regulatory bodies, as necessary for addressing matters around:
Providing information and support for strategic decision-making: To a supplier of raw material ingredients, the target markets for food supplements, traditional medicine and functional food all appear to be interlinked. In order to strengthen the functional food programs, it becomes imperative to identify the potential sectors 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 studying each market segment in depth. Each member of the supply chain must be given an opportunity to make rational and informed choices. This can happen only if the market and regulatory information is made available to them.
Strengthening mass communication for specific health nutrition factors
norms for packaging and labeling urgent attention of the government or the regulatory body in this direction which covers all aspects of Advertising, Packaging and Labeling and evaluate all products before they enter the market (and not in the form of post facto approvals/ withdrawals, as is currently the case).
Child and womens 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 renewals 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 Nutrition and the FSSAI have issued guidelines and
Nutraconsensus
44
References
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34.
Regulations and standards
Micronutrients, Macro Impact:- The story of vitamins and a hungry world (www.sightandLife.com) Nutrition Business Journal, S&P International Journal of Pharmacy and Pharmaceutical Sciences - DIETARY SUPPLEMENTS: A LEGAL STATUS IN INDIA & IN FOREIGN COUNTRIES Health Enhancing Foods Country Case Studies of China and India The World Bank Expert Panel Findings, Copenhagen Consensus 2012 Next-Generation Nutraceuticals, Business Insights Nutraceuticals as therapeutic agents: A Review, Research J. Pharm. and Tech An Overview Of Nutraceuticals Current Scenario, Journal of Basic and Clinical Pharmacy Advanced analysis of nutraceuticals , Journal of Pharmaceutical and Biomedical Analysis Hunger And Malnutrition, Challenge paper, Copenhagen Consensus 2012 Regulatory environment for nutraceuticals and functional foods, National Research Council of Canada Nutraceuticals: What Are They And Do They Work? Kentucky Equine Research, Inc.,Versailles, KY East Meets West: Bridging the Cultures with Innovative Food Solutions - Dr. Sharon Shoemaker + Dr. Karen Lapsley, Moderators Nobel Laureates: More Should Be Spent On Hunger, Health Classification, Regulatory Acts And Applications Of Nutraceuticals For Health and Dietary Supplements: A Legal Status In India & In Foreign Countries, International Journal of Pharmacy and Biological Sciences Regulatory Perspective of Nutraceuticals in India, Interlinker Health Enhancing Foods Opportunities for Strengthening the Sector in Developing Countries, The World Bank Multiple articles and references from www.nutraworld.com Multiple articles and references from www.sightandlife.org Food and Nutraceutical Regulations - Global Snapshot, www.fnbnews.com Food-and-Nutraceutical-Regulations, foodsafetyauthorityindia.blogspot.in NRC Publications Archive Archives des publications du CNRC http://www.fda.gov/ http://www.fda.gov/food/dietarysupplements/default.htm, http://ods.od.nih.gov/About/DSHEA_Wording.aspx FTC - http://www.ftc.gov/ FDCA http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/default.ht m CODEX - http://www.codexalimentarius.org/ Health Canada - http://www.hc-sc.gc.ca/index-eng.php FSSAI - http://www.fssai.gov.in/ ANVISA - http://www.anvisa.gov.br/eng/index.htm SFDA - http://eng.sfda.gov.cn/WS03/CL0755/ EFSA - http://www.efsa.europa.eu/ EU Directives: http://ec.europa.eu/eu_law/introduction/what_directive_en.htm FSA - http://www.food.gov.uk/
Nutraconsensus
45
35. 36. 37. 38. 39. 40. 41. 42. 43. 44. 45. 46. 47. 48. 49.
FOSHU - http://www.foshu.com/ FNFC - http://www.mhlw.go.jp/english/topics/foodsafety/fhc/01.html FHC - http://www.mhlw.go.jp/english/topics/foodsafety/fhc/index.html Russian Ministry of Health - http://government.ru/eng/power/23/ http://pharmabiz.com/NewsDetails.aspx?aid=70232&sid=1 www.slideshare.net/Overview of FSS Act Rules Regulation2012 Capital IQ VCC Edge: http://www.vccedge.com/index_new.php Nutritional Capital: http://www.nutritioncapital.com/ http://www.business-standard.com/india/news/sanofi-arm-to-buy-universal-medicare%5Csnutraceuticals-biz/446976/ http://www.business-standard.com/india/news/hester-biosciences-acquires-innoves-animalhealth/489900/ http://www.vivimedlabs.com/news/2011/vivimed-labs-acquires-octtantis-nobel-pvt-ltd/ http://www.business-standard.com/india/news/dabur-buys-ajanta-pharma-capsule-brand-focusotchealthcare/434431/ http://www.indiainfoline.com/Markets/News/Bafna-Pharma-to-acquire-Johnson-and-Johnsonreport/5111036623 http://profit.ndtv.com/news/market/article-socrus-bio-sciences-ltd-socrus-bio-acquires-anti-obesitybrand-34-full-fit-34-19513 http://www.worldbank.org/ http://www.who.int/en/ http://www.wfp.org/nutrition
Deal References
Emerging Trends
50. 51. 52.
Nutraconsensus
46
Appendix
Regulation
The National Health Surveillance Agency (ANVISA) 1999 Vitamin/Mineral supplements
Ministry of Health and Social Development
The Food Safety and Standards Authority of India (FSSAI) 2006 Foods for Special Dietary Use/Medical use
State Food and Drug Administration (SFDA)
Effective from Definition
1997 Biologically Active Food Supplements-
2003 Special Dietary Food/Functional Food
Supplements fall within the food category when their levels do not exceed the Recommended Daily Allowance (RDA) if exceeded; these are then treated as medicines. Supplements are referred to as Vitamin and /or mineral supplements. Other ingredients, such probiotics or herbs, are not allowed in supplements and might be regulated under specific standards in the food and/or medicine category.
According to the Ministry of Health, BAS (nutraceuticals and parapharmaceuticals), are concentrates intended for internal consumption or inclusion in products to enrich the diet with biologically active substances or their complexes. According to the above definition, the following products can be identified as biologically active supplements: Polysaturated acids Mineral substances, micro and macro elements. Some aminoacids Some mono and disaccharides Food fibres Microorganisms present in human body Vitamins, whose daily dose does not exceed the one needed for the human body.
Foods for special dietary use are specially processed or formulated to satisfy particular dietary requirements that exist because of a particular physical or physiological condition and/or specific disease and disorder. The composition of these foods must differ significantly from the composition of ordinary foods of comparable nature, if such food exists. Health Supplements include Vitamins, minerals, proteins, fatty acids, amino acids, plants or botanicals, other dietary substances, substances from animal origin with known or established physiological effect, intended to supplement normal diet and usually marketed in unit dose or other dosage forms such as capsules, tablets, powders, solutions. Products with reduced calorie content as a formula for losing 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
Health Foods require pre market registration and approval by SDFA. Special Dietary food: food which is used to fulfil the specific dietary requirements of consumers. Special dietary food cannot make functional claims with regards to the product itself, but claims can be made with regards to the ingredients of the product itself, but claims can be made with regards to the ingredients of the product
Nutraconsensus
47
Emergence of Nutraceuticals and their Health Benefits
Lipids (except fatty acids)

Nutraceutical Plant sterols (Phytosterols) Glycerolipids Phytosterols, -oryzanol and steryl ferulates octacosanol, and squalene. Sterols Glycerolipids Sterols Phytosterols and phytostanols Phytosterols Squalene Terpenes and terpenoids Terpenoids Milk lipids (triglycerides, diacylglycerides, saturated fatty acids and PUFAs). Gangliosides Matrix Vegetable oils (olive, sunflower, rice bran, seeds) Seed oils Rice Mediterranean mussel and Rapana venosa (hard-shellclam) Microalga Italian walnut Milk and yoghurt Tetraploid and hexaploid wheats Vegetable oil Essential oils Quinoa flour (pseudo-cereal) Milk Dairy products (milk) Possible Health Benefit Phytosterols decrease cholesterol associated with LDL, have anti-cancer activity and modulate the immune function and inflammation. Skin care and source of fatty acids Antioxidant, decrease cholesterol absorption, protect against atherosclerosis, nerve imbalance and disorders of menopause Skin-care Antimicrobial and anti- inflammatory activities Decrease cholesterol and reduce the risk of coronary heart disease Decrease cholesterol levels Decrease cholesterol levels Decrease cholesterol and anti-cancer activity Antiseptic, carminative, antimicrobial, and antioxidative effects. Antibacterial and antineoplastic properties. Immuno-suppressive, anti-inflammatory, andantimicrobial properties. Protect against enteric pathogens, and prebiotic functions.
Carotenoid nutraceuticals
Nutraceutical -carotene, -cryptoxanthin, mutatoxanthin, antheraxanthin, luteoxanthin, epoxycarotenoids esters. . . -carotene, lycopene -carotene, lutein, lycopene -carotene Astaxanthin, -carotene, lutein, cantaxanthin, violaxanthin, neoxanthin Lycopene Matrix Mandarin, Orange juices Possible Health Benefit Antioxidant, inmunomodulation and cancer prevention
Thai fruits Chestnut Tea seed oils Alga
Antioxidant, anti-cancer, prevent degenerative diseases Antioxidant, inmunomodulation and cancer prevention Antioxidant effects Antioxidant, inmunomodulation and cancer prevention. Antioxidant, anti-cancer
Tomato products, nutritional supplements
Nutraconsensus
48
Vitamins
Nutraceutical Tocopherols (Vitamin E) Matrix Vegetable and vegetable oils Possible Health Benefit Antioxidant, antitumor, hypocholesterolemic potential and for the treatment of cardiovascular disease and angiogenic disorders Antioxidant and prevents degenerative disorders Antioxidant Antioxidant and co-enzymes
Tocopherols (Vitamin E) Vitamin B1 and B2 Water-soluble vitamins (B1, B2, two B3 vitamers, B5, five B6 vitamers, B8, B9, B12 and C). Vitamins B2, B3 and B6 Vitamin C (L-ascorbic acid) L-ascorbic acid dehydroascorbic acid) S-methyl-L-methionine (vitamin U) Fat and water soluble vitamins
Microalga Mushrooms Maize flour, green and golden kiwi and tomato pulp.
Energy drinks Fruits Buckwheats Centella asiatica Beer and bioactive drinks
Antioxidant and co-enzymes Antioxidant Antioxidant Wound healing Antioxidant and co-enzymes
Proteins, peptides and aminoacids

Nutraceutical Milk proteins, peptides Lactoferrin and immunoglobulin G. Amino acids Matrix Milk and derived products Possible Health Benefit Antihypertensive, antimicrobial, anti-inflammatory and inmunostimulating activities. Important source of amino acids Effect on the nervous system, antioxidant, anti-cancer and source of muscle energy Antihypertensive, antioxidant and anticoagulant activities Can suppress Rheumatoid arthritis (RA) and promote healthy joints. Antioxidant properties Immunomodulation activity Prevention and treatment of hypertension, diabetes, hepatitis, cancers and AIDS Antimicrobial activity Estrogen like activity in vivo May reduce calorie absorbance, thereby promoting weight loss. Antioxidant, anti-cancer, anti-heart disease
Sprouts, alga and sport drinks and tablets Fishes Chick Curry leaves Garlic (Allium sativum) Ganoderma lucidum (fungi)
Peptide Type II collagen 35 kDa antioxidant protein Immunomodulatoryproteins Total proteins
Lysozyme-derivedpeptides Cyclopeptides Phaseolamin Selenopeptides
Hens egg Cow cockle seed Kidney bean (Phaseolus vulg.) Nuts
Nutraconsensus
49
Glycosides
Nutraceutical Saponins Matrix Vegetables Raw materials, formulations and dietary supplements. Poria cocos (fungus) Black currant pomace Dairy-based prebiotic Ingredient. Nutraceutical preparations and Tablets Plants Possible Health Benefit Stimulate muscle growth and raise Testosterone levels. Antidiabetic or anti-obese effects, antibacterial and antineoplastic properties Treatment of osteoarthritis and some ophthalmologic diseases. Anti-inflammatory effects Antioxidant properties Increased absorption of calcium and magnesium, and improved elimination of toxic compounds Treatment of osteoarthritis Choleretic, anti-inflammatory, anti-cancer, antioxidant, anorexant and diuretic properties
Chondroitin sulfate Polysaccharide (1,3--galactan) Saccharides Galactooligosaccharides Glucosamine Glycosides (glucosinolates, glycyrrhetic acid, glycyrrzhin, liquiritin, steroidal glycosides)
Phenolic compounds
Nutraceutical Phenolic acids Phenolics Anthocyanins Anthocyanins Phenolics Catecholamines Rutin Flavone isomers Phenolics Phenolic acids Flavonol Phenolics Phenolics Curcuminoids Lignans Phenolic acids, proanthocyanidins, and lignans Flavonoids Demethyloleuropein Alkil phenols Flavonoids Phenolic acids, isoflavones Phenolics Phenolic acids Catechins and condensed tannins Phenolic acids Phenolics Matrix Seed-oil Fruits, Mushrooms, legumes Fruits, Nutraceutical Capsules Fruits, tubers Marula (Sclerocarrya birrea) Banana peel Buckwheats lemon juice Potatoe Cooked meat Bean Moscatel sweet wines Carex distachya roots Curcuma longa Flaxseed Triticale Possible Health Benefit Antioxidant Antioxidant Antioxidant Antioxidant Antioxidants and Antiatherogenic Antioxidant Antioxidant Antioxidant Antioxidant Antioxidant Antioxidant Antioxidant Antioxidant Antioxidant Antioxidant Antioxidant
Ulmus davidiana Olive fruit Anacardum Hypericum perforatum Black Soybeans Pepper Malt Green Tea Mangosteen Bergenia ciliate
Antioxidant Antioxidant Antioxidant Antioxidant Antioxidant Antioxidant Antioxidant Antioxidant Antioxidant Antioxidant
Nutraconsensus
50
Nutraceutical Phenolics Phenolics Flavonoids and phenolic acids Resveratrol Phenolics Lignans Prunate Polymethoxilated Flavones Carnosic Licochalcone A Phlorotannins Phytoestrogens Flavonol glycosides Isoflavones Isoflavones Phenolics Flavonoids Resveratrol Oligomers and Flavonoids Phenolic acids O-glucoside phenolic compounds Isoflavones Isoflavones Isoflavones
Matrix Vanilla planifolia Grape Chinese herbal tea Nutraceutical capsules Grape skin Myristica fragrans (nutmeg) Prunus Orange Oil Rosemary Glycyrrhiza uralensis Alga (Ishige okamurae) Dietary supplements Ginkgo biloba Soy milk Soy supplements Tamarix gallica Citrus peel Carex folliculata Seeds Infant cereals Olive by-products Soybean seeds Red clover Nutritional supplements
Possible Health Benefit Antioxidant Antioxidant Antioxidant Prevention of atherosclerosis Antioxidant Anticariogenic Anticarcinogenic Antioxidant Antioxidant Lipase inhibition Cholinesterase inhibition Estrogenic activity Memory enhancing Estrogenic activity Antimenopausial sympthoms Antioxidant and antimicrobial Antiinflammatory, anticarcinogenic and antiatherogenic Antioxidant, cytotoxicity and antibacterial Antioxidant & aroma Antioxidant, maturity indicators Antimenopausial sympthoms Antifungal activity Estrogenic activity
Other potential nutraceuticals

Nutraceutical Sulforaphane Phenylpropanoid amide Phaeophytines Monacolins Capsaicinoids Matrix Crucifer vegetables (Brassica species) Transgenic tomato Amaranthus tricolor (Amaranthaceae) Rice Peppers Possible Health Benefit Anticarcinogenic properties Antioxidant and chemotherapeutic effects Antioxidant, cancer prevention Cholesterol lowering and anticancer agent Antioxidants, anti-mutagenic, anti-inflammatory and anti-tumoral properties Anticarcinogenic properties
Acids (bitter acids, asiatic acid and asiaticoside)
Plants (Centella asiatica, hop)
Nutraconsensus
51
Nutraconsensus
52
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, Nutraceuticals, 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.
Nutraconsensus
53
About Grant Thornton
About Grant Thornton International Ltd
About Grant Thornton India LLP
Grant Thornton International is one of the world's leading organisations of independently owned and managed accounting and consulting firms. These firms provide assurance, tax and specialist advisory services to privately held businesses and public interest entities. Clients of member and correspondent firms can access the knowledge and experience of more than 2500 partners in over 96 countries and consistently receive a distinctive, high quality and personalised service wherever they choose to do business. Grant Thornton International strives to speak out issues that matter to business and which are in the wider public interest and to be a bold and positive leader in its chosen markets and within the global accounting profession.
Grant Thornton India LLP is a member firm within Grant Thornton International Ltd, one of the six largest global accountancy organisations, and the global leader in serving the needs of dynamic privately held businesses. From its origins in 1935, the firm has today grown to be one of the largest accounting and advisory firms in India with over 1,100 professional staff based out of 10 locations in the country. The firms mission is to be the advisers of choice to dynamic Indian businesses who have global ambitions- raise global capital, expand into global markets or adopt global standards. The firm specialises in providing compliance and advisory services to growth oriented, entrepreneurial companies and adopts best in class international tools, methodologies and risk management standards for all its services.
Our offices in India

NEW DELHI National Office Outer Circle L 41 Connaught Circus New Delhi 110 001 T +91 11 4278 7070 CHENNAI Arihant Nitco Park, 6th floor No.90, Dr. Radhakrishnan Salai Mylapore Chennai 600 004 T +91 44 4294 0000 BENGALURU Wings, 1st floor 16/1 Cambridge Road Ulsoor Bengaluru 560 008 T +91 80 4243 0700 CHANDIGARH SCO 17 2nd floor Sector 17 E Chandigarh 160 017 T +91 172 4338 000 HYDERABAD 7th floor, Block III White House Kundan Bagh, Begumpet Hyderabad 500 016 T +91 40 6630 8200
GURGAON 21st floor, DLF Square Jacaranda Marg DLF Phase II Gurgaon 122 002 T +91 124 462 8000 MUMBAI 16th floor, Tower II Indiabulls Finance Centre SB Marg, Elphinstone (W) Mumbai 400 013 T +91 22 6626 2600
KOLKATA 10C Hungerford Street 5th floor Kolkata 700 017 T +91 33 4050 8000
PUNE 401 Century Arcade Narangi Baug Road Off Boat Club Road Pune 411 001 T +91 20 4105 7000
Grant Thornton India LLP is registered with limited liability with identity number AAA-7677 and its registered office at L-41 Connaught Circus, New Delhi, 110001.
Nutraconsensus
54
Nutraconsensus
55
Contact details
For FICCIMs Piya Singh Director Federation of Indian Chambers Of Commerce & Industry 33-B, Krishnamai, Sir Pochkhanwala Road, Worli, Mumbai 400 030 (T) - 022 2496 8000 (F) - 022 2496 6631 / 32 (E) piya.singh@ficci.com
For Grant Thornton India LLP Mahadevan Narayanamoni Partner and Leader, Healthcare and Life-sciences Advisory, Grant Thornton India LLP 7th Floor, Block III, White House, Hyderabad 500016 (T) - 040 6630 8200 (E)- Mahad.N@in.gt.com We would be delighted to receive your feedback. Kindly mail us at- contact @in.gt.com Editorial team - Vrinda Mathur Sanjana Shankar Tavishi Bhargava Design and Production - Sushant Hivale

GT FICCI Nutraconsensus Whitepaper

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

GT FICCI Nutraconsensus Whitepaper

Uploaded by

Copyright:

Available Formats

Nutraconsensus

Emerging insights on Nutraceuticals - players and policy makers

FICCI-HADSA Nutraceuticals 2012 Regulation, Categorisation and Commercialisation

Grant Thornton India LLP. All rights reserved.

Foreword: Grant Thornton

Grant Thornton India LLP. All rights reserved.

Grant Thornton India LLP. All rights reserved.

Grant Thornton India LLP. All rights reserved.

Celebrating a hundred years of Vitamins - 2012

1910 Umetaro Suzuki discovers product, later identified as Vit B1

Grant Thornton India LLP. All rights reserved.

Grant Thornton India LLP. All rights reserved.

Multiple micronutrient intervention studies

approach could act as an effective means for large scale intervention.

Grant Thornton India LLP. All rights reserved.

Grant Thornton India LLP. All rights reserved.

Nutrition Support Groups

Grant Thornton India LLP. All rights reserved.

Learning from a nourished counterpart

Grant Thornton India LLP. All rights reserved.

Illustrative list of players in the US region

US Company Name Nutraceutical Companies

Nutrition Deal History (2011/2012)

Operating dynamics and differentiators

Pfizer Nutrition S-26 Gold, SMA and Promil

Pfizer Nutrition sold to Nestle for $11.85bn (2012)

Pfizer Nutrition acquisition to complement existing Infant Nutrition Portfolio.

Glucerna Pediasure Ensure Muscle Health Immune Balance NutriPals

No history of recent acquisitions

Grant Thornton India LLP. All rights reserved.

US Company Name Ingredient Supplier

Nutrition Deal History (2011/2012)

Operating dynamics and differentiators

DSM Nutritional Products

Formula 1, Active Fiber l, Herbalife24, Prolessa Duo, HerbalifeKids

No history of recent acquisitions

Grant Thornton India LLP. All rights reserved.

Quick Brick fact-files

Grant Thornton India LLP. All rights reserved.

372010 18capita 2008 GNI per (current US$) $4940 2011

Grant Thornton India LLP. All rights reserved.

Building Nutra BRIC by BRIC

Grant Thornton India LLP. All rights reserved.

Nutraceutical trends in Brazil

Country specific developments and challenges

Grant Thornton India LLP. All rights reserved.

Probitica Laboratrios (Brazil)

Tortuga Companhia Zootcnica Agrria

Mylner Indstria E Comrcio Ltda

Frutarom Industries Ltd

Grant Thornton India LLP. All rights reserved.

Nutraceutical trends in Russia

Country specific developments and challenges

Grant Thornton India LLP. All rights reserved.

ABC (Vitamins) Vetoron (beta-carotene) Qudesan (co-enzyme)

Grant Thornton India LLP. All rights reserved.

Nutraceutical trends in India

Country specifications and challenges

Grant Thornton India LLP. All rights reserved.

Grant Thornton India LLP. All rights reserved.

Grant Thornton India LLP. All rights reserved.

Grant Thornton India LLP. All rights reserved.

Deals, alliances and expansion strategies

Grant Thornton India LLP. All rights reserved.