Nutraconsensus - Grant Thornton Thinking

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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
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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.
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Contents
Page
Foreword – FICCI
3
Foreword – Grant Thornton
4
A framework of definition
5
A framework of operation
10
A framework of regulation
31
Recommendations
42
Member firm of Grant Thornton International Ltd
Offices in Bengaluru, Chandigarh, Chennai, Gurgaon, Hyderabad, Kolkata, Mumbai, New Delhi and Pune
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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.
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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
5
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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
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Celebrating a hundred years of Vitamins - 2012
1980’s – 1990’s
Emerging physician acceptance
Awareness through numerous journals
and articles on benefits
1910
Umetaro
Suzuki discovers product, later
identified as
Vit B1
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
1900
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.
1950
2000
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
body’s 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.
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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
Foods providing nutrients that
are not consumed in sufficient
quantity in a person's diet
 Nutrition Fortified Foods
•
Liquids quenching thirst as
well as replenishing minerals, provide energy, prevent
ailments, and promote
healthy lifestyle
Vitamin & mineral supplements
 Probiotic food like yogurt
 Protein powder
•
Amino acids
 Paediatric nutrition
•
Antioxidants
•
Herbal and non-herbal extracts
•
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)
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Emerging trends
Multiple micronutrient intervention
studies
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.
approach could act as an effective means for large
scale intervention.
Food, Water and Sanitation – underpinning
the success of 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.
Partnering in Nutrition
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
•
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.
Nutraconsensus
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
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Global landscape
Distribution
Network
Nutra
Companies
Material
Supplies
Customer
Nutrition
Support
Groups
Regulator
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.
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
The Regulator
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.
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Learning from a nourished counterpart
USA
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
Key players
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!
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Illustrative list of players in the US region
US Company
Name
Key brands
Nutrition Deal History
Operating dynamics and differen-
(2011/2012)
tiators
Nutraceutical
Companies
Pfizer Nutrition sold to
Nestle for $11.85bn (2012)
Pfizer Nutrition
S-26 Gold, SMA and Promil
Acquires Emergen C (Supplement)
Pfizer Consumer
Healthcare
Nestle
Abbott
Acquires Ferrosan’s Consumer Healthcare Business
Infant Nutrition - Nan, Gerber, Lactogen, Nestogen and Cerelac infant
cereal
Glucerna
Pediasure
Ensure Muscle Health
Immune Balance
NutriPals
Nestlé Health Science to
acquire a stake in Accera
Nestle acquisition of PowerBar ($130 million sales)
Long term supply agreement with Martek for infant
nutrition (Martek acquired
by DSM)
More than 80% of Pfizer Nutrition
sales were in emerging markets.
Focus – “Infant Nutrition “
Dietary Supplements is the key
focus area within Nutraceuticals.
Pfizer Nutrition acquisition to complement existing Infant Nutrition
Portfolio.
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 (Plethico)
Natrol, Laci Le Beau, Trinovin,
Prolab, Vedic Mantra, NuHair,
Shen Min, Promensil
EID Parry Ltd acquired
stake US Nutraceuticals
(Valensa) (2008)
No history of recent acquisitions
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).
Nutraconsensus
US Company
Name
14
Key brands
Nutrition Deal History
(2011/2012)
Quali blends, Carotenoids
(Carocare, Actilease), Life’sDHA,
Resvida, GeniVida, fabuless, Peptopro,
Acquires Cargill’s Cultures
and Enzymes Business for
Euro 85bn (2012)
Acquires Martek, Microbia
and Vitatene (2010-11)
Alliances with Kemrock and
Sinochem in India (2011)
Operating dynamics and differentiators
Ingredient
Supplier
DSM Nutritional
Products
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
Amway
Nutrilite, XS Energy Drinks, personal care, home care, air and
water purifiers, Artistry cosmetics
Herbalife
Formula 1, Active Fiber l, Herbalife24, Prolessa™ Duo, HerbalifeKids
Plans to spend $185 million
on U.S. manufacturing expansion to meet growing
global demand Nutrilite
brands.
No history of recent acquisitions
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.
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.
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Quick Brick fact-files
Brazil
Russia
India
China
2011
$trillion
US GDP
2.48
1.85
1.86
7.31
GDP
growth
(Annual)
3%
4%
7%
9%
Area (Mn
Sq. Kms)
8.52
17.08
3.29
9.60
Population
(Mn)
197
142
1241
1344
Ages 0-14
(% of total)
25%
15%
30%
19%
Ages 15-64
(% of total
68%
72%
65%
73%
Ages 65 and
above (% of
total)
7%
13%
5%
8%
Population
growth
1%
0%
1%
0.5%
Life
expectancy
73 years
69 years
65 years
73 years
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Emerging trends
BRAZIL
RUSSIA
Prevalence of
overweight (%
above 15 years)
Underweight (under-five, 000)
49% 2010
2222008
GNI per capita
(current US$)
Infant Mortality
Rate (per 1000 live
births)
GNI per capita
(current US$)
6%2008
$10720 2011
12 2008
$10400 2011
Health expenditure
per capita (current
US$)
Maternal mortality
ratio (per 100,000
live births)
Health expenditure
per capita (current
US$)
Maternal mortality
ratio (per 100,000
live births)
Number of people
who are undernourished
11.7 million 2008
Prevalence of
overweight (above
15 years)
Prevalence of undernourishment
(%of population)
57%2010
$990 2010
56 2010
INDIA
Prevalence of under nourishment
(% of population)
Lifetime risk of
maternal death
$525 2010
CHINA
Number of people
who are undernourished
129 million 2008
Under-five mortality rate:
21 per 1,000 live
births 2008
Maternal Mortality
Ratio (per 100,000
live births)
19% 2008
1 in 702009
Under-five mortality rate:
69 per 1000 live
births 2009
GNI per capita
(current US$)
Malnutrition –
Height for age (below five years)
$1410 2011
9.4%2010
Health expenditure
per capita (current
US$)
Infant Mortality
Rate (per 1000 live
births)
$542010
522008
Health expenditure
per capita (current
US$)
342010
$2212010
372010
18capita
2008
GNI per
(current US$)
$4940 2011
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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 Low‐Cost Drugs for Acute Heart Attacks
lated)
(Health/ Disease related)
 Malaria Combination Treatment
 Salt Reduction Campaign (Health/ Dis(Health/ Disease related)
ease related)
 Childhood Immunisation Coverage
 Solar radiation management
(Health/ Disease related)
 Conditional Cash Transfers
 Deworming (Health/ Disease related)
 HIV Vaccine R&D (Health/ Disease re TB treatment (Health/ Disease related)
lated)
 R&D to Increase Yield Enhancement to
 Information Campaigns on Schooling
fight hunger
Benefits
 Effective Early Warning Systems
 Borehole and Public Hand Pump Inter Strengthening Surgical Capacity (Health/
vention
Disease related)
Nutraconsensus
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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
Feb 2012
Probiótica Laboratórios
(Brazil)
Valeant Pharmaceuticals
Deal Size: $86.3 Mn
Probiotica currently markets a full line of over-thecounter sports nutrition products and other food supplements.
August 2012
Tortuga Companhia Zootécnica Agrária
Royal DSM
Enterprise Valuation: is € 465 mn. Tortuga deals in
nutritional supplements with a focus on pasture raised
beef and dairy cattle.
February 2012
Mylner Indústria E Comércio
Ltda
Frutarom Industries Ltd
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.
August 2012
Yoki
General Mills
Deal size: $ 1160 Mn
Privately-held food company headquartered in São
Bernardo do Campo, Brazil.
Nutraconsensus
20
Nutraceutical trends in Russia
Country specific developments and challenges
Russia’s evolution in the nutraceutical space has been marred by the presence of an equal number of 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
Evalar
Diod
Akvion
Brand
CardioActiv, Ginkgo Biloba, Everyday
Calm, Stress free, Slim by nature, Bromelain
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.
Capilar, Viardo, Iod-Active, Phase 2, arthroActive, optometrist , Orvirem, Hypoxen –
Pharmaceuticals,
Mir ekologii' - Retail Chain
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.
ABC (Vitamins)
Vetoron (beta-carotene)
Qudesan (co-enzyme)
Develops, produces and promotes vitamin
and vitamin-mineral complexes – supplied
to several Russian companies for fortification
Kardiosredstva, tools for vision correction,
Energotropic drugs.
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:









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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.
PLETHICO/ (including subsidiary NATROL)
Dominant player in the herbal and nutraceutical segment with a focus on
Sports Nutrition and Women’s 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
GRD (protein supplement), Fol-5 (folic acid), Globac
Activ (iron), C-yum (calcium), Sugar Free D’lite (health
drink), Nutralite (cholesterol free spread), Actilife (nutritional milk additive), Globac-Z.
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).
Key differentiators
- Formed an Indian advisory board for rational use of
nutraceuticals
- Dedicated nutraceutical range with emphasis on
women health, infant and child nutrition.
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 Healthcare’s 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
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“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.
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.
SEGMENT PRESENCE
Presence across 5 therapeutic segments – women
healthcare, anti-infective, wound & pain management, nutraceuticals, and life care products.
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
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.
KEY BRANDS
The portfolio of nutraceuticals and lifestyle management products includes brands like Sea Cod®,
Primosa, Multivite and Freeflex
MARKETING STRATEGY
Part of Sanofi’s 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, TIL’s 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
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.
25
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 country’s growing geriatric population by ensuring a disease
free life presents an excellent opportunity of growth. Our SHELCAL brand for example targets
the nutrition needs (especially of calcium and vitamin D) of a broad based population segment –
from the paediatric to the geriatric population.”
- Himanshoo Nayak,
Head - Business Development, Elder Pharma
INTERNATIONAL PRESENCE
DSM Nutritional Products
DSM is a global supplier of nutritional and specialty ingredients to food, beverage and dietary supplement manufacturers. Providing ingredients and ‘Health benefit Solutions’ globally, DSM focuses on the production of vitamins, minerals
and micronutrients that enhance the health profile of products, as well as areas where end consumers are looking for
answers and support.
Health Benefit Solutions
Eye Health, Bone Health, Essentials for women, Essentials for men, Essentials for kids and teens, Essentials for 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 Europe’s leading sports nutrition brand, Maxinutrition. GSK portfolio includes a number of well-known brands such as Panadol, Sensodyne, Lucozade and Horlicks.
Revenue from Consumer Healthcare is Euro 5.2 billion in 2011 (19% of the group revenue).
Key Brands
Lucozade and Ribena – energy and sports drink, Horlicks, Boost and Maltova - malted, milk-based drinks and foods
and Viva, a vitamin supplement.
Nutraconsensus
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
Amway’s 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.
26
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
Investor
Transaction Details
August 2011
Universal MedicareNutraceutical Business
Sanofi India
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.
October 2012
Innoves Animal Health
Pvt.
Hester Biosciences
Innoves Animal Health Pvt. is engaged in the marketing of large animal
health products.
September 2011
Octtantis Nobel Labs
Pvt.
Vivimed Labs
Octtantis Nobel Labs Pvt. is engaged in trading, manufacturing and
marketing of pharmaceuticals and nutraceuticals formulations.
May 2011
30 plus brand from
Ajanta Pharma
Dabur India
Ajanta Pharma is a Mumbai based company. 30 plus is an energiser
brand.
April 2011
Johnson & Johnson ,
Raricap
Bafna Pharmaceuticals
Raricap is the trademark for manufacturing tablets for iron deficiency
anaemia used in pregnancy of Johnson & Johnson
September 2010
Full Fit
Socrus Bio Sciences Ltd
Full Fit is an anti-obesity brand. The brand Full Fit is a formulation contains the herbal ingredients which have no side effects.
Elder Pharmaceuticals
Private Placement
The company offers various products in the fields of women’s
healthcare, wound care and pain management, nutraceuticals, cardiovascular, central nervous system, neuro drugs, and anti-infective.
NA
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.
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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.
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CHINA
Key expansion activities (involving China) in 2011 and 2012
Month
Target Name
Transaction Details
June 2011
Zhejiang Medicine
Private Placement
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.
June 2010
Baby Care
USANA Health Sciences Inc.
Deal Size: $ 62.15 Mn
Develops, manufactures and sells nutritional products for
the entire family, with an emphasis on infant nutrition.
March 2011
Guangdong Jiuji
Biotech
Xiangxue Pharmaceutical
Deal Size: $ 5.71 Mn
Seller of healthcare equipment, chemicals, and
cosmetics.
May 2011
Guangming Pharmaceutical
Shenzhen Kangzhe
Pharmaceutical
Producer of health supplements, biological diagnostic
reagent and bioengineering fields.
June 2012
Northeast Pharmaceutical Group Co.
Liaoning Fangda
Group Industrial
Deal Size: $43.79 Mn
Vitamin Series, Antibiotics, Anti-AIDS, Digestives, Narcotic medicines, Cardiovascular and Cerebrovascular medicines.
June 2011
Jiangsu Spring Fruit
Biological Products
Yihai Kerry Investments
Vitamin E oil manufacturer.
2011-12
Lonza
Facility Set Up
For Vitamin B3 – Niacin.
Nutraconsensus
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
30
Nutraconsensus
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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.”
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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.
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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
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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.
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Regulatory Framework in developed countries –
USA, European Union, and Japan
Regulatory/NonRegulatory
Regulatory Acts
Defined
Nutraceutical
Segments
Role of Regulatory
Body
Labelling & Marketing Regulations
USA
Regulatory body –
Food & Drug Administration
Food & Drug Administration (FDA),
Dietary Supplement Health and
Education Act
(DSHEA), Federal
Food Drug and
Cosmetic Act
(FDCA), CODEX
(Codex Alimentarius Commission).
Functional Foods
and Dietary Supplements.
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.
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.
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Regulatory Acts
Defined
Nutraceutical
Segments
Role of Regulatory
Body
Japan
Regulatory
(FOSHU) as well
as non-regulatory
(non-FOSHU)
Foods for Specific
Health Use
(FOSHU), Japan
Health Food Association (JHFA) purposeful government involvement that regulates the field, but
does not overly
restrict it.
Functional foods
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).
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.
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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
Defined
Nutraceutical
Segments
Regulatory
Acts
Role of Regulatory
Body
Brazil
Health claims ‐
reference
to the cure or
prevention of
disease ‐ are not
allowed
National Health
Surveillance
Agency (ANVISA), State
Food and Drug
Administration
(SFDA)
Functional
Foods
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
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 multi‐vitamins, while its single minerals category displays rapid growth.
Among the developed country manufacturing packaging labelling and marketing of nutraceuticals and dietary
supplements are regulated by the well-furnished and managed government regulatory body. But in the developing country like India, regulations have been evolving over the last decade with a formalisation of the policy in
2011-12.
Nutraconsensus
38
Evolution of the Nutraceutical Regulation in India
The Food Safety and Standards Regulations, 2011. How is it different from the previous
(multiple) law/s?
Prior to the FSSA, there were multiple laws and regulations governing food safety and standards. 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
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
41
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
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:





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
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
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
Child and women’s health and sports nutrition appear to be the focus areas of almost all industry players in the developing regions. A national emphasis
on such matters, which is already present in case of
infant and women nutrition to an extent, needs to be
extended to emphasising on the importance of sports
activities in school curriculum as well as in the
younger and middle aged population.
Change enablement
The FSSAI regulations include the set-up of nodal
agencies for the immediate implementation of the
guidelines. Industry representatives feel that several
time limits are currently not being complied with for
existing product applications and there have been
significant delays resulting in financial losses for the
cautious players. Interim, temporary approvals need
to be allowed for players and products which have a
long history of having sold these products in the
domestic and international market.
A formulation or a facility based approval
Current approval processes designed for each and
every product (whether new or already being marketed) is a lengthy process and also holds validity only
for a defined time period. This may be streamlined
with practices in the pharma industry where both
product and facility approvals can co-exist and 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
43
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).
Nutraconsensus
44
References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
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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
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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
Regulations and standards –
23.
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25.
26.
27.
28.
29.
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31.
32.
33.
34.
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
35.
36.
37.
38.
39.
40.
45
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
Deal References
41.
42.
43.
44.
45.
46.
47.
48.
49.
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
Emerging Trends
50.
51.
52.
http://www.worldbank.org/
http://www.who.int/en/
http://www.wfp.org/nutrition
Nutraconsensus
46
Appendix
Regulation
The National Health
Surveillance Agency
(ANVISA)
Ministry of Health and
Social Development
The Food Safety and
Standards Authority of
India (FSSAI)
State Food and Drug
Administration (SFDA)
Effective
from
1999
1997
2006
2003
Definition
Vitamin/Mineral
supplements
Biologically Active
Food Supplements-
Foods for Special Dietary Use/Medical use
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
Matrix
Possible Health Benefit
Plant sterols (Phytosterols)
Vegetable oils (olive,
sunflower, rice bran, seeds)
Phytosterols decrease cholesterol associated with
LDL, have anti-cancer activity and modulate the
immune function and inflammation.
Glycerolipids
Seed oils
Skin care and source of fatty acids
Phytosterols, γ-oryzanol and
steryl ferulates octacosanol,
and squalene.
Rice
Antioxidant, decrease cholesterol absorption, protect against atherosclerosis, nerve imbalance and
disorders of menopause
Sterols
Mediterranean mussel and
Rapana venosa
(hard-shellclam)
Skin-care
Glycerolipids
Microalga
Antimicrobial and anti- inflammatory activities
Sterols
Italian walnut
Decrease cholesterol and reduce the risk of coronary heart disease
Phytosterols and phytostanols
Milk and yoghurt
Decrease cholesterol levels
Phytosterols
Tetraploid and hexaploid
wheats
Decrease cholesterol levels
Squalene
Vegetable oil
Decrease cholesterol and anti-cancer activity
Terpenes and terpenoids
Essential oils
Antiseptic, carminative, antimicrobial, and antioxidative effects.
Terpenoids
Quinoa flour (pseudo-cereal)
Antibacterial and antineoplastic
properties.
Milk lipids (triglycerides,
diacylglycerides, saturated
fatty acids and PUFAs).
Milk
Immuno-suppressive, anti-inflammatory, andantimicrobial
properties.
Gangliosides
Dairy products (milk)
Protect against enteric pathogens, and prebiotic
functions.
Carotenoid nutraceuticals
Nutraceutical
Matrix
β-carotene, β-cryptoxanthin,
mutatoxanthin, antheraxanthin,
luteoxanthin, epoxycarotenoids
esters. . .
Mandarin, Orange juices
Antioxidant, inmunomodulation and cancer prevention
β-carotene, lycopene
Thai fruits
Antioxidant, anti-cancer, prevent degenerative diseases
β-carotene, lutein, lycopene
Chestnut
Antioxidant, inmunomodulation and cancer prevention
β-carotene
Tea seed oils
Antioxidant effects
Astaxanthin, β-carotene, lutein,
cantaxanthin, violaxanthin,
neoxanthin
Alga
Antioxidant, inmunomodulation and cancer prevention.
Lycopene
Tomato products, nutritional
supplements
Antioxidant, anti-cancer
Nutraconsensus
48
Vitamins
Nutraceutical
Matrix
Tocopherols (Vitamin E)
Vegetable and vegetable oils
Antioxidant, antitumor, hypocholesterolemic potential
and for the treatment of cardiovascular disease and
angiogenic disorders
Tocopherols (Vitamin E)
Microalga
Antioxidant and prevents degenerative disorders
Vitamin B1 and B2
Mushrooms
Antioxidant
Water-soluble vitamins (B1,
B2, two B3 vitamers, B5, five
B6 vitamers, B8, B9, B12 and
C).
Maize flour, green and golden
kiwi and tomato pulp.
Antioxidant and co-enzymes
Vitamins B2, B3 and B6
Energy drinks
Vitamin C (L-ascorbic acid)
Fruits
Antioxidant
L-ascorbic acid dehydroascorbic
acid)
Buckwheats
Antioxidant
S-methyl-L-methionine
(vitamin U)
Centella asiatica
Wound healing
Fat and water soluble vitamins
Beer and bioactive drinks
Proteins, peptides and aminoacids
Nutraceutical
Matrix
Milk proteins, peptides
Lactoferrin and
immunoglobulin G.
Milk and derived products
Antihypertensive, antimicrobial,
anti-inflammatory and
inmunostimulating activities.
Important source of amino acids
Amino acids
Sprouts, alga and sport drinks
and tablets
Effect on the nervous system,
antioxidant, anti-cancer and source of
muscle energy
Peptide
Fishes
Antihypertensive, antioxidant and
anticoagulant activities
Type II collagen
Chick
Can suppress Rheumatoid arthritis
(RA) and promote healthy joints.
∼35 kDa antioxidant protein
Curry leaves
Antioxidant properties
Immunomodulatoryproteins
Garlic (Allium sativum)
Immunomodulation activity
Total proteins
Ganoderma lucidum (fungi)
Prevention and treatment of
hypertension, diabetes, hepatitis,
cancers and AIDS
Lysozyme-derivedpeptides
Hen’s egg
Antimicrobial activity
Cyclopeptides
Cow cockle seed
Estrogen like activity in vivo
Phaseolamin
Kidney bean (Phaseolus vulg.)
May reduce calorie absorbance,
thereby promoting weight loss.
Selenopeptides
Nuts
Antioxidant, anti-cancer, anti-heart
disease
Nutraconsensus
49
Glycosides
Nutraceutical
Matrix
Saponins
Vegetables
Stimulate muscle growth and raise
Testosterone levels. Antidiabetic or
anti-obese effects, antibacterial and
antineoplastic properties
Chondroitin sulfate
Raw materials, formulations
and dietary supplements.
Treatment of osteoarthritis and some
ophthalmologic diseases.
Polysaccharide
(1,3-α-galactan)
Poria cocos (fungus)
Anti-inflammatory effects
Saccharides
Black currant pomace
Antioxidant properties
Galactooligosaccharides
Dairy-based prebiotic
Ingredient.
Increased absorption of calcium and
magnesium, and improved elimination
of toxic compounds
Glucosamine
Nutraceutical preparations and
Tablets
Treatment of osteoarthritis
Glycosides (glucosinolates,
glycyrrhetic acid, glycyrrzhin,
liquiritin, steroidal glycosides)
Plants
Choleretic, anti-inflammatory,
anti-cancer, antioxidant, anorexant
and diuretic properties
Phenolic compounds
Nutraceutical
Matrix
Phenolic acids
Seed-oil
Antioxidant
Phenolics
Fruits, Mushrooms,
legumes
Antioxidant
Anthocyanins
Fruits, Nutraceutical
Capsules
Antioxidant
Anthocyanins
Fruits, tubers
Antioxidant
Phenolics
Marula (Sclerocarrya birrea)
Antioxidants and
Antiatherogenic
Catecholamines
Banana peel
Antioxidant
Rutin
Buckwheats
Antioxidant
Flavone isomers
lemon juice
Antioxidant
Phenolics
Potatoe
Antioxidant
Phenolic acids
Cooked meat
Antioxidant
Flavonol
Bean
Antioxidant
Phenolics
Moscatel sweet wines
Antioxidant
Phenolics
Carex distachya roots
Antioxidant
Curcuminoids
Curcuma longa
Antioxidant
Lignans
Flaxseed
Antioxidant
Phenolic acids, proanthocyanidins, and
lignans
Triticale
Antioxidant
Flavonoids
Ulmus davidiana
Antioxidant
Demethyloleuropein
Olive fruit
Antioxidant
Alkil phenols
Anacardum
Antioxidant
Flavonoids
Hypericum perforatum
Antioxidant
Phenolic acids, isoflavones
Black Soybeans
Antioxidant
Phenolics
Pepper
Antioxidant
Phenolic acids
Malt
Antioxidant
Catechins and condensed
tannins
Green Tea
Antioxidant
Phenolic acids
Mangosteen
Antioxidant
Phenolics
Bergenia ciliate
Antioxidant
Nutraconsensus
50
Nutraceutical
Matrix
Phenolics
Vanilla planifolia
Antioxidant
Phenolics
Grape
Antioxidant
Flavonoids and phenolic acids
Chinese herbal tea
Antioxidant
Resveratrol
Nutraceutical capsules
Prevention of atherosclerosis
Phenolics
Grape skin
Antioxidant
Lignans
Myristica fragrans (nutmeg)
Anticariogenic
Prunate
Prunus
Anticarcinogenic
Polymethoxilated Flavones
Orange Oil
Antioxidant
Carnosic
Rosemary
Antioxidant
Licochalcone A
Glycyrrhiza uralensis
Lipase inhibition
Phlorotannins
Alga (Ishige okamurae)
Cholinesterase inhibition
Phytoestrogens
Dietary supplements
Estrogenic activity
Flavonol glycosides
Ginkgo biloba
Memory enhancing
Isoflavones
Soy milk
Estrogenic activity
Isoflavones
Soy supplements
Antimenopausial sympthoms
Phenolics
Tamarix gallica
Antioxidant and antimicrobial
Flavonoids
Citrus peel
Antiinflammatory, anticarcinogenic and antiatherogenic
Resveratrol Oligomers and
Flavonoids
Carex folliculata Seeds
Antioxidant, cytotoxicity and antibacterial
Phenolic acids
Infant cereals
Antioxidant & aroma
O-glucoside phenolic
compounds
Olive by-products
Antioxidant, maturity indicators
Isoflavones
Soybean seeds
Antimenopausial sympthoms
Isoflavones
Red clover
Antifungal activity
Isoflavones
Nutritional supplements
Estrogenic activity
Other potential nutraceuticals
Nutraceutical
Matrix
Sulforaphane
Crucifer vegetables
(Brassica species)
Anticarcinogenic properties
Phenylpropanoid amide
Transgenic tomato
Antioxidant and chemotherapeutic
effects
Phaeophytines
Amaranthus tricolor
(Amaranthaceae)
Antioxidant, cancer prevention
Monacolins
Rice
Cholesterol lowering and anticancer
agent
Capsaicinoids
Peppers
Antioxidants, anti-mutagenic,
anti-inflammatory and anti-tumoral
properties
Acids (bitter acids, asiatic
acid and asiaticoside)
Plants (Centella asiatica,
hop)
Anticarcinogenic properties
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.
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.
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.
The firm’s 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
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
CHENNAI
Arihant Nitco Park, 6th floor
No.90, Dr. Radhakrishnan Salai
Mylapore
Chennai 600 004
T +91 44 4294 0000
GURGAON
21st floor, DLF Square
Jacaranda Marg
DLF Phase II
Gurgaon 122 002
T +91 124 462 8000
HYDERABAD
7th floor, Block III
White House
Kundan Bagh, Begumpet
Hyderabad 500 016
T +91 40 6630 8200
KOLKATA
10C Hungerford Street
5th floor
Kolkata 700 017
T +91 33 4050 8000
MUMBAI
16th floor, Tower II
Indiabulls Finance Centre
SB Marg, Elphinstone (W)
Mumbai 400 013
T +91 22 6626 2600
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

Nutraconsensus - Grant Thornton Thinking

Transcription

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