All about the marketing and regulatory issues of functional food

1. MARKETING AND REGULATORY ISSUES FOR
FUNCTIONAL FOOD AND NUTRACEUTICAL
PRESENTED BY
SAKSHI THAKUR
ROLL NO. 1732065
M.Sc. FOOD SCIENCE AND
TECHNOLOGY
PRESENTED TO
Dr. BARINDERJIT SINGH
I.K. GUJARAL PUNJAB
TECHNICAL UNIVERSITY

2. INTRODUCTION
• Nutraceutical which is the combination of words “ Nutrition”
and “Pharmaceutical” is a food product that reportedly
provides health and medical benefits, including the
prevention and treatment of disease.
• A nutraceutical is demonstrated to have a physiological
benefit or provide protection against chronic disease.
• Functional food is a food where a new ingredients ( or more
of an existing ingredient) has been added to a food and the
new product has an additional function (often one related to
health promotion or disease prevention) such as sports
drinks, vitamin-enriched products.

3. FUNCTIONAL FOOD COMPONENTS
COMPONENTS SOURCE POTENTIAL BENEFITS
CAROTENOIDS CARROTS, FRUITS, VEGETABLES NEUTRALIZE FREE
RADICAL, WHICH MAY
CAUSE DAMAGE TO CELLS
LUTEIN GREEN VEGETABLES REDUCE THE RISK OF
MACULAR DEGENERATION
LYCOPENE TOMATO PRODUCTS REDUCE THE RISK OF
PROSTATE CANCER
DIETERY FIBERS WHEAT BRAN REDUCE THE RISK OF
BREAST OR COLON CANCER
ẞ-GLUCAN OATS BARLEY REDUCE THE RISK OF
CARDIOVASCULAR
DISEASES
CONJUGATED
LINOLEIC ACID
CHEESE AND MEAT PRODUCT IMPROVE BODY
COMPOSITION
TANNINS CHOCOLATE, COCOA REDUCE RISK OF HEART
DISEASE

4. NUTRACEUTICAL AND FUNCTIONAL
FOOD REGULATION IN INDIA
• India has recently passed the Food Safety and Standard Act 2006,
a modern integrated food law to serve as a single reference point
in relation to regulation of food products including nutraceutical ,
dietary supplements and functional food.
• A significant augmentation is necessary for the act to havea large
impact on the Indian Functional Food and Nutraceutical Industry
like the Dietery Supplements Health Education Act (DSHEA) 1994
has had on the dietary supplement industry in the united state.
• The passing of this act in India is a significant first step, but much
more has to happen to eliminate the confusing overlap with old
laws and regulations.
• Yet, in India Functional Foods/Nutraceutical are not categorised
seperately as in the United State, Europe, and Japan

5. HISTORY OF FOOD REGULATION IN INDIA
• India is the world’s second largest producer of fruits and
vegetables, but only a small amount of perishable agriculture
products are processed at approximately 2% in comparison to 80%
in the United States.
• By the mid-1990s the food processing sector laws were framed in
a veritable grid of regulation including a multitude of state laws
as well as the following national laws:
• Export (Quality Control and Inspection) Act 1963
• Solvent Extracted Oil Control Order 1967
• The Insecticide Act 1968
• Meat Food Products Order 1973
• Prevention Food Adulteration Act (PFA) 1954 with last
amendments in 1986
• Milk and Milk Product Order 1992

6. • The Infant Milk Substitutes Feeding Bottles and Infant Food
Act 1992 and Rules 1993
• Food Product Order 1995
• Industrial License
• Vegetable oil Production Control Order 1998

7. FOOD SAFETY AND STANDARD ACT 2006
• The food safety and standard Act 2006 aims to establish a
single reference point for all matters relating to Food Safety
and Standard, by moving from multilevel, multidepartment
control to a single line of command.
• It incorporates the salient provision of the provision of
prevention of Food Adulteration Act 1954 and is based on
international legislation , Instrumentalities and the Codex
Alimentarius Commission. The salient feature of this Act are
as follows:
• The Food Safety and Standard Act 2006 consolidates the
eight laws governing the food sector and establish the Food
Safety and Standard Authority to regulate the sector and
other allied committees. FSSA will be aided by several
scientific panels and a central advisory commitee to lay
down standards for food safety.

8. • These standards will include specification for ingredients,
contaminants, pesticide residue, biological hazards, label
and others.
• Everyone in the food sector is required to get a license or a
registration that would be issued by local authorities.
• The law will be enforced through state ommisioners of food
safety and local level officials.
• The responsibility of framing and regulating standard for
nutraceutical rests with Food Safety and Standard Authority
of India ( FSSAI) as outlined in the Food Safety Act 2006. This
authority will be in charge of categories like functional
foods, nutraceutical, dietetic products and other similar
products.

10. BENEFITS OF IMPLEMENTATION OF ACTS
• Unification of eight laws i.e. Steps to harmonization
• Alignment of international regulations
• Science – based standards
• Clarity and uniformity or novel food areas
• Help to curb corruptions

11. PROBLEMS WITH IMPLEMENTATION OF
THE ACT
• Regulation broadly defines the intervention of government
in industry.
• Regulation primarily controls the product quality in case of
food.
• Every system of regulation has its own pros and cons.
• But the benefits from the implementation of the Food Safety
and Standard Act overwhelmed the problems that rise due
to implementation of this act.
• Unlike in the United States, where the DSHEA is in place to
regulate manufacturing, importing and marketing of health
foods, dietery supplements and other nutraceutical.

12. REGULATION OF CLAIMS PERTAINING TO
NUTRACEUTICALS
The following claims are permitted in Asian countries:
• Nutrient Content Claim: which state the level of certain
nutrient on the product label
• Nutrient Comparative Claims: which state the nutrient
content or energy value relative to other similar foods.
• Disease Risk Reduction Claims: established by international
standards setting body the Codex Alimentarius are generally
not permitted in Asia. However, these claims are used in
Northen Asian countries that have established regulations
for functional food. However, a health class regulatory
environment is evolving and significant changes in the next 5
years are expected.

13. LICENSING AND REGISTRATION
REQUIREMENT
• Every food business operator in the country will have to obtain
registration and license in accordance with the procedure laid
down in FSSAI regulations 2011.
• A manufacture can not commence business unless he is registered
or has a valid license.
• Pretty food manufacturers have to register with the commissioner
and manufacturers whose turnover is greater than 12 lacks to
obtain a food licence from FSSAI office.
• Existing license/registration should be converted into FSSAI
license/registration before August 5, 2012.
• An application for the grant of a license shall made in form B of
schedule 2 to the concerned licensing authority; the license shall
be issued within the 60 days from the date of issue of an
application ID number.

14. • 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 105 years.

15. LICENSES
Although the new FSSA promises to simplify licensing and
registration processes for nutraceutical, the actual process
varies depending upon the number of licenses will be
required depending on the actual product statussuch as:
• The company wants to sell bulk drug or finished
formulation
• The company has packaging license
• It requires a manufacturing license
• It requires a marketing license
• Import license
• Other state and national level clearance/licenses required
from the regulatory side.

17. HEALTH AND LABEL CLAIMS
• Developing health and label claims specific to Indian
regulatory guidelines is the major element to be focused on
while entering Indian Market.
• International as well as national clients have a number of
question about Indian Labelling and Packaging requirement,
Packing of consignment , need for sample material and
declaration for registration , composition of consignmnent
and approach for the same, label content, and structure –
function claims and label claim.

18. POSITIONING BENEFITS
• There are five primary benefit platforms for positioning
health and nutrition products. Virtually any functional
product can be positioned against any one or a
combination of these benefits:
• PREVENTION: Foods that provide health management
through disease and symptom prevention fall into this
category.
• PERFORMANCE: A product that provides health
enhancement through improved physical and mental
conditions.
• WELLNESS: Wellness benefits are about feeling good
and finding balance. This is a holistic approach to health
care that includes the body, mind, and spirit.

19. • NURTURING: Foods that can supply a sense of caring for
the health and quality of life for others and the
associated sense of satisfaction for the caregiver.
Marketing a product from this platform would include a
focus on growth and development, aging, and healing.
• COSMETICS: Cosmetic benefits are about looking good
and enhancing self- esteemthrough improved physical
condition and personal appearance.

21. INDIAN MARKET AND HEALTH
• The global nutraceutical market in 2008 was estimated to be $117
billion, of which India’s share was only 0.9%.
• The global market is estimated to reach $117 billion by next year,
growing at a healthy Compound Annual Growth Rate (CAGR) of
7%.
• With inreasing penetration of preventive health care products in
the Indian Market, growing health awareness, higher disposable
income and other factors, the Indian Nutraceutical Industry has
shown a promising CAGR of 18% in the last three years.
• According to one report, the total Indian nutraceutical market in
2015 is expected to be approximately $5 billion.
• Fast moving consumer goods companies and pharmaceutical
companies are major player in the Indian nutraceutical market

22. RECOMMENDATION AND CONCLUSION
Although the Food Safety and Standard Act 2006 defines
functional food/nutraceutical legally, there are still further
effective regulations ; guidelines and suitable protocols are
required to gain momentum for effective implementation
across the nation.
There should be an expansion of India Standards like Indian
Pharmacopeia so that manufacture of functional food/
nutraceutical complies with their safety and quality
standards.
To conclude the passing of Food Safety and Standard Act 2006
was a significant first step but a lot more has to happen to
eliminate the overlap of old laws and regulations. Prior to
FSSA, there were multiple laws and regulations governing
Food Safety and Standards. Nutraceutical were grouped
under PFA.

23. REFERENCES
• Nutraceutical/Functional food and health claims on foods:
Policy Paper [Health Canada,1998]
• Wildman REC, editor, Handbook of Nutraceutical and
Functional Foods, 1st Edition, CRC Series in Modern Nutrition,
2001
• Kalra EK., Nutraceutical: definition & introduction , AAPS
Pharmasci 2003; 5 (2)
• Hardy G., Nutraceutical and Functional Food : introduction
and meaning, Nutrition 2000
• BrowerV., Nutraceuticals: poised for healthy slices of
healthcare market, Nat biotechnol 1998