Functional food and their claims.

1. FUNCTIONAL FOODS -HEALTH
CLAIMS, REGULATIONS AND
INTERNATIONAL COMPARISON
SUVAJIT MAJUMDAR

2. INTRODUCTION
• Functional foods are defined as “any food and food
ingredients that may provide health benefit beyond
the traditional nutrition that it contains”.
• Japan was the first country to recognize functional
foods as a separate category when in 1991 it
introduced the FOSHU (Foods for Specific Health
Use) system to evaluate health claims.
• FSSAI issues Gazette notification for regulations on
Nutraceuticals, Functional Foods, Novel Foods and
others on 23 December 2016.

3. FUNCTIONAL FOOD
• Natural valuable substances with altered properties
of individual components.
• Foods which is enriched with functional ingredients,
• Foods with modified bioavailability of one or more
components.
• Foods provide health benefit beyond the traditional
nutrition that it contains.

4. CLAIMS-
FUNCTIONAL
FOODS
Nutrition content claims and health
claims are voluntary statements made by
food businesses on labels and in
advertising about a food.

5. Examples

6. Effects of claims on consumers
SHARES
BENEFICIAL
INFORMATIO-
-NS TO THE
BUYERS.
WRONG
INFO’S CAN
LEAD
TOWARD’S
A MAJOR
SERIOUS
CAUSE.

7. • Consumers thus, must rely on their governments to
make sure that they are not misled.
• Unfortunately, current government regulations leave
room for misleading claims.
• Deception is promoted by the fact that legislation of
health claims for foods is layered: there are soft
claims, which require soft evidence, and hard claims,
which require harder evidence.

8. International comparison
On health claims

9. Regulations
functional foods
• Japan was the first country to recognize functional
foods as a separate category when in 1991 it
introduced the FOSHU (Foods for Specific Health
Use) system to evaluate health claims.
• This system has valuable aspects: it regulates both
safety and health, and it demands that the food be
analyzed for the amount of effective component.
• Later on different other country’s government
adopted FOSHU with some modification and releases
their own regulations.

10. SCOPE OF FOSHU
• The health claims of FOSHU must not include
medical claims such as claims to “prevent” ,”cure”,
”diagnose”, “treat” human disease.
• FOSHU health claims are evaluated product by
product by the expert committee in the government
based on the scientific substantiation.

11. 1. Maintain or improve a marker determine by self-
diagonisis or health checkup. ex-”the product helps
to maintain normal blood pressure, blood sugar or
cholesterol”.
2. Maintains or improve physiological functions of
the human body.
3. Cause short term changes in body, but no long
term changes. Ex-”This product is good for or helps
people who feels fatigue”.
Types of permitted claims -
FOSHU

12. • In 2005 three new types of FOSHU categories
Qualified FOSHU : The product which have less
sufficient evidence but this product may be suitable
for a specific health issue.
• Standardized FOSHU: The product, whose health
claims is already established is granted on the basis
of compliances with separately prescribed standards.
• Reduction of disease risk FOSHU: The product with
the effective substance evaluated by the MHLW can
label the health claims related to risk reduction of a
disease.
Types of FOSHU

13. • The existing FOSHU heath claims can be classified it to
the following nine groups-
1. Gastrointestinal (GI) conditions:- this helps to maintain
a good GI conditions, the effective components are
several oligosaccharides and dietary fibers.
2. Blood pressure: this help for the person with slightly
elevated blood pressure, the effective compound are
peptides, glycoside and soy protein.
3. Serum cholesterol : this products helps people decrease
serum cholesterol, the effective compounds are soy
protein, chitosan and phytosterol.
Health claims in FOSHU

14. 4. Blood glucose : this is helpful for those who are
concerned about their blood glucose level.
5. Mineral absorption: this product has high bio
availability for humans and is suitable for
supplementing calcium and iron.
6. Blood lipid: this helps to reduce postprandial serum
triglyceride levels.
7. Tooth health : this product is a low or non carcinogenic
product which is beneficial for teeth's health.
8. Bone health: this could promote calcification
9. Body fat : this product makes it inhibit the increment of
the levels of body fat.

15. Food with Nutrient function claims
• The MHLW( ministry of health and labor welfare)
enacted in a regulatory system for standardized
nutrient function claims “Foods with Nutrient
function claims” and “Foods with health claims”
which consist of FOSHU and FNFC( standard
regulations systems for nutrients) in 2001.

16. The nutrient function claims are of 12 vitamins
and 5 minerals were standardized as follows
Nutrient functions
Vit A It is a nutrient that helps to maintain vision in the dark and maintain skin and
mucosa health.
Vit D Is a nutrient that promotes absorption of calcium in the gut intestine and aids
in the development of bones.
Vit E Is a nutrient that helps to protect fat in the body from being oxidized and to
maintain the cell healthy.
Vit B1 Is a nutrient that helps to produce energy from carbohydrate and to maintain
skin and mucosa health.
Vit B2 Helps to maintain skin and mucosa healthy.
Vit B6 Helps to produce energy from protein and to maintain healthy skin and
mucosa.
Niacin Helps to maintain skin and mucosa healthy.
Biotin Helps to maintain skin and mucosa healthy.
Pantothenic
acid
Helps to maintain skin and mucosa healthy.

17. Nutrient Functions
Folic acid Aids in the red blood cell formation and contributes to the normal growth of
the fetus.
Vit B12 Aids in the red blood cell formation.
Vit C Helps to maintain skin and mucosa healthy and has an antioxidizing effect
Calcium Is a nutrient necessary in the development of bone and teeth.
Iron Is necessary in the red blood cell formation
Zinc Necessary to maintain normal gustation, helps to maintain ski and mucosa
healthy ,participated in the metabolism of protein and nucleic acid, and helps
to maintain good health.
Copper Aids in the red blood cell formation and helps the normal activity of many
kinds of enzymes and bone development.
Magnesium It is necessary for the development of bone and teeth, helps the normal
activity of many kinds of enzymes and energy production, and is necessary to
maintain normal blood circulation
The nutrient function claims are of 12 vitamins
and 5 minerals were standardized as follows

18. • Effectiveness on the human body is clearly proven.
• Absence of any safety issues (animal toxicity tests,
confirmation of effects in the cases of excess intake, etc.)
• Use of nutritionally appropriate ingredients (e.g. no
excessive use of salt, etc.)
• Guarantee of compatibility with product specifications by
the time of consumption.
• Established quality control methods, such as specifications
of products and ingredients, processes, and methods of
analysis.
Requirements for FOSHU
Approval

19. • The NLEA(national labelling and education act) was
established in 1990.
• The act claims describes relationship between a food
or its substances and a disease or health related
condition.
• The claim consist same concept to the reduction of
risk of disease has been developed by the Codex
Alimentarius by the US Food and Drug Administration
that reviewed the scientific literature.
THE UNITED STATES

20. CONTD..
• The structure and function claims was defined by DSHEA
(dietary supplement health and education act ) 1994.
• Statement that describe the role of a nutrient or a dietary
ingredient intended to affect the bodily structure or
function in human .
• Under DSHEA, dietary supplement manufacturers can sell
their product with their structure/function claims by the
notification of the claim they make to the FDA.
• The manufacturers are responsible for ensuring the
accuracy and truthfulness of these claims.

21. THE EUROPEAN UNION
• The European Union enforced regulations on nutrition and health claims on food in 2007.
• Which consist of function claims , disease reduction claims and claims referring children’s
development and health.
Claims Purpose
The function
claims defined
under the article
13.
13(1)
13(2)
The role of a nutrient or other substance in growth, development, and the
functions of the body or psychological and behavioral functions; slimming
and weight control or reduction.
The health claims mentioned above shall be based on generally accepted
scientific evidence which is called “general function claim”.
The additional claims shall be based on newly developed scientific evidence
which is called “new function claim”.
Article 14
Disease reduction
claims
Claims referring children’s development and health.

22. Cont…
• The European Food Safety Authority (EFSA) makes a
scientific judgment on the extent to which a cause-
and-effect relationship is established between the
consumption of the food or the constituent and the
claimed effect.
• Animal or in vitro studies may provide supportive
evidence, human data are central for substantiation.
• The European Commission published a list of 222
permitted generic claims that were based on
scientific evaluation by the EFSA in December 2012.

23. People’s republic of china
• The ministry of health established the regulation
for the control of health food in 1996.
• Food products that claims health functions shall be
reviewed and approved by the Ministry of Health.
• Human intervention studies are important basic
data in this evaluation system.
• The Human intervention for already approved
health claims are performed by the government
research organization.

24. • The Food Standard Australia New Zealand (FSANZ) was
established to protect the health and safety of the
people in Australia and New Zealand by maintaining a
safe food supply.
• A new standard to regulate the health claims on foods
labels and in advertisement became in lam on January
18,2013.
• Two types of health claims are:
1. General level health claims – refer to a nutrient or
substance in a food and its effect on a health function.
2. High levels health claims – refer to a nutrient or
substance in a food and its relationship to a serious
disease or a bio marker of a serious disease.
Australia & New Zealand

25. Cont…
• Food businesses wanting to make a general level
health claim will be able to base their claims on one
of the more than 200 preapproved food-health
relationship in the standards in accordance with the
detailed requirements set out in the standards.
• High-level health claims must be based on a food-
health relationship preapproved by FSANZ.
• There are currently 13 approved food health
relationship for high-level health claims listed in the
standards.

26. INDIAN SCENARIO
• India has passed the Food Safety and Standard Act
2006, a modern integrated food law to serve
regulation of food products including nutraceutical,
dietary supplements and functional food.
• FSSAI issues Gazette notification for regulations on
Nutraceuticals, Functional Foods, Novel Foods and
others on 23 December 2016.
• FSSAI has stipulated that Food Business Operators
will need to comply with these regulations from 1
January 2018.

27. The new regulations : FSSAI
• The regulations cover eight categories of foods and
carry detailed requirements about their composition,
claims, labels etc. These foods are-Health
Supplements ,Nutraceuticals , Foods for Special
Dietary Use ,Food for Special Medical Purpose
Specialty Food containing plants or botanicals ,Foods
containing Probiotics ,Foods containing Prebiotics,
Novel Foods.

28. Regulations:FSSAI
• In case of food products falling under health supplement categories, the
individual nutrient content shall not be less than fifteen per cent of the
RDA where a nutrient content claim is being made.
• if claim of higher nutrient content is made, the nutrient content shall not
be less than thirty per cent of the RDA.
• The formulation of articles of food shall be based on the principles of
sound medicine or nutrition and supported by validated scientific data,
wherever required.
• The label on articles of food shall specify the purpose, the target
consumer group and the physiological or disease conditions which they
address, recommended duration of use, and the specific labelling
requirements as mentioned against each type of article of food.

29. Claims: FSSAI
• Every food business operator may make nutritional or health claims in respect
of an article of food.
• For health or nutritional claim and nutritional claims of ingredients as
specified in Schedule I Schedule II, Schedule III, Schedule IV, and Schedule VI
.
1. a nutritional claim shall consist of the ‘Ingredients (nutrient or nutritional)
content’.
2. Health related benefits.
• The health claim in respect of an article of food consists of the following I
• ingredients or nutrient or nutritional function
• enhanced function
• disease risk reduction
• health maintenance claims
• immunity or increased resistance
• anti-ageing

30. • All health claims must be validated through adequate
documentation and on the basis of human studies. If
other claims are made they will require the approval
of the Food Authority.
• The FSSAI has also prohibited the use of implied
claims for curing diseases or efficacy claims like cure
for cancer or prevention of diseases either by name
or through pictures, vignettes or symbols, namely,
electrocardiogram tracing, and lipid profile.
Claims which are
prohibited

31. • The FSSAI has also made provision for suspension or
restriction of sale of such articles of food as have
been placed in the market that -
• are not clearly distinguishable from articles of food
for normal consumption
• are not suitable for their claimed nutritional
purpose may endanger human health.
Restriction on sale or suspension

32. Conclusion
• There is no doubt that functional foods generate one
of the most promising and dynamically developing
segments of food industry.
• For FOSHU approval not only the experimental data
but also scientific evidence including published
scientific literature must be reviewed.
• The Codex Commission have harmonized the
regulations as international standards.
• The labelling of health related foods should be based
on scientific evidence which is desired to aiming the
international standards.

33. REFRENCES
• Nutraceutical and Functional Food Regulations in India Raj K. Keservani, Anil K.
Sharma, F. Ahmad† and Mirza E. Baig School of Pharmaceutical Sciences, Rajiv
Gandhi Proudyogiki Vishwavidyalaya, Bhopal, India †F-34, Okhla, New Delhi, India
Pfizer Ltd. Haryana, India.
• Clinical aspect of Functional foods and nutraceuticals, edited by Dilip Ghosh,
Debasis bagchi, Tetsuya Konishi.
• Health claims for functional foods
• Regulations vary between countries and often permit vague claimsMartijn B
Katan, professor-link- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC318474/
• https://www.sgs.com/en/news/2016/12/safeguards-19616-fssai-issues-rules-for-
functional-foods-and-health-supplements

34. Thank you…