Nutrition and Health Claim

Labeling and Guidelines

A Perspective

Sunil Adsule,
Director-Scientific & Regulatory Affairs
Coca-Cola India
26 July 2012 1
What to expect

● Background
● International Approaches to Nutrition &
Health claims
- Codex
- US - FDA
- European Union
● Developments in India
 WHY – Nutrition and Health Claims –
Consumer Perspective
● Increasing complexity of food production
● Consumers are increasingly interested in
the information appearing on food labels
● Sources of information
- Family knowledge,
- Education,
- Media and advertising
- And also food product label
● Diet conscious, its relationship to health
- Composition of foodstuffs
• deciding factor
 WHY – Nutrition and Health Claims –
Industry Perspective
● Industry’s response
- Nutrition labeling
- highlighting the nutritional value
• through claims in their labeling, presentation,
marketing and advertising
● Translating the benefits of science into a product
- which should have clear communication
- a claim - not understood is completely useless
- while a claim that is misunderstood could even be misleading
WHY – Nutrition and Health Claims –
Regulatory Perspective
● Nutrition labels and health claims on foods may
contribute to the
- achievement of public health objectives

● Uniform and Standardized provisions

- Level playing field

● Regulate and prevent misleading or

deceptive communication
 Helping consumers choose the right foods and
beverages for their life style, life stage and/or
the need state

Clear, accurate
Ingredient
statements

Must be Truthful,
not misleading

Nutrition and Health

Claims – solely based
Science and Evidence
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 Global Scenario
Nutrition and Health Claims

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● Founded 1963
● Parents: FAO and WHO
● 184 Member Countries and 1 member organization (EC)
● Recognized non-governmental organizations can participate in work
of Codex (e.g. ICBA, ICGMA) – 208 Observers
● Codex Commission is decision-making body
● Multiple committees carry out work of Codex
● Key committees for Nutrition and Health
- Codex Committee on Food Labeling (hosted by Canada)
- Codex Committee on Nutrition and Foods for Special Dietary Uses (hosted by
Germany)

http://www.codexalimentarius.org/

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Codex Member Countries

North Europe: 49
America: 2
EC Near East: 17

Asia: 23

Africa: 48
Latin America &
Caribbean: 33
Southwest
Pacific: 12

One country, one vote!

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Importance of Codex

● Protection of consumer health

● Facilitates cross-border trade
● Basis for harmonization of national regulations
● Key reference point in WTO disputes
● Opportunity for stakeholder interaction
- Governments
- Academia
- INGOs
- Industry

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Codex Alimentarius and Claims
● Guidelines for Use of Nutrition and Health
Claims
- (Nutrition and Health Claims (CAC/GL 23-1997 Revised
2011)
- Nutrient content/comparison claims: types
and conditions defined
- Functional health claims, disease risk
reduction claims
• Conditions defined
• Specific types not defined
- Used by many governments when setting
conditions for health claims
- Guideline on “Scientific basis for health
claims” is under development
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 Codex Definition of Nutrition Claim/s
● Nutrition claim means any representation which states, suggests
or implies that a food has particular nutritional properties
- Include energy value, protein, fat and carbohydrates, vitamins
and minerals
- What does not constitute nutrition claims:
 Mandated - Listing of Ingredients - Nutrition Panel - QUID
● Nutrient content claim is a nutrition claim that describes the
level of a nutrient contained in a food. (Examples: “source of
calcium”; “high in fiber and low in fat”.)

● Nutrient comparative claim is a claim that compares the

nutrient levels and/or energy value of two or more foods.
(Examples: “reduced”; “less than”; “fewer”; “increased”; “more
than”.)
Codex Definition of Health Claim/s
● Health claim any representation that states, suggests or
implies of relationship between
- a Food or
- a Constituent of that Food &
- Health
● Health claims include
- Nutrient function claims – a nutrition claim that describes
the physiological role of the nutrient in growth, development
and normal functions of the body
- Other function claims – Specific beneficial effects of food
consumption on normal functions or biological activities of
the body
- Reduction of disease risk claims – Linking consumption of a
food to the reduced risk of developing a disease or health-
related condition
Nutrient content claim – Examples
Condition – Not More Than

Note the differences applicable for solids and liquids

Nutrient content claim – Examples
Condition – Not Less Than
HEALTH CLAIMS – Requirements Under Codex
● Health claims should be permitted provided that ALL of
the following conditions are met:
- must be based on current relevant scientific
substantiation
- level of proof must be sufficient to substantiate the type
of claimed effect
- the relationship to health as recognized by generally
accepted scientific review of the data
● The health claim must consist of two parts:
- Information on the physiological role of the nutrient or
on an accepted diet-health relationship
- Information on the composition of the product relevant
to the physiological role of the nutrient or the accepted
diet-health relationship
● The claimed benefit should arise from the consumption
of a reasonable quantity of the food or food constituent
in the context of a healthy diet.
 Codex Criteria for the Substantiation of
Health Claims
● Primarily be based on evidence provided by well-designed human
intervention studies.
● Human observational studies are not generally sufficient to
substantiate a health claim
● Animal model studies, ex vivo or in vitro data may be provided as
supporting knowledge base for the relationship between the food
or food constituent
● The totality of the evidence, including unpublished data should be
identified and reviewed
- evidence to support the claimed effect
- evidence that contradicts the claimed effect
- evidence that is ambiguous or unclear.
● Evidence based on human studies should demonstrate
- consistent association between the food or food constituent
and the health effect with little or no evidence to the contrary
What makes a sustainable claim?

Consumer
benefit

Business
interest

Scientific substantiation
Role of Governance through time bound
regulatory mechanism
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 USA

● Positive list of nutrient content claims

● Structure/ Function claims allowed without
prior approval
- No positive list
- Must be able to defend scientific basis
● Disease risk reduction claims (referred to as
Health Claims)
- Any statement on labels or labelling (may be
direct/implied)
- Elaborate review process

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REF: 21 CFR 101.14 - Health claims: general requirements
 Nutrient Content Claims

REF: 21 CFR 101.13 Nutrient content claims—General Principles

 US Non-qualified health claims

- Significant scientific agreement

- Approved by FDA or based on authoritative statement
of federal scientific body or the NAS)
- Language requirements defined

Calcium and osteoporosis

"Regular exercise and a healthy diet with enough calcium helps teen and
young white and Asian women maintain good bone health, and may
reduce their risk of osteoporosis later in life"

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 US Qualified health claims

- Non-conclusive scientific agreement

- FDA reviews all evidence,
- Issues “letter of enforcement discretion” if there is
reasonable basis for claim
- Specific language required

Walnuts and CHD

"Supportive but not conclusive research shows that eating 1.5 ounces per day of
walnuts, as part of a low saturated fat and low cholesterol diet and not resulting
in increased caloric intake, may reduce the risk of coronary heart disease. See
nutrition information for fat (and calorie) content."

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 USA: Allowed disease risk reduction claims
(Health Claims)
Non-qualified (Significant scientific agreement)
1. Calcium and osteoporosis
2. Sodium and hypertension
3. Dietary fat and cancer
4. Dietary saturated fat and cholesterol and coronary heart disease (CHD)
5. Fibre-containing grain products, fruits and vegetables and cancer
6. Fruits, vegetables and gain products that contain fibre, particularly soluble fibre, and CHD
7. Fruits and vegetables and cancer
8. Folate and neural tube defects
9. Dietary sugar alcohol, D-tagatose and dental caries
10. Soluble fibre from certain foods and CHD
11. Soy protein and CHD
12. Free and esterified plant sterols, plant stanols and CHD
13. Whole grain and heart disease and certain cancers
14. Potassium and high blood pressure and stroke

Qualified (Emerging scientific evidence)

15. Nuts and CHD
16. Omega-3 fatty acids and CHD
17. Olive oil and CHD
18. Green tea and breast/prostate cancer 23
Slide 23
Conditions for use of “Healthy”

RACC = Reference Amounts Customarily Consumed

Health Claim US FDA
A Claims Trajectory for Calcium

Diets rich in calcium

may help reduce the
risk of osteoporosis”

“Calcium helps improve Disease risk

bone density” reduction claim

Other function
“Calcium builds
claim
strong bones”

Nutrient function
claim
“High in calcium”

Nutrient content
Health Claims
claim

Nutrient claim
Level of scientific substantiation
increases with the strength of the claim
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 European Union: Regulation on Nutrition
and Health Claims
● Published Dec. 2006, applies in all 27 EU countries

● Nutrient claims
● "Well established" health claims
Positive lists
open to all
● Health claims requiring prior approval
- Approval expected to take up to 2 years
- Includes
• claims about children’s growth and development Some
• Claims about reduction of disease risk
exclusivity
• Any claim not considered to be based on
“well established” science

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Slide 15
 EU Broad Framework
● Regulations No 1924/2006 of the
European Parliament of the Europe
and of the Council of20 December
2006

● COMMISSION REGULATION (EU)

No 432/2012 of 16 May 2012
establishing a list of 222 permitted
health claims made on foods, other
than those referring to the
reduction of disease risk and to
children’s development and health
Examples of permitted health claims Under
COMMISSION REGULATION (EU) No 432/2012
Indian Scenario – Nutrition and Health Claims

● Prior to FSSAI –
- Labeling Regulations under GSR 664 – March 2009
mandated
• Nutrition Labeling of BIG 4 and Sugar
• List of ingoing percentages if emphasized as
present on the label through words or pictures or
graphics and other conditions
• the amount of any other nutrient for which a
nutrition or health claim is made
• Defined Nutrition, Health and Disease Reduction
Claims – on lines of Codex

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 Food Safety and Standards Act 2006 - Relevant Provisions

● Section 3(d) “Claim” means any representation which states,

suggests, or implies that a food has particular qualities relating
to its origin, nutritional properties, nature, processing,
composition or otherwise
● Section 3(zf) (A)“Misbranded food” means an article of food
………………..or is being (i) offered or promoted for sale with
false, misleading or deceptive claims
● Section 3(zf) (C) )“Misbranded food” in case food is offered for
is offered for sale for special dietary uses, unless its label bears
such information as may be specified by regulation

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Current Issues in Market

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Proposals for Nutrition and Health Claim Regulations

● Codex - Nutrition & Health Claim Guidelines to be the

bedrock
● Examine suitability of approaches of US, EU, ANZ, HC
- Positive list of Nutrition and Health Claims for India
- Allowing Generic Health Claims with established
nutrient – physiological condition
• E.g. Calcium – Osteoporosis
• Iron in alleviation of IDA
• Vitamin A – improved eyesight
- Premarket Approval Only For Novel ingredients and
Claims based on new scientific evidence
- Objective and Time-bound Process for approval of
new health claims
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Thank You

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