Nutrition and Health Claim

Labeling and Guidelines

A Perspective
Sunil Adsule,
Director-Scientific & Regulatory Affairs
Coca-Cola India
26 July 2012

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
Industrys 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

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
America: 2

Europe: 49
Near East: 17

EC

Asia: 23
Latin America &
Caribbean: 33

Africa: 48
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 healthrelated 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

Role of Governance

Scientific substantiation
through time bound
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regulatory mechanism

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 claimsGeneral 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)
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.

15.
16.
17.
18.

Slide 23

Non-qualified (Significant scientific agreement)

Calcium and osteoporosis

Sodium and hypertension
Dietary fat and cancer
Dietary saturated fat and cholesterol and coronary heart disease (CHD)
Fibre-containing grain products, fruits and vegetables and cancer
Fruits, vegetables and gain products that contain fibre, particularly soluble fibre, and CHD
Fruits and vegetables and cancer
Folate and neural tube defects
Dietary sugar alcohol, D-tagatose and dental caries
Soluble fibre from certain foods and CHD
Soy protein and CHD
Free and esterified plant sterols, plant stanols and CHD
Whole grain and heart disease and certain cancers
Potassium and high blood pressure and stroke

Qualified (Emerging scientific evidence)

Nuts and CHD
Omega-3 fatty acids and CHD
Olive oil and CHD
Green tea and breast/prostate cancer

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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

bone density

Calcium builds
strong bones

High in calcium
Nutrient content
claim

Disease risk
reduction claim

Other function
claim

Nutrient function
claim

Health Claims

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

Health claims requiring prior approval

- Approval expected to take up to 2 years
- Includes

Slide 15

claims about childrens growth and development

Claims about reduction of disease risk
Any claim not considered to be based on
well established science

Positive lists
open to all

Some
exclusivity

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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
childrens 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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