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Nutrition and Health ClaimLabeling and Guidelines

A Perspective

Sunil Adsule, Director-Scientific & Regulatory Affairs

Coca-Cola India26 July 2012

●Background● International Approaches to Nutrition &

Health claims- Codex - US - FDA- European Union

●Developments in India

What to expect

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

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

the need state

Must be Truthful, not misleading

Clear, accurateIngredient statements

Nutrition and HealthClaims – solely basedScience 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

Africa: 48

Asia: 23

Europe: 49

Latin America &Caribbean: 33

NorthAmerica: 2

SouthwestPacific: 12

EC Near East: 17

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

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”.)

● 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

Codex Definition of Health Claim/s

Nutrient content claim – ExamplesCondition – Not More Than

Note the differences applicable for solids and liquids

Nutrient content claim – ExamplesCondition – 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

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What makes a sustainable claim?

Consumer benefit

Scientific substantiation through time bound regulatory mechanism

Role of Governance

Business interest

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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

REF: 21 CFR 101.14 - Health claims: general requirements

Nutrient Content Claims

REF: 21 CFR 101.13 Nutrient content claims—General Principles

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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 osteoporosis2. Sodium and hypertension3. Dietary fat and cancer4. Dietary saturated fat and cholesterol and coronary heart disease (CHD)5. Fibre-containing grain products, fruits and vegetables and cancer6. Fruits, vegetables and gain products that contain fibre, particularly soluble fibre, and CHD7. Fruits and vegetables and cancer8. Folate and neural tube defects9. Dietary sugar alcohol, D-tagatose and dental caries10. Soluble fibre from certain foods and CHD11. Soy protein and CHD12. Free and esterified plant sterols, plant stanols and CHD13. Whole grain and heart disease and certain cancers14. Potassium and high blood pressure and stroke

Qualified (Emerging scientific evidence)15. Nuts and CHD 16. Omega-3 fatty acids and CHD17. Olive oil and CHD18. Green tea and breast/prostate cancer

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Conditions for use of “Healthy”

RACC = Reference Amounts Customarily Consumed

Health Claim US FDA

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A Claims Trajectory for Calcium

Nutrient contentclaim

Nutrient function claim

Other function claim

Disease risk reduction claim

Health Claims“High in calcium”

“Calcium builds strong bones”

“Calcium helps improve bone density”

Diets rich in calcium may help reduce the risk of osteoporosis”

Level of scientific substantiation increases with the strength of the claim

Nutrient 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

• claims about children’s 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

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Some exclusivity

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

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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