NUTRASOURCE DIAGNOSTICS INC. www.nutrasource.ca

A GLOBAL PERSPECTIVE ON FOOD HEALTH CLAIMS

CANADA, THE US, THE EU, AUSTRALIA & NEW ZEALAND

Presented to:

August 21, 2013

Generally speaking, a food health claim is considered to be “any representation in labelling and advertising that states, suggests or implies

that a relation exists between the consumption of foods or food constituents and health”

Codex Alimentarius Commission, 2004

REGULATORY DEFINITION: HEALTH CLAIM

FOOD HEALTH CLAIMS CANADA

• Foods, as well as claims related to health that appear on packaging or in advertising of foods in Canada, must comply with:

The Consumer Packaging and Labelling Act (1971)

the Food and Drugs Act (1985)

the Food and Drug Regulations

REGULATORY FRAMEWORK (CANADA) REGULATIONS

REGULATORY FRAMEWORK (CANADA) ROLE OF THE GOVERNMENT

NUTRIENT CONTENT CLAIMS

B.01.500 FDR

HEALTH CLAIMS

B.01.600 FDR

GENERAL CLAIMS

FUNCTION CLAIMS

DISEASE RISK REDUCTION

CLAIMS

THERAPEUTIC CLAIMS

REGULATORY FRAMEWORK (CANADA) FOOD HEALTH CLAIM CATEGORIES

• No specific regulations governing use;

• No standardized nutritional criteria required;

• Do not refer to a specific health effect, disease, or health condition;

• Can promote choosing a food for overall health or promote healthy eating;

• Can provide dietary guidance, such as:

“Healthy for you...”

“Healthy choice...”

FOOD HEALTH CLAIMS (CANADA) GENERAL HEALTH CLAIMS

• Function claims refer to the

maintenance and/or support of body functions associated with the maintenance of good health or performance

FOOD HEALTH CLAIMS (CANADA) FUNCTION HEALTH CLAIMS

“Coarse wheat bran helps to promote regularity.”

• Link consumption of food or food constituents to a reduced risk of developing a diet-related disease or condition in the context of the total diet.

FOOD HEALTH CLAIMS (CANADA) DISEASE-RISK REDUCTION CLAIMS

Sodium, potassium and hypertension

Calcium, vitamin D and osteoporosis

Saturated and trans fat and heart disease

Vegetables, fruit and some cancers

Non-fermentable carbohydrates and dental caries

REGULATORY FRAMEWORK (CANADA) APPROVED DISEASE/RISK-REDUCTION CLAIMS

Enable consumers to easily recognize the health benefit of a food Claims about the treatment or mitigation

of a health-related disease or condition, or about restoring, correcting or modifying body functions; Include a dose per serving of the food and

daily dose

FOOD HEALTH CLAIMS (CANADA) DISEASE RISK-REDUCTION CLAIMS THERAPEUTIC CLAIMS

Psyllium fibre and Blood cholesterol Lowering

Plant sterols and Blood cholesterol Lowering

Oat fibre and blood cholesterol lowering

Unsaturated fats and Blood Cholesterol Lowering

Barley Products and Blood Cholesterol Lowering

REGULATORY FRAMEWORK (CANADA) APPROVED THERAPEUTIC CLAIMS

FOOD HEALTH CLAIMS THE UNITED STATES (US)

REGULATORY FRAMEWORK: FOODS ROLE OF THE GOVERNMENT

U.S. Food Authorities / Regulatory Bodies:

Food and Drug Administration [FDA] • Center for Food Safety and Applied

Nutrition [CFSAN] U.S. Department of Agriculture [USDA] Federal Trade Commission [FTC]

NUTRIENT CONTENT CLAIMS

21CFR101.13

STRUCTURE/ FUNCTION

CLAIMS

21CFR101.93

HEALTH CLAIMS

21CFR101.14

REGULATORY FRAMEWORK (USA) FOOD HEALTH CLAIM CATEGORIES

FOOD HEALTH CLAIMS APPROVED HEALTH CLAIMS

Soluble fiber from certain foods and risk of Coronary Heart Disease

(21 CFR 101.81)

Plant Sterol/stanol esters and risk of Coronary Heart Disease

(21 CFR 101.83)

Soy Protein and risk of Coronary Heart Disease

(21 CFR 101.82)

HEALTH CLAIMS

Nutrition Labelling & Education Act [NLEA]

Authorized Health Claims (1990 )

Food and Drug Administration Modernization Act

[FDAMA] Authorized Health Claims

(1997)

Qualified Health Claims (2003)

FOOD HEALTH CLAIMS HEALTH CLAIMS

FOOD HEALTH CLAIMS NLEA AUTHORIZED HEALTH CLAIMS

The SSA Standard : The Continuum of Scientific Discovery

• Confidence must exist in the validity of the substance-disease relationship;

• Consensus between qualified experts that the claim is true and valid;

• It should be unlikely that future studies or new data will oppose the relationship;

• Overall, there needs to be a body of consistent, relevant evidence.

Emerging Evidence

Consensus

FOOD HEALTH CLAIMS FDAMA AUTHORIZED HEALTH CLAIMS

• Health claims based on current, published, authoritative statements from a credible scientific body of the U.S.A ;

• Scientific evidence for the claim is considered to have met the SSA standard;

• Submission of claim at least 120 days prior to first use in interstate commerce; FDA will review and notify the petitioner of the outcome of compliance ruling.

FOOD HEALTH CLAIMS QUALIFIED HEALTH CLAIMS

Based on FDA guidance documents (not legislation);

Claims are based on emerging science;

Evidence is not well-established; The SSA standard cannot be met; therefore the FDA

cannot issue an authorizing regulation. Instead a “letter of enforcement” or “letter of denial” is issued.

Qualifying language is used to illustrate the level of

scientific support

FOOD HEALTH CLAIMS THE EUROPEAN UNION (EU)

REGULATORY FRAMEWORK: FOODS (EU) ROLE OF THE GOVERNMENT

EUROPEAN COMMISSION

EUROPEAN PARLIAMENT

EU MEMBER STATES

EUROPEAN FOOD SAFETY AUTHORITY (EFSA)

EXECUTIVE DIRECTOR

SCIENTIFIC EVALUATION OF REGULATED PRODUCTS

DIRECTORATE

APPLICATIONS DESK FEED

PESTICIDES NUTRITION

GMO FOOD INGREDIENTS & PACKAGING

NUTRITION CLAIMS

CHAPTER III

HEALTH CLAIMS

GENERAL FUNCTION CLAIMS

CHAPTER IV (ARTICLE 13)

DISEASE RISK REDUCTION

CLAIMS*

CHAPTER IV (ARTICLE 14)

REGULATORY FRAMEWORK (EU) FOOD HEALTH CLAIM CATEGORIES

*Also includes Child Development or Health Claims

• When consideration a food health claim evaluation, EFSA will consider: If the food and/or food constituent is

defined and characterized; If the claimed effect is defined and is

a beneficial physiological effect; If a cause and effect relationship is

established between the consumption of the food/constituent and the claimed effect

REGULATORY FRAMEWORK (EU) EVALUATION OF CLAIMS (EFSA)

• The food or substance must be sufficiently characterized in relation to the claimed effect (compared to reference food) • Replacement Effect: evidence which

demonstrates the ‘replacement’ food (ie/ sweetener) has no effect on postprandial [PP] glucose or insulin as compared to the reference food (which would blood glucose)

• Independent or Comparative Effect: evidence to demonstrate a significant in PPG, and a significant in insulin or no change in insulin

REGULATORY FRAMEWORK (EU) EVIDENCE REQUIREMENTS (PPG)

DIETARY FIBRE “Consumption of arabinoxylan contributes to a reduction

of the glucose rise after a meal”.

SWEETENERS “Consumption of foods/drinks containing xylitol instead of sugar induces a lower blood glucose rise after meals

compared to sugar-containing foods/drinks”.

FRUCTOSE “Consumption of fructose leads to a lower blood glucose

rise than consumption of sucrose or glucose”

FOOD HEALTH CLAIMS APPROVED GENERAL FUNCTION CLAIMS

FOOD HEALTH CLAIMS AUSTRALIA & NEW ZEALAND

NUTRITION CONTENT CLAIMS

PART 3 DIVISION 1 SCHEDULE 1

HEALTH CLAIMS

HIGH LEVEL HEALTH CLAIMS

PART 3 DIVISION 2 SCHEDULE 2

GENERAL LEVEL HEALTH CLAIMS

PART 3 DIVISION 2 SCHEDULE 3

PART 3 DIVISION 2 SELF-

SUBSTANTIATED

REGULATORY FRAMEWORK (A&NZ) FOOD HEALTH CLAIM CATEGORIES

General claims: • The food meets the Nutrient Profiling Scoring Criterion,

unless the food is standardized by Part 2.9 of the Code; and

• The claim or the nutrition information panel under Standard 1.2.8 includes the numerical value of the Glycemic Index of the food

Specific claims: • LOW: Glycemic Index ≤ 55 • MEDIUM: Glycemic Index of 56-69 • HIGH: Glycemic Index ≥ 70

REGULATORY FRAMEWORK (A&NZ) GLYCEMIC INDEX CLAIMS

General claims: • The food meets the Nutrient Profiling

Scoring Criterion, unless the food is a food standardized by Part 2.9 of the Code

• Descriptors of ‘low’, ‘medium’, and ‘high’ cannot be used in relation to Glycemic Load claims, however, numbers of the measure can be used, e.g. Glycemic Load =30

REGULATORY FRAMEWORK (A&NZ) GLYCEMIC LOAD CLAIMS

JURISDICTION

NUTRIENT CLAIMS

HEALTH CLAIMS

GENERAL LEVEL CLAIMS HIGH LEVEL CLAIM

CANADA Nutrient Content Claims

General Health Claims Function Claims

Therapeutic Claims Disease Risk Reduction Claims

USA Nutrient Content Claims Structure/Function Claims SSA Health Claims

Qualified Health Claims

EUROPE Nutrition Claims General Function Claims Disease Risk Reduction Claims

AUSTRALIA NEW ZEALAND

Nutrition Content Claims General Level Health Claims High Level Health Claims

REGULATORY FRAMEWORK (SUMMARY) FOOD HEALTH CLAIM CATEGORIES

JURISDICTION

NUTRIENT CLAIMS

HEALTH CLAIMS

GENERAL LEVEL CLAIMS HIGH LEVEL CLAIM

CANADA n/a -

USA n/a X SSA 1 Qualified

EUROPE -

AUSTRALIA NEW ZEALAND

GI & GL X -

REGULATORY FRAMEWORK (SUMMARY) POSTPRANDIAL GLYCEMIA CLAIMS?

THANK YOU! KRISTA COVENTRY, PH.D. CANDIDATE

DIRECTOR, NUTRITION AND NUTRACEUTICAL RESEARCH KCOVENTRY@NUTRASOURCE.CA

TWITTER: @KCOVENTRY_NDI LINKEDIN: HTTP://CA.LINKEDIN.COM/PUB/KRISTA-COVENTRY/26/B78/9A4

www.nutrasource.ca