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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

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A Global Perspective on Food Health Claims

  • 1. NUTRASOURCE DIAGNOSTICS INC. www.nutrasource.ca A GLOBAL PERSPECTIVE ON FOOD HEALTH CLAIMS CANADA, THE US, THE EU, AUSTRALIA & NEW ZEALAND
  • 3. 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
  • 4.
  • 6. • 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
  • 8. 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
  • 9. • 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
  • 10. • 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.”
  • 11. • 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
  • 12. 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
  • 13.
  • 14. 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
  • 15. 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
  • 16. FOOD HEALTH CLAIMS THE UNITED STATES (US)
  • 17. 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]
  • 19. 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)
  • 20. 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
  • 21. 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
  • 22. 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.
  • 23. 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
  • 24. FOOD HEALTH CLAIMS THE EUROPEAN UNION (EU)
  • 25. 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
  • 26. 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
  • 27. • 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)
  • 28. • 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)
  • 29. 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
  • 31. 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
  • 32. 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
  • 33. 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
  • 34.
  • 35. 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
  • 36. 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?
  • 37. 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