NUTRASOURCE DIAGNOSTICS INC. www.nutrasource.ca
A GLOBAL PERSPECTIVE ON FOOD HEALTH CLAIMS
CANADA, THE US, THE EU, AUSTRALIA & NEW ZEALAND
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 [email protected]
TWITTER: @KCOVENTRY_NDI LINKEDIN: HTTP://CA.LINKEDIN.COM/PUB/KRISTA-COVENTRY/26/B78/9A4
www.nutrasource.ca
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