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A Global Perspective on Food Health Claims
 

A Global Perspective on Food Health Claims

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On Wednesday, August 21st, Pulse Canada hosted an expert panel workshop in Toronto on the potential for a health claim related to Lentils and Post-prandial Glycaemia in Toronto. Invited delegates to ...

On Wednesday, August 21st, Pulse Canada hosted an expert panel workshop in Toronto on the potential for a health claim related to Lentils and Post-prandial Glycaemia in Toronto. Invited delegates to the workshop included over 30 representatives from the pulse industry, food industry, academia as well as and regulatory experts. The purpose of the workshop was to provide a forum in which to discuss a systematic literature review that was conducted in 2012 by Nutrasource Diagnostics Inc (NDI) with respect to achieving a health claim related to lentils and short term blood sugar control in Canada, the US or the EU.

Krista Coventry from NDI presented a background on the regulatory frameworks in Canada, the US, the EU and Australia/New Zealand.

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    A Global Perspective on Food Health Claims A Global Perspective on Food Health Claims Presentation Transcript

    • 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