From the design to validation of health claims. What about claims and food benefits?

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Dr. Francesc Puiggròs. Scientific coordinator of Technological Center of Nutrition and Health (CTNS)

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From the design to validation of health claims. What about claims and food benefits?

  1. 1. From the design to validation of health claims. What about claims and food benefits?  Dr. Francesc Puiggròs, Scientific Coordinator of Technological Center of Nutrition and  Health (CTNS‐TECNIO)
  2. 2.  Analysis of communication related facts Claims made on foods – Communicating health benefits Science communication – a matter of all stakeholders How to get consumer’s reliability thorugh science Conclusions
  3. 3. Analysis of communication related facts
  4. 4. FACT 1 – Global recommendations for healthier diet habits Global recommendations PopulationHealth Public Policy Strategies RECOMMENDED DIET COMPOSITION 55-60% carbohydrates 10-15 % proteins 30% fat 5 a day (vitamins and minerals) Less salt, saturated fat and simple sugars More physical activity
  5. 5. FACT 2 – are they really effective? Mediterranean food is being consumed less and less in the Mediterranean region and more and more in other parts of the world. This alarming fact, which has been observed by many researchers and professionals (Rastoin, 2009; Abos, 2009), illustrates the challenges of restoring the Mediterranean Diet to its region of origin. Mediterra 2012. The Mediterranean Diet for Sustainable Regional Development. International Centre for Advanced Mediterranean Agronomic Studies (CIHEAM)- Paris: Presses de Sciences po, 2012
  6. 6. FACT 3 – Obesity data Evolution of energy uptake (kcal/person/d) 1961 2001 No disponibles 2.200 – 2.400 3.200 – 3.400 < 1.600 2.400 – 2.600 3.400 – 3.600 1.600 – 1.800 2.600 – 2.800 > 3.600 1.800 – 2.000 2.800 – 3.000 2.000 – 2.200 3.000 – 3.200
  7. 7. FACT 4 – The Risk Transition
  8. 8. FACT  5 – Many EU initiatives to promote healthier habits
  9. 9. FACT 6 – Increase the scientific knowledge on nutrition Role of dietary compounds in human nutrition  increasing area of concern and investigation Findings Findings Findings Wide‐ranging implications for all stakeholders producers processors distributors health‐care providers regulators educators consumers
  10. 10. FACT 7 – Controversial on communicating food propertiesWays for living more…. And better? Lifestyle Diet  Physical activity  Technology Medicine Science Increase of the incidence of non  communicable chronic diseases Success of the reduction measures will depend  strikingly on the balance between these factors.
  11. 11. FACT 8 – Food Industry‐Media‐Consumers Channel Year Channel Year Channel Year TV3  2005 TV2  2005 TV2  1997 Nº  % Nº  % Nº  % Foods counter to improved nutrition 260 76,6 342  66,0 235  87,5 Foods favoring to improved nutrition 12 3,6 32 6,2 22 8,2 Foods/meals with balanced concern /not 68 20 144 27,9 12 4,5 concern health profiles Total 340 100 518 100 269 100 Wilson N et al., Marketing fat and sugar to children on New Zealand television.  Preventive Medicine, 2006. 
  12. 12. CONSEQUENCES (1)  food influence the health new dimension of appreciation on how and wellfare of people, beyond providing the nutrients needed
  13. 13. CONSEQUENCES (2)  Huge increase in World’s Functional Food Market
  14. 14. Claims made on foods – Communicating health benefits
  15. 15. Definition of a Functional Food“A Functional Food is similar in appearance to conventional foods, is consumed as a part of a normal diet and has demonstrated physiological benefits and/or reduces risk of chronic diseasebeyond basic nutritional function”   (Health Canada, 1999) A food that beneficially affects one or more target functions in the body beyond adequate  nutritional effects in a way that is relevant to either an improved state of health and well‐being  and/or reduction of risk of disease. It is consumed as part of a normal food pattern. It is not a  pill, a capsule or any form of dietary supplement.  EC Concerted Action on Functional Food Science in Europe (FUFOSE, 2001) a natural food, modified or not by plant breeding or other  technologies (e.g. lycopene‐enhanced tomatoes, vitamin E‐enriched  vegetable oils, vitamin A‐enriched rice) or with an added component;  or removed component  food in which one or several components, have been modified,  replaced or enhanced to improve its health properties (e.g. a  juice  drink with enhanced antioxidant content, a yogurt with added prebiotic  or probiotic). 
  16. 16. Functional food is a  food that beneficially affects […]. It is consumed as part of a normal food pattern.  It is not a pill, a capsule or any form of dietary supplement.  EC Concerted Action on Functional Food Science in Europe (FUFOSE, 2001)Nutraceutical “ A food or food ingredients that have defined physiological effects A Nutraceutical is a product isolated from foods but sold in powders, pills and other  medicinal forms not generally associated with food and is demonstrated to have  physiological benefits or provode protection agains chronic diseases.  Health Canada, 1999
  17. 17. FAVOURABLE  Expansion opportunity on market of functional food seems to be  quite favorable, Consumer interest is quite high.UNFAVOURABLE Insufficient clarity of information provided by producers Disinformation of consumers may involve a number of risks, due  not only to the UNCERTATINTY about health promoted effects,  but also by enhancing an  overconsumption
  18. 18. XANTHOHUMOL
  19. 19. So…could this claim exist in future?
  20. 20. Need of regulation. Goal: Consumer trust2004 Allowed HC of function and risk reduction HC depending on nutrients Regulatory framwork to allow specific products bearing specific HC Developing a regulatory framwork Specific HC Codex as a legal framework
  21. 21. Need of regulation. Goal: Consumer trust2009 Allowed HC of function and risk reduction HC depending on nutrients Regulatory framwork to allow specific products bearing specific HC Developing a regulatory framwork Specific HC Codex as a legal framework
  22. 22. FOSHU (MHLW) 
  23. 23. EU Nutrition & Health Claims Regulation 1924/2006 (NHCR)  Main goals lays down harmonised EU-wide rules for the use of health or nutritional claims on foodstuffs. help European consumers to make more informed choices about their diet  scientific soundness  easy to read – easy to understand (to average consumer)
  24. 24. Claims What are they?any message or representation, which is not mandatory under Community or national legislation, including pictorial, graphic or symbolic representation, in any form, which states, suggest or implies that a food  has particular characteristics  (art.2.2)HEALTH CLAIM … health benefits can result from consuming a  given food.
  25. 25. But…Do we need health claims? Do we really need to communicate them? Claims on food labels/packaging/associated advertising/promotional literature provide the most direct way of  comunicating the benefits of functional food to consumers The simplest and most direct way in which consumers can learn ?  …. about functional foods is through product labelling ??  but labelling information must be easily understood and  trusted !!! .
  26. 26. This is good for you Calcium improvesbone strength Improves your health GOODNIGHT`t~xá çÉâ {tÑÑç Slim fast Vitamin C boostsyour immunity Contains ProbioticsEat 5 a day Gives you powerPhytosterols decrease cholesterol absorptionthus disminishing cardiovascular risk injury
  27. 27. There are different types of claims1 2 3 4 5 Other Puffery Nutrition Health Ingredient regulated claims claims Claims claims claims (slogans)“Source of  “Calcium helps to “100% fruit” “Organic” “Red Bull givescalcium” maintain strong you wings” teeth and bones” “With fresh “Suitable for “Haribo makes milk” vegetarians” your children happy”“High fiber” “Food X helps “Free from “Hallal” “Get on with decrease preservatives” it!” cholesterol,  which “With barn  “Gluten free” “Bring out the contributes to eggs” tiger in you!” reducing the risk of heart disease” COVERED by REG‐1924/2006 Source: EAS
  28. 28. Health claims context in EU NUTRITIONAL  HEALTH CLAIMS CLAIMS Referring to the Referring to the functional properties of the productnutritional properties of the product ARTICLE 13 ARTICLE 14 Energy, nutrients or ARTICLE 13.1 ARTICLE 13.5 substances Examples  Low in sugar  Energy intake free  Source of fiber  Growth, development and body Specific health topics functions  Disease risk  Psychological and behavioural functions reduction  Weight loss, weight control, reducing  Child health and  Listing of these claims hunger feeling,, increasing sense of  development in annex of  1924/2006/CE  satiety, reducing the energy value of diet regulation
  29. 29. Health claims context in EU Publication of the positive list of  Reg. 1924/2006 generic claims (13.3) 2.758 functional generic claims (6 Batches) End of the transition period 1 2 3 4 5 6 Oct 2009 July 2011                                July 2007 June 2012                                 December 2012 Approved claims Unapproved claims Unevaluated claims On‐hold claims ‐ 1.548 ? Claims not submitted for evaluation must be pulled off  from the market Approved 13.5 or 14 claims
  30. 30. Health claims context in EU  Claims under Art. 13.144.000 HC submitted  4.637 claims IDs 14 December 2012 222 authorised HC + 14 further potential positive claims (prunes, alpha‐cyclodextrines, etc.) + c. 2000 Ids botanica claims “on hold”
  31. 31. Health claims context in EU  Claims under Art. 13.1 Authorised Article 13.1 Claims
  32. 32. Health claims context in EU  Claims under Art. 13.5 & 14 Authorised Article 13.5 and 14 Claims
  33. 33. Health claims context in EU On‐hold claims ‐ 1.548 Breathing Space for Product Developers 1 yr?‐2 yr? … Compared with vitamins and minerals, there is much more  uncertaninty abou communication of plants Dietary supplements allowed claims not allowed before To innovate  realm of possibilities very high for new  plants or new extracts Easy to find for a contract manufacturer Regulation (EC) 258/97 of Novel Food (under revision) – Safety based on……but in terms of  Scientific evidence and significant consumption before 1997communication No danger , nor misleading neither unfavorable nutritive effect or… Demonstration of substancial equivalence (composition; metabolism; expected use;…) In contrast with vitamins and minerals there is no Europen harmonization on plants Each European country applies its own legislation Each European country free to establish its own list of  authorized and/or banned plants
  34. 34. As a citizen… do we need health claims regulation?  Are we too much overprotected?As a food company… do we really need to communicatethem?  Responsability  It is not about the claim, it is how to use it since HC is one part of an overall consumer pattern.  To make consumer’s choice easier and confirm (renew) their trust on food companyAs a regulator… do we really know how to regulate claims?  Definition and scientific rules to define scientific evidence?As a consumer …. do we need health claims? … are we really able to understand the claims?  HC into a consumer a concept and know the health benefit  Right to be informed and provide a reference to rely on.  Consumer average concept?
  35. 35. Science communication – a matter of all stakeholders
  36. 36. Consumer’s research at a very early stage of product development process Understand consumer’s needs and expectations What are the influencing factors for a purchasing decision? Image of the manufacturer Health care Accepted food Official bodies professionals Ingredient matrix knowledge(Social) Media Product positioning Socio-demographic Claims factors State of health Brand trust & Information Food choices Distribution awareness patterns channel
  37. 37. Communication gap between producers of functional food and  the market placeRegulation NHC in 2006 Nutrition Food Industry Functional Food PRODUCERS Research Standards Regulations Health Communication Gap Communication Gap Claims MARKET PLACE Retail Regulators Consumers Media Consumers Organisations Adapted of  M. Ginman, E. Väliverronen (eds.): Communicating Health and New Genetics: Workshop Proceedings, 17‐18th  September  2001). Finnish Information Studies 20, Åbo; Tampere; Oulu, 2002, pp. 57‐84. 
  38. 38. The information problem Health benefits are invisible – they have to be communicated in a way that is credible and understandable Health claims are regulated Consumers are sick and tired of complex, confusing and contradictory information about what is healthy and what is not Consumers are confused  by technical terms  by verbal qualifiers like ’research shows…’, ’may help…’  by probabilities and risk statementsINYS, Lund, November 29,  Dias 392006
  39. 39. The limits of information processingNutritional labelIngredients Under- Decision- Perception Evaluation Purchase list standing making Health claims Brand Associations Affect Purchase Appearance Source INYS, Lund
  40. 40. Simplification of communications gaps to answer:How to findan optimal product claim? Consumer acceptance What would I like to claim Product claim Legal frame Technological feasibility What am I allowed to claim? What could I claim
  41. 41. How to get consumer’s reliability thorugh science
  42. 42. Health claims true & comprehensibleSCIENCE & COMMUNICATION What are the main challenges for reliable and serious communication of  health benefits on foods?
  43. 43. SCIENCE & COMMUNICATION Consumer acceptance Universal CONCEPT FORMAT SCIENCE COMMUNICATION Arial 20  Bookshelf Symbol 20 SCIENCE COMMUNICATION Script MT Bold 18 Not misleading Complex to easy translation
  44. 44. SCIENCE & COMMUNICATION Consumer acceptance THERAPEUTIC FIELD PREVENTIVE FIELD
  45. 45. SCIENCE & COMMUNICATION Legal frame ‐ Food Industry – Technological Feasibility Check list for achieving a HC* Primary in importance - Characterization if the food/constituents - Demonstration of the claims effect - Relevance to human health Secondary in importance - Bioavailability - Mechanistic data - Dose-response relationship * According to NDA Panel
  46. 46. SCIENCE & COMMUNICATION Legal frame ‐ Food Industry – Technological Feasibility Demonstration of the claims effect Relevance to human health  Human intervention studies are needed  The benefit is needed  For combination products: Study conduct with the combination product (final product)  Study population must be the same like target group, perhaps extrapolation of the data from patients/invalids will be accepted  Effects must be clinically relevant (1cm sign. Reducing the waist circumference is not considered to be relevant)  The tested parameter has to be validated and accepted  The statistical analysis must be conducted scientifically correct  Correct blinding and randomization
  47. 47. SCIENCE & COMMUNICATION Legal frame ‐ Food Industry – Technological Feasibility Consensus on biomarkers Published and unpublished data  Opinions (preclinical, clinical) etc Guidances General positions Identification of the best combination: “claim wording x population x  EFSA & EC POSITION dose RISK ANALYSIS Data protection? Go No Go Gaps identification Health claim application between sceicnee R&D writing and submission anmd regulation Time investment?  Cost investment? Scientific risk?
  48. 48. SCIENCE & COMMUNICATION Legal frame ‐ Food Industry – Technological Feasibility  General guidance  Scientific and technical guidance Guidance for health claims related to gut and immune function Guidance on health claims related to antioxidants, oxidative damage and cardiovascular health Guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations Guidance on the scientific requirements for health claims related to bone, joints, skin and oral health Guidance on the scientific requirements for health claims related to physical performance Guidance on the scientific requirements for health claims related to functions of the nervous system, including psychological functions
  49. 49. SCIENCE & COMMUNICATION Updating data...
  50. 50. SCIENCE & COMMUNICATION ...while emerging technologies...
  51. 51. ...while food industry increases its R&D  investment... Consequences of the Union list?“…strength the position of those companies that seriously invest on R&D”“ … we will achieve a long term protection of functional food”“Overall strengthening of functional food category on consumer mindset” New strategies? “… apply through the Article 13.5 process by reinforcing scientific studies.”
  52. 52. SCIENTIFIC EVIDENCE ACHIVEMENT& COMMUNICATION
  53. 53. Conclusions
  54. 54.  At present, there is still lack of rigorousity on health claims made on foods Investment on R&D is the most important way to achieve a new HC for keeping/increasing competitiveness in the helthy sector Legal frameworks must (should) maintain their rules for industry stakeholders? We are complaining about the misleading claims but we are living on a serious risk by taking non-healthy habits.
  55. 55. Whereas… Decision making tree for HC’ identification and communication NO Is your product Is your claim a brand name or a  meant for trade mark construed as a  children only e.g.  health claim? with cartoon,  etc.. YES NO NO Was it on a market Is your health claim a  YES Is your claim before January 2005? health recommendation? You have on Art.  referring to 14 claim. Use an reduction of a  Art.14 authorised disease risk claim factor? YES NO YES NO No changes You should Is it a reco from a  Is your claim general required until 19  accompany it by national/local Authority? or specific? SPECIFIC Jan 2022 a health claim Is your claim NO realting to It is likely that you children’s claim is a health claim development and  YES NO health? GENERAL It is likely you can make the Is it a reco. From a  Is it a marketing  claim in line with the nutritional, dietetic,  Is your claim close in meaning puffery? national/local Authority rules professional‐related charity? to any claim from the authorised list of 222 health claims? YES NO YES NO NO YES It is likely you can  Reco from individual  Your claim is If it is a general non  Is your claim referring You can make your make the claim in line  doctors, dieticians out of the specific claim, it to a plant/botanical claim but should with national rules etc. are not scope of  should be  claim that is still under provide the info from e.g. Greece authorised. Your Claim’s Reg. It accompanied by a  EFSA evaluation? Art. 10. claim has to be taken can satay on specific health claim off the label and  the market from the authorised other advertising list of claims. It can  material, including YES stay on the market NO TV adverts. You can keep using the Your claim is not claim in line with authorised national rules
  56. 56. This is good for you Calcium improves bonestrength Improves your healthGOOD NIGHT`t~xá çÉâ {tÑÑç Slim fast Vitamin C boosts Contains Probioticsyour immunityEat 5 a day Gives you power
  57. 57. Decision making tree for HC’ identification and communication NO Is your product Is your claim a brand name or meant for a trade mark construed as a  children only e.g.  health claim? with cartoon,  etc.. NO YES Is your health claim a  NO Was it on a market YES health Is your claim before January 2005? You have on Art.  recommendation? referring to 14 claim. Use an reduction of a  Art.14 authorised disease risk claim factor? YES NO YES NO No changes You should Is it a reco from a  Is your claim general required until 19  accompany it by national/local Authority? or specific? SPECIFIC Jan 2022 a health claim Is your claim NO realting to It is likely that you children’s claim is a health claim development and  YES NO health? GENERAL It is likely you can make the Is it a reco. From a  Is it a marketing  claim in line with the nutritional, dietetic,  Is your claim close in meaning puffery? national/local Authority rules professional‐related charity? to any claim from the authorised list of 222 health claims? YES NO YES NO NO YES It is likely you can  Reco from individual  Your claim is If it is a general non  Is your claim referring You can make your make the claim in line  doctors, dieticians out of the specific claim, it to a plant/botanical claim but should with national rules etc. are not scope of  should be  claim that is still under provide the info from e.g. Greece authorised. Your Claim’s Reg. It accompanied by a  EFSA evaluation? Art. 10. claim has to be taken can satay on specific health claim off the label and  the market from the authorised other advertising list of claims. It can  material, including YES stay on the market NO TV adverts. You can keep using the Your claim is not claim in line with authorised national rules
  58. 58. Goal From global recommendations for healthier diethabits to personalised nutrition Global Healthy Diet Personalised recommendations Nutrition Subpopulation Genotype/Phenotype Population Health Public Policy Clinical Nutrition Personalised Diet Strategies Nutritional Genomics GLOBAL RECOMENDATIONS COULD BO NOT OPTIMUM FOR YOU
  59. 59. Thank you and ….…questions? Dr. Francesc Puiggròs, Scientific coordinator of Technological Center of Nutrition and  Health (CTNS‐TECNIO)

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