Understanding the potential of immune health ingredients for consumers

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1 Understanding the potential of immune health ingredients for consumers Dr. Annegret Auinger analyze&realize GmbH Food Matters Live November 2014 analyze & realize GmbH Waldseeweg Berlin Germany

2 Agenda Understanding the potential of immune health ingredients for consumers The immune system a complex system Consumer needs and expectations How to translate immune benefits to consumer?

3 Understand consumers needs and expectations What are the influencing factors for a purchasing decision? KOLs Brand trust Official bodies Price (Social) media State of Health Sociodemographig factors Country specific differences 3

4 Understand consumers needs and expectations What are the influencing factors for a purchasing decision? KOLs Brand trust Official bodies Price (Social) media State of Health Sociodemographig factors Country specific differences 4

5 Target of supplement use Supplements - Who needs them? NHS Choices, 2011

6 The immune system ILSI; Nutrition and Immunity in Man,

7 The immune system Factors affecting the immune system Michal Kolodziejczyk - Fotolia.com

8 The immune system Consequences of weakened immune system People are more vulnerable to infections prone to frequent infections prone to longer infections Most consumers associate the immune system with seasonal common cold infections. Indeed, common cold infections occur quite frequently with adults presenting with 2-5 infections/year BUT

9 The Immune system... is more than defending a cold

10 The Immune system is more than defending a cold

11 Consumers expectations 11

12 Consumers expectations Benefits sought per country (botanicals) Findings from the PlantLIBRA Consumer Survey PlantLIBRA Conference, Vienna Bernadette Egan

13 Consumers expectations Trends in immune health products Copyright 2014 by Informa Exhibitions LLC. 13

14 How to translate immune benefits to consumer? Where marketing meets regulation! Consumer acceptance What would I like to claim? Which wording is consumer friendly? Legal frame What am I allowed to claim? Technological feasibility What can I claim?

15 How to translate immune benefits to consumer? What claims to be made on food products/supplements? Ingredient Health benefits Vitamins & minerals (Copper, folate, iron, selenium, zinc, vitamin A, C, B12, B6, D) Beta-glucan Probiotics Approved 13.1 health claim normal function of the immune system No approved EFSA health claim but scientific evidence from common cold studies No approved EFSA health claim for none of the probiotic strains 15

16 How to translate immune benefits to consumer? What claims to be made on food products/supplements? Ingredient Health benefits Vitamins & minerals (Copper, folate, iron, selenium, zinc, vitamin A, C, B12, B6, D) Beta-glucan Probiotics Differentiation to other Approved 13.1 health claim normal function products of the difficult!! immune system No approved EFSA health claim but scientific evidence from common cold studies No approved EFSA health claim for none of the probiotic strains 16

17 Translating consumer expectations into science Product specific, innovative health claims (13.5) Innovative claims Individual authorization Convincing RCTs are required Submission to any national food agency; evaluation by EFSA and approval by the European Commission No associated fees Data designated as proprietary are protected for 5 years Applicants get their own protected claim, which cannot be used by competitors for at least 5 years if data designated as proprietary 17

18 EFSA and Immune Health EFSA guidance on immune function Function claims related to defence against pathogens Defence against pathogens at a specific site of the body where the type of the infection need to be specified (e.g. upper respiratory tract) to be assessed by e.g. the number of episodes and severity or duration of the infection Claims on the function of the immune system Number of episodes and severity or duration of the together with concomitant changes in relevant immunological parameters Change of an immune parameter (e.g. cytokines, immune cells) in itself is not a beneficial physiological effect 18

19 EFSA and Immune Health An appropriate outcome parameter an example Clinical outcome Number of episodes and severity or duration of infection while the nature of the infection such as common cold should be established by clinical diagnosis by a physician microbiological data and/or the use of validated questionnaires (e.g. WURSS) Revision of the currently available guidance on the scientific requirements for health claims related to gut and immune function. more guidance on appropriate immune markers

20 Summary Immune function - hot topic in consumer perception A weakened immune system and vulnerability to infections is something that everybody has experienced in his or her life. A weakened immune system/increased incidence of f.e. common cold can be described by the consumer, and corresponding body responses can self-diagnosed or diagnosed by medical doctors. Almost every person seeks to strengthen the immune system and by that to reduce the incidence of infections High consumer awareness for foods and drinks as being effective in improving immune function

21 analyze & realize GmbH core competence Research and consulting services worldwide for over 20 years Nutrition Herbal medicine CRO Supplements, FSMP & functional foods Product Development Regulatory Support & Scientific Evaluation Notification Novel Food Applications Health Claims Herbal Medicinal Products & Medical Devices Regulatory Affairs Product Development Safety & Quality Assessment Scientific Consulting Expert Statements Meetings with the Authorities Medical Writing Clinical Trials Phases II-IV Project Management Quality Assurance Monitoring Medical Writing Own study site

22 Thanks for your attention! Own study site Regulatory Science 20 years of expertise Strategy CRO Curious? Like to learn more? analyze & realize GmbH Berlin, Germany

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