Wim H.M. Saris

DSM Delft

Maastricht University

How does the Food Industry deals with Nutritional Health claims?

Declaration of competing interests

3

Healthy Food Innovation is a must … and a business opportunity

• Aging population • Nutrition-related health effects, increasing health care

costs • Consumer demands: safe, tasty & healthy • Competitiveness of EU Agro-food sector High Level Group on the Competitiveness of the Agro-Food Industry 2008 – 2009 Recommendation no 21: Enhance the research and innovation efforts (…) innovative

products as well as (…) production and processing methods.

4

Consumer Protection

To ensure a high level of protection for consumers and to facilitate their (healthy) choice. “Make the easy choice the healthy choice”

Objectives of the Nutrition & Health Claims 1924/2006 and 353/2008 Regulation

To create equal conditions of competition for the food industry.

Equal conditions for competition

Foster innovation

In order to stimulate research and development within the agro-food industry as well as IP protection.

It also generated great expectations for the nutrition and food sciences in Europe

Identify beneficial interactions between the presence or absence of a food component and a specific function or functions in the body.

Improve understanding of role of food and food components in maintaining and improving human health and in reducing the risk of chronic diseases.

Establish science/evidence-based approaches to underpin regulatory developments on nutrition and health claims.

European classification of claims on foods

Nutrition

claims ―nutrient

content

―comparative

―’other substance’

Annex

Health claims

Based on generally accepted scientific evidence

Article 13.1

Based on newly developed scientific data/IPR protection

Article 13.5

Reduction of disease risk and claims referring to children’s development and health

Article 14

EFSA NDA Panel assessments

Consider the extent to which:

The food/constituent is defined and characterised The claimed effect is defined and has a beneficial nutritional or physiological effect (‘beneficial to human health’) A cause and effect relationship is established between the consumption of the food/constituent and the claimed effect (for the target group under the proposed conditions of use)

Reference: Technical Report of EFSA: EFSA Journal (2009) 7

(11): 1386

Intervention • Randomized controlled trials • Non-randomized controlled trials Observational • Prospective cohort studies • Retrospective case control studies • Cross-sectional studies Supporting • Animal studies • In vitro cell and molecular studies • Studies of genotype

Stronger

Weak

Weighing the Scientific Evidence

EFSA NDA Panel assessment Outcome

• ~ 2700 Art 13.1 health claims evaluated

• ~ 20% approved

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Learnings

• Sufficient characterisation – High specifity as to

• Food/constituent • Function claimed

• Definition of beneficial effect

• Study in target population

• Emphasis on „gold standard“ RCTs

• Epidemiological data mainly on food, no/insufficient information on constituents

• End point often a disease, no (valid) marker or risk factor

•Short term only limited effects by nutrition interventions

• Intervention studies are performed preferably on subjects at risk or patients

• Substantiation via RCTs not for all nutrient related functions possible (ethical, financial, compliance constraints)

Pharmaco-dynamics vs. nutri-dynamics

de Vos et al 2006

“healthy”

“diseased” Early biomarkers of disease/effect

end point biomarkers of disease/effect

Time

From “healthy” to “diseased”: disturbing homeostasis

nutrition pharma

Changes in pathway dynamics to maintain homeostasis

Predisposition markers

Limitations of RCTs in evidence-based nutrition (EBN)

RCTs in evaluating medical treatments has its limitations to evaluation of nutrient effects in healthy subjects.

Foods and food constituents, nutritional recommendations and health claims are first of all for healthy people. The response to a drug is typically evaluated relative to its absence. The few validated biomarkers are developed for diseases, not adaptive responses in healthy people. Nutritional effects manifest themselves in small differences over long periods of time. Homeostatic mechanisms keep physiology within an individual’s normal range.

Eat 400 g fruit and vegetables per day

Challenge to the nutritional science: Following the EFSA criteria, did we substantiate the health claim?

Conclusion: pharma- and disease biomarkers may not be suitable.

Van Ommen et al 2008

Challenges to the nutritional sciences

• Ample nutrition science available to substantiate health claims for healthy people.

• Methodologies are missing for the assessment of the totality of the available evidence.

• Identification and validation of relevant biomarkers that can detect early signs of homeostatic disturbance and/or predict potential health benefits and reduced risk of disease.

Multiple biomarker profiling approach such as pathways analysis

Pertubation of homeostasis to reveal health and adaptation

capacity: Challenge tests

Lipid overload

Resistance (vaccination)

Exercise

Challenge tests probe the quality of homeostatic regulation

Healthy

Disease

Compromised

Van der Greef et all Curr. Opinion Chem Biol 2004

Challenge Tests

•Harmonizing the scientific process •Adopting a biomarker evaluation framework •Improving evidence-based regulation

DSM Public Affairs 21 Jan 2010

For most of the new promising and serious health claims evidence falls within the probable category.

Time, R&D investments, level of scientific evidence

WCRF (2007); USFDA (2003); FOSHU (2003) WHO (2004); CODEX (2008); Menté et al. (2009)

DSM Public Affairs 21 Jan 2010

4 year – € 4-8 mln

Lifecycle stages & costs for internally developed new Ingredients

Feasibility

Opportunity Development

Up-Scaling

Lau

nch

“Take-o

ff”

Tu

rno

ver

(in

gre

die

nt

sale

s)

Time

Average peak sales of successful products (excluding “one product wonders”)*

4-6 year – € 5-10 mln 6 year – € 3-6 mln

Early adoption

• Product Push • Awareness

creation • Market

creation

• Product Pull • Awareness

development • Fulfillment

and market development

• Meets value proposition criteria

• Solid business case

• Available for sales in pilot markets

• Health claims dossier approved

• Justified existence • Ready for adoption by

large CPG • Proof of sustainability • Solid business case • Global roll out

€ mln

Satu

rati

on

, “W

inn

ers

”

Market capturing

• Health claims dossier approved

DSM Public Affairs 21 Jan 2010

Lengthening time to market reduces ROI

Scenario 1: Peak sales of € 20 mln.

Scenario 2: Wait 2 years for various approvals

Scenario 3 Spend 3 years extra and € 3 mln doing additional studies

Scenario 4 Spend 6 years and € 6 mln doing additional studies

DSM Public Affairs 21 Jan 2010

Delays wipe out profit potential 20

08

2009

2010

2011

2012

2013

2014

2015

2016

2017

2018

2019

2020

2021

2022

2023

2024

2025

2026

2027

2028

DSM Public Affairs 21 Jan 2010

Dynamics in the value chain

Financial hurdles to start with new health related ingredient

project are becoming high

Ingredient suppliers will have smaller ROI in innovation

(Regional) SME’s face increased financial risks, which they are not well placed to deal with

The one-product specialty player model becomes a bet few can afford

DSM Public Affairs 21 Jan 2010

Innovation moves out of Europe

R&D functional foods moves to market places

DSM Public Affairs 21 Jan 2010

Conclusions

EU Harmonization Protecting consumers Promoting health & innovation

• Looking for new scientific paradigm in nutritional science • Clear path and requirements

Delays in approval procedures Increases in R&D costs

Discouraging R&D/innovation

• (Too?) Long and (too?) expensive pathway • Favors old science over new science

A proportionate and affordable system is required to safeguard a

realistic time to market.