Tim Adetona

Voisin Consulting Life Sciences3 rue des Longs Pres

92100 Boulogne France

Tel: +33 1 41 31 83 02

email: adetona@voisinconsulting.com

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Navigating The Regulatory Maze

16th February 2011

Innovative Healthcare Product Development&

Regulatory Strategy

Expertise

Anticipate, convince and participate in creating forthcoming regulations

Products

New classes of products at border between or combining drugs, biologics, bioactives, medical devices, diagnostics, cosmetics:

• Personalized & predictive medicine• Targeted therapies

+/- 70 connected men & women working as one multicultural, scientific & regulatory team

Ph.D, M.D, Pharm.D, M.Sc, Engineers

Multilingual: English, French, German, Spanish, Italian, Serbian, Hindi…

One Multidisciplinary Team

Our Connected Offices

Cambridge, MA - USAvccambridge@voisinconsulting.com

Paris & Rennes - Francevcparis@voisinconsulting.com

vcrennes@voisinconluting.com

Lausanne –Switzerland vclausanne@voisinconsulting.com

Melbournevcmelbourne@voisinconsulting.com

Bangalore - Indiavcbangalore@voisinconsulting.com

Singaporevcsingapore@voisinconsulting.com

Navigating The Nutraceutical Maze

• The Nutraceutical Promise

• Marketing Objectives

• Historical Perspective & Current Status– Differing Classification Questions

– Product Positioning Questions

• Global Regulatory Frameworks– FSSAI Alignments

• Universal Health Claim Considerations

• Human Data Elements

• Strategic Regulatory Advice

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The Nutraceutical Promise

• Community of supplement users continue to drive growth impressively

• A 2008 BCC research positions global Nutraceuticals at 7.4% growth

• Projected to hit $176.6 billion by 2013

• Herbal supplements to 93 billion in 2015 (Global Industries Analysts)

• Globalisation of Nutraceuticals has come to stay

• However increasing growth typically attracts increasing regulation

– High degree of consumer protection

– Promotion of fair trade, and

– Not at the expense of product research & innovation

• Hence, there are challenges inherent with the growth potentials

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Marketing Objectives

• Get products to the market in the shortest time possible

• Optimally communicate products’ health benefit to consumers

• Achieved within the appropriate regulatory regimen

• Preferably, operate the same requirements globally!

• Harmonization facilitates global trade, R&D, predictability

• Pharmas have taken very huge harmonization steps through ICH

• Global market development success relies on sound knowledge of extensive as well as emerging legislative frameworks

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Historical Perspectives & Status

• National regulations used to be “local” in concept and application

• Harmonized rules present opportunities for global brands

• Regional harmonization are gradually evolving e.g. ASEAN: AFTA

• Asia, LAM at various stages of development

• EC, USA, Canada, Japan are “stand-alone” at the most

• With “work in progress” in key aspects e.g. EU’s – substances other than Vits/Min;

– certain aspects of PARNUTS;

– Nutrient Profile being a basis for NHCR

• Discrepancy exists globally with definition, classification & requirements

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Differing Classification Questions• Product designation

– Food supplements, dietary Supplements, Vit/Min level,

– PARNUTS, FOSHU, Medical Food,

– Herbal Product, Botanical product,

– Medicinal?, Nutrient?, Ingredient status?

– Permmited List for Nutrients, Functional Food,

– Probiotic, Prebiotic,

– Novel?, Sports food,

– Additive permitted, Excipients,

– Nutricosmetics, Cosmeceuticals

• Market authorization: – registration vs. notification,

– duration of procedure,

– Life Cycle Management impact

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Product Positioning Questions

• Regulatory approach questions:– Harmonized procedure

– National procedure

– Duration & Stringency

• Communicating product’s health benefit questions:– NHCR,

– Generic Art.13(1), Art.13(5),

– Art.14(a) & (b),

– Qualified health claims,

– SSA,

– National rules,

– NHPD requirements

• Global brand packaging differences: – Label content presentation,

– Minimum font size requirements,

– Regional RDA,

– Mandatory warnings,

– Geographical regions (Australia, USA, FDA, EU, Canada, LAM, MEA)

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Global Regulatory Frameworks

• EU (EFSA, National Authorities)– NHCR 1924/2006

– Nutrition claims/nutrient content

– Art. 13 (1) & (5); Art. 14 (a) & (b)

– PASSCLAIM criteria

• USA (FDA)– Health Claims

NLEA 1990: Authorized Health Claims (SSA – Significant Scientific Agreement)

FDAMA 1997: Authoritative Statements by scientific bodies (not Food Supp)

CHI&BNI 2003: Qualified Health Claims (evidence not as strong as SSA)

– Nutrient Claims: NLEA 1990 (similar to EU Nutrition claim)

– Structure/Function Claims: DSHEA 1994 (FDA non pre-approved disclaimer)

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• Japan– Foods for special health Use (FOSHU) established from 1991

– Includes processed food products, tablets & capsule forms

– Dietary ingredients with beneficial physiological functions in humans

– Maintain/promote health; improve health conditions

– Similar to other structure/function claims in USA or other functions in Codex Alimentarius

– Requires validation of quality, efficacy and safety

– Disease risk reduction possible (Ca & osteoporosis; Fä & neural tube defects)

– Since 2005, Qualified FOSHU claims (a la FDA) also possible

• ASEAN (Association of South East Asian Nations)– Progressive harmonization at the instance of ASEAN Free Trade Agreement (AFTA, 1967)

– Definition of Food supplement

– Supplements diet to enhance or improve the health function of the human body

– Contains one or more of vitamins, minerals, amino acids, enzymes, probiotics, bioactives

– Health claim evidence increases from general/nutritional; functional; disease risk reduction

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Global Regulatory Frameworks

• Korea (KFDA)– Health functional food (HFF) includes

– Any form of foods, food supplements with functional ingredients useful to the body

– Established in 2002, regulation recognizes Generic HFF (with spec & standards in HFF code)

– And product-specific HFF (requires pre-market registration/approval of specific ingredients)

– 3 types of claims: nutrient function; other function; reduction of disease (Codex Alimentarius)

– Other functions. convincing; probable; or insufficient

• China (SFDA)– Functional food: has special health functions or is able to supply vitamins or minerals

– Suitable for consumption by special groups of people and regulates human body functions

– Toxicity, functionality, stability and hygiene tests are required for pre-market approval

– 27 categories of product-specific health claims (function and reduction of disease risk)

– Historical/traditional & present-day use data to be provided on herbs

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Global Regulatory Frameworks

• Latin America– No harmonized provisions on health claims and substantiation

– National legislations to be considered separately (Argentina, Brazil, Chile, Colombia, Mexico)

• Argentina– No provisions for health claims in the food regulation

– Claims on diseases and therapeutic conditions are prohibited

– Ads can describe physiological effect of nutrients (vitamins & minerals) on healthy people

• Brazil– Food and food supplement labeling is regulated

– Positive list on functional and health claims approved in 2008 for 18 nutrients & ingredients

– Evidence to support food claims: nutritional, physiological, toxicological trials on animals; biochemical, epidemiological, clinical trials; proof of efficacy through traditional use in the population; and scientific literature

• Mexico– Guidelines on nutrition and health claims are based on the Codex Alimentarius

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Global Regulatory Frameworks

FSSAI Alignment

• Food Safety and Standards Authorities of India (FSSAI)

• Traditional medicines not part of Nutraceuticals– USA’s Dietary Supplements include traditional and herbal products

– Canada’s Natural Health Products include traditional and herbal products

– EU’s Food Supplements (Traditional Herbal Medicines separately regulated)

– Japan’s FOSHU (Traditional & Herbal Medicines not part of definition for dietary supp)

• FSSA 2006 lists ingredients (& properties) that can be Nutraceuticals

• Foods for Special Dietary Uses – May contain plants/botanicals, vit/min, substances of animal origin & dietary supps

– Similar to EU’s Food supplements

• References India RDA– Ca|Vit. D: [EU: 800mg|200IU]; [US/CAN: 1000+mg|600IU]; [Ind: 400/600mg|400IU]

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Universal Health Claim Considerations

• Clarify the relationship between the food/constituent and health effect

• Clarify valid measurements for the food/constituent and the health effect

• Rank all the pertinent scientific data

• Verify the quality of each supportive scientific data

• Interpret each pertinent study

• Consider the totality and the weighing of available scientific evidence

• Best substantiated by well-designed human intervention studies.

• Demonstrates association between food/constituent and health effect

• Observational studies are not typically accepted as strong evidence

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• Sufficient characterization of the food component for the claimed effect

• Study group is representative of the target population

• The use of appropriate controls

• Adequate duration of exposure in view of the intended effect

• Sufficient characterization of the study group’s background diet and lifestyle

• Amount of food/component is consistent with intended pattern of consumption

• Compliance monitoring & test of hypothesis

• Use of appropriate markers instead of difficult-to-measure true endpoints

• Use of biologically valid biomarkers

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Human Data Elements

Strategic Regulatory Advice

• Determine ideal classification (e.g. EU Ingredient Decision Tree)

• Become familiar with pertinent regulatory requirement

• Determine optimal regulatory strategy

• Investigate possible alternative market authorization route

• Review every aspects of the product and pack presentation

• Analyze and validate ingredients & formulas in different markets

• Conduct data gap analysis for registration/notification & claims

• Verify compliant product labeling as per market

• Design and compile technical dossier as per chosen strategy

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More Regulatory Advice

• Deploy strategic planning for changing regulatory environment

• Invest time & effort behind marketing claim proposition

• Investigate appropriate regulatory strategy for claim positioning

• Ensure protocol design & study data supports NHCR, HC, QHC, SSA …

• Identify & bridge gaps in claim support data

• Consider compromise claims wordings as interim strategy

• Conduct comprehensive products’ regulatory market readiness

• Validate your findings with experienced Experts

• Develop & market product on the basis of expert-validated outputs

• Plan for Adverse Events Reporting/Vigilance reporting (US, France…)

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Lest We Forget

• The Nutraceuticals market holds much promise

• And directly affected by apparent regulatory classification constraints

• Passing a health claim application presents another hurdle

• Within these challenges are opportunities, and solutions remains in:– Strategic consideration of life-cycle and regulatory alternatives,

– Correct application of knowledge of local/national/regional peculiarities

– Rigorous gap analysis of regulatory market readiness plans

– Constructive scientific data positioning and justification

• The obvious may not necessarily be the only or optimal pathway

• The seeming difficulty may not be a “show-stopper”

• To every problem is a solution! We only need to find the right one.

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Thank You

Tim Adetona

Voisin Consulting

3 rue des Longs Pres

92100 Boulogne France

Tel: +33 1 41 31 83 02

Mob: +41 7 95 49 38 12

email: adetona@voisinconsulting.com

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