AMWAY is a GLOBAL leader Second largest direct-selling company in - PDF document

4/29/13 Global T Trends i in Health S h Supplement Re Regulations National Regulatory Conference 2013 Kuala Lumpur, May 8, 2013 Michelle Stout Regulatory Policy Director, Amway AMWAY is a GLOBAL leader § Second largest direct-selling company in the world § 2012 Annual sales of more than $11.3 billion for Alticor Inc. § More than 450 products in more than 100 countries and territories supported by more than 20,000 employees § We’ve enabled more than 3 million distributors to achieve their dream of becoming entrepreneurs Helping people live better lives! 1

4/29/13 Amway R&D Using the power of science to help people live better lives Product Development Tech. Regulatory Quality § 900+ Global employees § 100+ technical advanced degrees § 70 PhD ’ s Chemistry, BioChemistry, Microbiology, Molecular Biology, Food Science, Food Technology, Nutritional Sciences, Horticulture & Plant Sciences, Chemical Engineering, Mechanical Engineering, Package Engineering, Toxicology, Quality Engineering, Pharmaceutical Sciences… Geography: ¡ North ¡America ¡ Employees: ¡552 ¡ (60%) ¡ Product ¡Development ¡ ¡324 ¡ Technical ¡Regulatory ¡ ¡ ¡ ¡ ¡63 ¡ Quality ¡ ¡ ¡ ¡193 ¡ Regions ¡ Key Employees: ¡368 ¡ (40%) ¡ Product ¡Development ¡ ¡ ¡ ¡98 ¡ ¡ Markets with labs QA lab only Technical ¡Regulatory ¡ ¡115 ¡ ¡ Quality ¡ ¡ ¡155 ¡ IADSA ¡ Established ¡in ¡1998 ¡ ¡ • Brings ¡together ¡food/health ¡supplement ¡associaHons ¡from ¡6 ¡conHnents ¡ • • World-­‑leading ¡experHse ¡in ¡science, ¡technical ¡and ¡regulatory ¡ ¡ ¡ • Focus: ¡ – Provide ¡an ¡internaHonal ¡plaNorm ¡for ¡debate ¡and ¡informaHon ¡exchange ¡with ¡ regulators, ¡scienHsts ¡and ¡internaHonal ¡experts ¡ – Support ¡development ¡of ¡scienHfically ¡sound, ¡legislaHve ¡and ¡poliHcal ¡ environment ¡for ¡the ¡food ¡supplement ¡sector ¡ • A ¡trusted ¡source ¡of ¡informaHon ¡about ¡regulatory ¡and ¡scienHfic ¡developments ¡in ¡ the ¡world ¡and ¡a ¡trusted ¡partner ¡for ¡many ¡governments ¡ ¡ 2

4/29/13 LegislaHon ¡in ¡development ¡ Austria Hong Kong Peru Australia Hungary Philippines Belarus India Poland Belgium Indonesia Romania Brazil Ireland Russia Brunei Israel Singapore Bulgaria Italy Slovakia Cambodia Japan South Africa Canada Kazakhstan South Korea China Laos Spain Colombia Latvia Sweden Croatia Lithuania Taiwan Czech Republic Luxembourg Thailand Cyprus Malaysia Turkey Denmark Malta United Kingdom Estonia Mexico United States Finland Myanmar Uruguay France Netherlands Venezuela Germany New Zealand Vietnam Greece Norway ASEAN ¡& ¡EU ¡HarmonizaHon ¡ � Focus of regulation Classification • Definition • Benefits and safety of food supplement ingredients. • Scientific justification of health claims • Quality of food supplements • Requirements for market access • Monitoring products once they are on the market. • 3

4/29/13 Why so much Regulatory Change? • Harmonization (EU 27+ / ASEAN 10) Codex Guidelines on vitamin & mineral supplements 2005 • • set limits based on scientific risk assessment, not multiple of RDI WTO and international trade obligations • • working toward alignment on SPS issues and reduction of TBT Consumer demand & consumer protection • • Estimated over US$100 billion global market by 2014 • Ensuring minimum standards across the sector to achieve goal of safe, quality and effective products Evolution to risk based approach as markets mature • Global ¡Supplement ¡Developments ¡ CODEX ( (Global): NRVs, Fish Oil Standard, Food Additives (Mg Stearate), New Spice/herb committee CAN ANAD ADA CHINA CHI NA RU RUSSIA Claims Revised Framework; Quality & Substantiation claims, ingredients, EUROP EUR OPE GMP standards market access (Guideline revision) (Health Food Provisions) Health Claims Botanicals USA US Vit/Min limits New Ingredients JAP APAN AN & GMP Health Claims Implementation INDIA INDIA KO KOREA NEW Health Health Claims LATIN AM AMERICA Supplement & (HFF Act Revision) Category Claims Regulations Vit/Min limits AS ASEAN AN Botanicals NEW Framework Claims (TMHS Harmonization AUSTRAL ALIA & National Regulations) Claims Substantiation (Guideline revision) 4

4/29/13 Supplement category • Vitamins & & M Minerals • Single & multiple vitamin/mineral products • Botanical & & H Herbs • Fruits, vegetables, spices, echinacea, garlic, ginseng, ginkgo biloba • Specialty S Supplements • Glucosamine, probiotics, fish oils/shark cartilage, bee products, CoQ10, amino acids Supplement Terminology • Cod Codex: ex: Vitamin & Mineral Food Supplements • AS ASEAN AN: Health Supplements • Australia: Au Complimentary Medicines • Brazi Br zil: Foods (no supplement category) • Ca Canada: Natural Health Products (NHP) • Chi hina: Health Foods • EU: EU: Food Supplements • Japan: Japan: Foods (no supplement category) • Kore Korea: a: Health Functional Foods (HFF) • Russia: Rus ia: Biologically Active Food Supplements (BAFS) • USA: A: Dietary Supplements 5

4/29/13 Regulatory Framework Cl Classi ssifica cati tion on Distribut Dist ribution ion Definit De inition ion Mar Market Ing Ingre redie dient nts Access Ac Supplemen Su ement t Framework Fr GMP/ / Additives/ / Qualit Quality y Excipie Ex cipient nts Labeling/ / Claims Cl ms Pa Packaging Supplement Classification Food Medicine Intermediate Law Law Brazil Colombia Australia China Central America Canada EU Malaysia ASEAN India (to be determined) Japan Korea Mexico Russia Taiwan Thailand USA Predominantly u under F Food L Law 6

4/29/13 Trends ¡in ¡ClassificaHon ¡of ¡Supplements ¡ Regulated under food law Regulated as an intermediate category Regulated as specific category under pharmceutical law Supplement Definition To supplement the diet Pu Purpose ose To provide nutrients or other substances with a nutritional Ro Role or physiological effect Include a range of substances, whether natural or Conten Con ent t artificial, ranging from vitamins and minerals to plants and substances of animal and mineral origin Form Fo Capsules, tablets, liquids, powders etc… 7

4/29/13 EU Food Supplements Directive EC/2002/46 : : “..foodstuffs the purpose of which is to supplement the normal diet and which are co conce centrated so source ces o s of n nutrie ients o s or o other su subst stance ces w s wit ith a a nutrit itio ional o l or p physio siolo logica ical e l effect ct, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to b be t take ken in in m measu sured sm small u ll unit it q quantit itie ies;” EU Food Supplements Scope o of i ingredients • Preamble (6)* “There is a wide range of nutrients and other ingredients that might be present in food supplements including, but not limited to, • vitamins, • minerals, • amino acids, • essential fatty acids, • fibre • various plants and herbal extracts 8

4/29/13 USA Dietary Supplements Dietary Supplement Health & Educations Act (DSHEA) - 1994 • a product (other than tobacco) intended to supplement t the he d diet and that contains one or more of the following dietary ingredients: • vitamin • mineral • herb or other botanical • amino acid • a dietary substance used to supplement the diet • a concentrate, metabolite, constituent, extract • combination of any ingredient (named above) • Intended for ingestion in tablet, capsule, powder, softgels, gelcap, or liquid form - or - • Cannot be represented as a conventional food or for use as the sole item of a meal or of the diet ASEAN Health Supplements Definition from ASEAN TMHS: ..any product that is use sed t to su supple lement a a d die iet and to main intain in, enhance ce and im improve t the h healt lthy f funct ctio ion o of h human b body and contains one or more, or a combination of the following: a. Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics and other bioactive substances b. Substances derived from natural sources, including animal, mineral and botanical materials in the forms of extracts, isolates, concentrates, metabolite It is presented in dosage forms (to be administered) in in sm small u ll unit it d dose ses such as capsules, tablets, powder, liquids and it shall not include any sterile preparations (i.e. injectable, eyedrops). 9