Understanding of Korean Regulation and Market. Apr 2, 2014 Yang-Hee Cho Korea Health Supplement Association

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Sabina Short
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1 Understanding of Korean Regulation and Market Apr 2, 2014 Yang-Hee Cho Korea Health Supplement Association 1

2 Marke&ng strategy emphasizing nature using product material & origin Ingredient Considera)on Product Specifica)on Product segmenta&on is persistent through detailed effects Increased interest in immunity & related product sales Immunity Market Diversifica)on of form Product A form convenient & that gives plea sure of ea&ng has increased Expand Target All- in- One Expanded target customer to 20 s~30 s & kids from current middle aged target. Communica)on Increase of mul& effec&ve product that contains mul&ple benefits Ad Communica)on Expansion Changed Adver)sing Concept Increased adver&sing expense du e to more TV ads Create issue with star- marke&ng of top celebri&es Change to emo&onal marke&ng concept emphasizing the material & authen&city Growth rate of HFF reduced from 28% to 3% in 2012 due to economy depression and decrea sed red ginseng business. Moreover, HFF market is expected to be stagnant due to recession. HFF production trend Top 6 ingredients in Korea (unit : 00mil won) 1) Decreased red ginseng production by 10% 2) Economy depression Vitamin / Mineral Omega-3 Oil + 3% -6 % + 28% 13,682 14,092 Red Ginseng 7,235 8,031 9,598 10,671 Probiotics 2, HCA (Garcinia Cambogia ex.) Glucosamine (2012 importing/manufacturing report, MFDS, modified KHSA) 2

3 Do you want to make the Claim on efficacy on food? Food NO YES Health Functional Food Food Sanitation Act (FS Act) Health Functional Food Act (HFF Act) 3

4 Production / Registration Delivery to Consumer Pre- market Approval Pre- market n o)fica)on GMP or HACCP Labeling requi rements Adver)sing Approval (KHSA) Post- market su rveillance Adverse event others Food (Food Sanit a&on Act) HFF (HFF Act) Product-specific ingredients Safety Generic ingredi ents Consumer HFF through Label, Ads, etc. Standar diza&on Efficacy 4

ingre dients Generic Ingredi ents Product-specifi c Ingredients

5 Positive list Food Sanitation Act Food Ingredient s Negative list Food Additives Ingredients for HFF HFF Act Functional ingre dients Generic Ingredi ents Product-specifi c Ingredients Nutrients Food Use Medical Use Then.. Traditional Medicinal Herbals? 5

6 Black Cohosh Echinacea Cistanche Devil s Claw 6

7 R&D Registration Production Distribution Functional ingredients HFF Scientific Substantiation of Claims Efficacy Safety Standardiza&on Human study Animal study In vitro study Distribu&on / Sales Intake history Toxicology data Manufacturing process Marker compound Specifica&on 7

8 Indica&on of a physiological func&on related to body growth/ enhance & normal func&on Improvement of func&on related to normal func&on or biological ac&vity of body, indica&on of health maintenance/ improvement ac&on Using level of diverse scien&fic Indica&on of related to occurrence of disease or decrease of health risk Using reachable level of scien&fic agreement Xylitol can decrease a risk of ge[ng a cavity " Using level of University textbook Calcium needs development of strong born. Nutrient fu nc)on (listed) Indiges&ble maltodextrin can be helpful for control of blood sugar. Bioac)ve func)on (premarket approved) Reduc)on of disease risk func)on (listed) USA / FDA Nutrient Claim Structure/Functional Claim (Qualified) Health Claim Nutrient Function Other Function CODEX Reduction of disease ris k claim 8

9 Current Issues in Korea? Diversity of Claim Claims (Claim research on DS and FF by Amway Korea, 2013) 9

Korean Working Group The only official industry group in HFF fi elds Focused on manufacturing company Amway is the only company in the advis ory board Chair : Amway Korea (Sangwoo Kim) Started on Sep.

industry Discussion on delivery routes How to deliver our opinions? KHSA Global Commicee? Seminar? Symposium?

10 Korean Working Group The only official industry group in HFF fi elds Focused on manufacturing company Amway is the only company in the advis ory board Chair : Amway Korea (Sangwoo Kim) Started on Sep Expectation : Another strong route to contact to gover nment Can influence on regulation with various Need more various route to deliver op experiences from foreign countries inion of import industry Discussion on delivery routes How to deliver our opinions? KHSA Global Commicee? Seminar? Symposium? Dec Visit to US Ambassy Discussion on issues, especially GMO labeling Oct Priori&za&on of Issues Nov Sep Brain stormin g on dra^ iss ues Short- term issues Expanding the scope of ingredient/raw materials Expanding claims for HFF GMO labeling Grace Period Long- term issues Innova&on in technology (e.g. nano, etc.) Overages/Tolerances applica&on in GMP 10

Expanding the scope of ingredients/raw materials for Supplements HFF 1) Even though the form(tablet, capsule, etc.) is the same as the drug, the scope of excipients is limited.

11 Expanding the scope of ingredients/raw materials for Supplements HFF 1) Even though the form(tablet, capsule, etc.) is the same as the drug, the scope of excipients is limited. 2) Some herbal raw materials that are widely used for food in foreign cou ntries are banned. Drug 1) All drugs containing unapproved ingredients must go through clinical tri als, even if those ingredients are already used for food/hff without any sa fety concerns (e.g. colorants lutein, etc.) Thank you 11

Market Entry and Regulation

Market Entry and Regulation Regulatory overview: Latest regulation landscape and market trends in South Korean Health Functional Food (HFF) and Processing Food Speaker: Sun-Ho Frank Kim, President, SEAH