Introduction to DHSA 새로이발효된건강기능식품법의이해. Status of Functional Foods in Korea [ 심포지움 ] 김대병. Science, Industry & Consumers

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2004 년대한임상건강증진학회추계학술대회 Korean Society for Health Promotion and Disease Prevention [ 심포지움 ] 새로이발효된건강기능식품법의이해 김대병 식품의약품안전청 Science, Industry & onsumers Status of Functional Foods in

1 2004 년대한임상건강증진학회추계학술대회 Korean Society for Health Promotion and Disease Prevention [ 심포지움 ] 새로이발효된건강기능식품법의이해 김대병 식품의약품안전청 Science, Industry & onsumers Status of Functional Foods in Korea Academia Dai Byung Kim Korea Food and Drug Administration Industries onsumers Science, Industry, onsumers & Government Academia Introduction to DHSA onsumers Government Industries S123

2 Dietary Health Supplement Act Objectives To enhance public health and consumer protection To ensure safety and quality of Dietary Health Supplements Background Nov/29/00 Aug/26/02 Jan/31/04 Proposal for DHSA by Health & Welfare ommittee of National Assembly Declaration of DHSA Enforcement rules & regulations of DHSA Defines Dietary Health Supplement as, A product that is intended to use to enhance and preserve the human health by the functional food ingredients Authorizes KFDA (Korea Food and Drug Administration) to regulate dietary health supplements A product that is intended for ingestion in tablet, capsule, powder, granule, pill or liquid form Pre-market approval is mandatory. Requires evidences that a new active food ingredient is safe and effective before marketing, if it is not in the authoritative list of functional food ingredients and/or if petitioner wants specific claim(s). Requires establishing standards and specifications of a product containing preapproved active food ingredient(s) before marketing Before 2004 Food Hygiene Act Processed Foods Food Additives Food Packages Special Dietary Uses Infant Formulars Foods for Patients Nutrient Supplements Nutrient Function laims Enhanced Function laims Health Supplements Ginseng & its Products Fats & Oils Sugars... S124

3 After 2004 Food Hygiene Act Processed Foods Food Additives Food Packages Special Dietary Uses Infant Formulars Nutrient Function laims Foods for Patients Enhanced Function laims Fats & Oils Sugars... After 2004 (cont d) DHSA Generic DHS Product-specific DHS Nutrient supplements... Ginseng & its products... Health supplements... Nutrient Function laims Enhanced Function laims Reduction of Disease Risk laims for DHSs Nutrient function claim The link between a nutrient and function benefit (only for nutrient supplements) Example: Iron can help to make red blood cells Other function claim The link between the food ingredients and structure/ function benefit Example: X may help regulate bowel movements Reduction of Disease Risk laim The link between a food ingredients and the reduced risk of developing a disease Must be supported by totality of scientific evidence Example: X may reduce the risk of cardiovascular disease. Drugs Regulation: Pharmaceutical Affairs Act (PAA) Risk/benefit analysis Forms limited to tablet, capsule, powder, etc. Disease claims (Disease treat, cure, mitigate, and prevent) Drugs vs DHSs vs Foods DHSs Regulation: Dietary Health Supplement Act (DHSA) Min Risk Forms limited to tablet, capsule, powder, etc. Health benefit claims (Nutrient function, Other function and Reduction of disease risk) Foods Regulation: Food Hygiene Act (FHA) No Risk Forms: all allowed except for tablet, capsule, etc. No health benefit claims Evaluation of New Active Food Ingredients Overview of Evaluation of DHSs Evaluation of new active food ingredients Safety and Efficacy Evaluation of finished products containing approved active ingredient(s) - Standard/Specification ode of DHSs for generic DHSs Approval of product-specific DHSs S125

4 Flow of Safety & Efficacy Evaluation What is the Starting Point? Null hypothesis Submission of Documents Safety Evaluation Efficacy Evaluation Labeling of Efficacy Not effective Effective Body of evidence Not safe Safe Essential Requirements for Safety & Efficacy Evaluation Scientific evidences and/or documents to prove the safety of DHSs Scientific evidences (human intervention studies, cohort studies, animal studies, in vitro studies, etc.) to prove the efficacy of DHSs * Manufacturer/distributor has to provide KFDA with all scientific evidences that show the safety and efficacy of their products. Decision Tree for Safety Evaluation of DHSs Authorized food ingredient/no known side effects/no extract Authorized food ingredient/no known side effects/extract No food ingredient/side effect Purified or chemically modified natural food ingredient hemically synthesize compds GMO ingredients BT ingredients, Non-nutrient minerals and its extract Others H 2 O, EtOH, Hexane Ether, Acetone, Isopropyl alcohol, O 2 Other solvents Developed as drugs Developed as foods KFDA Approval Not approved Filtration Pur/onc NS intake change Sigf intake change A A A B or F F D F E A. No toxicology study required B. Risk Assessment. Baseline studies (1) Single-dose toxicity studies(rodents, non-rodents) (2) Repeat-dose toxicity studies(min 30 days, rodents) (3) Genotoxicity studies using (min two in vitro and one in vivo) D. Baseline studies (1) ~ (3) Reproductive toxicology studies arcinogenicity studies Immuno-toxicity studies D. Toxicology studies decided on case-by-case basis E. Not an ingredient allowed to use for health supplements Evidence-based Review of Efficacy Scientific Evidences linical/human studies Animal studies in vitro studies Epidemiological studies Review papers 1. Review of individual studies in terms of study type and quality 2. Review of totality of evidence in terms of amount, consistency and relevance 3. Report the rank and appropriate qualifying language S126

5 Standardized Language for Grade Appropriate language 1 SSA an help to reduce the risk of (disease) Evaluation of Finished Products 2 onvincing an have a benefitial effect on 3 4 Possible Insufficient May improve May increase (decrease). May have possibility to improve..., however the evidence is limited and not conclusive Overview of Evaluation of DHSs Evaluation of new active food ingredients Safety and Efficacy Evaluation of finished products containing approved active ingredient(s) - Standard/Specification ode of DHSs For generic DHSs Approval of product-specific DHSs Essential Requirements for Standards & Specification Evidence required to support the quality of finished dietary health supplements Identity Purity Quantity and Potency Tolerance limits of finished products - Tolerances in purity - Tolerances in quantity/potency Methods for Testing or examining ombinations Any combinations are allowed, as long as there are no safety concerns If there is a logical rationale for their combinations Advisory ommittee S127

Advisory ommittee Twenty outside advisers each in 2 committees One-day meeting every month Primary role To provide independent advice that will contribute to the quality of KFDA s regulatory

6 Advisory ommittee Twenty outside advisers each in 2 committees One-day meeting every month Primary role To provide independent advice that will contribute to the quality of KFDA s regulatory decision-making To lend credibility to the product review process. Labeling of on the Label Nutrition/Function Information laim(s) Serving size Per serving ontents % RDI alories 150 kcal arbohydrate 23 g 7% Protein 2 g 3% Lipid 6 g 11% Sodium 55 mg 2% Vitamin 11 mg 20% alcium 20 mg 7% % RDI : Percentage of Recommended Dietary Intake Pre-approved health benefit claim Information on the nutrient contents per serving & percentage of RDI S128

GUIDELINES FOR USE OF NUTRITION AND HEALTH CLAIMS

1 CAC/GL 23-1997 GUIDELINES FOR USE OF NUTRITION AND HEALTH CLAIMS CAC/GL 23-1997 Nutrition claims should be consistent with national nutrition policy and support that policy. Only nutrition claims that