NUTRACEUTICALS AND FUNCTIONAL FOOD - REGULATION OF NUTRACEUTICALS

NUTRACEUTICALS AND FUNCTIONAL FOOD - REGULATION OF NUTRACEUTICALS

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  12/11/2022 1 REGULATIONS OFNEUTRACEUTICALS Presented by Priyanka Chaudhary M.Pharmacy (Ayurveda) Lovely Professional University
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  12/11/2022 2 INTRODUCTION NUTRACEUTICAL NUTRITION PHARMACEUTICAL Theterm "Nutraceuticals" is the combination of two words "Nutrition” and "pharmaceutical" coined in 1989 by Stephen DeFelice, MD, founder and chairman of the Foundation for Innovation in Medicine (FIM)
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  12/11/2022 3 According toDeFelice Nutraceutical can be defined as, "a food (or part of a food) that provides medical or health benefits, including the prevention and/or treatment of a disease. DEFINITION Or It is “any non toxic food component that has scientifically proven health benefits including disese treatment or prevention”.
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  12/11/2022 4 CONTD…. Dietary supplement Food Supplements Foods for Special dietaryuse Natural Health Product Dietary supplement
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  12/11/2022 5 CLASSIFICATION OFNUTRACEUTICALS NUTRACEUTICALS DIETARY SUPPLEMENTS VITAMINS AND MINERALS HERBAL PROTEIN SUPPLEMENTS FUNCTIONAL FOOD AND BEVARAGES FUNCTIONAL FOOD PROBIOTIC FORTIFIED OMEGA FATTY ACID PROTEIN BARS AND OTHERS FUNCTIONAL BEVARAGES ENERGY DRINKS SPORTS DRINKS FORTIFIED JUICES
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  12/11/2022 6 LAWS GOVERNINGNEUTRACEUTICALS COUNTRY REGULATORYACT USA Nutrition labeling and Education Act (NLEA), 1940 Dietary supplement health and education act ( DSHEA), 1994 Food safety and modernization Act (FSMA), 2011 Food and Drug Administration (FDA) INDIA The Prevention of Food Adulteration Act, 1954 Food Products Order Drugs And Cosmetics Act Food safety standard and standards act(FSSA): 2006 Food safety and standards Authority of India (FSSAI), 2008 Food safety and standards Rules and Regulations, 2009 FSSAI, 2010
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  12/11/2022 7 NEPAL Dietarysupplement guideline,2016 (Ministry of Agriculture and livestock Development) CHINA State Food and Drug Administration of China (SFDA) EUROPE Functional Food Science in Europe (FUFOSE),1996 Regulations CANADA Natural Health Products Directorate (NHPD),2003 CONTD……. JAPAN Food for specified health use (FOSHU), 1991 Food with health claims (FHC),2001 Foods with Health claims (FNFC), 2005
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  12/11/2022 8 REGULATIONS OFNUTRACEUTICALS IN INDIA A food business operator may extract, isolate and purify nutraceuticals from food or non-food sources, that is preparing amino acids and their derivatives by bacterial fermentation under controlled conditions The nutraceuticals shall contain any of the ingredients specified in Schedule I or Schedule II or Schedule IV or Schedule VII or Schedule VII or Schedule VIII [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April,2022]
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  12/11/2022 9 Formulated as…
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  12/11/2022 10 Should notcontain…. Narcotic and psychotropic substance under the NDPS Act OR drugs listed in Schedule E(1) OF D$C Act Meant for oral administration
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  12/11/2022 11 Label mustcontain
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  12/11/2022 12 REGULATIONS OFNUTRACEUTICALS IN USA A dietary supplement is limited to products that are intended for ingestion in tablet, capsule, powder, gel and liquid form. IN case of ODI (Old dietary ingredient) no premarketing approval required from FDA But in NDI (New dietary ingredient) pre marketing is mandatory Drug must undergo FDA approval after clinical studies to determine effectiveness and safety. Manufacture is responsible for safety evaluation. Manufacture must submit information that ingredient within 75 days of marketing.  The USFDA has released GMP regulations for dietary supplements, applied to all the foreign and domestic companies. FDA has the authority to take action against any adulterated or misbranded dietary supplement product after it reaches the market.
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  12/11/2022 13 Labelling ofdietary supplements
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  12/11/2022 14 Contd…
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  12/11/2022 15 CONCLUSION Currently, nutraceuticalindustry is operating as a blend of regional regulations of different countries. The existing regulatory framework for nutraceuticals is disorganized with no global standards for compliance. Therefore harmonization of regulations is necessary to remove the regulatory flaws across the countries and to ensure the product quality.
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  12/11/2022 16 REFERNCES 1. VijayPal Dalmia. Law Of Nutritional & Supplemental Food Products In India - The Conflict: Food Or Drug?, Vaish Associates Advocates [Internet]. 2013 [cited 2013 Feb 12] 2. Food safety and standards authority of India [Internet] New Delhi [India] Food product standards and Food Additives (Amendment) Regulations, 2015 [cited 2015 Feb 17] 3. Sharma A, Kumar P , Sharma P , Shrivastav B. A Comparative Study of Regulatory Registration Procedure of Nutraceuticals in India, Canada and Australia. International Journal of Pharmaceutical Quality Assurance. [Internet] 2013 [cited 2013 October 13] 4(4): pg 61-66. 4. Pasumarthy N V Gopal, Kumar Lakshmi S, P Anusha, D Nagarjuna Reddy, M V Nagabhushanam. Comparison of registration process of Nutraceuticals and herbal supplements in India, US And Europe, an international journal of advances in pharmaceutical sciences[internet]. 2014 July [cited 2014 Aug] 6. Gnk, Ganesh & A., Ramachandran & V., Suresh & V., Senthil & Baviya, Priyadharshini. (2018). NUTRACEUTICALS - A REGULATORY REVIEW. International Journal of Drug Regulatory Affairs. 3. 22-29. 10.22270/ijdra.v3i2.165.
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