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  1. Prof. Shubini A Saraf Govind Yadav 1
  2. Contents:  Introduction  Function of labels  Objective of labels  Contents in labels  Regulation of nutraceutical labeling in India  Labeling system in Japan  Different labels 2
  3. Introduction Label :- ( As per IP) Any printed packing material, including package inserts that provide information on the article The oxford dictionary defines a label as “a slip of paper, card, liner, metal for attaching to an object and indicating its nature, owner, name,etc 3
  4. Function of labels  To identify the product  Provide ingredients  Purpose /use of the product  Decoration as evidence  Child safety  Other information like maximum retail price(MRP), Batch NO, Shelf-life,etc 4
  5. Objective of labeling 5
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  8. Who uses product labeling  Pharmaceutical Food Personal care  Bio-tech Beverages Cosmetics  Medical devices  Nutraceuticals 8
  9.  To Summarize - Which Information Is Mandatory? Labeling of packaged food products shall include the following information: 9
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  15. Contents in a Nutraceutical label 15
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  18. Regulation of Nutraceuticals in India  No clear regulatory framework exists: ◦ The Prevention Of Food Adulteration Act, 1954 ◦ Food Products Order ◦ Drugs and Cosmetics Act (Ayurvedic, Unani & Siddha Drugs Technical Advisory Board) ◦ The Drugs And Magic Remedies (Objectionable Advertisements) Act, 1954 18
  19. Food Safety and Standards Authority of India 2011 General Requirements:  Every pre-packaged food shall carry a label containing information  Label in pre-packaged food shall be applied in such a manner that they will not become separated from the container 19
  20. Food Safety and Standards Authority of India 2011  The particulars of declaration required under these regulations to be specified on the label shall be in English or Hindi  Pre-packed food shall not be described or presented on any label or in any label manner that is false, misleading 20
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  27. Labeling in Japan 27
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  31. Labeling in India 31
  32. New FDA Labeling Requirements  On May 20, 2016, the U.S. Food and Drug Administration (FDA) finalized significant changes to food, beverage, and supplement labeling, including updates to daily values, serving sizes, the Nutrition Facts chart, and more. The new rules become effective on July 26, 2016 and require most food 32
  34. Definition  INDIA: Food Safety and Standards authority (FSSA) defines Nutraceuticals as “Foods for special dietary uses” in India.  CANADA: In Canada Nutraceuticals are known as Natural health Products. Under the Natural Health Product Regulations.  AUSTRALIA: In Australia, traditional, herbal, natural and alternative medicines and remedies are referred to as ‘complementary medicines’. 34
  35. Regulatory Act(s) and Issues of India, Canada and Australia Country Regulatory act Regulatory issues India The Food Safety and Standard Act (FSSA), 2006 The Food Safety and Standard Authority of India (FSSAI), 2008 Manufacture, sell or import of novel foods, GMF, functional food, nutraceuticals and health supplements Canada Canadian Food and Drugs Act,2001 Natural Health Product Directorate (NHPD), 2003 Describe foods with health benefits Define nutraceutical Australia Therapeutic Goods Act 1989 FSANZ 1991 Regulation of CMs Develops food standards 35
  36. REGULATORY REGISTRATION PROCEDURE OF NUTRACEUTICALS IN INDIA, CANADA AND AUSTRALIA 1. Regulatory Registration Requirements in India A. Product Evaluation : Examination of each active ingredient & additive. B. Licenses: To get Product registered in India, number of licenses (almost 4 - 5) might be required, depending on the actual product status. 36
  37. C. Health and label Claims: “Health claims” means any representation that states, suggests or implies that a relationship exists between a food or a constituent of that food and health . Health claims can further be grouped into: 1. Nutrient function claims 2. Other function claims and 3. Reduction of disease risk claims. 37
  38. 2. Regulatory Registration requirements in Canada Natural Health Products Regulations for Traditional medicines, Herbal remedies, homeopathic medicines, vitamins, minerals, probiotics, amino acids and essential fatty acids. A. Product licensing: A product licensing system requires that all licensed products display a Product identification 38
  39. Number prefixed by NPN/NPN-HM The number is issued once a product is authorized for sale in Canada by Natural Health Product Directorate. B. Evidence requirements for Safety & efficacy: The safety and efficacy of NHPs and their health claims must be supported by proper evidence C. Labelling: All NHPs must meet specific labelling requirements, to help us make safe and informed choices about the NHPs which are choosen to use. 39
  40. D. Site Licensing: A Site licence issued by the NHPD (Natural Health Products Directorate) gives the licensee authorization to manufacture, package, label and/or import NHPs. E. Good Manufacturing Practices: The site to meet GMPs as per Natural products Regulations. GMPs are to be employed to ensure product safety and quality. 40
  41. F. Adverse Reaction Reporting: The Natural Health Products Regulations require product licence holders to monitor all adverse reactions related to their product. License holders must report serious adverse reactions to Health Canada. G. Clinical Trials: A clinical trial is when natural health products are tested using human subjects. 41
  42. Health Claims: a health claim for food is considered to be “any representation in labeling and advertising that states, suggests, or implies that a relation exists between the consumption of foods or food constituents and health”. Types: 1. Specific health claims: are claims about the effects of a food, or food constituent, on a specific organ, disease, biomarker, or health condition. 42
  43. There are 2 types of specific health claims: A. Disease risk-reduction claims. B. Function claims. 2. General health claims: are claims that do not refer to a specific health effect, disease or health condition . 43
  44. 3. Regulatory Registration requirements in Australia CMs in Australia are regulated under the following legislation:  Therapeutic Goods Act 1989  Therapeutic Goods Regulations 1990 (as amended) 1) Product licensing: All CMs must be entered (on application to the TGA) in the ARTG. Regulation is on the basis of risk. Products can be either listed (low risk) or registered (higher risk). 44
  45. 2) Good manufacturing practice: All products must be manufactured in compliance with GMP. 3) Site licensing: The TGA licenses manufacturers and audits GMP compliance. 4) Labelling requirements: Registered medicines (higher risk) are identified on the label by AUST R followed by a unique number. Listed medicines (low risk) are identified on the label by AUST L followed by a unique number. 5) Post-market regulatory activity: The TGA takes a risk-based approach to post-market surveillance. 45
  46. Health Claims: Types 1. General level claims: General level claims are claims where the manufacturer has to make an assessment of the evidence supporting the claim prior to the product going to market, and to hold the evidence 2. High level claims:-  High level claims are those claims which make reference to a serious disease, including:  Claims that refer to the potential for a food or component to assist in controlling a serious disease or condition. 46
  47. COMPARATIVE STUDY OF REGULATORY REGISTRATION OF NUTRACEUTICLAS IN INDIA, CANADA AND AUSTRALIA S. No. India Canada Australia Definition FSSA define Nutraceutical as “Foods for Special dietary use” NHPD define Nutraceutical as “Natural Health Products” TGA define Nutraceutical as “Complementary Medicines” Rules/Regulations for licensing and registration The Food Safety and Standards Regulations Natural Health Products Regulations Therapeutic Goods Regulations. Regulations came into force in year 2011 2004 1989 Responsible Regulatory authorities for Registration of Nutraceuticals Food Safety and Standard Authority of India (FSSAI) Natural Health Product directorate (NHPD), Health Canada Therapeutic Good Administration (TGA) 47
  48. Continued… Regulatory Requirements for Registration A. Product evaluation B. Licenses C. Health & label claim A. Product licensing B. Evidence requirements for Safety & efficacy C. Libeling D. Site Licensing E. GMP F. Adverse Reaction reporting G. Clinical Trials A. Product Application B. GMP C. Labeling D. Post-market Surveillance 48
  49. Continued… Fees for registration Rs. 100 Currently No fees required $AUS 720 Authorities for approval of claims FSSA Health Canada FSANZ Health Claims 1) Nutrient function claim, 2) Other function claims, 3) Reduction of disease risk claims General Health Claims Specific Health claims General Level Health Claim High Level Health claim 49
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  51. THANK YOU 51