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GRAS Notice (GRN) N0.887, Menaquinone-7

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GRAS Notice (GRN) N0.887, Menaquinone-7 GRAS Notice (GRN) No. 887, Menaquinone-7 https://www.fda.gov/food/generally-recognized-safe-gras/gras-notice-inventory SYNERGIA LIFE SCIENCES PVT. LTD. (CIN ; U24230MH2004PTC145390) Corporate Office: 1503, Universal Majestic, P. L. Lokhande Marg, Ghatkopar - Mankhurd Link Road, Govandi, Mumbai - 400 043, INDIA Phone No: +91 22 6266 9600. Email: [email protected] October 8, 2019 Food and Drug Administration £9a~CG~OW~ [Q) Center for Food Safety and Applied Nutrition Office of Food Additive Safety (HFS-200) OCT 2 1 2019 5100 Campus Drive OFFICE OF College Park, MD 20740 FOOD ADDITIVE SAFETY Subject: GRAS Notification for the intended use of lV[enaquinone-7 (MK-7) in oral nutritional supplements Dear Sir/Madam: In accordance with 21 CFR part 170, subpart E, Synergia Life Sciences Pvt. Ltd., (Synergia), Mumbai, INDIA, hereby submits the enclosed notice of a claim that the food ingredient Vitamin K2-7 (Menaquinone-7), derived from Bacillus licheniformis preparation for use in Foods for Special Dietary Use (21 CFR 105.3) in oral nutritional supplements such as PediaSure® for children ( 1 to 13 years of age) as described in the enclosed notification document is exempt from the premarket approval requirement of the Federal Food, Drug, and Cosmetic Act because it has been determined to be Generally Recognized As Safe (GRAS), based on scientific procedures. · As required, please find enclosed three copies of the notification. If you have any questions or require additional information, please feel free to contact me by phone at +91 22 62669600 or by email at [email protected] and [email protected]. Sincerely, Director Enclosure: Three copies of GRAS notification Reg . Office: 6/312, Jogani industrial Complex, V, N. Purav Marg, Chunabhatti (E), Mumbai - 400 022, INDIA Works : Gut No.IS. No. 65, H. No. 2 Paiki, At Village - Gatesh Budruk, Talathi - Saja Kone, Taluka - Wada, Dist. Palghar - 421 303. Maharashtra, India. (All Correspondence at Corporate Office only) CONCLUSION OF THE GENERALLY RECOGNIZED AS SAFE (GRAS) STATUS OF VITAMIN K2 (MENAQUINONE-7) FOR USE IN ORAL NUTRITIONAL SUPPLEMENTS FOR CHILDREN Prepared for: Synergia Life Sciences Pvt. Ltd., 6/312, Jogani Industrial complex, V.N. Purav Marg, Chunabhatti, Mumbai - 400022 INDIA Panel Members Leon J. Schurgers, Ph.D. Robert L. Martin., Ph.D. John A. Thomas, Ph.D., FATS, FACT Madhusudan G. Soni, PhD, FACN, FATS September 2 7, 2019 Synergia Page I of72 MK-7-GRAS CONCLUSION OF THE GENERALLY RECOGNIZED AS SAFE (GRAS) STATUS OF VITAMIN K2 (MENAQUINONE-7) FOR USE IN ORAL NUTRITIONAL SUPPLEMENTS FOR CHILDREN TABLE OF CONTENTS TABLE OF CONTENTS .................................................................................................. 2 1. PART I- SIGNED STATEMENTS AND CERTIFICATION ........................ 4 1.1. Basis of Conclusion: .............................. ............................................................. 4 1.3. Name and address of organization: ..................................................................... 4 1.4. Name of substance: ....................................... .... .. ................................................ 4 1.5. Intended conditions of use: ............................................................................. .. .. 4 1.6. Statutory Basis for GRAS conclusion: ............................................................... 5 I. 7. Exemption from Premarket approval requirements: ..... .. ................................. .. 5 1.8. Availability of data and information: ........................ .............. ........ .................... 5 1.9. Data exempt from Disclosure: ............................. ............................................. .. 5 1.10. Certification: ................... ................. ................................................................. 6 1.11. Name, position/title of responsible person who signs dossier and signature: ........................................................ .............................. .................. 6 1.12. FSIS/USDA - Use in Meat and/or Poultry: ...... ................................................ 6 2. PART II- IDENTITY AND TECHNICAL INFORMATION ................................... 7 2.1. Description ......... ............. .. .. ............................. ..................... .. ........ .................... 7 2.2. Specifications and Identity ....................... ............................................. .. ............ 7 2.3. Manufacturing Process ................................................. .. ............... ...................... 9 2.4. Biological Activity ....................................... ..................................................... I 0 3. PART III- DIETARY EXPOSURE ........................................................................... 12 3. I. Intended Uses and Food Categories .................................................................. 12 3.2. Methods for Estimates of Background and Proposed Uses .................... .......... 12 3.3. Estimates of Background Intake ...... .......................................... ................ ....... 13 3.4. Cumulative Intake from Background and Proposed Uses .... .. .. .................. ...... 14 3.5. Summary of Intake Assessment from Safety Perspective ........ ........... .......... ... 15 3.6. Consumption conclusion ................ .. ... .. .. .. .. ......... ... .. ....................................... 18 4. PART IV- SELF LIMITING LEVELS OF USE ...................................................... 20 5. PART V-EXPERIENCE BASED ON COMMON USE IN FOODS BEFORE 1958 ............................................................................................................................. 21 6. PART VI- NARRATIVE ............................................................................................ 22 Synergia Page 2 of72 MK-7-GRAS 6.1. Traditional and Current Uses ..................... ....................................................... 22 6.1.1. Traditional Uses ............. .............................. ......................................... ......... 22 6.1.2. Current Approved and other Uses ..................................................... ............. 22 6.1.3. Published Reports on Exposure to MK-7 ...................................................... 23 6.2. Data Pertaining to Safety .................................................................................. 24 6.2.1. Preamble ................................................ ... ..... .. .............................................. 24 6.2.2. Bioavailability and Metabolism ............. .... ... ........................................ ......... 25 6.2.3. Human Studies ............................................................................................... 27 6.2.3.1 . Human Clinical Studies and Observations .............. .... ............................... 28 6.2.4. Animal Toxicity and Genotoxicity Studies ................... ... .... .......................... 38 6.2.4.1. Acute Toxicity Studies ............................................................ .. .................. 38 6.2.4.2. Subchronic Toxicity Studies ............................................................. ... ....... 39 6.2.4.3. Genotoxicity Studies ......................... ............................................... ........... 41 6.2.5. Studies with MK-4 ...................................... ................................................... 42 6.2.5.1. Human Clinical Studies of MK-4 ............................................................... 42 6.2.5.2. Animal Toxicity Studies of MK-4 ............... .............................. ................. 46 6.2.6. Vitamin Kand Coagulation ........................................................................... 47 6.2.6.1. Vitamin K and Anticoagulants ............................ .... .. ... .. ....... ...................... 48 6.2.6.2. Dietary Vitamin Kand Anticoagulation by VKAs ...... ............................... 50 6.2.6.3. Risk Related to the Use of VKAs .. ................................... ... ....................... 51 6.2.6.4. Stability of Anticoagulant Treatment.. ........................................................ 51 6.2.6.5. Low Dose Vitamin K Supplementation to Improve INR Stability ............. 52 6.2.7. MK-7 and Drug Interaction ............................................................... ... ......... 53 6.2.7.1. MK-7 Catabolism ................................................................................... ..... 54 6.2.7.2. MK-7 as a Ligand of SXR .......................................................................... 54 6.2.8. Institute of Medicine Report ................................................. ................ ... ... ... 55 6.2.8. European Food Safety Authority Review ..................................................... 56 6.3. GRAS Panel Review, Summary and Discussion .. ................ .................... ........ 56 6.4. GRAS Panel Conclusion ........ .......... ................... ..................... ...................... ... 60 7. PART VII- LIST OF SUPPORTING DATA AND INFORMATION .................... 61 8. Appendix I .................................................................................................................... 71 9. Appendix II ................................................................................................................... 72 Synergia Page 3 of72 MK-7-GRAS 1. PART I- SIGNED STATEMENTS AND CERTIFICATION In accordance
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