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GRAS Notice 791 for Urolithin A

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GRAS Notice 791 for Urolithin A Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004 Hogan T +1 202 637 5600 F +1 202 637 5910 Lovells www.hoganlovells.com By Federal Express JUN 1 5 2018 June 14 , 2018 OFFICE OF Office of Food Additive Safety (HFS-200) FOOD ADDITIVE SAFETY Center for Food Safety and Applied Nutrition Food and Drug Administration 5001 Campus Drive College Park, MD 20740-3835 Re: GRAS Notice for Urolithin A Dear Sir or Madam: On behalf of our client Amazentis SA (Amazentis), we hereby submit the enclosed GRAS notice for urolithin A, manufactured by Amazentis and intended for use among older adults (i.e., adults aged 40 years and above) as an ingredient in select foods or for special dietary uses in meal replacement products to support general mitochondrial health. As discussed in more detail in the GRAS notice, the intended uses include powdered (reconstituted) protein shakes, beverages (ready-to-drink protein shakes, non-milk based meal replacement beverages, instant oatmeal, protein and nutrition bars, and yogurts (Greek yogurts, high-protein yogurts, and yogurt drinks) at typical use levels of 250 mg/serving or 500 mg/serving up to a maximum of 500 mg/serving or 1,000 mg/serving, with an estimated aggregate intake of 1g/person/day . The statutory basis of Amazentis' GRAS conclusion is scientific procedures. Urolithin A is not intended for use in infant formula or meat, poultry, and egg products that would require additional regulatory review by the United States Department of Agriculture. The GRAS notice does not contain any designated confidential business information. In accordance with the agency's guidelines, we have enclosed one original copy of the GRAS notice, and one complete electronic copy of the GRAS notice on a compact disk (CD). We are committed to cooperating with the agency and believe an open dialog is one of the most effective ways to accomplish that objective. In that regard , we met with the agency staff twice on June 1, 2017 and May 22 , 2018 to discuss the GRAS notice submission. We want to thank the agency for the very helpful recommendations and input we received during these pre-submission meetings. If any questions arise in the course of your review, please contact us , preferably by telephone or e-mail, so that we can provide a prompt response. Hogan Lovells US LLP is a limited liability partnership registered in the District of Columbia, ~Hogan Lovells~ is an international legal practice that includes Hogan Lovells US LLP and Hogan Lovells International LLP , with offices in: Alicante Amsterdam Baltimore Beijing Berlin Brussels Caracas Colorado Springs Denver Dubai Dusseldorf Frankfurt Hamburg Hanoi Ho Chi Minh City Hong Kong Houston London Los Angeles Luxembourg Madrid Miami Milan Moscow Munich New York Northern Virginia Paris Philadelphia Prague Rio de Janeiro Rome San Francisco Shanghai Silicon Valley Singapore Tokyo Ulaanbaatar Warsaw Washington DC Associated offices: Budapest Jakarta Jeddah Riyadh Zagreb. For more information see www .hoganlovells.com \\DC - 032046/000001 - 12391696 v1 - 2 - June 14, 2018 Sincerely, (b) (6) Martin J. Hahn Partner Hogan Lovells US LLP [email protected] 202 637 5926 Cc: Renata Kolanos, Ph.D. Consumer Safety Officer Office of Food Additive Safety Division of Biotechnology and GRAS Notice Review Center for Food Safety and Applied Nutrition U.S. Food and Drug Administration E-mail: [email protected] \\DC - 032046/000001 - 12391696 v1 {II Amazentis GRAS NOTICE FOR UROLITHIN A PREPARED FOR: Office of Food Additive Safety (FHS-200) Center for Food Safety and Applied Nutrition Food and Drug Administration 5100 Campus Drive College Park, MD 20740 DATE: June 8, 2018 \\DC-032046/000001-12323833v8 GRAS Notice for Urolithin A TABLE OF CONTENTS PART 1. §170.225 SIGNED STATEMENTS AND CERTIFICATION ..................................................................... 1 1.1 Name and Address of Notifier............................................................................................. 1 1.2 Common Name of Notified Substance................................................................................ 1 1.3 Conditions of Use ................................................................................................................ 1 1.4 Basis for GRAS ..................................................................................................................... 2 1.5 Availability of Information................................................................................................... 3 1.6 Freedom of Information Act, 5 U.S.C. 552 .......................................................................... 3 PART 2. §170.230 IDENTITY, METHOD OF MANUFACTURE, SPECIFICATIONS, AND PHYSICAL OR TECHNICAL EFFECT ........................................................................................................................... 4 2.1 Identity ................................................................................................................................ 4 2.1.1 Common or Usual Name ........................................................................................ 4 2.1.2 Chemical Name ...................................................................................................... 4 2.1.3 Chemical Abstract Service (CAS) Number .............................................................. 4 2.1.4 Chemical Formula................................................................................................... 4 2.1.5 Molecular Structure .............................................................................................. 4 2.1.6 Molecular Weight................................................................................................... 4 2.2 Manufacturing..................................................................................................................... 5 2.2.1 Raw Materials and Processing Aids........................................................................ 5 2.3 Production Details and Schematics..................................................................................... 5 2.4 Product Specifications and Batch Analysis.......................................................................... 8 2.4.1 Chemical Specifications.......................................................................................... 8 2.4.2 Microbial Specifications ......................................................................................... 9 2.4.3 Batch Analyses........................................................................................................ 9 2.4.4 Microbiological Analysis....................................................................................... 11 2.4.5 Micronization of Urolithin A................................................................................. 12 2.4.6 Stability................................................................................................................. 14 PART 3. §170.235 DIETARY EXPOSURE........................................................................................................ 16 3.1 History of Use in Food ....................................................................................................... 16 3.2 Estimated Intake of Urolithin A from Proposed Use in Food............................................ 16 PART 4. §170.240 SELF-LIMITING LEVELS OF USE ....................................................................................... 19 PART 5. §170.245 EXPERIENCE BASED ON COMMON USE IN FOOD BEFORE 1958.................................... 19 PART 6. §170.250 NARRATIVE AND SAFETY INFORMATION ....................................................................... 19 6.1 Introduction....................................................................................................................... 19 6.2 Metabolic Fate .................................................................................................................. 21 6.2.1 Absorption, Distribution, Metabolism, and Excretion (ADME) in Animals .......... 21 6.3 Toxicological Studies ......................................................................................................... 23 6.3.1 Subacute Studies.................................................................................................. 23 6.3.2 Subchronic Toxicity Study .................................................................................... 23 AMAZENTIS SA i \\DC-032046/000001-12323833v8 6.3.3 Short-Term Tests for Genotoxicity....................................................................... 25 6.4 Other Published Toxicity Studies....................................................................................... 30 6.5 Corroborating Safety Evidence.......................................................................................... 30 6.6 Expert Panel ...................................................................................................................... 31 6.7 Conclusions........................................................................................................................ 32 PART 7. §170.255 LIST OF SUPPORTING DATA AND INFORMATION................................................. 34 List of Appendices Appendix 1 Estimated Daily Intake of Urolithin A by the U.S. Population from Proposed Food-Uses (2013-2014 NHANES) ............................................................................................................. 38 Appendix 2 Expert
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