GRAS Notice (GRN) No. 884 https://www.fda.gov/food/generally-recognized-safe-gras/gras-notice-inventory •. Tox Innovative solutions FEB 7 2019 Sound science OFFICE OF February 6, 2019 FOOD ADDITI\/c SAFETY Dr. Paulette Gaynor Office of Food Additive Safety (HFS-200) Center for Food Safety and Applied Nutrition Food and Drug Administration 5001 Campus Drive College Park, MD 20740-3835 Subject: GRAS Notification - Rice Bran Extract Dear Dr. Gaynor: On behalf of Florida Food Products, LLC, ToxStrategies, Inc. (its agent) is submitting, for FDA review, a copy of the GRAS notification as required. The enclosed document provides notice of a claim that the food ingredient, rice bran extract, described in the enclosed notification 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, for addition to food. If you have any questions or require additional information, please do not hesitate to contact me at 919-797-9938, or rhendersonr'q)toxstrategies.com. In addition, 1 will be your contact during the GRAS determination review process at FDA. Sincerely, Rayetta G. Henderson, Ph.D. Managing Scientist ToxStrategies, Inc., 1121 Milita,y Cutoff Rd., Suite C, Box 352, Wilmington, NC 28405 1 Office (919) 797-9938 • www.toxstrategies.com GRAS Determination of Rice Bran Extract for Use in Food DECElVIBER 12, 2018 Innovative solutions Sound science GRAS Determination of Rice Bran Extract for Use in Food SUBMITTED BY: Florida Food Products, LLC 2231 W. CR44 Eustis, FL 32726 SUBMITTED TO: U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Food Additive Safety HFS-200 5100 Paint Branch Parkway College Park MD 20740-3835 r CONTACT FOR TECHNICAL OR OTHER INFORMATION Rayetta G. Henderson, Ph.D. ToxStrategies, Inc. 1121 Military Cutoff Rd. Suite C, Box 352 Wilmington, NC 28405 DECEMBER 12, 2018 2 Table of Contents GRAS Determination of Rice Bran Extract for Use in Food ....................................... 2 List of Acronyms ............................................................................................................... 5 § 170.225 Part 1, GRAS Notice: Signed Statements and Certification ........................ 6 (1) GRAS Notice Submission ..................................................................................................... 6 (2) Name and Address ................................................................................................................ 6 (3) Name of Notified Substance ................................................................................................. 6 (4) Intended Use in Food ............................................................................................................ 6 (5) Statutory Basis for GRAS Determination .......................................................................... 6 (6) Premarket Approval Statement .......................................................................................... 6 (7) Availability of Information .................................................................................................. 7 (8) Data and Information Confidentiality Statement ............................................................. 7 (9) GRAS Notice Certification .......................................~ .......................................................... 7 (10) Name/Position of Notifier ................................................................................................... 7 (11) FSIS Statement ................................................................................................................... 7 § 170.230 Part 2, Identity, Method of Manufacture, Specifications, and Physical or Technical Effect ................................................................................................................. 8 Identity ........................................................................................................................................ 8 Common Names ......................................................................................................................... 8 Trade Name ................................................................................................................................ 8 Chemical/Structural Formulas .................................................................................................. 8 Rice Bran Extract Composition ................................................................................................ 8 Manufacturing Process .............................................................................................................. 9 Product Specifications ............................................................................................................. 11 Stability Data ................................................................................................................... 15 § 170.235 Part 3, Dietary Exposure ............................................................................... 16 Purpose ...................................................................................................................................... 16 Food Uses .................................................................................................................................. 16 Levels of Use ............................................................................................................................. 16 Estimated Exposure ................................................................................................................. 16 § 170.240 Part 4, Self-Limiting Levels of Use ............................................................... 19 § 170.245 Part 5, Experience Based on Common Use in Food ................................... 20 § 170.250 Part 6, GRAS Narrative ......•......................' ................................................... 21 History of Use and Regulatory Approvals ............................................................................. 21 Safety ................................................................................................................................ 22 Safety Assessment of Rice Bran Extract ................................................................................ 22 Studies on Rice Bran Extract .................................................................................................. 24 Animal Studies .. .. ... ............................. .... ......................... ........... ..... ....... ... ..... ...... .... ..... ........ 24 Studies in Humans ............................. .................. ........... .............. ..... .................... ......... .. ..... 25 Safety of the Components of the Rice Bran Extract ............................................................. 26 Phosphorus ................................. ............................................................................... .......... ... 27 Allergy ....................................................................................................................................... 28 Basis for the GRAS Determination ............................................................................... 30 Introduction .............................................................................................................................. 30 Safety Determination ............................................................................................................... 30 3 General Recognition of the Safety of Rice Bran Extract ...................................................... 32 § 170.250 Part 7, Supporting Data and Information ................................................... 35 References ........................................................................................................................ 36 Appendix A Analytical Results Appendix B Intake Assessment Report Appendix C Stability Testing Results Exhibit I Report of the Expert Panel 4 List of Acronyms AOAC Association of Official Agricultural Chemists bw body weight CCP critical control point CFR Code of Federal Regulations cfu colony-forming units cGMP current Good Manufacturing Practide CIR Cosmetic Ingredient Review CV cultivar EDI estimated daily intake EFSA European Food Safety Authority EU European Union FAO Food and Agriculture Organization of the United Nations FDA Food and Drug Administration FD&C Federal Food, Drug, and Cosmetic Act FGIS Federal Grain Inspection Services FNB Food and Nutrition Board (US) FSIS Food Safety and Inspection Service GIPSA Grain Inspection, Packers and Stockyards Administration GLP Good Laboratory Practice GMP Good Manufacturing Practice GRAS Generally Recognized as Safe GRN GRAS Notification HFD high-fat diet IOM Institute of Medicine LDL low-density lipoprotein NHANES National Health and Nutrition Examination Survey RDA recommended daily allowance RDI reference daily intake TPA 12-O-tetradecanoy lphorbol-13-acetate UL tolerable upper intake level u.s.c. United States Code USDA U.S. Department of Agriculture WWEIA What We Eat in America 5 § 170.225 Part 1, GRAS Notice: Signed Statements and Certification (1) GRAS Notice Submission Florida Food Products, LLC (Florida Food), through its agent, ToxStrategies, Inc., hereby notifies the U.S. Food and Drug Administration (FDA) of the submission of a Generally Recognized as Safe (GRAS) notice