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GRAS Notice 849, Inulin from Artichoke GRAS Notice (GRN) No. 849 https://www.fda.gov/food/generally-recognized-safe-gras/gras-notice-inventory. Toi• Strategies Innovative solutions FEB 11 2019 Sound science OFFICE OF FOOD ADDITIVE SAFETY February 7, 2019 Richard Bonnette Office of Food Additive Safety (HFS-200) Center for Food Safety and Applied Nutrition Food and Drug Administration 5100 Campus Drive College Park, MD 20740-3835 Subject: GRAS Notification - lnulin from Jerusalem Artichoke Dear Mr. Bonnette: On behalf of Intrinsic Organics, 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, inulin (from Jerusalem Artichoke), 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 (except infant formula). If you have any questions or require additional information, please do not hesitate to contact me at 630-352-0303, or [email protected]. Sincerely, Donald F. Schmitt, M.P.H. Senior Managing Scientist ToxStrategies, Inc., 931 W. 75th St., Suite 137, PMB 255, Naperville, IL 60565 Office (630) 352-030 • www.toxstralegies.com GRAS Determination of Inulin from Jerusalem Artichoke ·for 0fU,te in Food Innovative solutions Sound science GRAS Determination of Inulin from Jerusalem Artichoke for Use in Food SUBMITTED BY: Intrinsic Organics, LLC 1410 Organic Way Weiser, Idaho 83672 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 CONTACT FOR TECHNICAL OR OTHER INFORMATION Donald F. Schmitt, MPH ToxStrategies, Inc. 93 l W. 75 th St., Suite 137, PMB 255 Naperville, IL 60565 DECEMBER 21, 2018 2 Table of Contents 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 Chemical Structure and Empirical Formula .................................................................. 8 Manufacturing Process ........... .......... .. ... .... .......... .................. .... .. ..... .... ................ .. ........ 9 Product Specifications ..................................................................................................... 10 Stability Data .......... ... ......................... .. .... .................. .... ....... ... .............. .... .. .... ............ 16 § 170.235 Part 3, Dietary Exposure 17 § 170.240 Part 4, Self-Limiting Levels of Use 23 § 170.245 Part 5, Experience Based on Common Use in Food 24 § 170.250 Part 6, GRAS Narrative 25 History of Use and Regulatory Approval of lnulin and Fructooligosaccharides (FOS) ................................................................................................................................. 25 Safety ................................................................................................................................. 26 Introduction ..................... ..... .. .. ... .......... .. .. ..................... ... ....... .. ......... ..... .... ........... .... .. 26 Safety Data ... ............. .. ... ...... ... ............. .... .... .... ............. .. ........ .. .. ... ......... ......... ............. 27 Basis for the GRAS Determination ................................................................................ 34 Introduction ..... .................. ..... ... .... ................ ..... ................. .. .. .................. ................... 34 Safety Determination .. ........ .. .. ... .... ..... .... ...... .. ... .. .. ...... .. ... ............. .. ...... ... .. .................. 34 3 General Recognition of the Safety of Inulin Sourced from Jerusalem Artichoke ..... 36 § 170.250 Part 7, Supporting Data and Information 39 References ......................................................................................................................... 39 Appendix A Certificates of Analysis and Analytical Results Exhibit 1 Report of the Expert Panel List of Figures Figure 1. Structure of inulin containing a terminal glucopyranose unit (GFn) .............. 8 Figure 2. Inulin manufacturing process .......................................................................... 9 List of Tables Table 1. Specifications for !OF-SYRUP ....................................... ............................. 10 Table 2. Specifications for IOF-POWDER ................................................................. 11 Table 3. Analytical results for three non-consecutive batches of IOF-SYRUP .......... 12 Table 4. Individual heavy metals analytical results for a representative batch of !OF-SYRUP .................................................................................................. 13 Table 5. Analytical results for three non-consecutive batches of IOF-POWDER ...... 14 Table 6. Heavy metals analytical results for a representative batch ofIOF- POWDER ...................................................................................................... 15 Table 7. lnulin and oligofructose found in food sources eaten by Americans 1 .......... I 8 Table 8. Mean daily intakes of inulin and oligofructose in American diets 1.2 ............ 18 Table 9. Proposed food use categories and use levels of inulin .......................... 19 4 List of Acronyms ACF aberrant crypt foci ADME absorption, distribution, metabolism and excretion AIL acceptable intake level AOM azoxymethane CAS Chemical Abstracts Service CFR Code of Federal Regulations cfu colony forming unit cGMP current Good Manufacturing Practice CVM Center for Veterinary Medicine DP degree of polymerization EC European Commission EFSA European Food Safety Authority EU European Union FAO Food and Agriculture Organization of the United Nations FDA Food and Drug Administration FOS fructooligosaccharides FSANZ Food Standards Australia New Zealand FSIS Food Safety and Inspection Service GFR glomerular filtration rate GI gastrointestinal GMP Good Manufacturing Practice GRAS Generally Recognized as Safe GRN GRAS Notification lgA immunoglobulin A IgAN immunoglobulin A nephropathy lnuL long-chain inulin InuS short-chain inulin IOF Intrinsic Organics Full-spectrum inulin JA Jerusalem Artichoke JECFA Joint F AO/WHA Expert Committee on Food Additives OAS oral allergy syndrome ppm parts per million U.S.C United States Code USDA United States Department of Agriculture VLCI very long-chain inulin WHO World Health Organization 5 § 170.225 Part 1, GRAS Notice: Signed Statements and Certification (1) GRAS Notice Submission Intrinsic Organics, LLC (Intrinsic Organics), 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 for the use of inulin from Jerusalem Artichoke in human food. (2) Name and Address Intrinsic Organics, LLC 1410 Organic Way Weiser, Idaho 83672 (3) Name of Notified Substance The name of the substance that is the subject of this Generally Recognized as Safe (GRAS) notification is "inulin (from Jerusalem Artichoke)". The proposed inulin product is derived from Jerusalem Artichoke (Helianthus tuberosus), a member of the Asteraceae family. (4) Intended Use in Food lnulin is intended for use as a bulking agent in food for human consumption (except for infant formula), in which it serves as a source of a reduced-energy carbohydrate, for use as a sugar replacer, humectant, fat-replacer, and/or texture modifier as well as a source of non-digestible dietary fiber. The inulin ingredient that is the subject of this GRAS determination is proposed only as an alternative to other inulin ingredients, and the daily consumption of inulin is not expected to increase as a result of its introduction. (5) Statutory Basis for GRAS Determination Intrinsic Organics, through its agent ToxStrategies,
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