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GRAS Notice 829, Dried Biomass of Aspergillus Oryzae Fermented With GRAS Notice (GRN) No. 829 http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/default.htm JHeimbach LLC November 21 , 2018 Paulette Gaynor, Ph.D. Senior Regulatory Project Manager Division of Biotechnology and GRAS Notice Review (HFS-255) Office of Food Additive Safety Center for Food Safety and Applied Nutrition Food and Drug Administration 5100 Paint Branch Parkway College Park, MD 207 40 Dear Dr. Gaynor: Pursuant to 21 CFR Part 170, Subpart E, Cura Global Health, Inc., through me as its agent, hereby provides notice of a claim that the addition of Koji Mineral products to conventional foods is exempt from the premarket approval requirement of the Federal Food, Drug, and Cosmetic Act because Cura Global Health has determined that the intended use is generally recognized as safe (GRAS) based on scientific procedures. As required, one copy of the GRAS monograph and one signed copy of the conclusion from each member of the Expert Panel are provided. Additionally, I have enclosed a virus-free CD-ROM with the GRAS monograph and the signed statements of the Expert Panel. If you have any questions regarding this notification, please feel free to contact me at 804-742-5543 or [email protected]. ,F.AC.N President Encl. 923 Water Street, P.O. Box 66, Port Royal Virginia 22535, USA tel. (+1) 804-742-5543 cell (+1) 202-320-3063 [email protected] Generally Recognized As Safe (GRAS) Determination for the Intended Use of Koji Fermented Mineral Products (Koji Mineral) Prepared by: JHeimbach LLC Port Royal Virginia November, 2018 Koji Fermented Mineral Products GRAS 1 JHEIMBACH LLC Table of Contents Table of Contents ................................................................................................................................ 2 Part 1: Signed Statements and Certification ........................................................................................ 3 1.1. GRAS Notice Submission ........................................................................................................ 4 1.2. Name and Address of Notifier ................................................................................................. 4 1.3. Name of Notified Substance .................................................................................................... 4 1.4. Intended Conditions of Use ...................................................................................................... 4 1.5 Statutory Basis for GRAS Status .............................................................................................. 5 1.6. Premarket Exempt Status ......................................................................................................... 5 1.7. Data Availability ...................................................................................................................... 5 1.8. Freedom of Information Act Statement ................................................................................... 5 1.9. Certification .............................................................................................................................. 5 1.10 FSIS Statement ........................................................................................................................ 5 1.11. Name, Position and Signature of Notifier .............................................................................. 5 Part 2: Identity, Methods of Manufacture, Specifications, and Physical and Technical Effect .......... 6 2.1. Name of the GRAS Substance ................................................................................................. 6 2.2. Source, Mineral Uptake, and Method of Manufacture of the GRAS Substance ..................... 6 2.2.1. Source ................................................................................................................................ 6 2.2.2. Mineral Uptake .................................................................................................................. 7 2.2.3. Method of Manufacture of Koji Mineral Products............................................................ 9 2.3. Specifications ......................................................................................................................... 12 2.4. Stability .................................................................................................................................. 17 Part 3: Intended Use and Dietary Exposure ...................................................................................... 18 Part 4: Self-limiting Levels of Use .................................................................................................... 21 Part 5: Experience Based on Common Use in Food ......................................................................... 22 Part 6: Narrative ................................................................................................................................ 23 6.1. Studies of the Use of Aspergillus oryzae Derivatives as Animal Feed Supplements ............ 23 6.2. Safety of Aspergillus oryzae .................................................................................................. 24 6.3. Safety of Aspergillus oryzae Products ................................................................................... 25 6.4. Safety of Koji Mineral ........................................................................................................... 31 6.4.1. Animal Studies ................................................................................................................ 31 6.4.2. Human Studies ................................................................................................................ 31 6.5. Safety Assessment and GRAS Determination ....................................................................... 32 6.5.1. Evidence of Safety .......................................................................................................... 33 6.5.2. Conclusion of the Expert Panel ....................................................................................... 33 Koji Fermented Mineral Products GRAS 2 JHEIMBACH LLC 6.6. Statement Regarding Information Inconsistent with GRAS..................................................34 6.7. Conclusion of the Expert Panel..............................................................................................35 Part 7: List of Supporting Data and Information ..............................................................................36 7.1. Published................................................................................................................................36 7.2. Unpublished ...........................................................................................................................38 List of Tables Table 1. Comparison Between Control and Koji Mineral Fe-S..........................................................8 Table 2. Specifications for Examples of Koji Mineral Products. ....................................................12 Table 3. Physical and Chemical Characteristics of Iron-Enriched Koji Mineral Fe-S. ....................13 Table 4. Physical and Chemical Characteristics of Multi-7 Minerals Enriched Koji Mineral. ........14 Table 5. Heavy Metals, Polycyclic Aromatic Hydrocarbons, and Mycotoxins in Three Batches of Iron-Enriched Koji Mineral Fe-S..........................................................................................15 Table 6. Heavy Metals, Polycyclic Aromatic Hydrocarbons, and Mycotoxins in Three Batches of Multi-7 Minerals Enriched Koji Mineral..............................................................................16 Table 7. Testing Results in 6-Month Accelerated Stability Study....................................................17 Table 8. Examples of Single Mineral Koji Mineral Products...........................................................18 Table 9. Koji Mineral Multi 7 Added at 250 mg/Serving.................................................................18 Table 10. Food Categories and Serving Sizes (RACCs)...................................................................19 Table 11. Estimated Daily Intake of Koji Mineral Added to Foods at 250 mg/Serving...................20 List of Figures Figure 1. Capillary Electrophoresis Image of Amplified DNA from Koji Mineral............................6 Figure 2. Koji Mineral Manufacture Process....................................................................................11 Koji Fermented Mineral Products GRAS 3 JHEIMBACH LLC Part 1: Signed Statements and Certification 1.1. GRAS Notice Submission Cura Global Health, Inc., submits this GRAS notification through its agent James T. Heimbach, president of JHeimbach LLC, in accordance with the requirements of 21 CFR Part 170, Subpart E. 1.2. Name and Address of Notifier Cura Global Health, Inc. Notifier Contact Zoraida DeFreitas Vice President, Marketing and Sales Cura Global Health, Inc. 2635 Food Science Bldg Iowa State University Ames, IA 50011 [email protected] +1 (515) 664-2446 Agent Contact James T. Heimbach, Ph.D., F.A.C.N. President JHeimbach LLC P.O. Box 66 Port Royal VA 22535 [email protected] +1 (804) 742-5543 1.3. Name of Notified Substance The subject of this Generally Recognized as Safe (GRAS) notification is Koji Mineral products, comprising a number of products based on Koji Mineral, the biomass of the Koji culture of Aspergillus oryzae fermented on a medium containing specified concentrations
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