Food

Search Submitted 75-Day Premarket Notifications for New Dietary Ingredients

The list of notifications provided on this page contains notifications that we reviewed during fiscal year 2015. Other notification responses may be found on our Dockets Management Web site. The notifications are organized by fiscal year and are searchable by:

  • notification number;
  • ingredient name;
  • and the name of the firm that submitted the notification.

The information for each New Dietary Ingredient notification that is available using this Web site is the same information that is available at the Dockets Management Web site and the Division of Dockets Management (Dockets). However, some of these notifications contain copyrighted material that can only be obtained through a Freedom of Information (FOI) request or viewed at Dockets. You may view the New Dietary Ingredient notifications inclusive of copyrighted material at: Dockets Management Branch, Food & Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. If you would like a hard copy or a copy on CD-ROM of a New Dietary Ingredient notification with the copyrighted material, you may submit a FOI request to: Freedom of Information Staff, Food & Drug Administration, 5600 Fishers Lane, HFI-35, Rockville, MD 20857. For information on how to submit a FOI request, you may wish to refer to “A Handbook for Requesting Information and Records from FDA”. There is a cost for duplicating this material under the Freedom of Information Act.

You can sort the entries by each column header.

NDIN # FY New Dietary Ingredient Firm
NDIN 845 2015 Hyrdolyzed Sardine Protein Senmi Ekisu Co. Ltd.
NDIN 846 2015 L-Cysteine Glutathione Mixed Disulfide (CySSG)  Max International LLC
NDIN 847 2015 N-methylglucamine Dynamis Family of Companies
NDIN 848 2015 Algamune Algal Scientific Corporation
NDIN 849 2015 Amorphophallus konjac extract Unitika Ltd.
NDIN 850 2015 Red Fruit Extract (Pandanus conoideus Lam)
NDIN 851 2015 Astragalus dasyanthus (67%) herbal tea SaTek USA LLC
NDIN 852 2015 Astragalus dasyanthus (67 – 72%) herbal tea SaTek USA LLC
NDIN 853 2015 Carotenoid dicarboxylic acid glycosides (crocin) and carotenoid Quality Phytochemicals LLC
NDIN 854 2015 Lactobacillus johnsonii Microbio Pharma, Inc.
NDIN 855 2015 Ankascin 568-R Sunway Biotech Company, Ltd
NDIN 856 2015 Triticum Aestivum L E.P.I. France SARL
NDIN 857 2015 B-1,3-Glucan extracted from the microalgae Euglena Gracilis Klebs Algal Scientific Corporation
NDIN 858 2015 Reishimmune, Ganoderma Microsporum immunomodulatory protein (GMI) TomiLab LLC
NDIN 859 2015 Ceratonia silique L. Tru-Science LLC
NDIN 860 2015 Carotenoid Glycosides Quality Phytochemicals LLC
NDIN 861 2015 Algae powder derived from Schizochytrium Solarvest (PEI) Inc.
NDIN 862 2015 Phyllanthus emblica, Oryza sativa, Gynostemma pentaphyllum, Arthrospira sp, Camellia sinensis, Moringa oleirera, Mangostana garcinia, Morinda citrifolia, Papaya leaf, Plu Kow C2 Global Energy
NDIN 863 2015 Antrodia camphorate mycelium powder SciLucent, LLC
NDIN 864 2015 Quinic acid and quinic acid chelates Lund University and Genetic Health Enterprises (GHE)
NDIN 865 2015 Huperzine A Alzheimer’s Organization
NDIN 866 2015 Distillate of eucalyptus, sweet orange, lemon, and myrtle essential oils G. Pohl Boskamp GmbH & Co. KG
NDIN 867 2015 Palmitoylethanolamide Cutting Edge Medical Solutions LLC
NDIN 868 2015 Rebound Maximum Immune Builder Sports Innovative Services
NDIN 869 2015 Abigenol Pharmaceutical Regulatory Services
NDIN 870 2015 N-Acetylneuraminic acid Neu5Ac Ventrine S de R.L. de C.V.
NDIN 871 2015 Bovine serum protein concentrate Keller & Heckman, LLP
NDIN 872 2015 Oleoylethanolamide NutriForward, LLC
NDIN 873 2015 Auricularia Auricular-Juade extract
NDIN 874 2015 Abigenol Pharmaceutical Regulatory Services
NDIN 875 2015 Abigenol Pharmaceutical Regulatory Services
NDIN 876 2015 Abigenol Pharmaceutical Regulatory Services
NDIN 877 2015 Radix campanumoeae, Colla corii asini, Radix ophiopogonis japanici, Radix astragali membranacei, Radix glycyrrhizae, Radix angelicae sinensis, Radix rehmanniae glutinosae, Tuber stephaniae glabrae, Rhizoma zingiberis, Ralmulous cinnamomi, Fructus zizphi jujubae, Semen ziziphi mauritianae, talc Amerturk, Inc.
NDIN 878 2015 Astragalus membranaceus Bung., Eleutherococcus senticosus Maxim., Phlomis umbrosa Turez. Neu Med, Inc.
NDIN 800 2014 Incarvillea sinensis Infinitum Health LLC
NDIN 801 2014 Premium Lakle Life Trade Company, Ltd.
NDIN 802 2014 Bifidobacterium lactis, Lactobacillus acidophilus, and Lactobacillus rhamnosus Global Suppleceutical Formulations
NDIN 803 2014 Bifidobacterium lactis, Lactobacillus acidophilus, and Lactobacillus rhamnosus Global Suppleceutical Formulations
NDIN 804 2014 Euphausia superba powder Olympic Seafood, AS
NDIN 805 2014 Pyrroloquinoline Quinone (PQQ) Nascent Health Sciences LLC
NDIN 806 2014 Bifidobacterium lactis, Lactobacillus acidophilus, and Lactobacillus rhamnosus Global Suppleceutical Formulations
NDIN 807 2014 Bifidobacterium lactis, Lactobacillus acidophilus, and Lactobacillus rhamnosus Global Suppleceutical Formulations
NDIN 808 2014 Lactobacillus Duo Probiotics Global Suppleceutical Formulations
NDIN 809 2014 7 AM Assure Probiotics Global Suppleceutical Formulations
NDIN 810 2014 Spoon a Day Amaranthus LLC
NDIN 811 2014 Sucanon Pharnmaroth Latin America
NDIN 812 2014 Xylooligosaccharides Shangdong Longlive Bio-Technology Co., Ltd.
NDIN 813 2014 DHA Algal Oil from Schizochytrium DSM Nutritional Products
NDIN 814 2014 Astaxanthin-rich Phaffia rhodozyma Igene Biotechnology, Inc.
NDIN 815 2014 Astaxanthin esters from Haematococcus pluvialis calastin Genovia Bio LLC
NDIN 816 2014 Lactobacillus Johnsonii 456 New Life 1 Genovia Bio LLC
NDIN 817 2014 Distillate of eucalyptus, sweet orange, lemon, and myrtle essential oils (d-EOLM) G. Pohl Boskamp GmbH & Co. KG
NDIN 818 2014 Chondroitin sulfate sodium Gnosis, S.p.A.
NDIN 819 2014 Fatty acid esters derived from anchovy or menhaden oil (Provenal) Tersus Pharmaceuticals, LLC
NDIN 820 2014 Palmitoylethanolamide (PEA) CHD Technologies, Inc.
NDIN 821 2014 GMI (Ganoderma microsporum immunomodulatory protein) Mycomagic Biotechnology Co., Ltd.
NDIN 822 2014 GMI (Ganoderma microsporum immunomodulatory protein) Mycomagic Biotechnology Co., Ltd.
NDIN 823 2014 Synthetic L-Ergothioneine Tetrahedron
NDIN 824 2014 Clinoptilolite Glock Health GmbH
NDIN 825 2014 Pyrroloquinoline Quinone (PQQ, synthetic) Nascent Health Sciences LLC
NDIN 826 2014 Omega-3 Polyunsaturated fatty acids (primarily eicosapentaenoic acid) Qualitas Health Inc.
NDIN 827 2014 L-Theanine Sato Pharmaceutical Co., Ltd.
NDIN 828 2014 Calcium Formate Nephro-Tech 1, LLC
NDIN 829 2014 Astaxanthin-rich Carotenoid Extract (ARE) JX Nippon Oil and Energy Corporation
NDIN 830 2014 Liquid chlorophyll Biobersa S.A. de C.V.
NDIN 831 2014 CO2 Supercritical extraction of the botanical Artemisia annua Promisia Integrative Ltd.
NDIN 832 2014 Justicia Gendarussa TryNatureFirst LLC.
NDIN 833 2014 Antrodia Camphorata (aka Antrodia Cinnamomea) mycelia extract Grape King Bio LTD
NDIN 834 2014 Cordyceps Cicadae Mycelia extract Grape King Bio LTD
NDIN 835 2014 Glycine mas (L.) Merrill (soybean) Grape King Bio LTD
NDIN 836 2014 Monascus purpureus [red yeast] fermented product Sunway Biotech Company Ltd.
NDIN 837 2014 1,6-bis [L-phenylalanin-N-alpha-amino] hexanediamide Smith-Ennismore Industries Limited
NDIN 838 2014 S-adenosylmethionine (SAMe) and its stabilitzing salt disulfate tosylate Farmasino Pharmaceuticals
NDIN 839 2014 Sideritis scardica Pirin LLC
NDIN 840 2014 Anatabine Rock Creek Pharmaceuticals Inc.
NDIN 841 2014 Lagerstroemia speciosa aka Banaba extract InQpharm (North America) LLC
NDIN 842 2014 Lactobacillus johnsonii Microbio Pharma Inc.
NDIN 843 2014 Artemisia annua extract Promisia Integrative Ltd.
NDIN 844 2014 Astragalus dasyanthus and Astragalus membranacus mixtures SaTex USA LLC
NDIN 770 2013 Astragalus extract TA-65 Telomerase Activation Sciences a.k.a. TA Sciences
NDIN 771 2013 Ceramosides Powder Neutra E.P.I. France SARL
NDIN 772 2013 Myrtol: oil of eucalyptus, sweet orange, lemon, and myrtle G. Pohl Boskamp GmbH & Co., KG
NDIN 773 2013 Sodium butyrate Biolek Inc.
NDIN 774 2013 Ceramosides Powder E.P.I. France SARL and Seppic Inc.
NDIN 775 2013 Guanidinoacetic acid AlzChem AG
NDIN 776 2013 Premium Lakle Life Trade Co. Ltd.
NDIN 777 2013 Androst-3-5-diene-717-dione Proprietary Wellness
NDIN 778 2013 Laminaria hyperborea FMC BioPolymer Corporation
NDIN 779 2013 Tenostat Amarex LLC
NDIN 780 2013 Xylooligosaccharides Shangdong Longlive Bio-Technology, Co. Ltd
NDIN 781 2013 Moringa oleifera F&R Health
NDIN 782 2013 Citrus sinensis GRZ Pharma LLC
NDIN 783 2013 Origanum vulgare extract DSM Nutritional Products
NDIN 784 2013 Streptococcus oralis 89a NuBiome, Inc.
NDIN 785 2013 Essence of Yunzhi PNP Pharmaceuticals, Inc.
NDIN 786 2013 Inositol stabilized arginine silicate (Nitrosigine) Nutrition21
NDIN 787 2013 Calcium sennonsides (SennaBiotics) Jiva Pharma Inc.
NDIN 788 2013 Sucanon (dried root radix Trichosanthes) Jeiven Pharmaceutical Consulting, Inc.
NDIN 789 2013 Petasites hybridus leaf extract (#Ze 339) Zarbee's Inc.
NDIN 790 2013 Premium Lakle Trade Co., Ltd.
NDIN 791 2013 G.D. Antrodia Camphorata Golden Biotechnology Corporation
NDIN 792 2013 Polysaccharide Peptide (PSP) and extract from Trametes versicolor [L.] Wonder Herb USA
NDIN 793 2013 Myrciaria cauliflora Laboratorio Catarineense S/A
NDIN 794 2013 Eugenia uniflora Laboratorio Catarineense S/A
NDIN 795 2013 Sarrencia purpurea Gowey Research Group, PLLC/Dr. B's Natural Remedies, LLC
NDIN 796 2013 Eucalyptus, sweet orange, lemon, and myrtle essential oils distillate (d-ELOM) G. Pohl Boskamp GmbH & Co., KG
NDIN 797 2013 3-Phytase Tolerase P DSM Nutritional Products
NDIN 798 2013 Bovine hemoglobin powder (OptiFer) Meditech/FerroCare
NDIN 799 2013 Zinc carnosine Twinlab Corporation

 

Page Last Updated: 03/13/2017
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