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  1. New Dietary Ingredients (NDI) Notification Process

Submitted 75-Day Premarket Notifications for New Dietary Ingredients

The spreadsheet available for download from this page contains a list of publicly displayable New Dietary Ingredient Notifications (NDINs) that we have reviewed to date. For each NDIN, there is a link to information at http://www.regulations.gov relevant to that notification. The notifications are organized by the NDIN number and are sortable and searchable by:

  • NDIN number;
  • ingredient name;
  • name of the party that submitted the notification;
  • date of submission;
  • and date of FDA’s response.

The information for each NDIN that is available using this website is the same information that is available through FDA’s Division of Dockets Management (Dockets) and at http://www.regulations.gov. However, some of these notifications contain copyrighted material that can only be obtained through a Freedom of Information (FOI) request or viewed in person at the Dockets Public Reading Room. Please see FDA’s FOI website for more information on how to view materials in person or to submit a FOI request.

Note: The entries without an active link are in the process of being posted on Regulations.gov. Please check back for updates.

Download List of NDINs
1995 to the Present
(XLSX, 108 KB)


Recent Updates to the List of NDINs

For your convenience, the following are entries that have recently been updated.

New Dietary Ingredient Notification # Name of New Dietary Ingredient Firm Date of Submission Date of FDA's Response
1080 7-hydroxymatairesinol, a lignan component from Picea albies L. that will be marketed under the trade name of “Fountain of Life” Opulence Global 6/7/2018 8/2/2018
1081 D-chiro-inositol (DCI) derived from Ceratonia siliqua pods (Carob plant) Biosearch Life 7/9/2018 9/11/2018
1082 Bifidobacterium longum strain BORI (B. longum BORI) BIFIDO Co 7/24/2018 9/27/2018
1083 Enzolytics Pepsin From Porcine Supplement Spray (IPF) or Irreversible Pepsin Fraction Enzolytics Inc 8/6/2018 10/12/2018
1084 Ethyl-(alpha-guanido methyl) ethanoate aka alpha GEE Vireo Systems Inc 8/8/2018 10/18/2018
1085 Menaquinone-7 [MK-7] dipropropionate Kappa Bioscience 8/13/2018 10/23/2018
1086 Lactobacillus Plantarum CJLP55 CJ CheilJedang 8/15/2018 10/23/2018
1087 N-6-trimethyl-L-Lysine (TML) NeuroMetabolic Energy Solutions LLC 8/23/2018 10/30/2018
1088 Hamelia patens tea under trade name of CelSana Oral Tea Ontogeny Inc 8/25/2018 10/30/2018
1089 Lactobacillus paracasei strain KLB-1. Navigant Consulting 8/29/2018 11/6/2018
1090 Omega 7 fish oil Tersus Life Sciences Ltd 9/4/2018 11/15/2018
1091 Korean Red Ginseng Extract Korean Ginseng Corporation 9/7/2018 11/13/2018
1092 Bupleurum falcatum L. under trade name of ARI-BJ US Botanical Safety Laboratory 10/10/2018 12/4/2018
1093 Rehmannia glutinosa , Alisma orientale, Cornus officinalis, Paeonia suffruticosa, Poria cocos, and Dioscorea batatas under the trade name of ARI-YM AriBio Co., LTD 10/18/2018 12/19/2018
1094 5-Aminolevulinic Acid Phosphate with Sodium Ferrous Citrate (SFC) Neopharma Inc. 10/18/2018 12/19/2018
1095 Chicken Collagen derived from Freeze-Dried Chicken Bone Powder Performance by Science LLC 10/25/2018 12/19/2018
1096 Sophora japonica Linne (Leguminosae) fruit extract under trade name of Rexflavone Novarex 10/29/2018 1/9/2019
1097 7-hydroxymatairesinol, a lignan component from Picea albies L. that will be marketed under the trade name of “Fountain of Life” Opulence Global (a subsidiary of Global Wealth Trade Corporation) 11/2/2018 1/12/2019
1098 Tamarindus indica seed powder extract under trade name of TBP RPS Biologiques Inc 11/7/2018 1/31/2019
1099 Renovase (bioavailable glutathione) under trade name of 126 PLUS Solosale S.r.l. 11/8/2018 2/1/2019
1100 5-HTP or 5-hydroxytryptophan, or 5-hydroxy-L-tryptophan under trade name of Oxitriptan BiotecEra Inc. 11/12/2018 2/1/2019
1101 CelSana Dried Biomass Tea derived from leaves of Hamelia patens Ontogeny Inc 11/15/2018 1/29/2019
1102 Tetrapleura tetraptera (dried, grated, & sterilized fruit) Miracle Herbs Company 11/20/2018 2/1/2019
1103 Beta-alanine under trade name of Carnosyn or CarnoSyn® Beta-alanine (CAS 107-95-9) Natural Alternatives International, Inc. 11/20/2018 2/1/2019
1104 A tablet of magnesium, malic, and tartaric acids Natural Wellness Now Health Products Inc. 12/3/2018 2/12/2019
1105 Omega-7 fish oil under the trade name, Provinal® Tersus Life Sciences LTD 2/1/2019 3/22/2019
1106 DIL-10 Bionat Industrial 4/7/2019 6/6/2019
1107 Triacylglycerol Lipase from Candida cylindracea Amano Enzyme Inc. 4/11/2019 6/20/2019
1108 Lactobacillus Plantarum CJLP55 CJ CheilJedang 4/15/2019 6/20/2019
1109 Korean Dandelion Extract Powder Famenity Co. Ltd 4/16/2019 6/25/2019
1110 Hamelia patens (Hp) CelSana Beauty & Health, LLC 4/30/2019 7/10/2019
1111 Propolis Faida Gida Ilac Sanayi ve Ticaret Anonim Sirketi 5/16/2019 7/17/2019
1112 Menaquinone-7-dipropionate under the trade name, Proquinone® or PQ7® Kappa Bioscience AS 5/29/2019 8/1/2019
1113 Dietary nanofiber under the trade name, Dr. Hummel Nanofiber Gel NATURA-PRO KFT 6/5/2019 8/6/2019
1114 Ethyl-(alpha-guanido methyl) ethanoate under the trade name, Alpha-GEE® Vireo Systems, Inc. 6/18/2019 8/20/2019
1115 Safr’Inside™ Activ'Inside 6/18/2019 8/26/2019
1116 Cannaworx Compound Liquid Supplement Cannaworks, Inc. 6/19/2019 8/29/2019
1117 Cannabidiol (CBD) KBHEMP, LLC 6/21/2019 8/29/2019
1118 Bifidobacterium animalis subsp. lactis strain AD011 BIFIDO Co., Ltd 7/5/2019 9/16/2019
1119 Cirsium japonicum var. maackii (Maxim.) Matsum) Famenity Co. Ltd. 7/8/2019 9/19/2019
1120 PhaeoSOL Microphyt 7/9/2019 9/19/2019
1121 Mixed Plant Cell Wall Fibers AVVA Pharmaceuticals 7/17/2019 9/29/2019
1122 Cotinine HCl Capsulean LLC 7/22/2019 9/29/2019
1123 Bitter Orange (Citrus aurantium L.) Extract under the trade name, Advantra Z® Innophos LLC 8/5/2019 12/9/2019
1124 Gelidium elegans extract powder Newtree Company Ltd. 8/6/2019 10/16/2019
1125 7-hydroxymatairesinol under the trade name, Fountain of Life Opulence Global 8/13/2019 10/22/2019
1126 Mitragyna speciosa strain XML007 under the trade name, Kratura™ BD Botanicals Ltd. 8/15/2019 10/25/2019
1127 Korean Red Ginseng Extract Korea Ginseng Corporation 8/15/2019 10/25/2019
1128 Cannaworx Compound Liquid Supplement  Cannaworx, Inc. 8/31/2019 11/12/2019
1129 TI-11 under the trade name, FIBRO.P Gibeah Inc 9/9/2019 11/18/2019
1130 Sea Squirt Plasmalogen Oil VITAE CORP Japan Inc. 9/11/2019 11/18/2019
1131 Labisia pumila Aqueous Ethanolic Standardized Extract or SKF7 Orchid Life Sdn. Bhd. 10/15/2019 12/19/2019
1132 Mixed Plant Cell Wall Fibers AVVA Pharmaceuticals 10/25/2019 1/6/2020
1133 Ganoderma Microsporum Immunomodulatory Protein (GMI) Tomilab LLC
DBA Emerald Botanicals
10/31/2019 1/13/2020
1134 AB-Free Kava Kuality Herbceutics 11/22/2019 2/5/2020
1135  ZBGTECH Holding Compound Liquid Supplement ZBGTECH Holding, LLC 11/25/2019 2/6/2020
1136 Ethyl-(alpha-guanido methyl) ethanoate under the trade name, Alpha-GEE Vireo Systems Inc. 12/13/2019 2/25/2020
1137 Peptylin Braini LLC 12/24/2019 2/27/2020
1138 Bacillus clausii and Bacillus subtilis Ana Bio Research & Development JSC 1/13/2020 3/23/2020
1139 Magnesium Acetyl Taurinate under the trade name, ATA-Mg® AIDP Inc. 1/24/2020 3/31/2020
1140 ZBGTECH Compound Liquid Supplement ZBGTECH Holding, LLC 2/12/2020 4/23/2020
1141 Gynostemma pentaphyllum Extract US Natural Remedy Company 2/13/2020 4/27/2020
1142 Di-magnesium Citrate Glycinate Co-Salt Jost Chemical Company 2/28/2020 5/11/2020
1143 Labisia pumila Aqueous Ethanolic Standardized Extract or SKF7 Medika Natura Sdn Bhd. 3/4/2020 5/13/2020
1144 LYMBERUP® Gutis Ltd 3/9/2020 5/21/2020
1145 Cantech Pharma ImmuneBooster Cantech Pharma, Inc. 3/19/2020 5/29/2020
1146 Microchloropsis gaditana Buggy Power Group 4/16/2020 6/30/2020
1147 Greenyn Antrodia cinnamomea Mycelia under the trade name, Antromax Greenyn Biotechnology, Inc. 4/16/2020 6/12/2020
1148 Herbal dietary supplement from extracts of Croton membranaceus and Annona muricata (Prostat 60) Hermon Naturals 4/21/2020 7/1/2020
1149 Tetraselmis chuii Buggy Power Group 4/28/2020 7/8/2020
1150 Panax Ginseng Berry Concentrate AMOREPACIFIC 5/7/2020 7/16/2020
1151 Protetite®,  a composite product consisting of hydroxyapatite and collagen CBC Americas Corp. 5/7/2020 7/16/2020
1152 Cnidium officinale Makino AriBio Co., Ltd. 5/7/2020 7/16/2020
1153 Korean Red Ginseng Extract (KGRE) Korean Ginseng Corporation 5/18/2020 7/29/2020
1154 Anacardic acid extract from Pistachio kernels (Pistacia vera L.) Zymex Industries, Inc. 5/20/2020 7/29/2020
1155 Lactobacillus rhamnosus, strain DSM33426 in conjunction with Lactobacillus reuteri, strain DSM33016 Chr. Hansen Inc. 5/26/2020 8/7/2020
1156 Levilactobacillus brevis strain Lb-6108 Danisco USA, Inc. dba DuPont Nutrition & Biosciences 6/1/2020 8/13/2020
1157 Oleandrin Phoenix Biotechnology Inc. 6/2/2020 8/14/2020
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