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  1. Dietary Supplements

Submitted 75-Day Premarket Notifications for New Dietary Ingredients

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
624 Lignin hydrolyzed derived from wood chips of Picea abies (L.) H. Karst, Pinus silvestris L. var. mongolica Litv., Betula alba L. Ehrh, and Populus tremula f. pendula G. Kirchn (Filtrum-Safari) AVVA Pharmaceuticals AG 12/9/2009 2/22/2010
885 Panax Ginseng Berry Extract AmorePacific 9/22/2015 12/1/2015
887 Abigenol, dervied from Abies alba Mill. (european silver fir) bark extract (Rev.Up Wellness ENDURANCE) Portals Pharma, Inc. 10/2/2015 12/10/2015
888 Abigenol, dervied from Abies alba Mill. (european silver fir) bark extract (Rev.Up Wellness DEFENSE) Portals Pharma, Inc. 10/2/2015 12/10/2015
889 Abigenol, dervied from Abies alba Mill. (european silver fir) bark extract (Rev.Up Wellness VELOCITY) Portals Pharma, Inc. 10/2/2015 12/10/2015
972 Sophora japonica Linne fruit extract under trade name Rexflavone Novarex 1/10/2017 3/10/2017
974 Jodis concentrate, crude material for foodstuff iodination under trade name Jodis-Concentrate (JC) Vitel Line Company LLC 1/16/2017 3/10/2017
996 Pyrroloquinoline quinine (PQQ) disodium salt Zhejiang Medicine Company Ltd 2/24/2017 5/2/2017
999 Earthworm protein Bocom Pharmaceutical USA Corp 3/3/2017 5/15/2017
1013 Pyrroloquinoline Quinone (PQQ) Disodium Salt NutraLand 3/21/2017 5/31/2017
1017 Vege-Ca-scent Ascentin LLC 3/30/2017 5/5/2017
1026 Oxaloacetate (OAA) Terra Biological LLC 4/25/2017 9/8/2017
1027 Solanum dulcamara extract EcuaBIRM Cia, Ltda 4/28/2017 7/5/2017
1031 Vegcascent Ascentin LLC 5/10/2017 7/6/2017
1039 Curcumin 95% Cadila Pharmaceuticals Limited 5/23/2017 10/12/2017
1040 Fibraceb (Allium cepa) Biomeb 6/1/2017 8/8/2017
1041 Brain Factor-7 Silk Fibroin Peptide Famenity Company LTD 6/6/2017 8/11/2017
1042 Shea Olein Vermont Soap 6/12/2017 8/22/2017
1043 DeVertigo Tai L. Guo, PhD, DABT 6/21/2017 8/24/2017
1045 Lactobacillus salivarius CECT5713 Biosearch S.A. 7/7/2017 1/16/2018
1048 Fucoxanthin Algatechnologies 8/22/2017 10/31/2017
1049 Lactobacillus Coryniformis CECT5711 Biosearch S.A. 11/14/2017 1/16/2018
1050 AB Free kava Kuality Herbceutics 11/15/2017 1/19/2018
1051 Uva ursi Nuna Med LLC 11/15/2017 1/19/2018
1052 Bio-Hericium Tomilab LLC 11/16/2017 1/19/2018
1053 Bupleurum falcatum Linne Aribio Co. Ltd. 11/17/2017 1/19/2018
1054 Agave salmiana sap concentrate AGMEL S.A. DE C.V. 11/20/2017 1/19/2018
1055 Camellia sinensis PureGrab, LLC. 12/3/2017 1/30/2018
1056 Lactobacillus paracasei Katsuragi Sangyo, Co. 12/14/2017 2/22/2018
1057 Harmala powder Hyatt Life Sciences, Inc. 12/21/2017 2/28/2018
1058 Arum palaestinum powder Hyatt Life Sciences, Inc. 12/21/2017 2/28/2018
1059 Deep Ocean Minerals Concentrate Taiwan Yes Deep Ocean Water Co., LTD 12/19/2017 3/1/2018
1060 Korean Red Ginseng Extract Korean Ginseng Corporation 12/22/2017 3/5/2018
1061 Lactobacillus fermentum SBS-1 Danisco USA, Inc 12/22/2017 3/5/2018
1062 Nicotinamide Riboside Chloride ChromaDex, Inc 12/27/2017 3/7/2018
1063 Mitragynine extracted from Mitragyna speciosa American Botanical Corporation 1/2/2018 4/17/2018
1064 Creatine acesulfame Sweet Nutraceuticals 1/11/2018 2/8/2018
1065 Refined Shrimp Peptide Concentrate Marealis AS 2/6/2018 4/17/2018
1066 Freeze dried chicken bone powder Performance by Science LLC 2/7/2018 4/19/2018
1067 Astaxanathin-rich oleoresin Yunnan Alphy Biotech Co. Ltd 2/26/2018 5/2/2018
1068 Coriander seed oil Seppic Inc 3/1/2018 5/7/2018
1069 Moringa oleifera Farmer Fem Limited 3/16/2018 5/14/2018
1070 Anosohip (extracts from Silybum marianum, Trigonella foenum-graecum, and Matricaria recutita) SAFECURE LLC 3/19/2018 5/21/2018
1071 Ankascin 568-R (red yeast fermented product extracted from Monascus purpureus) SunWay Biotech Co. LTD 3/23/2018 6/1/2018
1072 ARI-JE (concentrated extract from Angelica gigas Nakai roots) Aribio Co. Ltd 4/11/2018 6/20/2018
1073 Anti-Chol (dried fruit of Tetrapleura tetraptera) Dr. Delali Kwami Agbodza 4/16/2018 6/26/2018
1075 Leader Antrodia Cinnamomea Capsule (LAC-Capsule) (mycelia powder of Antrodia cinnamomea) Taiwan Leader Biotech Corporation 4/16/2018 6/26/2018
1076 Agave salmiana sap concentrate AGMEL S.A. DE C.V. 4/17/2018 6/26/2018
1077 Folinic Plus James Grote 5/31/2018 7/18/2018
1078 Ceratiq phytoceramides Unexampled LLC dba Well Within 5/31/2018 7/18/2018
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
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
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
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
1102 Tetrapleura tetraptera (dried, grated, & sterilized fruit) Miracle Herbs Company 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