Food

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 Notifications

For your convenience, the most recent notifications from 2017 - 2018 are listed below. 

New Dietary Ingredient Notification # Name of New Dietary Ingredient Firm Date of Submission Date of FDA's Response
1047 DHA concentrated ethyl ester algal oil DSM Nutritional Products, Inc. 8/14/2017 2/20/2018
1046 Methylphosphonic acid Aardsma Research & Publishing 7/28/2017 9/26/2017
1045 Lactobacillus salivarius CECT5713 Biosearch S.A.  7/7/2017 1/16/2018
1044 Bifidobacterium breve CECT7263 Biosearch S.A.  7/6/2017 9/18/2017
1043 ReaLemon and Kosher USP Grade Vegetable Glycerin under trade name  DeVertigo Tai L. Guo, PhD, DABT 6/21/2017 8/24/2017
1042 Shea Olein derived from Vitellaria paradoxa Gaertn. Vermont Soap 6/12/2017 8/22/2017
1041 Brain Factor-7 Silk Fibroin Peptide Famenity Company LTD 6/6/2017 8/11/2017
1040 Fibraceb derived from Allium cepa variety "Reca" and variety "Figueres" PharmaBioServ US 6/1/2017 8/8/2017
1039 Curcumin 95% Cadila Pharmaceuticals Limited 5/23/2017 10/12/2017
1038 Exfoliating backwash Joy and Kindness 5/21/2017 7/18/2017
1037 Joy and Kindness Joy and Kindness 5/21/2017 7/18/2017
1036 Exfoliating backwash Joy and Kindness 5/21/2017 7/18/2017
1035 Exfoliating backwash Joy and Kindness 5/20/2017 7/18/2017
1034 Myristic acid condensate ThirdWaveGlobal Trading Company, LLC 5/13/2017 7/18/2017
1033 Addium 3rd Generation:  Implied Odds 5/12/2017 7/17/2017
1032 Addium Twenty One Twelve 5/12/2017 7/6/2017
1031 A combination of vegetables and calcium Ascentin LLC 5/10/2017 7/6/2017
1030 Phosphoric acid food grade Guangxi Fangchenggang Duolin Chemical Co., LTD 5/10/2017 7/5/2017
1029 Liwa water American Society of Thermalism 5/2/2017 7/5/2017
1028 Quercus macranthera NutraLinks LLC 5/1/2017 7/5/2017
1027 Solanum dulcamara extract EcuaBIRM Cia, Ltda 4/28/2017 7/5/2017
1026 Oxaloacetate (OAA) Terra Biological LLC 4/25/2017 9/8/2017
1025 Singulair LILIANA YAZMIN CRUZ FLORES 4/25/2017 6/19/2017
1024 Lactobacillus paracasei FFT USA Corporation 4/24/2017 6/27/2017
1023 Rhodiola rosea Freedom of Purpose LLC 4/22/2017 6/27/2017
1022 Oxaloacetate (OAA) Terra Biological LLC 4/21/2017 9/8/2017
1021 Fucoxanthin extracted from alga Phaeodactylum tricornutum under trade names Fucoxanthin and FucoPro Algatechnologies 4/13/2017 6/19/2017
1020 Upload Globek USA 4/8/2017 5/5/2017
1019 Quality dist Quality Distributors 4/6/2017 5/5/2017
1018 Advocare Spark MariGoods 4/4/2017 6/2/2017
1017 A combination of vegetables (asparagus, spinach, broccoli, cauliflower, green and yellow squashes, cucumber, carrot, parsley, tomato, red and green peppers, and avocado) and calcium under trade name Vege-Ca-scent Ascentin LLC 3/30/2017 5/5/2017
1016 Manat Torsor Manat Torsor 3/29/2017 5/12/2017
1015 FenuGreek (Hulbo) Sauce Mama Weliya LLC 3/28/2017 5/12/2017
1014 NeoKimchi Phyto Symbio Tech Inc 3/25/2017 5/5/2017
1013 Pyrroloquinoline Quinone (PQQ) Disodium Salt NutraLand 3/21/2017 5/31/2017
1012 Hemp oil Honest Globe Inc 3/17/2017 5/30/2017
1010 Escavite D multi-vitamin Lames Salacheep 3/15/2017 5/12/2017
1009 Cassia angustifolia TVC Life Sciences Limited 3/14/2017 5/12/2017
1008 Avocado Oil Anthony Washington Industries LLC 3/13/2017 5/22/2017
1007 Curcuma longa TVC Life Sciences Limited 3/13/2017 5/12/2017
1006 Sesamum indicum TVC Life Sciences Limited 3/13/2017 4/4/2017
1005 Cassia angustifolia V.A. Worldwide Ltd 3/13/2017 5/12/2017
1004 Curcuma longa V.A. Worldwide Ltd 3/13/2017 5/12/2017
1003 Release essential oil blend La Pixie LLC 3/13/2017 5/5/2017
1002 Sesamum indicum V.A. Worldwide Ltd  3/13/2017 4/4/2017
1001 Biore Charcoal Cleanser Rattigan Plainbumrung 3/12/2017 5/5/2017
1000 Water Kefir SCOBY Immerse and Grow 3/9/2017 5/5/2017
999 Earthworm protein Bocom Pharmaceutical USA Corp 3/3/2017 5/15/2017
998 Novofertil Noveco Invest & Trade Corp 3/1/2017 4/4/2017
997 Lyophilized royal jelly powder Hangzhou Hefengyuan Health Food Co., Ltd. 2/28/2017 4/4/2017
996 Pyrroloquinoline quinine (PQQ) disodium salt Zhejiang Medicine Company Ltd 2/24/2017 5/2/2017
995 Aloe vera extract Nutrition & Balance 2/22/2017 4/4/2017
994 Seattle Pomade Co Seattle Pomade Company 2/20/2017 4/4/2017
993 Creatine Nitrate ThermoLife International LLC 2/17/2017 4/28/2017
992 Mitragynine derived from Mitragyna speciosa American Botanical Corporation 2/17/2017 4/28/2017
991 Adrafinil Gehirn Life LLC 2/16/2017 4/4/2017
990 Vitamin K  Viagem International Ltd 2/14/2017 4/4/2017
989 Product name not provided Viagem International Ltd 2/14/2017 4/4/2017
988 Vitamin K from dried kale Immobius 2/13/2017 4/4/2017
987 Pinon Pine Needles capsules derived from Pinus edulisEngelm KIKNBAC Assets LLC 2/3/2017 4/4/2017
986 Wakeup Nootropic, a combination of 300 mg Bacopa monniera and 300 mg Rhodiola rosea. Rubys Future LLC 1/31/2017 4/4/2017
985 HS1 Ingredient CrazyCurious 1/30/2017 4/4/2017
984 Superior Hemp Oil HoneyColony 1/30/2017 4/5/2017
983 Wakeup, a combination of 300 mg Bacopa monniera and 300 mg Rhodiola rosea. Rubys Future LLC 1/30/2017 4/4/2017
982 Silicon dioxide aka "Vegesil". Aqia Quimica Industrial LTDA 1/30/2017 4/4/2017
981 Product name (vitamin in capsule form) Not provided 1/29/2017 4/4/2017
980 Anese hydrating elixir Anese 1/29/2017 4/4/2017
979 Amazon   Whatsupstairs 1/27/2017 4/4/2017
978 NA-TBD Vitamin, Herb or other botanical (Fat burner in capsule form) BeachBody Solutions LLC 1/22/2017 4/4/2017
977 Svelo Shake Neurosciences Naturals LLC 1/18/2017 3/10/2017
975 Essential Oil Blend Jenna's Essential 1/18/2017 3/10/2017
974 Iodis concentrate, crude material for foodstuff iodination under trade name Jodis-Concentrate (JC) Vitel Line Company LLC 1/16/2017 3/10/2017
973 Bee venom JH Group Inc  1/12/2017 3/9/2017
972 Sophora japonica L. fruit extract under trade name Rexflavone Novarex 1/10/2017 3/10/2017
971 Boric Acid Natural Wellness Suppliers 1/7/2017 3/9/2017
970 Relief Magnesium Salve Eye of the Butterfly, LLC 1/7/2017 3/9/2017
969 Refined Shrimp Peptide Concentrate under trade name ProCardix Marealis AS 1/6/2017 3/9/2017
967 Protease from Penicillium citrinum Amano Enzyme Inc 12/6/2016 2/14/2017
966 Pinon Pine Needles derived from Pinus edulis Engelm. Plant Symbol = PIED KIKNBAC Assets LLC 12/21/2016 2/24/2017
964 Allium cepa extract under trade name "Fibraceb" or "Fibracep" Biomeb, Dietary Molecular Diagnostics SL 12/6/2016 2/13/2017
963 Refined DHA Oil Heliae Development LLC 12/1/2016 2/3/2017
962 Phlebodium aureum (L.) J. Sm. under trade name Fernblock (the NDI) and Heliocare (the dietary supplement containing the NDI). Ferndale Pharma Group, Inc 11/22/2016 2/3/2017
961 Astaxanthin-Rich Carotenoid extract derived from Paracoccus carotinifaciens under trade name ARE-1P and ARE-10P JX Nippon Oil and Energy Corporation 11/16/2016 1/19/2017
960 SpermHope Supplement derived from Glycyrrhiza glabra root extract. Med-Hija LLC 11/13/2016 1/18/2017
959 Matricaria chamomillaflowers -100% Arkada Market 11/9/2016 1/18/2017
958 Glycine max (L.) (soybean) whole broth extract from fermentation under trade name BioAid-995 Grape King Bio LTD 11/9/2016 1/18/2017
957 AstaPure oleoresin containing 10% astaxanthin esters from Haematococcus pluvialis Flotow under trade name AstaPure Algatechnologies 11/3/2016 1/10/2017
956 Bupleurum falcatum, One of 2 NDIs in NDI 954 (a mixture of 9 dried botanical extracts). Trade name ARI-BJ AriBio Ltd 10/28/2016 1/9/2017
955 Atractylodes japonica One of 2 NDIs in NDI 954 (a mixture of 9 dried botanical extracts). Trade name ARI-BJ AriBio Ltd 10/28/2016 1/9/2017
954 Dried aqueous extracts of 9 botanical herbs under trade name ARI-BJ; 1. Astragalus membranaceus 2. Atractylodes japonica 3. Angelica sinensis 4. Bupleurum falcatum 5. Zizyphus jujuba var. inermis. 6. Glycyrrhiza uralensis 7. Panax ginseng 8. Citrus unshiu 9. Zingiber officinale. AriBio Ltd 10/28/2016 1/9/2017
953 Shea butter Vermont Soap 10/28/2016 1/4/2017
952 Antrodia camphorata (aka Antrodia cinnamomea) mycelia extract under trade name Antrodia King Grape King Bio LTD 10/14/2016 12/21/2016
951 Huperzine A DvRyl International 10/7/2016 12/9/2016
950 Pterostilbene DvRyl International 10/6/2016 12/9/2016
949 S-Adenosyl Methionine (SAMe) DvRyl International 10/6/2016 12/9/2016
948 Sophora japonica Linne (Leguminosae) fruit extract under trade name Rexflavone Novarex 9/23/2016 11/30/2016
947 Blend of purified edible fatty acids derived from anchovy or menhaden oil, with palmitoleic acid (C16:1) under trade name Provinal TG Tersus Life Sciences LLC  9/16/2016 11/22/2016
946 Coconut oil, jojaba oil and shea olein for topical application to treat dry skin Chevy Jules 9/13/2016 9/29/2016
944 Mitrasafe derived from Mitragyna speciosa Industrial Chemical 9/8/2016 12/20/2016
943 Haematococcus Pluvialis extract containing astaxanthin esters under trade name AstaZine BGG North America, Inc. 9/1/2016 11/7/2016
942 Kangaroo Meat Powder Wellwisse Pharma Inc 8/26/2016 1/10/2017
941 Matcha Green Tea derived from Camellia Sinensis L. Fushishi Herbs 8/15/2016 9/29/2016
939 Dry Facial Clay Powder Southern Health Innovations LLC 8/9/2016 9/29/2016
938 Lactobacillus gasseri CECT5714, LC9 and Lactobacillus coryniformis CECT5711, K8 Biosearch S.A. [Biosearch Life] 7/22/2016 12/5/2016
937 HPMC, Hydroxypropyl methylcellulose capsule coating, called "Vegetable empty capsule shell" ACB Pharma Com, LTD 7/22/2016 9/29/2016
936 GABA produced from fermentation of Sea Tangle (Saccharina japonica) Marine Bioprocess Co. Ltd 7/20/2016 9/27/2016
935 Super Tumeric derived from Curcuma Longa Joy’s Remedy 7/8/2016 9/19/2016
934 Caryodendron orinocense under trade name Kahai Protein Powder Blend Kaibae 7/6/2016 1/3/2017
933 Bromelain [protease] Enzyme derived from Ananas comosus (pineapple plant) Excellent Biotechnologies 7/4/2016 8/18/2016
932 Astragalus D.P. herbal tea derived from Astragalus dasyanthus Pall SaTek Sweden HB 6/24/2016 9/1/2016
931 Hamelia patens (firebush or hummingbird bush) under trade name Cupio-Rase CelSana LLC 6/8/2016 8/16/2016
930 Glucevia, an extract from the samara of Fraxinus angustifolia Vahl Naturex SA 5/24/2016 8/4/2016
929 Crocus sativus undert trade name Premium Kashmiri Saffron Premium Health Foods LLC 5/21/2016 8/2/2016
928 Ceriporia lacerata under trade name CL EPS Onbix Corporation 5/19/2016 7/22/2016
927 Dietary supplement Zinc+ Copper+ Chromium under trade name Biochelate Zn-Cu-Cr Invex Remedies SP. Z.O.O. 5/10/2016 7/14/2016
926 Dietary supplement Zinc+ Copper+ Magnesium under trade name Biochelate Zn-Cu-Mg Invex Remedies SP. Z.O.O. 5/10/2016 7/14/2016
925 Dietary supplement with organic silica and boron under trade name SILOR+B Invex Remedies SP. Z.O.O. 5/10/2016 7/14/2016
924 Lactobacillus fermentum CECT5716 under trade name Hereditum LC40 Biosearch Life 4/26/2016 7/7/2016
923 Sea buckthorn seed oil derived from Hippophae Rhamnoides L. Qinghai Tsinghua Biotry Bio-Tech Co. LTD 4/21/2016 6/28/2016
920 L-5-MTHF-Ca (6(S)-5-methyl-tetrahydrofolic acid, calcium salt or L-5-methyltetrahydrofolicacid, calcium salt under trade name Magnafolate-C Lianyungang Jinkang Hexin Pharmaceutical Co 4/15/2016 8/29/2016
919 Sucupira seed from Pterodon Emarginatus Vogel under trade name NaturNurish Altto Natural Foods & Beverages, Inc 4/12/2016 6/21/2016
918 Cranberry extract (Vaccinium macrocarpon Aiton) with proanthocyanidins (PACs) under trade name Oximacro Biosfered S.r.l. 4/12/2016 6/21/2016
917 Caryodendron orinocense under trade name Kahai Protein Powder Blend Kaibae 4/8/2016 6/14/2016
916 Aster spathulifolius Extract Newtree Co, LTD 4/7/2016 6/14/2016
915 Candelilla wax derived from Euphorbia cerifera Organic Green Human & Co LLC 3/17/2016 5/23/2016
914 Astragalus D.P. herbal tea derived from Astragalus dasyanthus Pall SaTek USA LLC 3/10/2016 5/19/2016
913 Omega 3 fatty acid lysine salts Evonik Nutrition & Care GmbH 2/29/2016 5/9/2016
912 Gamma-Aminobutyric acid (GABA) and L-theanine under trade name Take5 Green Rose LLC 2/11/2016 4/20/2016
911 A proprietary blend of Ca Mg Na K under trade name Daily Peak Performance Root Cause Response, LLC 2/1/2016 6/7/2016
910 Copper Niacin C LAB Pharma International 2/1/2016 4/14/2016
909 Vegetable extract EcuaBIRM Cia, Ltda 1/29/2016 3/31/2016
908 Vitamin A, Vitamin E, Calendula Oil, Lavender Oil, Rosemary Oil and Chamomile Oil under trade name BIO OIL A&E Global Limited 1/19/2016 3/31/2016
907 Cystox  (L-2-oxothiazolidine-4-carboxylate) (CAS 19771-63-2) Scientific Cystems 1/7/2016 3/17/2016
906 Odyliresin Swiss Formula Food Supplement derived from Iresine celosia. Iresine International Inc 1/5/2016 3/16/2016
905 Amazon almond derived from Caryodendron orinocense Karsten. Kaibae 12/31/2015 3/2/2016
904 Pinulone derived from Pinus longaeva seedlings Forest Organics LLC 12/24/2015 2/25/2016
903 Steviol derived from leaves of Stevia rebaudiana (Bertoni) DSM Nutritional Products, Inc. 12/23/2015 3/1/2016
902 Cranberry extract (Vaccinium macrocarpon Aiton.) under trade name Oximacro Biosfered S.r.l.  12/11/2015 2/22/2016
901 Phlebodium aureum (L.) J. Sm. under trade name Fernblock and Heliocare Ferndale Pharma Group, Inc  12/18/2015 6/28/2016
900 Lactobacillus plantarum CJLP33 CJ Cheil Jedang 12/1/2015 2/8/2016
899 Antrodia camphorata under trade name Liverty Golden Biotechnology Corp. 11/30/2015 2/10/2016
898 Bifidobacteria and Lactobacilli 100 billion (Renew Life Ultimate Force) Midwest Cold Brew 11/25/2015 2/3/2016
897 Black ginseng extract concentrate (CJ EnerG) CJ Cheil Jedang 11/18/2015 1/27/2016
896 Combination of Sabel palmetto, Sabal minor, Serena repens, Washintonia robusta, Phoenix sylvestris, Quercus virginiana, and Quercus hemisphaerica (NutraCarbon) Life Carbon, LLC 11/16/2015 1/15/2016
895 Municipal water subjected to ultra-purification and sterilization by UV light and treated with a special electromagnetic force (Xenwater) New Century Company 10/26/2015 12/23/2015
894 Vaccinium uliginosum L. (Bog bilberry) extract Dong-A Pharmaceuticals Co. Ltd 10/13/2015 12/23/2015
893 Cuprous nicotinic acid C LAB Pharma International 10/8/2015 12/16/2015
892 Astragalus dasyanthus Pall. herbal tea (Astragalus D.P.) SaTek USA LLC 10/5/2015 12/15/2015
891 Cannabinoids (Neuroprotecting Antioxidants) Purevolution Enterprise 10/5/2015 12/15/2015

 

Page Last Updated: 04/27/2018
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