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  1. New Dietary Ingredient (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 Dockets Management Staff (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, 170 KB)

Download List of NDINs 1995 to the Present
(PDF, 642 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
1254 ProGo® Hofseth BioCare ASA 5/25/2022 7/27/2022
1255 TEES-10® Ligularia stenocephala extract powder Famenity Co. Ltd. 7/13/2022 9/19/2022
1256 Greenyn Insumate® powder Greenyn Biotechnology Co., Ltd. 7/21/2022 9/21/2022
1257 Crocin Rich® Quality Phytochemicals LLC 7/21/2022 9/23/2022
1258 Lactobacillus paracasei subsp. paracasei HY2782; Lacticaseibacillus paracasei subsp. paracasei HY2782; or Lactobacillus casei HY2782 hy Co., Ltd. 7/22/2022 9/27/2022
1259 β-Nicotinamide Mononucleotide (NMN) Inner Mongolia Kingdomway Pharmaceutical Limited 7/28/2022 10/11/2022
1260 Buckwheat Husk Extract TCI Co., Ltd 9/2/2022 11/9/2022
1261 Weissella confusa WIKIM51 (Wilac D001) Pharmsville Co., Ltd. 11/18/2022 12/19/2022
1262 EuBone® Chenland Nutritionals, Inc 9/30/2022 12/1/2022
1263 Alomac - powdered Aloe macroclada gel JWJames Consulting 10/19/2022 12/30/2022
1264 NPI-001, a dried kratom leaf powder Johnson Foods LLC 10/21/2022 1/4/2023
1265 beta-nicotinamide mononucleotide (β-NMN or NMN); SIRTality™ Cellmark USA 12/14/2022 1/18/2023
1266 Alpha-glyceryl phosphoryl choline (A-GPC), AlphaSize® Alpha Glyceryl Phosphoryl Choline Chemi Nutra, LLC 11/1/2022 11/9/2022
1267 nicotinamide mononucleotide (NMN), beta-nicotinamide mononucleotide, or β-NMN; Uthever Effepharm, Ltd. 11/7/2022 1/18/2023
1268 S-Adenosyl-L-Methionine Disulfate Tosylate with Propyl Gallate (SAMe-DT + PG) JDS Therapeutics, Bonafide Health 11/16/2022 1/23/2023
1269 Alpha-glyceryl phosphoryl choline (A-GPC), AlphaSize® Alpha Glyceryl Phosphoryl Choline Chemi Nutra, LLC 11/17/2022 1/26/2023
1270 Undaria pinnatifida Extract Powder Naturalendo Tech Co. Ltd. 12/16/2022 2/17/2023
1271 HemoHIM® Herbal Extract Kolmar BNH Co. Ltd. 12/20/2022 2/24/2023
1272 Botalys Red Ginseng Botalys 12/22/2022 2/27/2023
1273 Poly-γ-glutamic acid, potassium salt (PGA-K) BL Corporation 12/23/2022 3/2/2023
1274 Sugar Katcher S52™ Kolmar BNH Co. Ltd. 1/12/2023 3/20/2023
1275 Asta-S Crystal Trade Wind Biotech Co., Ltd. 1/19/2023 2/1/2023
1276 Gynostemma pentaphyllum Extract TG Biotech Co., Ltd. 1/31/2023 2/10/2023
1277 Lactiplantibacillus plantarum strain DSM 33464 Novozymes North America 2/6/2023 2/10/2023
1278 DoH2 Mineral Powder H2 Universe, LLC 2/8/2023 4/14/2023
1279 DHA ethyl ester algal oil Algarithm Ingredients, Inc. 2/10/2023 4/21/2023
1280 Yeast Protein Yeap proteins 2/27/2023 4/4/2023
1281 Lactiplantibacillus plantarum strain DSM 33464 Novozymes North America 2/21/2023 5/4/2023
1282 Sodium butyrate SynergoLab Kft. 2/23/2023 4/1/2023
1283 Fermented Soy Extract Containing Water-Soluble Isoflavone Derivatives (RenoFlavone™) Hughes Biotechnology Co., Ltd. 2/24/2023 5/5/2023
1284 Gynostemma pentaphyllum Extract TG Biotech Co., Ltd. 3/9/2023 5/12/2023
1285 Puriton Water Kadesh Incorporation 3/15/2023 5/9/2023
1286 Antrodia GK Grape King Bio Ltd. 3/24/2023 6/1/2023
1287 Golden Caps Nourished Vines LLC 3/31/2023 4/19/2023
1288 Ecklonia cava Extract Powder Naturalendo Tech Co. Ltd. 4/4/2023 6/14/2023
1289 Uphenon® Suheung 4/20/2023 6/28/2023
1290 Nicotinamide mononucleotide Malaga Imports LLC 4/21/2023 7/5/2023
1291 Rhamnox 100 Konan Chemical Manufacturing Co., Ltd. 4/21/2023 6/27/2023
1292 Lysoveta-LP19, Lysophosphatidylcholine (LPC)-Rich Oil Extract of Antarctic Krill (Euphausia superba) Aker BioMarine Antarctic AS 5/15/2023 7/24/2023
1293 OLEANOX (Olive fruit dry extract standardized in hydroxytyrosol (10 or 20%)) NATAC Biotech S.L. 5/22/2023 7/24/2023
1294 Microencapsulated iron saccharate Pharmafen LLC 5/23/2023 8/1/2023
1295 Sea Grapes Extract TCI Co., Ltd 5/23/2023 7/27/2023
1296 PeLiv Microphyt 5/24/2023 7/28/2023
1297 Dicholine L-5-Methyltetrahydrofolate Aprofol AG 5/26/2023 8/2/2023

 

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