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, 174 KB)
Download List of NDINs 1995 to the Present
(PDF, 459 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 |
|---|---|---|---|---|
| 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 |
| 1298 | DHA r-TG algal oil (thetmega3 750 r-TG) | Algarithm Ingredients, Inc. | 6/9/2023 | 8/16/2023 |
| 1300 | Odd-Chain Fatty Acid (OCFA) algal oil | Heliae Development, LLC | 6/29/2023 | 8/31/2023 |
| 1301 | S-Adenosyl-L-Methionine Disulfate Tosylate with Propyl Gallate (SAMe-DT with PG) | JDS Therapeutics, Bonafide Health | 7/3/2023 | 9/7/2023 |
| 1302 | BLMO | Ben's Lab Co., Ltd. | 7/21/2023 | 7/31/2023 |
| 1303 | Inulinase Enzyme Preparation | BIO-CAT, Inc. | 8/1/2023 | 9/28/2023 |
| 1304 | Cinnovel™ Cinnamon Extract | Cinnovel Inc. | 8/21/2023 | 10/20/2023 |
| 1305 | Life's Omega O3020 (DHA and EPA Algal Oil from schizochytrium sp.) | DSM | 8/29/2023 | 11/7/2023 |
| 1306 | Microencapsulated Iron Saccharate | Pharmafen LLC | 9/15/2023 | 11/21/2023 |
| 1307 | Caesalpinia spinosa | Fundacion Laboratorio de Farmacologia Vegetal | 9/25/2023 | 12/4/2023 |
| 1308 | Chrysanthellum indicum dry hydroalcoholic extract | Valbiotis | 9/25/2023 | 12/5/2023 |
| 1309 | Sanzyme powder | Noveco Group | 9/26/2023 | 12/6/2023 |
| 1310 | SHOGUN Maitake Powder | BioKey, Inc. | 10/3/2023 | 12/13/2023 |
| 1311 | Nicotinamide Mononucleotide Hydrate | Malaga Imports LLC | 10/23/2023 | 1/5/2024 |
| 1312 | Nicotinamide Riboside Hydrogen Malate | Thorne Health Tech, Inc. | 10/26/2023 | 1/9/2024 |
| 1313 | BLH308 | Ben's Lab Co., Ltd. | 10/31/2023 | 1/11/2024 |
| 1314 | Anagain Nu | Regensify Pte Ltd | 11/6/2023 | 1/17/2024 |
| 1315 | Açaí Juçara (Euterpe edulis) | Duas Rodas | 11/7/2023 | 1/18/2024 |
| 1316 | GlucoCalm | Sara Rusana Consult Group Eood | 11/27/2023 | 2/5/2024 |