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 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: Any 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
in XLSX, 184 KB / in PDF, 1.3 MB
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 |
|---|---|---|---|---|
| 1364 | Heat-killed Enterococcus faecalisEF-2001 (EF-2001®) | Bereum Co., Ltd. | 12/2/2024 | 2/6/2025 |
| 1365 | LC-MUFA Concentrate | Epax Norway As | 10/7/2024 | 12/18/2024 |
| 1368 | Pinorox (Pine Bark Extract) | AMBE PHYTOEXTRACTS PVT LTD | 10/28/2024 | 12/20/2024 |
| 1369 | Tocotrienols from annatto seed oil derived from the seeds of the annatto Bixa orellana L. | New Max Industrial LTDA | 10/31/2024 | 12/30/2024 |
| 1370 | Low molecular collagen peptide NS | NONGSHIM CO. LTD. | 11/12/2024 | 1/21/2025 |
| 1371 | Anaerobutyricum soehngenii CH106 | Caelus Health | 11/13/2024 | 12/20/2024 |
| 1372 | Lentinula edodes (Berk.) Pegler, 1976 mycelium extract powder (MycoBiotic®LEX) | Gourmet Mushrooms Inc. | 11/20/2024 | 1/30/2025 |
| 1373 | CG-A1 | Caregen Co., Ltd | 11/29/2024 | 2/5/2025 |
| 1374 | adiDAO® Veg. (microencapsulated diamine oxidase-rich dried pea sprout powder) | DR HEALTHCARE ESPANA, S.L. | 12/10/2024 | 2/14/2025 |
| 1375 | Alternansucrase | ADVANCED ENZYME TECHNOLOGIES LTD. | 1/6/2024 | 2/14/2025 |
| 1376 | S-Adenosyl-L-Methionine Disulfate Tosylate (SAMe-DT) | Shandong Jincheng Bio-pharmaceutical Co. Ltd. | 12/12/2024 | 2/20/2025 |
| 1377 | PrimaColl Type 21 Collagen | Geltor | 12/24/2024 | 2/24/2025 |
| 1378 | KM2-HPB01 | KookminBio Corporation | 12/26/2024 | 2/26/2025 |
| 1379 | DHA and EPA MAG algal oil | Solutex, GC, SL | 1/2/2025 | 2/27/2025 |
| 1380 | Camelyn Honey Extract | International Biotherapy Institute | 1/2/2024 | 2/14/2025 |
| 1381 | Tamarind Seed Polysaccharide | DEVINTEC SAGL | 1/15/2025 | 3/6/2025 |
| 1382 | Pichia yeast | Arbela Laboratories, Inc. | 1/22/2025 | 3/21/2025 |
| 1383 | Combination of Cuscutae Semen and Rehmanniae Radix Preparata Extract | Invivotec Inc | 2/3/2025 | 2/5/2025 |
| 1384 | Astaxanthin Esters from Haematococcus pluvialis (AstaLuxe®) | PT. Evergen Resources | 2/10/2025 | 3/12/2025 |
| 1385 | Spirulysat | ALGOSOURCE | 2/14/2025 | 3/13/2025 |
| 1386 | SHCog® | Suheung Co. Ltd. | 3/3/2025 | 5/9/2025 |
| 1387 | Phaeodactylum tricornutum extract powder | Microalgae Ask Us | 3/11/2025 | 3/18/2025 |
| 1388 | Saccharomyces cerevisiae S288C EV1-Peptide | BioDrive, Inc. | 3/17/2025 | 3/28/2025 |
| 1389 | Purified Terminalia chebula extract (Y100N) | Yuva Biosciences, Inc. | 3/21/2025 | 5/29/2025 |
| 1390 | Cheezheng Willow tea leaves (Liucha) | Gansu Cheezheng Industrial Group Co., Ltd. | 3/27/2025 | 6/5/2025 |
| 1391 | Fisetin (Cotinus Coggygria) | Malaga Imports LLC | 3/28/2025 | 4/15/2025 |
| 1392 | Spermidine Trihydrochloride | Malaga Imports LLC | 3/28/2025 | 4/15/2025 |
| 1393 | Nicotinamide Riboside Hydrogen Malate | Malaga Imports LLC | 3/28/2025 | 4/15/2025 |
| 1394 | Vernonanthura nudiflora extract | O Sigma Cell and Genetics LLC | 4/4/2025 | 6/11/2025 |
| 1395 | Ora-pro-nobis | MKbio USA | 4/11/2025 | 5/7/2025 |
| 1396 | Saccharomyces cerevisiae S288C EV1-Peptide | BioDrive, Inc. | 4/28/2025 | 7/3/2025 |
| 1397 | ALH-L1005 | AngioLab, Inc. | 4/15/2025 | 6/26/2025 |
| 1398 | Astaxanthin-rich carotenoid fermentation product | LCY Biosciences, Inc. | 5/20/2025 | 7/28/2025 |
| 1399 | Yeast powder IT | INTAKE Co.,Ltd | 4/25/2025 | 6/4/2025 |
| 1400 | Leanepic Rosemary Concentrate containing 50% ursolic acid | CJ CheilJedang Corporation | 4/30/2025 | 7/9/2025 |