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, 176 KB)
Download List of NDINs 1995 to the Present (PDF, 887 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 |
|---|---|---|---|---|
| 1320 | Omega-3 Fish Oil | Spirit Pharmaceutical LLC | 1/8/2024 | 3/20/2024 |
| 1321 | Deep sea minerals | QBM Co., Ltd. | 1/18/2024 | 3/25/2024 |
| 1322 | Chios mastic gum powder (CMP) | Chíos Mastiha Growers Association | 1/23/2024 | 3/29/2024 |
| 1323 | Plant Origin Lactic Acid Bacteria K-1 | Kerry Ingredients and Flavors, Inc. | 2/7/2024 | 4/1/2024 |
| 1324 | Propolis Drops | Ozgur Yasar | 2/8/2024 | 4/2/2024 |
| 1325 | PE0401 powder | Glac Biotech Co., Ltd. | 3/11/2024 | 5/17/2024 |
| 1326 | Akkermansia muciniphila | ADM Deerland | 3/11/2024 | 4/8/2024 |
| 1327 | PMF | PMF Natural Products Company | 3/15/2024 | 5/23/2024 |
| 1328 | Vernonanthura nudiflora extract | O Sigma Cell and Genetics LLC | 3/21/2024 | 5/3/2024 |
| 1329 | PrimaColl Type 21 Collagen | Geltor | 3/26/2024 | 5/13/2024 |
| 1330 | SitFree (Euphorbia Prostrata Tablet) | Panacea Biotec Pharma Limited | 4/10/2024 | 6/17/2024 |
| 1331 | Fermented Chrysanthemum Extract (RenoSage™) | Hughes Biotechnology Co., Ltd. | 4/12/2024 | 6/18/2024 |
| 1332 | Recombinant human lactoferin rhLF | DBA Paula Marcinkeviciute | 4/22/2024 | 6/25/2024 |
| 1333 | Red algae extract | MH Biotechnology Corporation Ltd. | 4/23/2024 | 5/31/2024 |
| 1334 | Black pearl wax apple extract | MH Biotechnology Corporation Ltd. | 4/23/2024 | 5/31/2024 |
| 1335 | Herbal Extract - QishenYiqi (T101) | NatureKue Inc. | 4/25/2024 | 7/2/2024 |
| 1336 | Uzara - Xysmalobium undulatum (TRUZARA) | Afriplex (Pty) Ltd | 5/2/2024 | 7/2/2024 |
| 1337 | Shilajit | GAUNGZHOU YITIJIAN BIOENGINEERING CO., LTD | 5/10/2024 | 5/14/2024 |
| 1338 | Biomass of Levilactobacillus brevis (formerly classified as Lactobacillus brevis) AL003 (DSM33682) | Alfasigma S.p.A. | 5/14/2024 | 7/25/2024 |
| 1339 | HRG24 | Botalys | 5/15/2024 | 5/30/2024 |
| 1340 | Wasabi Sulfinyl | Kinjirushi Wasabi International Co., Ltd. | 6/10/2024 | 8/19/2024 |