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, 143 KB)
Download List of NDINs 1995 to the Present
(PDF, 749 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 |
---|---|---|---|---|
1094 | 5-Aminolevulinic Acid Phosphate with Sodium Ferrous Citrate (SFC) | Neopharma Inc. | 10/18/2018 | 12/19/2018 |
1196 | Lactobacillus plantarum KY1032 | Korea Yakult Co., Ltd. | 4/6/2021 | 5/28/2021 |
1197 | MagH2 Mineral Powder | Nano H2 Minus Inc | 2/1/2021 | 4/12/2021 |
1198 | HOWARU | Danisco USA Inc. | 4/12/2021 | 5/28/2021 |
1199 | Full-Spectrum Hemp Extract | Irwin Naturals | 5/3/20201 | 7/23/2021 |
1200 | Lactobacillus plantarum APsulloc 331261 | AmorePacific Corporation | 3/23/2021 | 5/28/2021 |
1201 | Pep2Dia | Ingredia SA | 3/23/2021 | 5/28/2021 |
1202 | Full Spectrum Hemp Extract | Charlotte’s Web Inc. | 5/12/2021 | 7/23/2021 |
1203 | Whole Broth Extract of Cordyceps Cicadae mycelium, intend to market in a dietary supplement under the trade name "BIO-CORDYCEPS GK-4" | Grape King Bio Ltd. | 4/27/2021 | 6/30/2021 |
1204 | Avocado oil extract | Dongkook Pharmaceuticals | 4/27/2021 | 6/30/2021 |
1205 | “Banana stamen extract” that you intend to market as a bulk dietary ingredient under the trade name, “Happy Angel® Stamen Extract powder.” | TCI Co., Ltd. | 5/4/2021 | 7/12/2021 |
1206 | Banana peel extract | TCI Co., Ltd. | 5/4/2021 | 7/12/2021 |
1207 | Nutriterra® Total Omega-3 | Nuseed Nutritional US Inc | 5/13/2021 | 7/21/2021 |
1208 | “MoodElite”, which is a combination of an extract powder of the botanical ingredients Hypericum perforatum L. (whole aerial part), Eleutherococcus senticosus Maxim (Root), and Paeonia suffruticosa Andr. (Root park) | Chenland Nutritionals, Inc. | 6/1/2021 | 7/30/2021 |
1209 | Bifidobacterium breve | IFF Health & Biosciences Danisco USA, Inc. | 6/16/2021 | 8/20/2021 |
1210 | powdered water extract from the aerial parts of Agastache rugosa (Fisch. & C.A. Mey.) Kuntze that you call “Agatri®” | Cosmax NBT, Inc. | 6/21/2021 | 8/26/2021 |
1211 | Bifidobacterium animalis subsp. lactis HEM 20-01 or B. lactis HEM 20-01, marketed as a bulk dietary ingredient under the trade name HEM 20-01™ | HEM Pharma Inc. | 7/9/2021 | 9/2/2021 |
1212 | Fermented bilberry fruit extract, marketed as a dietary ingredient under the trade name SEPITONE™ | SEPPIC S.A. | 7/13/2021 | 8/6/2021 |
1213 | Momordica charantia | NutraLife Ltd., Co | 8/3/2021 | 9/22/2021 |
1214 | Rhamnox 50 | REJIMUS, INC. | 8/13/2021 | 10/14/2021 |
1215 | HemoHIM® Herbal Extract | Kolmar BNH Co. Ltd. | 8/17/2021 | 10/18/2021 |
1216 | Micro-encapsulated and Micronized Iron Saccharate | Pharmafen LLC | 8/19/2021 | 10/8/2021 |
1217 | Banana stamen extract | TCI Co., Ltd. | 8/19/2021 | 9/22/2021 |
1218 | Serratiopeptidase | Meteoric Biopharmaceuticals Pvt Ltd | 8/23/2021 | 9/13/2021 |
1219 | Fermented bilberry fruit extract, marketed as a dietary ingredient under the trade name SEPITONE | SEPPIC S.A. | 8/23/2021 | 10/21/2021 |
1220 | Native extract of the dried ground leaf of Mitragyna speciosa (Korth.) Havil (Rubiaceae) | American Botanicals Corporation | 8/30/2021 | 11/5/2021 |
1221 | Lactobacillus curvatus HY7601 | hy Co., Ltd. | 8/30/2021 | 11/5/2021 |
1222 | Ginsenose | Proteinworks Co. Inc. | 9/3/2021 | 11/10/2021 |
1223 | TL1 (Trypsine Serine Protease 1) | Representing Novozymes | 9/7/2021 | 12/29/2021 |
1224 | GCWB106 (Chrysanthemum zawadskii var. latilobum Extract) | Green Cross Wellbeing Corporation | 9/8/2021 | 11/10/2021 |
1225 | CalGo | Hofseth BioCare ASA | 9/10/2021 | 11/17/2021 |
1226 | OmeGo | Hofseth BioCare ASA | 9/10/2021 | 11/17/2021 |
1227 | affron® | Pharmactive Biotech Products | 9/22/2021 | 11/30/2021 |
1228 | life'sOmega Ultra (DHA and EPA Algal Oil from schizochytrium) | DSM Nutritional Products | 10/1/2021 | 12/7/2021 |
1229 | Hydrangea serrata leaf extract | COSMAX BIO LTD | 10/5/2021 | 12/8/2021 |
1230 | Lactobacillus plantarum HY7714 or L. plantarum HY7714 | hy Co., Ltd | 10/12/2021 | 12/14/2021 |
1231 | Bolgre™ Solution | Chong Kun Dang Pharm Corp. | 10/21/2021 | 12/30/2021 |
1232 | Basic Copper Gluconate | Jost Chemical Co. | 10/21/2021 | 12/22/2021 |
1233 | Cyclocarya paliurus Extract | Infinitus (China) Company Ltd. | 10/27/2021 | 12/23/2021 |
1234 | β-Nicotinamide Mononucleotide (NMN) | Willy Nutra, Inc. | 11/15/2021 | 1/18/2022 |
1235 | L-β-Aminoisobutyric Acid (L-BAIBA) | NNB Nutrition | 11/23/2021 | 1/27/2022 |
1236 | Serratiopeptidase | Meteoric Biopharmaceuticals Pvt Ltd | 11/24/2021 | 2/2/2022 |
1237 | neoagarooligosaccharides (NAO) | Dyne Bio Inc. | 11/24/2021 | 2/1/2022 |
1238 | Dry Aloe macroclada gel (Alomac) | JWJames Consulting | 12/8/2021 | 2/10/2022 |
1239 | Safr'Inside™ | ACTIV'INSIDE | 12/20/2021 | 2/15/2022 |
1240 | nicotinamide mononucleotide (NMN), beta-nicotinamide mononucleotide, or β-NMN | SyncoZymes (Shanghai) Co., Ltd. | 12/27/2021 | 2/24/2022 |
1241 | Deglusterol powder | Caregen Co., Ltd | 1/7/2022 | 3/21/2022 |
1242 | Chios Mastic Gum (CMG) | CHIOS GUM MASTIC GROWERS ASSOCIATION | 2/15/2022 | 4/7/2022 |
1243 | Nicotinamide Riboside Hydrogen Malate | Thorne Health Tech, Inc. | 3/22/2022 | 5/24/2022 |
1244 | Polygonatum kingianum Extract | TCI Co., Ltd. | 2/24/2022 | 4/29/2022 |
1245 | W Beauty® Wasabi Leaf Extract | TCI Co., Ltd. | 4/29/2022 | 6/16/2022 |
1246 | Bi-Su Swiftlet's Nest Extract | M Style America | 3/2/2022 | 5/6/2022 |
1247 | beta-nicotinamide mononucleotide (β-NMN) | SyncoZymes (Shanghai) Co., Ltd. | 3/21/2022 | 5/16/2022 |
1248 | Alpiniae Oxyphyllae Fructus | The Hong Kong Institute of Biotechnology Limited | 3/28/2022 | 6/2/2022 |
1249 | YES-10 | Famenity Co. Ltd | 3/30/2022 | 6/6/2022 |
1250 | SKF7® Aqueous Ethanolic Standardized Extract of Labisia pumila var. alata | Medika Natura Sdn Bhd | 4/1/2022 | 6/2/2022 |
1251 | Micro-encapsulated and Micronized Iron Saccharate | Pharmafen LLC | 4/4/2022 | 6/8/2022 |
1252 | Somacy-FP100 | Macrophi Inc. | 4/20/2022 | 6/28/2022 |
1253 | RenoCidin™ (Fermented Citrus Bioflavonoids Containing Water-Soluble Hesperetin Derivatives, Marketed as a Bulk Dietary Ingredient) | Hughes Biotechnology Co., Ltd. | 5/4/2022 | 7/7/2022 |
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 |