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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, 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
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