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 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, 108 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 |
---|---|---|---|---|
1133 | Ganoderma Microsporum Immunomodulatory Protein (GMI) | Tomilab LLC DBA Emerald Botanicals |
10/31/2019 | 1/13/2020 |
1134 | AB-Free Kava | Kuality Herbceutics | 11/22/2019 | 2/5/2020 |
1135 | ZBGTECH Holding Compound Liquid Supplement | ZBGTECH Holding, LLC | 11/25/2019 | 2/6/2020 |
1136 | Ethyl-(alpha-guanido methyl) ethanoate under the trade name, Alpha-GEE | Vireo Systems Inc. | 12/13/2019 | 2/25/2020 |
1137 | Peptylin | Braini LLC | 12/24/2019 | 2/27/2020 |
1138 | Bacillus clausii and Bacillus subtilis | Ana Bio Research & Development JSC | 1/13/2020 | 3/23/2020 |
1139 | Magnesium Acetyl Taurinate under the trade name, ATA-Mg® | AIDP Inc. | 1/24/2020 | 3/31/2020 |
1140 | ZBGTECH Compound Liquid Supplement | ZBGTECH Holding, LLC | 2/12/2020 | 4/23/2020 |
1141 | Gynostemma pentaphyllum Extract | US Natural Remedy Company | 2/13/2020 | 4/27/2020 |
1142 | Di-magnesium Citrate Glycinate Co-Salt | Jost Chemical Company | 2/28/2020 | 5/11/2020 |
1143 | Labisia pumila Aqueous Ethanolic Standardized Extract or SKF7 | Medika Natura Sdn Bhd. | 3/4/2020 | 5/13/2020 |
1144 | LYMBERUP® | Gutis Ltd | 3/9/2020 | 5/21/2020 |
1145 | Cantech Pharma ImmuneBooster | Cantech Pharma, Inc. | 3/19/2020 | 5/29/2020 |
1146 | Microchloropsis gaditana | Buggy Power Group | 4/16/2020 | 6/30/2020 |
1147 | Greenyn Antrodia cinnamomea Mycelia under the trade name, Antromax | Greenyn Biotechnology, Inc. | 4/16/2020 | 6/12/2020 |
1148 | Herbal dietary supplement from extracts of Croton membranaceus and Annona muricata (Prostat 60) | Hermon Naturals | 4/21/2020 | 7/1/2020 |
1149 | Tetraselmis chuii | Buggy Power Group | 4/28/2020 | 7/8/2020 |
1150 | Panax Ginseng Berry Concentrate | AMOREPACIFIC | 5/7/2020 | 7/16/2020 |
1151 | Protetite®, a composite product consisting of hydroxyapatite and collagen | CBC Americas Corp. | 5/7/2020 | 7/16/2020 |
1152 | Cnidium officinale Makino | AriBio Co., Ltd. | 5/7/2020 | 7/16/2020 |
1153 | Korean Red Ginseng Extract (KGRE) | Korean Ginseng Corporation | 5/18/2020 | 7/29/2020 |
1154 | Anacardic acid extract from Pistachio kernels (Pistacia vera L.) | Zymex Industries, Inc. | 5/20/2020 | 7/29/2020 |
1155 | Lactobacillus rhamnosus, strain DSM33426 in conjunction with Lactobacillus reuteri, strain DSM33016 | Chr. Hansen Inc. | 5/26/2020 | 8/7/2020 |
1156 | Levilactobacillus brevis strain | Danisco USA, Inc. dba DuPont Nutrition & Biosciences | 6/1/2020 | 8/13/2020 |
1157 | Oleandrin | Phoenix Biotechnology Inc. | 6/2/2020 | 8/14/2020 |
1159 | Bacillus subtilis | Danisco USA, Inc. | 7/1/2020 | 9/10/2020 |
1160 | Sil-Q1 (Silk peptide) | Worldway Co. Ltd | 7/6/2020 | 9/10/2020 |
1161 | Bishkhapra | EBBA Healthcare & Cosmetics LLC | 7/7/2020 | 9/16/2020 |
1162 | Heat-treated Lactobacillus rhamnosus IDCC 3201 (RHT3201) | Ildong Pharmaceuticals | 7/9/2020 | 9/16/2020 |
1163 | Hydroxytyrosol | Nova Mentis | 7/10/2020 | 9/16/2020 |
1164 | Lactiplantibacillus plantarum strain (formerly classified as “Lactobacillus plantarum”) | Danisco USA, Inc. dba DuPont Nutrition & Biosciences | 7/13/2020 | 9/24/2020 |
1165 | Lactiplantibacillus plantarum strain (formerly classified as “Lactobacillus plantarum”) | Danisco USA, Inc. dba DuPont Nutrition & Biosciences | 7/13/2020 | 9/24/2020 |
1166 | Advantra Z™ Bitter Orange (Citrus aurantium L) Extract | Innophos Holdings, Inc. | 7/16/2020 | 9/29/2020 |
1167 | Bacillus clausii and Bacillus subtilis, under tradename LiveSpo® COLON | Ana Bio Research & Development JSC | 10/6/2020 | 12/15/2020 |
1168 | Enzolytics Pepsin from Porcine Liquid Supplement and Ascorbic Acid (Vitamin C) under tradename Cantech Pharma ImmuneBooster | Cantech Pharma, Inc. | 7/29/2020 | 10/7/2020 |
1169 | Adhatoda Vasaka under tradename Ebbasma (currently accepted scientific name is Justicia adhatoda L.) | EBBA Healthcare & Cosmetics LLC | 7/29/2020 |
10/8/2020 |
1170 | Greenyn Antrodia cinnamomea Mycelia (GACM) as bulk ingredient used in dietary supplement products | Greenyn Biotechnology, Inc. | 10/7/2020 | 12/10/2020 |
1171 | Cirsium japonicum var. maackii (Maxim.) Matsum. called TOSCARE | Famenity Co. Ltd. | 8/14/2020 | 10/19/2020 |
1172 | Epimedium brevicornum Maxim.,Salvia miltiorrhiza Bge., and Dioscorea nipponica Makino under trade name JointAlive® | Chenland Nutritionals, Inc. | 8/14/2020 | 10/23/2020 |
1173 | Astaxanthin Crystalline under trade name Astasana™ 5% CWS/S-TG | DSM Nutritional Products LLC | 8/25/2020 | 10/30/2020 |
1174 | β-Nicotinamide Mononucleotide (NMN), marketed in a dietary supplement product called Reju-Me | Willy Chemicals, Inc | 8/25/2020 | 11/2/2020 |
1175 | LemnaRed® Astaxanthin Crystal marketed in a dietary supplement product called LemnaRed® Astaxanthin Softgels | Lemnaceae Fermentation, Inc. | 8/31/2020 | 11/6/2020 |
1176 | Zinc Ascorbate Glycinate Co-Salt | Jost Chemical Co. | 9/1/2020 | 11/6/2020 |
1177 | Anacardic acid extract from Pistachio hulls (Pistacia vera L.) | Zymex Industries, Inc. | 9/4/2020 | 11/12/2020 |
1178 | Methylphosphonic Acid (MePA) marketed in a dietary supplement product under trade name Dr. Aardsma's Anti-Aging Vitamins | Aardsma Research & Publishing | 9/4/2020 | 11/9/2020 |
1179 | Methylphosphinic Acid (MePiA) marketed in a dietary supplement product under trade name Dr. Aardsma's Anti-Aging Vitamins | Aardsma Research & Publishing | 9/4/2020 | 11/9/2020 |
1180 | Withania somnifera marketed in a dietary supplement called EBBAKING | EBBA Healthcare & Cosmetics LLC | 9/10/2020 |
11/17/2020 |
1181 | Gastrodia combination extract powder (HX106) | Helixmith Co., Ltd. | 10/8/2020 | 12/17/2020 |
1182 | Lactobacillus reuteri 12246-CU | Biocare Copenhagen A/S | 10/22/2020 | 1/4/2021 |
1183 | Lactobacillus rhamnosus 19070-2 | Biocare Copenhagen A/S | 10/22/2020 | 1/4/2021 |
1184 | Basic Copper Gluconate | Jost Chemical Co. | 11/17/2020 | 1/29/2021 |
1185 | Sharpleaf galangal (Alpiniae oxyphyllae Fructus) marketed under trade name Nephrokin | The Hong Kong Institute of Biotechnology Limited | 11/25/2020 | 1/27/2021 |
1186 | Aloe macroclada, also known as Alomac ™, marketed under the trade name STEMRELEASE3 | Mioty Voajanahary | 11/27/2020 | 2/4/2021 |
1187 | Ribes fasciculatum var. chinense, combined with a seedless fruit extract of Cornus officinalis marketed as a bulk dietary ingredient under the trade names, CORF™, CORF1 and AdiZeros | Nine B Co., Ltd. | 12/1/2020 | 2/10/2021 |
1188 | LYMBERUP®, which is a mixture of 100 % Hydrolyzed Collagen, N-Acetyl Glucosamine, and Vitamin C, marketed as a dietary supplement under the trade name, LYMBERUP® | Gutis LTD. | 12/2/2020 | 2/10/2021 |
1189 | β-Nicotinamide Mononucleotide (NMN)”, marketed in a dietary supplement product you call Reju-Me | Willy Chemicals, Inc | 12/3/2020 | 2/11/2021 |
1190 | Cofactor Raphanin (CoR) | CoR4Mito Inc./Mito Liuxia Pharma Inc. | 12/10/2020 | 2/19/2021 |
1191 | L-Alanyl-L-Glutamine (98%), marketed as a bulk dietary ingredient under the trade name Argo® | Minsheng Group Shaoxing Pharmaceutical Co., Ltd. | 12/15/2020 | 2/24/2021 |
1192 | Celastrol, an extract containing ≥50% Celastrol isolated from the roots of the plant, Tripterygium wilfordii Hook. f., marketed as a bulk dietary ingredient under the trade name MBX200 | Advanced Muscle Technologies | 12/18/2020 | 2/26/2021 |
1193 | A powdered extract of Panax ginseng C. A. Meyer roots, marketed as a bulk dietary ingredient called Ginsamin™ | Famenity Co. Ltd. | 12/31/2020 | 3/9/2021 |
1194 | Dulcitol | Zhongwei International Life Science and Technology Co., Ltd. | 1/20/2021 | 3/29/2021 |
1195 | Gastrodia combination extract powder (HX106) | Helixmith Co., Ltd. | 1/26/2021 | 4/6/2021 |
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 |