Between late 2024 and mid-2025, the U.S. FDA issued responses for New Dietary Ingredient Notifications (NDINs) 1364 through 1400. EZFDA Consulting conducted a detailed review of the official FDA response letters to identify regulatory trends and common pitfalls affecting NDI outcomes.

Key Findings

• Only about half of NDINs received procedural acceptance (FDA acknowledgement under 21 CFR 190.6(c)).
• A significant number were rejected or objected to, often for reasons unrelated to toxicology data alone.
• FDA continues to apply a strict interpretation of “dietary ingredient” eligibility under section 201(ff) of the FD&C Act.

Most Common Reasons for FDA Objection

NDIN Number	Product Name	Company Name	FDA Outcome	Reason for Rejection (if applicable)
1364	Heat-killed Enterococcus faecalis EF-2001®	Bereum Co., Ltd.	Accepted
1365	LC-MUFA Concentrate	Epax Norway AS	Rejected	Not a dietary ingredient under 21 USC 321(ff)
1366	Amanita muscaria mushrooms	JY Industries, LLC	Rejected	Incomplete submission; insufficient safety narrative and identity
1367	Akkermansia muciniphila EB-AMDK19	Enterobiome Incorporation	Rejected	Not a dietary ingredient
1368	Pinorox (Pine Bark Extract)	AMBE Phytoextracts Pvt. Ltd.	Accepted
1369	Annatto tocotrienol	New Max Industrial LTDA	Accepted
1370	Low molecular collagen peptide NS	Nongshim Co., Ltd.	Rejected	Insufficient safety and identity information
1371	Anaerobutyricum soehngenii CH106	Caelus Health	Rejected	Not a dietary ingredient
1372	Lentinula edodes mycelium extract powder	Gourmet Mushrooms, Inc.	Accepted
1373	CG-A1 (CG-MyoKi)	Caregen Co., Ltd.	Accepted
1374	adiDAO® Veg. (DAO-rich pea sprout powder)	DR Healthcare España	Accepted
1375	Alternansucrase	Advanced Enzyme Technologies	Rejected	Insufficient safety and identity data
1376	SAMe-DT	Shandong Jincheng Bio-pharmaceutical	Accepted
1377	PrimaColl Type 21 Collagen	Geltor	Rejected	Not a dietary ingredient
1378	KM2-HPB01	KookminBio Corporation	Accepted
1379	DHA and EPA MAG algal oil	Solutex GC SL	Rejected	Not a dietary ingredient
1380	Camelyn Honey Extract	International Biotherapy Institute	Rejected	Incomplete; disease/drug claims
1381	Tamarind Seed Polysaccharide	Devintec Pharma	Accepted
1382	Pichia yeast	Arbela Laboratories	Rejected	Insufficient safety evidence
1383	Cuscutae Semen + Rehmanniae Radix extract	Invivotec, Inc.	Rejected	Incomplete; drug claims
1384	Astaxanthin Esters (AstaLuxe®)	PT Evergen Resources	Rejected	Insufficient identity and safety
1385	Spirulysat	Algosource	Rejected	Insufficient identity and safety
1386	SHCog®	Suheung Co., Ltd.	Accepted
1387	Phaeodactylum tricornutum extract powder	Microalgae Ask Us	Rejected	Incomplete; missing translations
1388	Saccharomyces cerevisiae S288C EV1-Peptide	BioDrive / Evolv	Rejected	FDA provided no response
1389	Terminalia chebula extract (Y100N)	Yuva Biosciences	Accepted
1390	Cheezheng Willow tea (Liucha)	Gansu Cheezheng Industrial Group	Accepted
1391	Fisetin (Cotinus coggygria)	Malaga Imports / Probase Nutrition	Rejected	Incomplete; botanical identity
1392	Spermidine Trihydrochloride	Malaga Imports / Probase Nutrition	Rejected	Incomplete submission
1393	Nicotinamide Riboside Hydrogen Malate	Malaga Imports / Probase Nutrition	Rejected	Incomplete submission
1394	Vernonanthura nudiflora extract	O Sigma Cell and Genetics LLC	Rejected	Insufficient safety evidence
1395	Ora-pro-nobis	Mkbio USA	Rejected	Incomplete; identity and safety gaps
1397	ALH-L1005	AngioLab, Inc.	Accepted
1398	Astaxanthin-rich carotenoid fermentation product	LCY Biosciences, Inc.	Accepted
1399	Yeast powder IT	INTAKE Co., Ltd.	Rejected	Incomplete; missing translations
1400	Leanepic Rosemary Concentrate (50% ursolic acid)	CJ CheilJedang Corporation	Accepted

Based on our analysis, FDA objections most frequently cited:

1. Not a dietary ingredient
   Ingredients such as certain microbial strains, novel lipids, or fermentation products failed to meet the statutory definition of a dietary ingredient.
2. Incomplete submissions
   Missing English translations, incomplete safety narratives, or insufficient identity characterization remain a leading cause of rejection.
3. Inadequate safety basis
   FDA often concluded that the information provided did not establish a reasonable expectation of safety under the proposed conditions of use.
4. Procedural “no response” letters
   In some cases, FDA explicitly stated it was “providing no response,” which does not constitute acceptance and should not be interpreted as a successful NDI outcome.

What “Accepted” Really Means

Even when an NDIN is accepted for filing, FDA emphasizes that:

Acceptance is a procedural acknowledgement only and does not represent FDA approval or a determination that the ingredient is safe or lawful in all contexts.

Companies remain responsible for ensuring compliance, safety, and truthful labeling.

Takeaway for Industry

The NDIN 1364–1400 data reinforces a clear message:
NDI success depends as much on regulatory strategy and ingredient classification as it does on safety data.

Early regulatory assessment, proper ingredient categorization, and submission completeness are critical to avoiding costly delays or negative FDA responses.

📩 If you are planning an NDI submission or reassessing an existing ingredient, EZFDA Consulting can help evaluate risk, identify gaps, and develop a compliant regulatory pathway.