NDI Notification Filed with FDA for NMN Supplied by Nutrition BioTech

California supplier expands its US-stocked actives portfolio

POMONA, Calif.--(BUSINESS WIRE)--The nicotinamide mononucleotide (NMN, CAS 1094-61-7) supplied by Nutrition BioTech USA Inc. (NaturalBestBio) is the subject of a New Dietary Ingredient (NDI) notification filed with the U.S. Food and Drug Administration, on record under reference OLS_NDI_30642 and currently under review. Nutrition BioTech supplies this material to the notified specification from US stock.

The company's actives portfolio, shipped from its California warehouse, includes NMN, urolithin A, fisetin, apigenin, quercetin, trigonelline, L-ergothioneine, pterostilbene and pterostilbene glucoside, polydatin, trans-resveratrol, PQQ disodium salt, magnesium acetyl taurate, berberine pro-micelle, 5-HTP, exosomes at 100 billion particles per vial, broccoli extract at 13% glucoraphanin paired with radish seed myrosinase (1500 u/g), and the copper peptides GHK-Cu (INCI: Copper Tripeptide-1) and AHK-Cu (INCI: Copper Tripeptide-3).

The copper peptides are specified for storage below 25 °C with a three-year shelf life, so no cold chain is required, unlike copper peptide material commonly offered at -20 °C.

Published specification sheets state the limit and the analytical method for each test item, for example USP <233> ICP-MS for heavy metals, and copper peptides are reported with peptide content and copper content declared separately, rather than as a single purity figure. Product pages also publish machine-readable identifiers, including CAS number, InChIKey and PubChem CID, for unambiguous matching during specification review.

"Brands formulating for the US market ask one question before anything else: can I use this here, and can I get it this quarter," said Lily Lau, VP Sales, Nutrition BioTech. "We answer both with documents and a domestic warehouse, not with a promise. A specification without the test method behind it is not a specification."

The broccoli extract and radish seed myrosinase ship as a matched two-part system, with formulation guidance for single-capsule formats.

Nutrition BioTech will share the outcome once FDA's review closes.

About Nutrition BioTech

Nutrition BioTech USA Inc. is a supplier of high-purity nutraceutical and cosmetic actives in Pomona, California. Quality systems include ISO 22000:2018, FSSC 22000, HACCP and GMP; certificates provided on request. Samples are available for evaluation.