NMN Quality and Labeling Standard
JHFC-S-001 Enacted: 3 September 2026 / Effective: the same day
Japan Certified Health Food Council (JHFC) — English translation of the standard. In case of discrepancy the Japanese text prevails. Japanese original
Japan Certified Health Food Council (JHFC)
Enacted: 3 September 2026 / Effective: the same day
Preamble (Rationale for Enactment)
The abbreviation NMN alone does not identify the chemical structure, isomer, or salt or solvation state, and manufacturing may originate from chemical synthesis, enzymatic reactions or other processes. Furthermore, NMN may be converted into related substances under the influence of moisture, heat, light and the acid-base conditions of the medium; consequently, the amount of raw material added does not necessarily correspond to the amount measured in the finished product. This Standard is established to specify the identity, origin, analyte and changes during storage particular to NMN, and to enable verification of labeled values against lot documentation.
Article 1 (Purpose)
The purpose of this Standard is to assess the state of quality management for health foods containing NMN with respect to identification of the substance concerned, manufacturing origin, isomers and chemical forms, content labeling, stability, testing and cautionary information.
Article 2 (Scope)
This Standard applies to raw materials containing nicotinamide mononucleotide as a principal constituent and to tablets, capsules, powders, granules, liquids and other oral products made using such raw materials. Nicotinamide, nicotinamide riboside and other related substances shall not be treated as NMN.
Article 3 (Terms and Definitions)
- 1. NMN: Nicotinamide mononucleotide, consisting of nicotinamide, ribose and phosphate moieties.
- 2. Isomer designation: Specification of the substance subject to quantification and labeling, including its stereochemistry, such as the beta or alpha form.
- 3. Related substances: Nicotinamide-related compounds other than NMN that may be present in raw materials or arise during reactions or storage.
- 4. Manufacturing origin: The method by which the NMN framework is obtained and the origins of the starting materials, including chemical synthesis, enzymatic reactions, processes involving fermentation and other processes.
- 5. Measured amount of NMN: The amount determined in the finished product by a method capable of distinguishing the designated isomer and chemical form.
Article 4 (Requirements)
- 1. The business operator shall state in the raw material specification the chemical name, abbreviation, molecular formula or information identifying the structure, isomer designation, and whether salts or solvates are present. Structural information obtained by methods such as infrared spectroscopy or nuclear magnetic resonance shall be combined with retention behavior relative to a reference material in separation analysis; NMN shall not be identified solely by a single nonspecific reaction. The origin, lot and use records of the reference material shall be linked to the raw material certificate of analysis.
- 2. Manufacturing origins, including chemical synthesis, enzymatic reactions and other processes, shall be distinguished, and the principal starting materials, reaction method, outline of purification and country of manufacture shall be identifiable in the raw material specification. Where labeling such as "fermentation-derived" is used, it shall specify whether the process involving microorganisms constitutes NMN production, precursor production or enzyme preparation, and this shall be verified using a process flow diagram and a supplier declaration.
- 3. The business operator shall establish specifications for the control of purity and related substances with regard to the manufacturing route and analytical method, and shall make them and their supporting rationale publicly available or available upon inquiry. For the alpha form, nicotinamide, nicotinamide riboside, nucleotides and other anticipated by-products or degradation products, the reasons for selecting the analytes and the feasibility of their separation shall be recorded. Where peak area ratios are directly regarded as purity by mass, the validity of this approach shall be demonstrated.
- 4. Content shall be labeled in mass units as NMN corresponding to the recommended daily intake, and it shall be stated whether only the beta form is included or whether isomers are summed. The amount of raw material incorporated, the calculated amount obtained by multiplying by raw material purity, and the measured amount in the finished product shall be distinguished. For raw materials containing salts or moisture, the conversion basis shall be retained. The business operator shall establish the labeled value and control specifications and shall be able to present their basis together with test records.
- 5. Stability evaluation shall observe changes in the amount of NMN and related substances caused by moisture, temperature, light, oxygen and, for liquid products, acid-base conditions, as appropriate to the dosage form and packaging. Where moisture absorption or changes in the dissolved state are anticipated after opening, handling after opening shall also be evaluated. The storage conditions, test time points, analytical methods and packaging specifications adopted shall be linked within the same study plan.
- 6. Lot testing shall include NMN identity, quantification of the designated isomer, related substances, moisture and other items relevant to stability. Where the manufacturing origin indicates a need to control residual solvents, catalysts, impurities originating from enzyme preparations or microorganisms, these shall be added to the test items. Where testing by an external organization is indicated, the certificate of analysis shall clarify whether the sample was the finished product or the raw material, whether isomers were distinguished, and the lot concerned.
- 7. Labeling shall be consistent with respect to the full name of NMN or its corresponding abbreviation, manufacturing origin, the substance to which the stated content refers, storage instructions and handling after opening. Raw material purity shall not be presented as the content of the finished product. Guidance on consultation for persons who are pregnant or breastfeeding, taking medicinal products or under medical supervision shall be established on the basis of the latest information from public authorities and product-specific evaluations. A legible statement shall instruct users to discontinue use and contact the consultation service if any abnormality occurs after intake.
Article 5 (Assessment Categories)
- Conformity: The isomer and chemical form are specified, and manufacturing origin, measured content, related substances, stability and labeling are mutually traceable for the lot concerned.
- Partial conformity: NMN identity and the labeled value can be verified, but parts of the explanation of origin or stability documentation are insufficient, and the matters requiring correction and deadlines are recorded.
- Nonconformity: Isomers cannot be distinguished, the amount of raw material added is treated as a measured amount, or the basis for the labeled value cannot be demonstrated because changes during storage have not been taken into account.
Article 6 (Implementation)
The business operator may make a self-declaration of conformity using raw material specifications, certificates of analysis that distinguish isomers, finished product quantification results and stability documentation. Upon application, the Council may verify traceability from the scope of NMN covered by the labeling to reference materials, manufacturing origin and the lot concerned. Conformity status shall be reassessed whenever the manufacturing route, raw material supplier, dosage form, packaging or analytical method is changed.
Supplementary Provisions
This Standard shall take effect on 3 September 2026.
Note: This Standard provides assessment criteria for information disclosure and quality management practices and does not guarantee the effects, efficacy or safety of individual products.