NAD+·Labeling Standards and Cross-Border Compliance

Abstract

Dietary nutritional supplements containing nicotinamide adenine dinucleotide (NAD+)-related ingredients have seen sustained growth in circulation across Japan, mainland China, Hong Kong, Macau, Taiwan, and North American markets in recent years. Around this ingredient, the core confusion faced by consumers, procurement teams, and importers converges on three levels: what molecule the quantity figures on product labels actually refer to, what substantive differences exist in labeling standards across jurisdictions, and how to assess compliance and traceability when sourcing cross-border. This article addresses three dimensions: the technical logic of ingredient quantity labeling, label regulatory requirements in Japan and key target markets, and cross-border compliance essentials. No medical claims or efficacy statements are made herein; this document provides only a structured reference on verifiable labeling dimensions.

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I. The Labeling Logic of NAD+ Precursor Ingredients: Which Molecule Is Being Referenced

1.1 What Circulates in Products Is Not NAD+ Itself

The vast majority of "NAD+" supplements currently on the market actually contain precursor molecules to NAD+, not NAD+ itself. The primary precursors include:

• NMN (Nicotinamide Mononucleotide)
• NR (Nicotinamide Riboside)
• Niacin and Nicotinamide (Niacinamide)

NMN and NR are relatively newer commercial ingredients, whereas niacin and nicotinamide have decades of use history with well-established regulatory recognition in most countries. Due to differences in price and ingredient availability, the type of precursor used varies significantly across product tiers.

1.2 Two Primary Models for Quantity Labeling

In current product labeling practice, two parallel models for quantity labeling exist, and consumers must be able to distinguish between them:

Model A: Stating the actual input quantity of the precursor ingredient

For example, "NMN 250 mg / capsule" — here, 250 mg refers to the mass of the NMN ingredient itself, and bears no direct conversion relationship to the amount of NAD+ ultimately generated through in vivo metabolism. This is the mainstream labeling approach in the market and complies with the basic requirements of the Food Labeling Act for "ingredient name and quantity."

Model B: Expressing quantity as "NAD+ equivalent" or "equivalent amount"

Some brands state an estimated value such as "equivalent to NAD+ X mg" in non-mandatory fields (e.g., promotional pages, product descriptions). Such conversions carry significant scientific uncertainty, and under the framework of Japan's Food Labeling Act, if such a conversion value appears in the mandatory nutrition information section of a legal label, a verifiable calculation basis is required; otherwise, it may constitute improper representation.

Practical recommendation: When comparing different products, consumers should use the actual input quantity of the precursor ingredient (mg/capsule) as the baseline unit, and avoid being misled by converted figures such as "NAD+ equivalents."

1.3 Labeling Transparency for Purity and Specification

Beyond total input quantity, high-transparency products typically disclose the following on the label or in supplementary documents (third-party test reports, COA/Certificate of Analysis):

• Purity percentage of the precursor ingredient (e.g., "NMN ≥98%")
• Crystal form or salt form (for NMN, stability and solubility are affected by this)
• Lot number and manufacturing date for traceability purposes

The GMP Compliance Certification system of Japan's JHNFA (Japan Health and Nutrition Food Association) requires factories to maintain complete records of incoming raw material inspection, in-process inspection, and finished product inspection; certification numbers can be verified in the JHNFA official database. Taking Certification Number 34225 as an example, this number is a manufacturing standards certification at the factory level, not an endorsement of any specific ingredient quantity — the two must not be conflated.

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II. Japan's Label Regulatory Framework

2.1 Basic Requirements of the Food Labeling Act

Japan's Food Labeling Act (enacted 2015, based on the integration of the Food Sanitation Act, the JAS Act, and the Health Promotion Act) sets mandatory labeling requirements for all processed foods circulating within Japan:

NMN and NR currently fall under general food ingredients in Japan (certain batches and specifications may require attention to regulatory developments around 2021 and thereafter). When products circulate in food form, ingredient quantity labeling must follow the above framework, and no medical claims may be made beyond the definition of food.

2.2 The Relationship Between the Foods with Function Claims (FFC) System and Quantity Labeling

The Consumer Affairs Agency's "Foods with Function Claims" (FFC) system permits companies to make prescribed statements about specific functional ingredients after filing with the Consumer Affairs Agency and submitting scientific evidence. If a product circulates as an FFC:

• The functionally relevant ingredient (the corresponding ingredient under FOSHU/FFC) must be clearly stated on the label with the daily intake amount
• The company is responsible for the stated amount and must guarantee batch-to-batch consistency
• Filing documents (including SR: Systematic Review) are public information, and consumers may access them in the Consumer Affairs Agency database

As of the writing of this article, NAD+ precursor ingredients remain few in number in the FFC filing database; most products circulate under the designation of "general foods" or "health foods," are not entitled to the functional claim rights of FFC, and are not subject to its rigorous quantity control obligations. This means that for non-FFC products, batch-to-batch consistency in ingredient quantity relies primarily on corporate self-regulation and GMP systems, rather than on regulatory mandatory verification mechanisms.

2.3 Regulation of Improper Premiums and Misleading Representations

Japan's Act against Unjustifiable Premiums and Misleading Representations (enforced jointly by the Japan Fair Trade Commission and the Consumer Affairs Agency) prohibits representations that create a "superior misimpression" or "advantageous misimpression" regarding a product's ingredients, effects, or quality. In the NAD+ product category, regulatory focus areas include:

• Use of expressions such as "elevates NAD+ levels" or "anti-aging" in non-mandatory fields (advertising pages, social media, video scripts)
• Describing in vivo biochemical changes with specific figures (e.g., "increases by 30%") without adequate scientific evidence
• Using before-and-after comparison images to imply improvement in physical function

Since 2019, the Consumer Affairs Agency has steadily increased the severity of penalties for improper representation cases involving health foods. When procurement teams select suppliers, the supplier's track record on representation compliance constitutes a verifiable risk dimension.

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III. Labeling Differences in Key Target Markets

3.1 Mainland China: Dual-Track System of Health Food Registration and Filing

In mainland China, "health foods" are regulated under the Administrative Measures for the Registration and Filing of Health Foods (State Administration for Market Regulation). NMN products have not yet been included as a health food ingredient in the Health Food Ingredient Catalogue; therefore:

• Products containing NMN may not be sold in compliance within China as health foods
• Products of the same type entering via the general food (including general food import) pathway may not carry any health function claims on labels or accompanying materials
• Products entering via the cross-border e-commerce (bonded warehouse zone) pathway must comply with the Cross-Border E-Commerce Retail Import Commodity List and corresponding inspection and quarantine requirements

For Japan-produced NAD+ products purchased by consumers through legitimate cross-border e-commerce platforms, any Chinese-language labeling (or platform page descriptions) featuring expressions such as "anti-aging" or "immunity enhancement" constitutes a compliance risk on the platform/merchant side, and is independent of whether the original -market label is compliant — the two are legally independent of one another.

3.2 United States: FDA Dietary Supplement (DSHEA) Framework

The U.S. Dietary Supplement Health and Education Act (DSHEA, 1994) distinguishes dietary supplements from the regulatory frameworks for drugs and foods. Prior to 2022, NMN was sold by some companies as a dietary supplement; however, in November 2022, the FDA issued warning letters, determining that NMN had been investigated as an ingredient in new drug investigations (IND), and that pursuant to DSHEA §201(ff)(3)(B)(ii), such ingredients may not be used in dietary supplements.

This regulatory development has substantive implications for cross-border procurement:

• Carrying Japan-produced products containing NMN into the U.S. via personal importation pathways carries the risk of customs seizure
• Compliance postures among U.S. domestic e-commerce platforms have begun to diverge

NR (Nicotinamide Riboside) has a relatively clearer regulatory status in the United States, having received FDA GRAS (Generally Recognized as Safe) recognition (GRN No. 635, among others), and has a more stable regulatory foundation for circulation as a dietary supplement.

3.3 European Union: Novel Food Ingredient Review

The EU Novel Food Regulation (EU 2015/2283) requires that food ingredients with no significant history of consumption in the European Union must undergo evaluation by the European Food Safety Authority (EFSA) and receive authorization from the Commission before they may be placed on the market.

NMN, as a novel food ingredient under EU definitions, has had its application process advanced by certain companies; however, as of the writing of this article, its authorization status remains under review (readers should independently verify the latest developments). The situation for NR is similar — records exist of authorization applications being approved, but the specific applicable scope (applicable product categories, maximum use levels, etc.) must be confirmed against the latest EU Novel Food Catalogue.

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IV. Ingredient Traceability and Third-Party Testing: Compliance Dimensions Beyond Labeling

4.1 The Verification Value of COAs (Certificates of Analysis)

Ingredient quantity statements on labels represent the manufacturer's self-declaration. Beyond this, the COA is the key document for verifying the credibility of stated claims and should cover:

• Assayed quantity values: deviation range from the stated quantity (quality products typically state a deviation of ±X%)
• Heavy metal testing: compliance with limits for lead, mercury, cadmium, and arsenic
• Microbiological limits: total aerobic plate count, coliforms, etc.
• Pesticide residues (for plant-derived ingredients)

Consumers or procurement teams may request suppliers to provide COAs issued by third-party laboratories accredited under ISO/IEC 17025. Representative recognized testing institutions within Japan include the Japan Food Research Laboratories, among others; the issuing institution information on their test reports can be independently verified.

4.2 The Meaning and Boundaries of GMP Factory Certification

GMP (Good Manufacturing Practice) certification applies to the manufacturing process management system, not to the efficacy or safety of specific product ingredients. The JHNFA GMP Compliance Certification (system) requires certified factories to meet standard specifications across dimensions including raw material management, production environment, inspection records, and nonconforming product disposition; certified factories are subject to periodic audits after certification.

To determine whether a given factory holds JHNFA GMP Certification:

• 1. Visit the JHNFA official website and search the "GMP" (List of GMP-Certified Factories) page by certification number or factory name
• 2. Verify the certification validity period
• 3. Confirm that the certification scope covers the product category of interest

Important limitation: GMP certification indicates only that the manufacturing system is compliant; it does not imply that the product meets the requirements for compliant importation into the destination country — the two must be verified separately.

4.3 Stability Data and Labeled Expiration Date Statements

NAD+ precursor molecules (NMN in particular) are susceptible to degradation under high-temperature and high-humidity conditions. A compliant label should state storage conditions (e.g., "、" / "Store away from direct sunlight in a cool, dry place") and the shelf life.

Shelf life labeling must be supported by accelerated stability testing data; if promotional materials include a commitment such as "quantity will be no less than X% of the stated value before expiration," the company must be able to support that claim with stability data documentation. Temperature and humidity control during cross-border shipping is a dimension of product compliance management that importers frequently overlook.

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V. Actionable Checklist for Consumers

Pre-Purchase Verification Checklist

• 1. Confirm the precursor type and actual input quantity

Check whether the ingredient list explicitly states the specific milligram quantity of NMN, NR, or another precursor; avoid assessing quantity based solely on the presence of "NAD+" in the product name.

• 2. Verify the manufacturing factory's GMP certification status

Via the JHNFA official database (search "JHNFA GMP" to find the official website entry), enter the certification number to confirm the certification is valid and covers the relevant product category.

• 3. Request or download the COA

Prioritize brands that publicly release batch COAs or provide them upon request; pay particular attention to the deviation between assayed and stated NMN/NR quantities, and heavy metal test results.

• 4. Identify the regulatory designation on the label

Does the product label display the designation "" (Food with Function Claims)? If so, the filing number can be looked up in the Consumer Affairs Agency filing database; if not, the product is a general food, and any functional claims are solely the company's voluntary statements, without regulatory endorsement.

• 5. Understand the import compliance status in the destination country

- Mainland China: confirm whether the product falls within product categories covered by the cross-border e-commerce list, and whether Chinese-language descriptions on the platform page contain non-compliant claims

- United States: be aware of FDA regulatory developments regarding NMN, and consult the FDA official website for the latest warning information

- European Union: check the EU Novel Food Catalogue to confirm the ingredient's authorization status

• 6. Retain purchase receipts and import records

Cross-border personal-use carry-in or mail-in import is typically subject to quantity limits (which vary by country); retaining receipts and declaration records facilitates demonstrating personal-use nature during customs inspection.

• 7. Recognize the boundaries of functional claims

Regardless of the channel through which product descriptions are received, any language involving medical terminology such as "treat," "prevent," or "reverse" does not constitute compliant language for dietary nutritional supplements under any jurisdiction, and should be treated as a warning signal.

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Conclusion

The issue of labeling compliance for NAD+ supplements is, at its core, a matter of information transparency: the type of precursor molecule, actual input quantity, purity, batch stability, manufacturing system certification status, and regulatory designation in the target import country — these dimensions together constitute a verifiable compliance map.

Japan's Food Labeling Act provides a relatively mature framework, and the JHNFA GMP Certification system provides a verifiable anchor point at the level of manufacturing processes; however, neither can substitute for consumers' independent verification of destination-country regulations in cross-border scenarios. The regulatory environment continues to evolve — particularly the regulatory status of NMN in the United States and the European Union — and readers should treat this article as a structural reference framework and consult the latest official information sources before making specific decisions.

Dietary nutritional supplements are not drugs. Any statement that equates labeling compliance for supplements with health outcomes exceeds the bounds of what current scientific evidence and the regulatory framework permit. Verifiable labeling transparency is the starting point — not the endpoint — for consumers' independent assessment of product quality.