Association for Japan Health Food Certified
JHFC
← Back to Resources

Hyaluronic Acid: Labeling Standards and Cross-Border Compliance

---

Abstract

Hyaluronic Acid (HA) is one of the fastest-growing ingredients in the dietary supplement markets of Japan and globally. Yet when consumers purchase HA products across borders, the core source of confusion is rarely the ingredient itself — it is the question of what the numbers on the label actually mean, whether labeling conventions are consistent across markets, and whether a given product meets the regulatory requirements of both the country of export and the country of import. This paper, written primarily from the perspective of Japan's health food industry, provides a systematic review of HA product ingredient quantity labeling standards, label compliance frameworks, and the key verification checkpoints consumers need when purchasing cross-border. No therapeutic or medical function claims are made anywhere in this document; all discussion is confined to verifiable dimensions — ingredient labeling, testing traceability, and information transparency.

---

1. Raw Material Forms and the Basics of Ingredient Labeling

1.1 Chemical Forms of HA Raw Materials

In the dietary supplement industry, commercially used HA raw materials exist predominantly as Sodium Hyaluronate, with a minority of products using the free-acid form (Hyaluronic Acid Free Form). The two differ in molecular weight distribution, solubility, and manufacturing process, yet product labels do not consistently distinguish between them — making raw material form the first blind spot in ingredient quantity verification.

Molecular weight (expressed in Daltons, Da, or kiloDaltons, kDa) is a key parameter for grading HA raw materials. The industry generally recognizes four ranges: high molecular weight (>1,000 kDa), medium molecular weight (100–1,000 kDa), low molecular weight (10–100 kDa), and oligomeric HA (<10 kDa). These ranges differ in production cost, solubility behavior, and processing stability. Some manufacturers voluntarily disclose molecular weight ranges on product pages or specification sheets, but this is not mandated under current labeling regulations and falls within the category of voluntary information transparency.

1.2 Production Origin and Raw Material Traceability

Industrial HA production follows two primary routes:

Japan's Food Labeling Standards impose allergen labeling obligations related to animal-derived raw materials (see Section 2). As a result, raw material origin information is a critical component of product traceability compliance. Consumers with Halal, Vegan, or other specific dietary requirements should pay particular attention to origin disclosures and any relevant third-party certifications displayed on packaging.

---

2. Ingredient Quantity Labeling Standards Under Japan's Food Labeling Act

2.1 Regulatory Foundation

Japan's Food Labeling Act, which came into force in 2015, consolidated the food labeling provisions previously scattered across the JAS Act, the Food Sanitation Act, and the Health Promotion Act into a unified food labeling framework. Its implementing regulation, the Food Labeling Standards (a Cabinet Office Ordinance), specifies the mandatory labeling items and format requirements for each category of food.

For functional ingredient content labeling in dietary supplements (known in Japan as *iyawayuru kenko shokuhin*, or "so-called health foods"), the Food Labeling Standards distinguish two tiers:

In practice, any product that states HA content numerically on its packaging (e.g., "120 mg of Hyaluronic Acid per capsule") is subject to this accuracy obligation.

2.2 Units and Comparability Issues in Ingredient Quantity Labeling

Cross-product comparisons of ingredient quantities are complicated by three common inconsistencies:

① Input Quantity of Raw Material vs. Active Ingredient Content

Some products label the input quantity of "HA raw material powder" rather than the verified active HA content calculated on a purity-adjusted basis. For example, if a raw material powder has an HA content of 80%, then 100 mg of that powder contains approximately 80 mg of actual HA. A label that states only "100 mg of Hyaluronic Acid raw material" without disclosing purity leaves the consumer unable to determine the true active ingredient content.

② Per-Unit Content vs. Per-Day Content

market products are commonly sold as capsules, tablets, or powders. Labels sometimes state only the per-unit (per-capsule or per-tablet) content without stating the total content at the recommended daily serving. Consumers must combine two figures — the per-unit content and the recommended daily serving size — to calculate actual daily intake.

③ Wet-Basis vs. Dry-Basis Measurement

Sodium Hyaluronate is highly hygroscopic; its moisture content varies with ambient humidity. Properly prepared raw material specification sheets state content on a dry basis. Where labels do not specify the measurement basis, there is a degree of inherent imprecision in precise cross-product quantity comparisons.

2.3 Allergen Labeling Obligations

Products using rooster-comb-derived HA should note that chicken is one of the 28 recommended allergens under Japan's Food Labeling Standards; eggs (a common co-contaminant concern in poultry-derived materials) are among the 8 mandatory allergens. Even where the HA ingredient itself has been purified, if the product is manufactured at a facility that also processes allergen-containing materials on shared lines, the manufacturer must assess cross-contamination risk and, where appropriate, include an advisory statement such as: "This product is manufactured in a facility that also produces products containing [allergen]."

---

3. The Foods with Function Claims System and HA Labeling

3.1 System Overview

Japan's Foods with Function Claims (FFC) system, which took effect in April 2015, allows operators to display functional claim language on food packaging after filing a notification with the Consumer Affairs Agency (CAA) and making their scientific substantiation publicly available. The FFC system is distinct from Foods for Specified Health Uses (FOSHU), which requires government approval; the FFC system operates on a self-notification model subject to public government review.

Current status of HA under the FFC system: As of the knowledge cutoff date of this document, the CAA notification database contains notified products for which HA is the functional ingredient. Functional claims for such products are subject to the following constraints:

Verification tip: Consumers can verify a product's notification status, the recommended daily serving of the functional ingredient, and the scientific evidence summary by searching the CAA's official Foods with Function Claims notification database using the product name or notification number.

3.2 Compliance Boundaries for Conventional Health Foods

Conventional health foods (*iyawayuru kenko shokuhin*) that have not been notified under the FFC system are prohibited from displaying any language on their labels that implies a physiological function — including any wording that could be interpreted as a functional claim relating to, for example, skin moisture or joint lubrication. Violations of Article 65 of the Health Promotion Act, which prohibits exaggerated advertising, are subject to administrative sanction. Compliance review applies not only to the principal packaging text but equally to product detail pages, social media promotional materials, and package inserts.

---

4. GMP Certification and Manufacturing Information Transparency

4.1 Japan's Health Food GMP Certification System

The credibility of a health food product's quality depends substantially on the quality management standards of its manufacturing facility. The primary health food GMP certification system in Japan is administered by the Japan Health and Nutrition Food Association (JHNFA). Facilities certified under JHNFA GMP must meet the following management requirements:

Certification status is public information. Both consumers and procurement professionals can verify a facility's certification number and expiration date through the JHNFA's official website. Where product packaging or a company's official website states that the product is manufactured at a JHNFA GMP-certified facility, the corresponding certification number should be verifiable in the official certified facility list.

4.2 Ingredient Testing and Third-Party Verification

Higher-quality-assurance products typically make the following verifiable testing information available:

When making purchasing decisions, consumers may take note of whether a company proactively publishes testing summary reports or provides a testing inquiry portal — this is a substantive indicator of information transparency.

---

5. Cross-Border Purchase Compliance Essentials

5.1 Japan → Mainland China: Cross-Border E-Commerce Compliance

China applies a strict licensing regime to imported health foods, with two principal channels:

① General Trade Channel: Products must obtain a Health Food Registration Certificate issued by the State Administration for Market Regulation (SAMR) — commonly referred to as the "blue-hat" registration. Registration requires submission of the product formula, manufacturing process, testing reports, and safety assessment data. HA products seeking to enter the market as formally registered health foods must complete this process, which typically takes one to three years.

② Cross-Border E-Commerce Channel (B2C): Under policies governing the Cross-Border E-Commerce Retail Import Positive List, consumers purchasing foreign health foods through cross-border e-commerce platforms for personal use are subject to personal parcel tax treatment. Single-transaction limits and annual personal purchase limits are explicitly stipulated (consult current Customs and the General Administration of Customs official notices for applicable thresholds, as these are subject to revision). Under this channel, products do not require health food registration, but the selling platform must be registered with the relevant regulatory authorities, and products must meet the compliance requirements of the country of export (Japan).

Key compliance points:

5.2 Japan → European Union: Compliance Framework

In the EU, HA is regulated as a Novel Food under Regulation (EU) 2015/2283. Because HA did not have a documented history of significant consumption in EU member states prior to 15 May 2000, it is classified as a novel food and must undergo evaluation by the European Food Safety Authority (EFSA) and receive authorization from the European Commission before it may be marketed as a food ingredient in the EU.

2023 status: The EU formally authorized Hyaluronic Acid (Sodium Hyaluronate / Hyaluronic Acid) as a novel food for use in food supplements in 2023, establishing a maximum daily intake and restricting use to adults (not suitable for individuals under 18 years of age). Consumers who purchase unauthorized, non-EU-approved products through informal channels risk having those products detained at customs.

5.3 Japan → United States: Compliance Framework

The United States regulates dietary supplements under the Dietary Supplement Health and Education Act (DSHEA, 1994), with oversight by the FDA. Core compliance requirements include:

products marketed in the United States that have not completed the above compliance procedures carry risk of personal-import seizure for quantities exceeding allowable limits; commercial imports require FDA Prior Notice and formal customs clearance.

5.4 Practical Considerations for -Language Labeling in Cross-Border Purchases

-speaking consumers purchasing products with -language labels typically rely on third-party translated inserts or platform-generated product pages. The following risk areas warrant attention:

It is advisable to treat the original -language label as the authoritative source and to cross-verify against the CAA's official Foods with Function Claims notification database.

---

6. Actionable Consumer Verification Checklist

The following verification steps are based on publicly accessible information sources and can be carried out independently by any consumer without specialist knowledge.

Step 1 — Confirm the product's regulatory classification

Check whether the principal display panel bears the designation "Food with Function Claims" or "Food for Specified Health Uses." The former must carry a CAA notification number (format: F×××× or H××××), which can be verified by name or number in the CAA's official Foods with Function Claims notification search system. The latter must carry a Ministry of Health, Labour and Welfare approval number. Products bearing neither designation are conventional foods and should not display any functional claim language.

Step 2 — Verify ingredient quantity labeling completeness

Cross-check the product label for: (a) whether the HA ingredient name is clearly stated (Hyaluronic Acid, Sodium Hyaluronate, etc.); (b) whether the unit of measure is unambiguous (mg, not vague descriptions); and (c) whether both per-unit content and recommended daily serving size are stated, enabling calculation of actual daily intake.

Step 3 — Look up manufacturing facility GMP certification status

If the product states that it is manufactured at a JHNFA GMP-certified facility, visit the Japan Health and Nutrition Food Association's official website and search the "Health Food GMP Certified Facility List" using the facility name or certification number to confirm that the certification is current and valid.

Step 4 — Confirm raw material origin disclosure

Check the company's official website or product detail page to determine whether the HA raw material is identified as "non-animal-derived" or "produced by fermentation," in order to assess compatibility with personal dietary restrictions or allergen concerns.

Step 5 — Verify the legality of the cross-border purchasing channel

Confirm that the purchasing platform holds the relevant cross-border e-commerce registration approved by the General Administration of Customs of China (platforms typically disclose this qualification on their official website or in their business registration information). Avoid purchasing through unlicensed personal purchasing agents to mitigate risk of customs detention and counterfeit product exposure.

Step 6 — Retain proof of purchase and batch information

Keep purchase order records, shipping documentation, and the product lot number. In the event of a product quality concern, the lot number is essential information for initiating a batch traceability inquiry with the manufacturer.

---

Closing Remarks

As a health food ingredient, HA involves the intersection of multiple regulatory frameworks at the level of both ingredient labeling and cross-border compliance. The core information asymmetry consumers face in their purchasing decisions stems primarily from inconsistent ingredient quantity labeling conventions, translation errors, and the tendency for differences in regulatory requirements across markets to be downplayed or obscured.

Enhancing information transparency — through explicit disclosure of ingredient form and quantity basis, public availability of manufacturing facility GMP certification status, and the maintenance of searchable notification records — is both a foundation of sustainable industry development and a prerequisite for consumers to make informed choices.

The verification pathways described in this document are based on publicly accessible official databases and regulatory texts. Where any regulatory framework is updated, the most recent official publications of the relevant competent authority take precedence. Dietary supplements are not a substitute for a balanced diet or professional medical advice. Specific health management matters should be discussed with a licensed physician or registered dietitian.

---

*Reference frameworks: Japan Food Labeling Act (2015); Food Labeling Standards (Cabinet Office Ordinance); Consumer Affairs Agency Foods with Function Claims Notification System; Japan Health and Nutrition Food Association GMP Certification System; EU Regulation (EU) 2015/2283 (Novel Food); United States DSHEA (1994); General Administration of Customs of the People's Republic of China Cross-Border E-Commerce Retail Import Regulations.*

This document concerns quality/transparency only and makes no claim of pharmaceutical efficacy or disease treatment/prevention.
← Back to Resources