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Hyaluronic Acid · Labeling Standards and Cross-Border Compliance

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Abstract

Hyaluronic Acid (HA) is one of the fastest-growing ingredients in Japan's dietary supplement market and in global markets in recent years. However, the core confusion consumers face when making cross-border purchases lies not with the ingredient itself, but with questions such as: what do the numbers on labels actually represent, whether labeling standards are consistent across different markets, and whether the products purchased meet the compliance requirements of both the exporting and importing countries. Using Japan's health food industry as the primary context, this paper systematically reviews the ingredient quantity labeling standards for hyaluronic acid products, the regulatory compliance framework for labeling, and the key verification points consumers need to master in cross-border purchase scenarios. This paper does not address any efficacy or medical function claims; all discussion is confined to verifiable dimensions such as ingredient labeling, traceability of testing, and information transparency.

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I. Raw Material Forms of Hyaluronic Acid and Fundamentals of Ingredient Labeling

1.1 Chemical Forms of Raw Materials

In the dietary supplement sector, commercially available hyaluronic acid raw materials exist primarily in the form of Sodium Hyaluronate , with a minority of products using the free acid form (Hyaluronic Acid Free Form). The two differ in molecular weight, solubility, and manufacturing process; however, commercial product labels do not always distinguish between or specify the raw material form — this constitutes the first blind spot in ingredient quantity verification.

In addition, the molecular weight (MW, unit: Dalton, Da or kDa) of hyaluronic acid is an important parameter for raw material grading. The industry generally classifies it into four ranges: high molecular weight (>1,000 kDa), medium molecular weight (100–1,000 kDa), low molecular weight (10–100 kDa), and oligomeric hyaluronic acid (<10 kDa). Raw materials in different molecular weight ranges differ in production cost, dissolution characteristics, and processing stability. Some manufacturers disclose the molecular weight range on their product pages or specification sheets, but this is not a mandatory requirement under the current labeling regulatory framework and falls under the category of voluntary information transparency.

1.2 Production Origin and Raw Material Traceability

Industrial production of hyaluronic acid raw materials is primarily conducted via two routes:

The market imposes allergen labeling obligations pertaining to animal-derived raw materials (see Section II for details), making raw material origin information an important component of product traceability compliance. Consumers with Halal, vegan, or specific dietary requirements should pay particular attention to raw material origin declarations and third-party certification marks.

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II. Ingredient Quantity Labeling Standards Under Japan's Food Labeling Act Framework

2.1 Regulatory Basis

Japan's Food Labeling Act came into full effect in 2015, consolidating the scattered food labeling provisions previously contained in the JAS Act, the Food Sanitation Act, and the Health Promotion Act into a unified food labeling management system. The companion Food Labeling Standards, issued as a Cabinet Office Ordinance, specify the mandatory labeling items and format requirements for various food categories.

Regarding the labeling of functional ingredient content in dietary supplements, the Food Labeling Standards distinguish between two tiers — mandatory and voluntary labeling:

In practice, any product that states hyaluronic acid content in numerical form on its packaging (e.g., "each capsule contains 120 mg of ") is subject to the aforementioned accuracy obligations.

2.2 Unit and Scope Discrepancies in Ingredient Quantity Labeling

When comparing products, three common types of scope discrepancies in ingredient quantity labeling arise:

① Raw Material Input Amount vs. Active Ingredient Amount

Some products label the input amount of the "hyaluronic acid raw material powder" rather than the active ingredient quantity calculated based on verified hyaluronic acid purity. For example, if a raw material powder contains 80% hyaluronic acid, then 100 mg of raw material powder contains approximately 80 mg of actual hyaluronic acid. If the label states only " 100 mg" without specifying purity, consumers will have no way of knowing the true active ingredient content.

② Per-Capsule Amount vs. Per-Day Intake Amount

Products in the market are commonly sold in capsule, tablet, or powder form. Labels sometimes state only the "per-capsule content" without also stating the "total content at the recommended daily intake." Consumers must combine the "1" (recommended daily intake amount) and the per-unit content to calculate the actual daily intake.

③ Wet Weight vs. Dry Weight

Sodium hyaluronate is highly hygroscopic, and the moisture content of raw materials varies depending on the humidity of the environment. Standardized raw material specification sheets typically express content on a dry basis. If product labels do not specify the measurement conditions, a certain margin of error exists in precise cross-product comparisons of ingredient quantities.

2.3 Allergen Labeling Obligations

If a product uses hyaluronic acid raw materials derived from rooster combs, chicken is one of the recommended allergen labeling items (one of 28 designated items) listed in the annex to Japan's Food Labeling Standards; eggs are similarly subject to mandatory allergen labeling (one of 8 designated items). Even if the hyaluronic acid raw material itself has been purified, if the product is manufactured on the same production line as products containing allergen-bearing raw materials at the same facility, a cross-contamination risk assessment must be conducted and precautionary statements such as "○○" (This product is manufactured in a facility that also produces products containing ○○) should be added where appropriate.

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III. The Foods with Function Claims System and Key Labeling Points for Hyaluronic Acid

3.1 System Overview

Japan's Foods with Function Claims system, which took effect in April 2015, allows businesses to display functional claims on food packaging after submitting a notification to the Consumer Affairs Agency and publicly disclosing the scientific basis. This system is distinct from Foods for Specified Health Uses (FOSHU), which require national government approval; instead, it operates on a model of business self-notification with government public review.

Current status of hyaluronic acid labeling under the Foods with Function Claims system: As of this paper's knowledge cutoff date, products with hyaluronic acid as the functional ingredient have been notified to and listed in the Consumer Affairs Agency's notification database. The functional claims that may be stated are subject to the following constraints:

Verification tip: Consumers can use the Consumer Affairs Agency's official "" (Foods with Function Claims Notification Information Search) database, entering the product name or notification number to verify the product's notification status, functional ingredient intake target amount, and scientific evidence summary.

3.2 Compliance Boundaries for Ordinary Foods

Ordinary health foods that do not qualify for notification under the Foods with Function Claims system must not include on their labels any language that implies a physiological function, including but not limited to: any statement regarding skin moisture, joint lubrication, or any other expression that could be construed as a functional claim. Violating Article 65 of the Health Promotion Act concerning "" (exaggerated advertising) will result in administrative penalties. Substantive review of label compliance applies not only to the text on the packaging itself, but equally to product detail pages, social media promotional materials, and accompanying inserts.

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IV. GMP Certification and Production Information Transparency

4.1 Japan's Health Food GMP Certification System

The credibility of health food product quality depends to a significant degree on the quality management level of the manufacturing facility. The primary health food GMP certification system in Japan is currently administered by the Japan Health and Nutrition Food Association (JHNFA). Facilities that obtain JHNFA GMP Conformance Certification must satisfy the following management requirements:

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

4.2 Ingredient Testing and Third-Party Verification

Products with a higher level of quality assurance typically provide the following verifiable testing information:

Consumers may note whether a company proactively discloses testing summary reports or provides a means to query them — this is one substantive indicator of information transparency.

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V. Key Compliance Points for Cross-Border Purchases

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

China enforces a strict licensing management system for imported health products, with two specific channels:

① General trade channel: Requires a health food registration certificate issued by the State Administration for Market Regulation (SAMR) (colloquially known as the "Blue Hat"). Registration requirements include the submission of product formulations, manufacturing processes, inspection reports, and safety evaluation materials. Hyaluronic acid products seeking to enter the Chinese market as formally registered health foods must complete this registration process, which typically takes 1–3 years.

② Cross-border e-commerce channel (B2C): Under policies related to the "Positive List" of goods eligible for cross-border retail e-commerce import, consumers purchasing overseas health foods through cross-border e-commerce platforms for personal use are subject to the "personal postal tax" policy, with both single-transaction limits and annual individual limits expressly stipulated (specific amounts are subject to the current regulations of the General Administration of Customs, and official announcements should be consulted for authoritative figures). Under the cross-border e-commerce model, products do not need to obtain a Chinese health food registration certificate, but the platform must operate on a cross-border e-commerce platform registered with the regulatory authority, and products must comply with the compliance requirements of the exporting country (Japan).

Key compliance points:

5.2 Japan → European Union: Compliance Framework

The EU regulates hyaluronic acid under the Novel Food framework. Pursuant to EU Regulation (EU) 2015/2283, hyaluronic acid did not have a sufficient history of consumption in EU member states prior to May 15, 2000, and is therefore classified as a novel food. It must be assessed by the European Food Safety Authority (EFSA) and authorized by the European Commission before it may be sold as a food ingredient in the EU market.

2023 status: The EU formally approved hyaluronic acid (Sodium Hyaluronate / Hyaluronic Acid) as a novel food for use in food supplements in 2023, establishing a maximum daily intake limit and restrictions on the target population (not suitable for persons under 18 years of age). Consumers who purchase products through non-regulated channels that have not received EU authorization risk having their products seized by 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 distributed in the United States that have not completed the above compliance procedures risk having quantities exceeding personal use limits seized when personally carried into the country; commercial imports require completion of FDA Prior Notice and import clearance procedures.

5.4 Practical Considerations for Chinese-Language Labeling in Cross-Border Contexts

Chinese-speaking consumers purchasing products with -language labels through cross-border channels commonly rely on third-party translated inserts or Chinese product pages provided by platforms. The following risk points should be noted:

It is recommended to treat the -language original label as the authoritative source, supplemented by cross-verification against the Consumer Affairs Agency's official notification database.

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VI. Actionable Verification Steps for Consumers

The following verification steps are based on publicly accessible information channels and can be performed independently by consumers without specialist knowledge:

Step 1: Verify the product's regulatory category

Check whether the front of the packaging states "" (Food with Function Claims) or "" (Food for Specified Health Uses). The former must carry a notification number (in a format such as F×××× or H××××), which can be verified by number or product name in the Consumer Affairs Agency's "" system; the latter must carry a Ministry of Health, Labour and Welfare approval number. Products without either designation are ordinary foods, and no functional claims should appear on their labels.

Step 2: Verify the completeness of ingredient quantity labeling

Cross-check the product label to confirm: (a) whether the ingredient name for hyaluronic acid is clearly stated (, etc.); (b) whether the content unit is clear (mg, not a vague description); and (c) whether both the per-unit content and the recommended daily intake amount are stated, enabling calculation of the actual daily intake.

Step 3: Verify the GMP certification status of the manufacturing facility

If the product states that it is manufactured in a JHNFA GMP-certified facility, visit the official website of the Japan Health and Nutrition Food Association, access the "GMP" (Health Food GMP Certified Facility List), and enter the facility name or certification number to verify the validity of the certification.

Step 4: Confirm the raw material origin declaration

Check the company's official website product page or product detail page to confirm whether the hyaluronic acid raw material is stated to be "" (non-animal-derived) or produced via "" (fermentation), to determine whether it meets personal dietary restrictions or allergen avoidance needs.

Step 5: Verify the legitimacy of the cross-border purchase channel

Confirm that the purchase platform is a cross-border e-commerce platform that has been approved and registered with China's General Administration of Customs (platforms generally disclose this qualification on their official websites or in their business registration information). Avoid purchasing through unlicensed personal purchasing agent channels to mitigate risks of customs seizure and counterfeit products.

Step 6: Retain proof of purchase and batch information

Keep records of purchase orders, logistics documents, and the product's LOT number. In the event of a product quality concern, the LOT number is the essential information for contacting the manufacturer to initiate a batch traceability inquiry.

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Conclusion

As a health food ingredient, hyaluronic acid involves the intersection of multiple regulatory frameworks at the levels of ingredient labeling and cross-border compliance. The core information asymmetry that consumers face in purchase decisions stems primarily from inconsistent ingredient quantity labeling standards, distortion of translated information, and the tendency for differences in regulatory requirements across markets to be minimized or overlooked. Enhancing information transparency — including clearly specifying ingredient form and quantity basis, publicly disclosing GMP certification status of manufacturing facilities, and maintaining notification records in searchable databases — is the foundation for the sustainable development of the industry and the prerequisite for consumers to make informed choices.

The verification pathways described in this paper are all based on publicly accessible official databases and regulatory texts; when any regulatory framework is updated, the most recently issued official documents from the competent authority shall take precedence. Dietary supplements are not a substitute for a balanced diet or medical advice. For specific health management matters, please consult a licensed physician or registered dietitian.

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*Reference frameworks: Japan's 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 (JHNFA) GMP Certification System; EU Regulation (EU) 2015/2283 (Novel Food); U.S. DSHEA (1994); People's Republic of China General Administration of Customs regulations on cross-border e-commerce retail imports.*

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