Placenta Extract · Labeling Standards and Cross-Border Compliance

Abstract

Placenta extract has long held a leading position among ingredients in Japan's health food market, circulating primarily in the form of porcine placenta and equine placenta extracts. However, significant information asymmetry exists between consumers and operators regarding ingredient quantity labeling practices, GMP certification systems, and cross-border purchase compliance requirements for this category. Drawing on Japan's Food Labeling Act, Health Promotion Act, and relevant industry guidelines, this paper systematically reviews the core standards governing placenta extract products across three dimensions: ingredient quantity labeling, label compliance, and cross-border distribution, for the reference of consumers and industry stakeholders. This paper contains no medical efficacy or health claims of any kind; all discussion is limited to verifiable labeling and compliance matters.

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I. Raw Material Forms and Market Background

1.1 Primary Raw Material Sources

Raw materials for placenta extract health foods sold in Japan fall into two main categories:

• Porcine Placenta Extract: Raw material countries of origin are primarily Japan itself or countries with comprehensive veterinary quarantine systems, such as Australia and Canada.
• Equine Placenta Extract: Horses are primarily sourced from Hokkaido (Japan), Mongolia, and Australia. Premium products typically indicate the specific farm or place of origin on the label.

The quarantine status of the raw material's country of origin and source animal represents the first layer of traceability assessment. A basic indicator of information transparency when selecting products is whether the label clearly states the country of origin of the raw material and the animal species.

1.2 Market Scale and Distribution Forms

According to publicly available materials from organizations such as the Japan Health Food Industries Association, placenta extract health foods are distributed primarily in the dosage forms of soft capsules, oral liquids, and powder preparations. Oral liquid formulations command a comparatively high share of cross-border e-commerce channels due to their faster absorption rate and portability. Distribution channels encompass drug stores, online mail-order retail, and overseas personal shopping, the latter two of which introduce significant labeling compliance risks.

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II. Ingredient Quantity Labeling Standards

2.1 Basic Framework of Japan's Food Labeling Act

In 2015, Japan consolidated three existing laws—the Food Sanitation Act, the JAS Act, and the Health Promotion Act—into the unified Food Labeling Act. This Act establishes separate labeling obligations for general-use processed foods and Foods with Function Claims.

For health foods in the broad sense, the core mandatory labeling items are as follows:

2.2 Specific Challenges in Ingredient Quantity Labeling for Placenta Extract

Placenta extract is a multi-component complex, and its labeling presents several industry-recognized challenges:

(I) Lack of Uniform Measurement Standards for "" Content

regulations have not yet established a single statutory quantitative standard for "placenta extract." The following labeling methods are commonly found in the market:

• Raw Material Powder Weight Labeling: States the weight (mg) of placenta raw material powder per capsule or per daily serving; this is the most straightforward method.
• Equivalent Extract Quantity : Calculated using a concentration factor relative to the dried raw material, e.g., " 500mg (5000mg)" [Placenta Extract Powder 500mg (equivalent to 5000mg fresh placenta)].
• Indirect Labeling via Active Constituents: Reflects the extract specification indirectly through measurable indicators such as total amino acid content, nucleic acid content, or protein content.

Consumers should note that "fresh placenta equivalent" is not a directly comparable standard unit; the conversion factor applied may differ between manufacturers. If the label does not explain the conversion methodology, the reference value of that figure is limited.

(II) Labeling Order When Multiple Raw Materials Are Mixed

When a product contains both porcine and equine placenta extracts, or includes supplementary ingredients such as collagen or hyaluronic acid, the Food Labeling Standards require that raw materials be listed in descending order by weight proportion. Consumers can use the order of the ingredient list to approximate the actual proportion of placenta extract within the product formulation.

(III) Separate Labeling of Food Additives

Food additives such as preservatives, colorants, and emulsifiers must be clearly distinguished from general raw materials, typically separated by a slash "/" or listed in a separate field. A label that does not make this distinction, or that includes additives within the general ingredient name field, is non-compliant.

2.3 The Foods with Function Claims System and Its Relationship to Placenta Extract

Japan introduced the Foods with Function Claims system in 2015, permitting companies to display specific functional claims on packaging after filing with and receiving acceptance from the Consumer Affairs Agency. However, as of the knowledge cutoff date of this paper, the number of Foods with Function Claims for which (placenta extract) serves as the sole functional ingredient is extremely small, and there remains insufficient systematically validated evidence linking ingredient quantity to functional claims.

This means that the overwhelming majority of placenta extract products on the market remain in the category of general health foods, and their labels must not display any functional claim language; doing so would violate the Food Labeling Act. If consumers encounter descriptions such as "whitening," "anti-aging," or "relief of menopausal symptoms"—whether printed on the packaging or appearing on a product page of an official website—these constitute non-compliant labeling and should be treated with caution.

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III. GMP Certification and Product Traceability

3.1 Significance of JHNFA GMP Conformance Certification

The Japan Health and Nutrition Food Association (JHNFA) operates a GMP (Good Manufacturing Practice) conformance certification program, which audits the full manufacturing process at factories—including raw material receipt management, manufacturing process management, quality control, and outbound shipment management—with certification numbers published and publicly searchable. Consumers can verify the certification status and validity period of a specific factory on the JHNFA official website using the certification number.

Taking products under the Tsurumatsuyakuhin/Showa brand as an example: these products are stated to be manufactured at a factory holding JHNFA GMP conformance certification (certification number 34225). Consumers can search this number on the JHNFA website to verify the factory's certification status. This represents an actionable verification pathway for assessing the credibility of a product's manufacturing.

It is important to note that GMP certification applies to the manufacturing factory itself, not to any specific product formulation. Factory certification does not automatically imply full labeling compliance for a given product; the two must be assessed separately.

3.2 Raw Material Traceability Documentation

Products with higher traceability typically exhibit the following characteristics:

• The official website or product information page clearly states the country of procurement and supplier qualifications for raw materials.
• Third-party testing reports are provided (for heavy metals, pesticide residues, microbiological indicators, etc.), and the testing institution's qualifications are verifiable.
• The lot number can be traced to specific production records via customer service or a scan-code system.

Raw material origin transparency is one of the most differentiating information dimensions within the health food category, and it does not necessarily correlate positively with product price.

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IV. Key Compliance Points for Cross-Border Purchases

4.1 Regulatory Restrictions on Shipments from Japan to Overseas Destinations

Personal-use shipments of health foods to overseas destinations are generally subject to the following rules:

(I) Export from Japan

Health foods (food classification) are generally not regulated items under Japan's Pharmaceutical and Medical Device Act. However, if a product contains ingredients of animal origin (porcine or equine placenta), it must comply with the importing country's quarantine regulations for products of animal origin upon export. Certain countries classify porcine- and equine-derived extracts as categories requiring declaration or subject to import restrictions.

(II) Importing Country Review

Taking mainland China as an example: personal mail imports of health foods containing ingredients of animal origin are subject to customs declaration and governed by the Law of the People's Republic of China on the Inspection and Quarantine of Animals and Plants Entering and Exiting the Country and related announcements. Items exceeding the duty-free threshold or subject to quarantine declaration requirements may face detention or return. Consumers should consult the importing country's currently effective customs and quarantine regulations before purchasing, rather than relying on informal representations made by personal shopping agents.

(III) Labeling Risks in Personal Shopping Channels

Products purchased through personal resellers or shopping agents carry the following specific risks:

• The outer packaging may have been repackaged, with original label information (manufacturing date, lot number, producer details) potentially missing.
• It is impossible to verify whether the product is genuine original merchandise, making it difficult to trace back to the manufacturing factory.
• In the event of a quality issue after the product enters circulation, consumer recourse options are extremely limited.

4.2 Compliance Differences Across Cross-Border E-Commerce Platforms

Purchasing through a brand's official overseas storefront (e.g., Tmall Global, Rakuten Global) differs fundamentally in compliance terms from purchasing through personal shopping agents:

4.3 Chinese Label Requirements (Applicable to the China Market)

health foods formally registered as cross-border e-commerce imports entering the mainland China market must satisfy the requirements of China's State Administration for Market Regulation and relevant customs regulations. They are generally required to carry a Chinese-language label containing: product name, ingredient list (in Chinese), net content, manufacturing date and shelf life, manufacturer and domestic responsible party information, storage conditions, and method and dosage of consumption.

The absence of a Chinese-language label, or inconsistency between the Chinese label content and the original packaging information, represents a fundamental compliance red line for products in legitimate cross-border channels.

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V. Actionable Checklist for Consumers

When purchasing placenta extract health foods, consumers can perform the following self-verification steps:

Step 1: Confirm Product Classification

Check the front of the packaging for wording such as "" (Foods with Nutrient Function Claims), "" (Foods with Function Claims), " " (Foods for Specified Health Uses), or "" (General Food). The vast majority of placenta extract products are general foods; any product bearing a function claim must be searchable in the Consumer Affairs Agency database.

Step 2: Review the Ingredient Name Labeling

The ingredient name field should clearly identify the animal source (porcine or /equine) and origin information for the placenta extract. If the labeling is vague and merely states "" without specifying the species, the level of information transparency is insufficient.

Step 3: Verify the Ingredient Quantity Labeling Method

If the label uses a "fresh equivalent" method of labeling, the conversion factor and calculation basis should also be stated; without them, the number lacks comparable meaning.

Step 4: Verify the Manufacturing Factory Certification

If a product claims to be manufactured at a GMP-certified factory, the certification number can be entered on the JHNFA official website (public search page) to verify the validity period and scope of certified product categories.

Step 5: Confirm Purchase Channel Compliance

Give priority to official brand channels or cross-border platforms with proper customs clearance. Retain complete purchase documentation (order records, photographs of actual packaging including the lot number) to facilitate future traceability.

Step 6: Identify Non-Compliant Claims

If a product description contains expressions such as "improvement of menopausal disorders," "whitening effect," "fatigue recovery," or "physician-recommended "—in any form—these exceed the permissible scope for general health foods and should be treated as a negative indicator of the product's regulatory compliance.

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Conclusion

Information transparency in the placenta extract health food market is gradually improving as the regulatory framework matures; however, non-compliant labeling practices remain widespread across various sales channels, and the problem is particularly concentrated at the cross-border distribution stage. Consumers who build an evaluation framework based on labeling compliance, raw material traceability, and channel legality are better protected than those who rely solely on brand marketing or word of mouth.

It bears emphasis that health foods are not pharmaceutical drugs under the legal frameworks of any country. Their value lies in the clear labeling of ingredients, the transparent and verifiable sourcing of raw materials, and the verifiability of manufacturing standards. These three dimensions are simultaneously the criteria by which consumers should make purchasing decisions and the compliance baseline that operators should continuously uphold. For consumers making cross-border purchases, verifying the destination country's currently effective import regulations before buying remains a necessary step that takes precedence over all other considerations.

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*The content of this paper is for informational reference only and does not constitute medical advice or investment advice. Regulatory information is subject to the latest official announcements from the competent authorities of each country.*