Health Foods and the PMD Act — Ingredients and Labeling for Import Sales
Interlink編集部Health Foods and the Pharmaceuticals and Medical Devices Act (PMD Act)
Health foods generally refer to foods consumed with the expectation of helping maintain or improve health.
In actual logistics practice, products such as supplements, nutritional supplements, health supplements, foods claiming functional benefits, herbal foods, plant extract-containing foods, protein products, enzyme foods, and lactic acid bacteria foods may be referred to as "health foods."
However, "health foods" is not an official classification under the PMD Act. Legally, classification needs to be checked against respective systems such as pharmaceuticals, quasi-drugs, food, and specified health foods.
From an import perspective, health foods are subject to import notification and inspection under the Food Sanitation Act. However, depending on their ingredients, forms, labeling, advertising, and sales methods, they may be deemed pharmaceuticals under the PMD Act.
Therefore, it is important not only to confirm whether they can be imported simply as foods but also to verify how they will be labeled, advertised, and sold within Japan.
Scope Covered in This Article
| Scope | Content Organized in This Article | Additional Confirmation Required |
|---|---|---|
| Basics of Health Foods | Clarifies that health foods are not an official classification under the PMD Act, and it is necessary to distinguish between food, specified health foods, and pharmaceuticals. | Legal classification of individual products should be checked considering ingredients, labeling, advertising, and sales methods. |
| Pharmaceutical Designation under the PMD Act | Summarizes the possibility of being classified as pharmaceuticals depending on ingredients, form, dosage and administration, efficacy claims, and advertising expressions. | For products containing exclusively pharmaceutical ingredients or unapproved/unlicensed pharmaceuticals, expert or administrative office confirmation is required. |
| Specified Health Food Systems | Outlines the differences among Foods for Specified Health Uses (FOSHU), Nutritional Function Foods, Functional Labeling Foods, and general health foods. | Details on notification, approval, labeling standards, and supporting documentation should be verified via each system’s official information. |
| Food Sanitation Act and Food Labeling Act | Summarizes import notification, inspections, additives, pesticide residues, Japanese labeling, nutritional content, and allergen declarations. | Necessity of import notification or inspection under the Food Sanitation Act should be checked with quarantine stations and customs brokers. |
| Act against Unjustifiable Premiums and Misleading Representations / Advertising Expressions | Highlights points to watch regarding deceptive claims, exaggerated functional claims, testimonials, rankings, and before-and-after expressions. | The appropriateness of individual advertisements requires advertising review, legal, or expert advice. |
| Personal Import vs. Commercial Purpose Import | Clarifies differences between imports for personal use and imports for domestic sale, resale, or distribution. | Individual confirmation of quantity, repetitive nature, sales intent, and business status of the importer is required. |
| Freight Forwarding and Customs Clearance Practice | Summarizes points to confirm upon seeing cargo descriptions such as supplement, health food, diet product, etc. | Freight forwarders should avoid making definitive judgments regarding PMD Act applicability and encourage confirmation with the importer and customs broker. |
The Positioning of the Term "Health Foods"
The term “health foods” is not an official classification under the PMD Act.
Generally, it is used to broadly refer to foods taken for purposes such as health maintenance, nutritional supplementation, beauty, physical condition management, or lifestyle improvement.
However, since these are foods, any labeling or advertising implying diagnosis, treatment, or prevention of diseases, or strongly affecting bodily functions, cannot be freely made.
Such labeling or advertising may be judged as claiming medicinal effects, potentially leading to issues regarding unapproved or unlicensed pharmaceuticals under the PMD Act.
Purpose and Background of the Systems
Health foods may be distributed as foods, but consumers may purchase them expecting treatment, prevention, symptom improvement, or effects on bodily functions.
Therefore, when importing and selling health foods, it is necessary to verify not only their safety as foods but also that they do not claim pharmaceutical-like efficacy, contain pharmaceutical ingredients, or feature exaggerated advertising.
Especially for overseas supplements and herbal products, even if sold internationally as dietary supplements or health supplements, confirmation may be necessary regarding pharmaceutical ingredients, designated ingredients, food additives, pesticide residues, labeling, and advertising regulations in Japan.
Importers need to organize in advance not only whether the product itself can be imported as food but also under which system it will be handled domestically and how it will be labeled, advertised, and sold.
Applicable Products
Products that may be imported and sold as health foods come in various forms, including tablets, capsules, powders, granules, liquids, beverages, jellies, and processed foods.
| Examples of Products | Main Characteristics | Points to Confirm | Notes |
|---|---|---|---|
| Vitamin, Mineral, Amino Acid Supplements | Products often sold for nutritional supplementation purposes. | Content amount, eligibility as nutritional functional foods, food labeling, advertising expressions | Check the components and standards for labeling as nutritional functional foods. |
| Protein, Enzyme, Lactic Acid Bacteria, Aojiru (green juice) | Products frequently marketed for health maintenance, beauty, and condition management. | Ingredients, additives, allergens, presence of functional labeling | Avoid exaggerated effect claims or disease improvement expressions. |
| Diet and Beauty Supplements | Products often promoted for weight, fat, beauty, metabolism, etc. | Ingredients, pharmaceutical components, advertising, testimonials, before-and-after expressions | Be cautious of pharmaceutical efficacies and misleading representations under the Premiums and Representations Act. |
| Herbal and Plant Extract-Containing Foods | Supplements or beverages containing plant-derived ingredients. | Scientific name, part used, extraction method, concentration, content amount | Ingredients that may be food overseas could require confirmation in Japan. |
| Foods Containing Animal-Derived Ingredients | May include gelatin, placenta, collagen, animal extracts, etc. | Country of origin, animal species, manufacturing process, quarantine and Food Sanitation Act checks | Not only ingredients but also import restrictions and quarantine confirmations are necessary. |
| Products Sold as Functional Foods with Claims | Foods with functional claims based on scientific evidence under the operator’s responsibility. | Notification details, functional ingredients, labeling, advertising | Be careful of advertising expressions that exceed the notification content. |
| Overseas Dietary Supplements | Products sold as supplements in overseas markets. | Ingredient regulations in Japan, food labeling, pharmaceutical eligibility, advertising | Overseas classifications cannot be directly applied in Japan. |
Differences from Health Functional Foods
Among items called health foods, there are health functional foods organized under the national system.
The main categories of health functional foods are Specific Health Foods, Nutritional Functional Foods, and Foods with Functional Claims.
Unlike general health foods, each of these categories has different allowable content for labeling and procedures.
| Category | Overview | Allowable Labeling Content | Practical Points of Caution |
|---|---|---|---|
| Specific Health Foods | Foods labeled as having specific health purposes that can be expected. | Health-related claims individually approved. | Since individual permission and review are involved, overseas product labeling cannot be used as-is. |
| Nutritional Functional Foods | Foods that can display functional claims about nutritional components set by the government if they meet certain criteria. | Functional claims about specified nutritional components regulated by law. | Confirmation is necessary for target ingredients, content amounts, labeling items, and caution statements. |
| Foods with Functional Claims | Foods labeled with specific health purposes based on scientific evidence under the operator’s responsibility. | Functional claims based on submitted notification content. | Caution is required regarding advertising or claims that exceed the notification and those that imply government approval of effectiveness. |
| General Health Foods | Foods sold with expectations for health maintenance but outside the health functional food system. | Cannot make pharmaceutical efficacy claims or functional claims like health functional foods. | Pharmaceutical efficacy claims, exaggerated representations, food labeling, and ingredient regulations need to be confirmed. |
Importers need to clearly determine whether the product will be sold simply as “health food,” or as a Food with Functional Claims, Nutritional Functional Food, or Specific Health Food.
Even if a product is sold overseas as a health supplement or dietary supplement, it does not necessarily mean health functional claims can be made in Japan.
Comparison with Other Systems
| System | Main Role | Items to Check for Health Food Imports | Common Problematic Scenarios | Practical Measures |
|---|---|---|---|---|
| Food Sanitation Act | A system to verify food safety, import notification, inspection, additives, residual pesticides, etc. | Raw materials, additives, manufacturing process, COA, import notification, need for inspection | Situations where only the Pharmaceutical Affairs Act is considered, causing import food notifications or inspections to be overlooked. | Obtain ingredient lists, specifications, and manufacturing process documents before procurement. |
| Food Labeling Act | A system managing the contents of food labeling. | Ingredient names, additives, nutritional components, allergens, country of origin labeling, Japanese labeling | Cases where overseas labels are directly translated and used for sales. | Prepare Japan-specific labeling before sales. |
| Pharmaceutical Affairs Act | A system regulating drug identification and drug-like efficacy claims. | Drug ingredients, core ingredients used exclusively for drugs, form, dosage and administration, efficacy claims, advertising | Cases where a product imported as food claims disease treatment or therapeutic effects. | Separate verification of ingredients and advertising is performed. |
| Act against Unjustifiable Premiums and Misleading Representations | A system regulating misleading representations, preferential misinformation, and excessive advertising claims. | Advertisements, landing pages, SNS, testimonials, rankings, before-and-after, supporting documents | Situations involving exaggerated claims such as "definitely lose weight" or "improvement in a short period." | Check consistency between advertising content and supporting documentation. |
| Health Functional Food System | A system permitting health function claims under certain conditions. | Categories of Specific Health Use Foods, Nutritional Function Foods, and Foods with Functional Claims | Cases where overseas functional claims are used as-is in Japan. | Verify the labeling requirements and notification/approval according to Japan's system. |
| Personal Import System | A framework for imports within certain limits for personal use. | Whether for personal use or business, quantity, frequency, buyers | Situations where personally imported items are sold or resold domestically. | Confirm compliance with the Food Sanitation Act, Pharmaceutical Affairs Act, etc., for imports intended for business purposes. |
Pharmaceutical Classification under the Pharmaceutical Affairs Act
The most frequent issue concerning health foods is the pharmaceutical classification under the Pharmaceutical Affairs Act.
Even if a product is intended to be sold as food, it could be classified as a drug if any of the following conditions apply:
- It contains drug ingredients
- It contains core ingredients used exclusively for drugs
- It claims disease treatment, prevention, or improvement
- It claims strong effects on bodily functions
- Dosage and administration are indicated similarly to drugs
- It is sold in a form or with labeling reminiscent of drugs, such as tablets, capsules, or ampoules
- It implies drug-like effects through doctors, experts, testimonials, or research data
If classified as a drug, free importation and sale as a food product are not permitted.
Importers need to comprehensively check ingredients, form, labeling, advertising, and sales methods to confirm whether the product can be treated as a food item within Japan.
Application Requirements and Exclusions
| Category | Concept | Documents to Verify | Notes |
|---|---|---|---|
| Products that may be treated as food | Products that do not contain drug ingredients, do not claim disease treatment or improvement, and are sold as food. | Ingredient lists, specifications, manufacturing process, labeling drafts, advertising drafts | Even if food, confirmation under the Food Sanitation Act, Food Labeling Act, and Act against Unjustifiable Premiums and Misleading Representations is required. |
| Products that could be classified as drugs | Those containing drug ingredients, core drug ingredients, disease improvement claims, or drug-like dosage/administration instructions. | Ingredient lists, COA, raw material information, advertising text, product pages | May not be importable or sellable as foods. |
| Products treated as health functional foods | Products with labeling in compliance with the system of Specific Health Use Foods, Nutritional Function Foods, or Foods with Functional Claims. | Approval or notification documents, nutrition component values, functional evidence, labeling drafts | Claims or advertising expressions beyond the scope of the system are not permitted. |
| Products limited to personal import | Imports within certain limits for personal use. | Quantity, purpose, order history, delivery address, intent to sell | Converting for domestic sale, resale, or distribution turns it into a business import. |
| Products imported for business purposes | Products imported for domestic sale, resale, distribution, or business use. | Sales plans, delivery destinations, sales pages, quantity, frequency | Confirmation of compliance with the Food Sanitation Act, Food Labeling Act, Pharmaceutical Affairs Act, and Act against Unjustifiable Premiums and Misleading Representations is required. |
| Products often mistaken as excluded | Products appearing as foods, such as herbs, natural ingredients, overseas supplements, and plant extracts. | Scientific names, parts used, extraction methods, content amounts, advertisements | Even natural ingredients may contain drug ingredients or have Pharmaceutical Affairs Act issues. |
Notes on Ingredient Verification
Products sold overseas as supplements may include ingredients that classify as drug ingredients in Japan.
Ingredients such as plant extracts, herbs, animal-derived components, minerals, and chemicals may require verification based on ingredient names, used parts, extraction methods, content amount, and concentration.
In import operations, product names or sales pages alone are insufficient to make a classification. Ingredient lists, specifications, COAs, manufacturing processes, scientific names of raw materials, parts used, and content amounts must be checked.
Especially for products claiming effects on diet, energy enhancement, sleep, blood sugar, blood pressure, immunity, hormones, beauty, joints, cognitive function, etc., ingredient verification and advertising verification should be handled separately.
Issues Related to Drug-Like Efficacy Claims
In health foods, expressions that claim to treat, prevent, or improve diseases should be avoided.
For example, the following expressions may become problematic as pharmaceutical-like efficacy or effects:
- Effective for diabetes
- Cures high blood pressure
- Prevents cancer
- Prevents infections
- Lowers blood sugar levels
- Boosts immunity to prevent illnesses
- Improves insomnia
- Breaks down fat
- Regulates hormone balance
Also, not only direct expressions but overall implication of pharmaceutical effects through testimonials, word-of-mouth, rankings, endorsements by doctors or experts, citation of research data, before-and-after images, etc., requires careful attention.
Advertising expressions need to be reviewed not only on product labels but also on e-commerce sites, social media, brochures, video explanations, landing pages, and email advertisements.
Difference Between Personal Import and Business Purpose Import
For health foods and supplements, the distinction between personal import and business-purpose import is also important.
The regulations to be checked differ between importing a certain quantity for personal use and importing for domestic sale, resale, or distribution.
Even if a certain quantity or conditions are permitted under personal import, these cannot be used for domestic sales.
In particular, when selling supplements purchased on overseas e-commerce sites domestically in Japan, these are considered import and sales for business purposes, not personal use. Verification of the Food Sanitation Act, Food Labeling Act, Pharmaceutical Affairs Act, and Act against Unjustifiable Premiums and Misleading Representations will be required.
Also, supplements sold as foods overseas but that contain pharmaceutical ingredients or claim pharmaceutical-like efficacy or effects in Japan may be treated as pharmaceuticals.
Main Verification Items for Import Sales
| Item to Verify | Main Content | Common Causes for Detainment |
|---|---|---|
| Food or Pharmaceutical Product | Confirm pharmaceutical applicability from ingredients, labeling, advertising, form, and sales methods. | Judging as food merely because it is sold as a supplement overseas. |
| Ingredient Verification | Check for pharmaceutical ingredients, designated ingredients, food additives, prohibited ingredients, and raw material names. | Judging based only on the English product name without checking ingredient lists or specifications. |
| Food Sanitation Act | Confirm import notification, inspections, additives, residual pesticides, raw materials, and manufacturing processes. | Focusing only on the Pharmaceutical Affairs Act and overlooking notification or inspections under the Food Sanitation Act. |
| Food Labeling Act | Check ingredient names, additives, nutritional components, allergens, country of origin labeling, etc. | Using overseas labels as is without properly preparing Japanese labeling. |
| Health Functional Food System | Confirm whether it is treated as functional food with health claims, nutritional functional food, or specified health food. | Mistakenly assuming overseas functional claims can be used as is in Japan. |
| Advertising Expressions | Check for pharmaceutical-like efficacy claims, exaggeration, misleading claims of quality or advantage. | Claiming disease names, treatment effects, or improvement effects on e-commerce sites or social media. |
| Purpose of Sale | Confirm whether for personal use or import sales for business purposes. | Attempting to sell personal import items domestically. |
System Application Flow
- Do not judge by product name alone; confirm ingredient lists, specifications, raw materials, and manufacturing processes.
- Confirm whether the product is imported as food or has the potential to be classified as a pharmaceutical.
- Check for presence of pharmaceutical ingredients, exclusively pharmaceutical ingredients, or regulated ingredients.
- Confirm import notification, inspection, additives, residual pesticides, and manufacturing process under the Food Sanitation Act.
- Perform checks under the Food Labeling Act such as Japanese labeling, nutritional components, allergens, and country of origin labeling.
- Confirm whether it is sold as functional food with health claims, nutritional functional food, or specified health food.
- Review e-commerce sites, social media, brochures, advertisements, testimonials, and word-of-mouth expressions.
- Clarify whether the import is personal or for business purpose based on quantity, frequency, sales purpose, and delivery destination.
- Before customs clearance, confirm with importer, customs broker, food import notification officer, and, if necessary, specialists in pharmaceutical affairs and labeling.
- Before starting sales, recheck labeling, advertising, sales pages, and explanations to sales destinations.
Import Operation Process
| Stage | Main Items to Check | Common Causes for Detainment |
|---|---|---|
| Before Purchasing | Confirm ingredients, form, intended use, sales expressions, and sales destinations. | Judging that it can be treated as food based only on overseas manufacturer’s product descriptions. |
| Before Import Arrangement | Confirm compliance with the Food Sanitation Act, Food Labeling Act, Pharmaceutical Affairs Act, and Unjustifiable Premiums and Misleading Representations Act. | Not obtaining ingredient lists or specifications until just before customs clearance. |
| At Customs Declaration | Organize information such as food import notification, raw materials, additives, usage, and quantity. | When the invoice only states "supplement" or "health food" without detailed information. |
| Customs and Quarantine Inspection | Respond to confirmations under the Food Sanitation Act, inspections if necessary, and submission of additional documents. | Lack of information on ingredient names, content quantities, manufacturing processes, or raw materials. |
| Preparation of Domestic Labeling | Confirm Japanese labeling, nutritional components, allergens, country of origin, and health functional claims. | Simply translating overseas labels or product pages as is. |
| Before Starting Sales | Review e-commerce sites, advertisements, social media, landing pages, testimonials, and word-of-mouth expressions. | Displaying pharmaceutical-like efficacy or exaggerated functionality on sales pages. |
Common Situations Where Problems Arise in Import Operations
Health foods may not be cleared solely by import notification or inspection under the Food Sanitation Act.
Depending on their ingredients, form, labeling, advertising expressions, and sales methods, it may be necessary to verify whether they fall under the definition of pharmaceuticals under the Pharmaceuticals and Medical Devices Act (PMD Act).
| Case | Potential Issues | Documents to Check | Practical Response |
|---|---|---|---|
| Claiming effects by naming diseases | May be regarded as pharmaceutical efficacy and pose legal concerns. | Product pages, advertisements, SNS posts, brochures | Avoid expressions related to treatment, prevention, or improvement of diseases and revise labeling accordingly. |
| Labeling with "cures," "improves," or "prevents" | May be seen as pharmaceutical claims rather than food-related. | Advertisements, landing pages (LPs), testimonials, sales materials | Remove pharmaceutical-like expressions and confirm expressions acceptable for foods. |
| Emphasizing effects on blood pressure, blood sugar, immunity, hormones, or sleep | Could imply strong physiological effects or disease prevention. | Advertisements, ingredient documents, functional evidence, notification records | Separate confirmation of ingredients and advertising content. |
| Products considered supplements overseas but contain pharmaceutical ingredients in Japan | May not be permitted for import and sale as food. | Ingredient lists, specifications, COA, scientific names and plant parts of raw materials | Verify ingredient nature and content before procurement. |
| Directly translating overseas labels or sales pages into Japanese | Functional claims permitted overseas may violate the PMD Act or Act against Unjustifiable Premiums and Misleading Representations in Japan. | Overseas labels, draft Japanese labels, advertising drafts | Redesign labeling and advertising specifically for the Japanese market. |
| Selling personally imported products domestically | Requires regulation check as commercial imports rather than for personal use. | Quantities, sales destinations, e-commerce listing info, order history | Confirm compliance with Food Sanitation Act, Food Labeling Act, PMD Act, and Act against Unjustifiable Premiums and Misleading Representations. |
| Advertising functional foods beyond notified content | Statements exceeding notified functionality or implying government-recognized effects could be problematic. | Notification documentation, advertisements, LPs, SNS posts, quoted reviews | Check consistency between notification details and advertising expressions. |
| Lack of ingredient lists, specifications, or manufacturing process documents | Prevents proper verification under the Food Sanitation Act, PMD Act, and food labeling requirements. | Ingredient lists, specifications, manufacturing process descriptions, COA | Obtain necessary documents from overseas manufacturers before shipment. |
Points to Check in Forwarder and Customs Clearance Operations
When the cargo name includes terms such as "supplement," "health food," "nutrition product," "diet product," or "herbal capsule," it is important for freight forwarders and customs-related personnel to be aware that verification under not only the Food Sanitation Act but also the PMD Act may be required.
Freight forwarders are not in a position to make final judgments on pharmaceutical classification or advertising expressions under the PMD Act.
However, if cargo names, ingredients, form, sales purposes, or product descriptions suggest that regulatory checks may be necessary, forwarders should encourage importers to confirm this, and share the information early with customs brokers and those responsible for food import notifications.
If customs or quarantine authorities request additional documents, forwarders should collect ingredient lists, specifications, manufacturing processes, product catalogs, sales pages, usage explanations, etc., from the importer and coordinate with customs brokers and relevant parties.
Forwarders should avoid definitively stating that "this is food, so there is no issue," or "this is not a pharmaceutical."
Extent of Forwarder Involvement
| Situation | What Support Can Be Provided | What Should Not Be Concluded | Practical Actions |
|---|---|---|---|
| If the cargo name includes "supplement" or "health food" | Encourage the importer to verify ingredient lists, specifications, intended use, and sales purpose. | Should not conclude that it poses no issues as food or that it is not a pharmaceutical. | Share information early with customs brokers and those in charge of food import notifications. |
| If ingredient documents are missing | Request the overseas manufacturer to provide ingredient lists, COA, and manufacturing process documents. | Should not judge import eligibility without documentation. | Compile a list of missing documents and request them from the importer. |
| If advertising includes disease names or treatment effects | Inform the importer that confirmation under the PMD Act is required. | Forwarders should not make final judgments on legality of advertising content. | Encourage checking with regulatory affairs or labeling specialists. |
| If it is unclear whether the import is personal or commercial | Prompt confirmation of quantities, repetition, delivery destinations, and intended sales. | Should not treat it lightly as personal use. | If for sales, classify the import as commercial accordingly. |
| If customs or quarantine authorities request verification | Collect necessary documents from the importer and coordinate with customs brokers. | Should not independently declare that the cargo is outside regulatory scope. | Communicate with reference materials and documentation from the importer attached. |
| If asked to review advertising before sales start | Advise that advertising review is subject to regulatory affairs, labeling, and legal review. | Do not approve or endorse wording on sales pages. | Encourage the importer to conduct expert confirmation. |
4-Column Decision Checklist
| Check Point | Person to Confirm With | Items to Confirm | Actions if Issues Arise |
|---|---|---|---|
| Before Procurement | Importer, Overseas Manufacturer | Ingredient list, specifications, raw materials, manufacturing process, classification in country of sale | If documents are insufficient, obtain them before shipment. |
| Before Import Arrangement | Importer, Customs Broker, Food Import Notification Staff | Status of compliance with Food Sanitation Act, Food Labeling Act, Pharmaceuticals and Medical Devices Act, Act against Unjustifiable Premiums and Misleading Representations | If not confirmed, review shipment timing and sales plans. |
| During Ingredient Confirmation | Importer, Regulatory Affairs Staff, Experts | Pharmaceutical ingredients, designated ingredients, usage parts, content levels, extraction methods | If pharmaceutical applicability is suspected, obtain expert verification before sale. |
| At Customs Declaration | Customs Broker, Importer | Product name, use, quantity, ingredients, food import notification, inspection requirement | If invoice is ambiguous, provide additional detailed documents. |
| When Creating Japanese Label | Importer, Labeling Staff | Raw material names, additives, nutrition facts, allergens, country of origin labeling | Create labeling tailored for Japan, not a direct translation of the overseas label. |
| When Creating Advertisements | Importer, Advertising Staff, Regulatory and Legal Staff | Disease names, treatment effects, improvement effects, testimonials, research data, before-and-after images | Correct pharmaceutical-like efficacy claims and exaggerated expressions. |
| When Selling as a Health Functional Food | Importer, Labeling Staff, Experts | Classification and labeling scope of specified health foods, nutritional function foods, foods with functional claims | Avoid labeling beyond the regulatory scope. |
| When Customs Clearance or Sales Are Halted | Importer, Customs Broker, Quarantine Station, Experts | Missing documents, ingredients, labeling, advertising, sales purpose, additional inspections | Isolate the cause and submit documents, revise labels, or change sales plans accordingly. |
Required Documents
| Document | Details to Confirm | Practical Purpose |
|---|---|---|
| Product Catalog | Product overview, usage, marketing claims, sales destination | This serves as the entry point for confirming whether the product is food or pharmaceutical-like. |
| Ingredient List / Raw Materials List | Names of raw materials, ingredient names, content levels, usage parts | Used to check pharmaceutical ingredients or regulated substances. |
| Specifications / COA | Quality standards, analysis values, content levels, test results | Used for compliance with Food Sanitation Act, ingredient confirmation, and quality verification. |
| Manufacturing Process Chart | Raw materials, processing methods, extraction, concentration, use of additives | Used for food import notification and ingredient confirmation. |
| Additive and Allergen Information | Food additives, allergens, labeling ingredients | Used for compliance confirmation with Food Sanitation Act and Food Labeling Act. |
| Overseas Label and Japanese Label Draft | Product name, labeling details, cautionary statements, nutrition facts | Used to create labeling for Japan. |
| Sales Page Draft and Advertisement Copy | Efficacy claims, testimonials, rankings, SNS expressions | Used to check compliance with Pharmaceuticals and Medical Devices Act and Act against Unjustifiable Premiums and Misleading Representations. |
| Functional Food Notification, Approval, and Supporting Documents | Documents relating to regulatory requirements for health functional foods | Confirms the allowable range of functional claims. |
| Sales Plan | Personal use or business purpose, sales destination, quantity, repetition | Differentiates between personal import and imports for commercial sale. |
Practical Scenario 1: Selling Overseas Supplements with Direct Japanese Translation
An importer sources supplements sold overseas and plans to sell them via e-commerce in Japan.
The overseas product pages use expressions like "blood sugar support," "immune booster," and "anti-inflammatory."
If the importer directly translates these into Japanese as "lowers blood sugar," "boosts immunity," or "reduces inflammation," this may be treated as pharmaceutical-like efficacy claims, which could cause compliance issues.
In such cases, the importer needs to review the Japanese advertisement texts, product descriptions, and labeling content to ensure they fall within the permissible expressions for food products.
Practical Scenario 2: Supplements Containing Pharmaceutical Ingredients Triggering Customs Issues
There are cases where products sold as supplements overseas are imported.
Even if the product names and sales pages appear as health foods, checking the ingredient list may reveal components that qualify as pharmaceutical ingredients or are considered substances primarily used as pharmaceuticals in Japan.
In such a case, import and sale as food products may not be allowed, leading to problems at customs or quarantine inspections, as well as regulatory review under the Pharmaceuticals and Medical Devices Act.
The importer should verify ingredient names, content levels, raw materials, manufacturing processes, and specifications, rather than relying solely on product names.
Practical Scenario 3: Advertising Exceeding Notification Scope for Functional Foods
Importers sometimes import products planned to be sold as foods with functional claims.
Even if the notified functional claims allow certain health-related labeling, if the sales page includes disease names, treatment effects, pharmaceutical-like improvement expressions, or exaggerated testimonials, this may cause compliance issues.
Foods with functional claims cannot freely advertise effects beyond the notified content.
The importer must confirm the notified content, label information, advertisement text, SNS posts, and quoted reviews all together.
Practical Scenario 4: Selling Personally Imported Products Domestically
There are cases where importers personally import supplements from overseas e-commerce sites and attempt to sell them in Japan.
Import for personal use and commercial import and sale are regarded differently in regulatory and customs practices.
When selling products obtained through personal importation within Japan, it is necessary to verify compliance with laws such as the Food Sanitation Act, Food Labeling Act, Pharmaceutical and Medical Device Act, and the Act against Unjustifiable Premiums and Misleading Representations.
Also, depending on the ingredients and advertising expressions, the product may be classified as a pharmaceutical rather than a food.
Freight forwarders and customs-related parties should encourage importers to confirm details if there are any irregularities regarding quantity, repetition, sales purpose, delivery destination, or product descriptions.
Impact When Customs Clearance or Sales Are Stopped
If scrutiny occurs during the import of health foods, it could cause customs clearance delays, storage fees, delivery delays, postponement of sales start dates, inspection costs, label revision costs, and advertising revision costs.
Delays may arise due to import declarations or inspections under the Food Sanitation Act, or issues related to pharmaceutical classification under the Pharmaceutical and Medical Device Act, food labeling, or advertising expressions that could be pointed out even after sales have started.
Importers need to verify not only customs clearance but also domestic labeling, e-commerce sales pages, advertising, social media, and explanations to sales destinations in advance.
Just because the product has been imported does not necessarily mean it can be freely sold or advertised within Japan.
Common Misunderstandings
| Misunderstanding | Correct Understanding | Practical Note |
|---|---|---|
| Health foods are unrelated to the Pharmaceutical and Medical Device Act | Even as foods, ingredients and efficacy claims may raise pharmaceutical classification issues under the Pharmaceutical and Medical Device Act. | Always verify ingredients and advertising claims. |
| If it’s a supplement overseas, it is also a food in Japan | Overseas categorization and the Japanese system differ. | Confirm ingredient restrictions, labeling, advertising, and the Food Sanitation Act in Japan. |
| If customs clearance is possible as food, sales and advertising are also free | Customs clearance and domestic sales/advertising are separate checks. | Review sales pages, social media, landing pages, and labeling before sales. |
| Natural ingredients are safe and not subject to regulation | Even plant, herb, or animal-derived ingredients require checks depending on the part used and the core ingredient. | Check scientific names, parts used, extraction methods, and content amounts. |
| Functional foods with notifications can freely claim effects | This is a system only for claims within the notified scope; disease treatment or exaggerated advertising is not allowed. | Match notification details against advertising expressions. |
| Small quantities of personal import items can be sold | Imports for personal use and for commercial purposes are different. | If intended for sale, resale, or distribution, it should be treated as commercial import and verified accordingly. |
| If the forwarder says it’s food, there is no problem | The forwarder is not the final decision-maker on the Pharmaceutical and Medical Device Act or food labeling requirements. | Collect documentation from the importer and consult customs agents or specialists. |
| Claims based on personal experience are allowed | Testimonials or reviews may imply pharmaceutical effects overall. | Check the overall impression of the advertisement. |
Practical Points for Logistics
Health foods are a category where both the Food Sanitation Act and the Pharmaceutical and Medical Device Act should be considered in import procedures.
Even when importable as a food, ingredients, labeling, advertising expressions, or sales purposes may cause classification as a pharmaceutical.
Importers need to separately verify food safety, ingredient content, food labeling, efficacy claims under the Pharmaceutical and Medical Device Act, the health functional food system, and advertising under the Act against Unjustifiable Premiums and Misleading Representations.
While a forwarder is not the decision-maker under the Pharmaceutical and Medical Device Act, upon seeing cargo names such as supplement, health food, diet product, or herbal capsule, they should prompt importers for confirmation and share information with involved parties.
Summary
Health foods are generally foods consumed with the expectation of maintaining or improving health, but this is not an official classification under the Pharmaceutical and Medical Device Act.
In import practice, it is important to check not only compliance with the Food Sanitation Act, Food Labeling Act, and Act against Unjustifiable Premiums and Misleading Representations, but also pharmaceutical classification and possible pharmaceutical-like efficacy claims under the Pharmaceutical and Medical Device Act.
Functional foods with notifications, nutritional function foods, and specified health use foods differ from general health foods as they have specific labeling requirements and procedures, so overseas product labeling cannot be used as is.
Importers must organize ingredients, form, labeling, advertising, sales purpose, and whether the import is personal or commercial in advance.
Health foods and the Pharmaceutical and Medical Device Act intersect where import clearance, pharmaceutical classification, advertising expressions, and domestic sales approvals overlap. Ingredient confirmation before sourcing and verifying labeling and advertising for Japan are the most crucial preventive measures.
