Medicinal Claims — PMD Act Assessment of Labels and Advertising for Import Sales
Interlink編集部What Are Pharmaceutical-like Efficacy Claims?
Pharmaceutical-like efficacy claims refer to labeling, display, or advertising expressions that indicate effects such as the treatment, prevention, or improvement of diseases, or actions on the structure or functions of the body.
Even for foods, health foods, supplements, cosmetics, general goods, health devices, or beauty equipment, if the labeling or advertising corresponds to pharmaceutical-like efficacy claims, issues may arise under the Pharmaceutical and Medical Device Act (PMD Act).
In import operations, it is necessary to check not only the ingredients and physical form of the cargo itself, but also product labels, instruction manuals, e-commerce pages, advertisements, social media posts, sales materials, testimonials, explanatory videos, landing pages, and other sales expressions.
Even if a product is sold as a general item overseas, sales expressions targeting Japan may raise issues concerning pharmaceutical classification, unapproved or unlicensed pharmaceuticals, and advertising regulations.
Scope Covered in This Article
| Item | Content Covered in This Article | Content Covered in Detail in Other Articles |
|---|---|---|
| Basics of Pharmaceutical-like Efficacy Claims | This article explains the concept of labeling and advertising expressions that indicate disease treatment, prevention, improvement, or effects on bodily functions. | The overall structure of the PMD Act is covered in the article "What is the PMD Act?" |
| Relationship with Unapproved or Unlicensed Pharmaceuticals | This article separates pharmaceutical classification based on ingredients and form from pharmaceutical-like efficacy claims based on labeling and advertising. | Approvals and licenses for pharmaceuticals themselves are covered in the article "Pharmaceuticals." |
| Advertising Expressions for Health Foods and Supplements | This article explains risks involving disease names, test values, bodily functions, testimonials, and direct translation of overseas advertisements. | Ingredient checks, the Food Sanitation Act, and the Foods with Health Claims system are covered in the article "Health Foods and the PMD Act." |
| Advertising Expressions for Cosmetics | This article explains expressions beyond the cosmetic scope, such as treatment, improvement, regeneration, hair growth, and inflammation suppression. | Cosmetic standards, full ingredient labeling, and the definition of cosmetics are covered in the article "Cosmetics." |
| Expressions for General Goods, Health Devices, and Beauty Equipment | This article explains medical device-related risks when general goods or devices claim treatment, prevention, or bodily function improvement. | Medical device applicability, device class, and the Medical Device Marketing Authorization License are covered in the article "Medical Devices." |
| Advertising Confirmation at Import and Sales | This article explains practical confirmation of overseas labels, e-commerce pages, social media posts, landing pages, testimonials, reviews, and video scripts. | Legal compliance judgments for individual products require confirmation by importers, regulatory affairs personnel, or specialists. |
| Freight Forwarder and Customs Practice | This article explains matters that forwarders should prompt importers to confirm, document collection, and practices to avoid firm conclusions. | Final judgments under the PMD Act, advertising review, and sales permission decisions must be confirmed by the importer side. |
Why Pharmaceutical-like Efficacy Claims Are Problematic
Under the PMD Act, displaying or advertising products that are not approved or licensed as pharmaceuticals with pharmaceutical-like efficacy claims may become problematic.
Especially for health foods, supplements, beauty products, general goods, and health devices, even if imported as food or general merchandise, the product may be treated as a pharmaceutical depending on the labeling or advertising used for sales in Japan.
Determining whether claims correspond to pharmaceutical-like efficacy claims is not based solely on individual words.
The overall impression of the advertisement, testimonials, charts, expert comments, research data citations, before-and-after images, sales page layout, product name, and instructions on dosage and usage are all considered in the determination.
Purpose and Background of the Regulation
Regulation of pharmaceutical-like efficacy claims is important to prevent consumers from mistaking foods, cosmetics, general goods, or health devices for pharmaceuticals and thereby missing appropriate medical opportunities or suffering health damage.
Expressions that create expectations of disease treatment or prevention have a significant impact on product selection.
Therefore, making pharmaceutical-like claims for products not approved or licensed as pharmaceuticals can lead to issues concerning advertising regulations under the PMD Act and unapproved or unlicensed pharmaceuticals.
In import sales, a typical risk is directly translating expressions allowed overseas into Japanese for use in Japan-oriented sales pages.
Relationship with Unapproved or Unlicensed Pharmaceuticals
Unapproved or unlicensed pharmaceuticals are products that, despite lacking the necessary pharmaceutical approvals or licenses, contain ingredients, forms, efficacy claims, dosage, or usage that should classify them as pharmaceuticals.
Even products planned for sale as health foods or supplements can become problematic as unapproved or unlicensed pharmaceuticals if they contain pharmaceutical ingredients or claim to treat, prevent, or improve diseases.
In import operations, it is essential to separately check issues related to ingredients and form and issues related to labeling and advertising.
| Verification Axis | Main Content | Common Problem Examples | Practical Verification Methods |
|---|---|---|---|
| Ingredients and Form | Verify pharmaceutical ingredients, ingredients mainly used as pharmaceuticals, dosage and usage, and dosage forms. | Cases where overseas supplements contain ingredients classified as pharmaceuticals in Japan. | Check ingredient lists, specifications, COAs, raw materials, content amounts, and instructions for use. |
| Labeling and Advertising | Check expressions claiming disease treatment, prevention, improvement, or effects on bodily functions. | Advertising a product imported as food as "effective for diabetes." | Check labels, e-commerce pages, social media posts, landing pages, testimonials, and video scripts. |
| Overall Impression | Check not just individual words but whether the entire page implies pharmaceutical-like effects. | Sales pages that create anxiety about illness and suggest that product use can solve it. | Review product names, headlines, images, reviews, graphs, and expert comments comprehensively. |
Even if ingredients are not problematic, pharmaceutical-like advertising expressions may still cause issues.
Conversely, even if advertising expressions are restrained, issues regarding classification as a pharmaceutical may arise due to ingredients, dosage, or usage.
Judgment Criteria
Whether something falls under pharmaceutical-like efficacy claims is determined by comprehensively assessing multiple factors.
| Judgment Criteria | Points to Check | Expressions or Constructions Prone to Issues | Practical Notes |
|---|---|---|---|
| Disease or Symptom Names | Check whether the expression targets disease names, symptoms, illnesses, or physical discomfort. | Diabetes, hypertension, cancer, atopy, insomnia, joint pain, infectious diseases | Using disease or symptom names makes the expression more likely to be seen as intended for treatment or prevention. |
| Treatment, Prevention, or Improvement | Check for expressions such as cures, prevents, improves, suppresses, disappears, lowers, and similar wording. | Lowers blood sugar, suppresses inflammation, improves pain, prevents diseases | Be cautious not only of direct treatment expressions but also expressions that strongly imply improvement. |
| Effects on Bodily Functions | Confirm that the expression does not strongly indicate action on the body's structure or functions. | Boosts immunity, regulates hormones, breaks down fat, regenerates cells | Check the boundary between general health maintenance expressions and pharmaceutical-like action claims. |
| Dosage and Usage | Check whether intake amount, frequency of use, or usage period is shown like a pharmaceutical product. | Take three times a day, use when symptoms appear, continue until cured | Even for foods or general goods, the way dosage is indicated may strengthen the impression of a pharmaceutical product. |
| Professionalism and Authority | Check whether treatment effects are implied using doctors, experts, research data, or clinical trials. | Doctor recommended, proven by clinical data, treatment results, medically effective | Expert comments may enhance the overall pharmaceutical-like impression of the advertisement. |
| Testimonials and Reviews | Check whether user voices imply disease improvement or treatment effects. | Stopped taking medicine, blood pressure normalized, no longer needs hospital visits | Even if not written by the seller, the expression may become an issue if used in advertising. |
| Images and Charts | Check whether before-and-after photos, graphs, body diagrams, or test values show effects. | Graphs showing numerical improvement, affected-area photos, diagrams showing fat melting, diagrams showing clean blood vessels | Even if wording is mild, images or charts may strongly imply pharmaceutical-like effects. |
| Overall Advertisement Impression | Even if individual words are mild, check whether the overall impression implies pharmaceutical-like effects. | Page structures that arouse fear of illness and suggest that product use can solve it | Do not only avoid prohibited words; check the overall impression of the page. |
In actual import and sales practice, it is not enough to avoid prohibited words alone.
It is necessary to check whether the overall advertisement structure leads to expectations of disease treatment, prevention, improvement, or effects on bodily functions.
Expressions to be Checked
Expressions that easily correspond to pharmaceutical-like efficacy claims include naming diseases, improving symptoms, treatment, prevention, and direct or indirect indications of effects on bodily functions.
- Expressions claiming healing, improvement, or prevention of diseases
- Expressions emphasizing effects on blood pressure, blood sugar, cholesterol, immunity, and similar functions
- Expressions promoting improvement of inflammation, pain, infections, allergies, and similar conditions
- Expressions about skin diseases, hair loss, hair growth, cell regeneration, and similar effects
- Expressions showing disease improvement through testimonials and reviews
- Expressions implying treatment effects using doctors, experts, or research data
- Expressions emphasizing improvement of measured or test values
- Expressions indicating dosage and usage like pharmaceutical products
Words such as "cure," "work," "improve," "prevent," "suppress," "lower," "disappear," "regenerate," "repair," "detoxify," "eliminate," and "detox" may be judged as pharmaceutical-like efficacy claims depending on context.
However, this does not mean these words always immediately violate regulations. Judgment depends on the product category, basis for the claim, regulatory scope, and the overall impression of the advertisement.
Boundaries by Classification
Issues regarding pharmaceutical-like efficacy claims apply to foods, health foods, cosmetics, quasi-drugs, general goods, and medical devices alike.
| Category | Original Classification | Expressions to Watch For | Typical Problematic Examples | Points to Confirm |
|---|---|---|---|---|
| Food / Health Food | Foods intended for nutritional supplementation, health maintenance, or consumption as food. | Treatment or prevention of diseases, strong effects on bodily functions | Effective for diabetes, lowers blood pressure, boosts immunity to prevent infections | Confirm ingredients, food regulations, advertising expressions, and classification as Foods with Health Claims. |
| Foods with Health Claims | Foods permitted to display specific functional claims based on regulations. | Expressions beyond notified, standard, or approved scope | Foods with Functional Claims advertising disease names or therapeutic effects | Cross-check notification details, approved claims, standard claims, and advertising text. |
| Cosmetics | Products that maintain cleanliness, beautify, enhance attractiveness, and keep skin or hair healthy. | Disease treatment, hair growth, inflammation improvement, cell regeneration, and similar expressions | Claims of curing atopic dermatitis, removing blemishes, promoting hair growth, curing inflammation | Confirm the permitted scope of efficacy claims for cosmetics. |
| Quasi-Drugs | A category under the PMD Act with certain recognized efficacy and effects. | Expressions exceeding approved efficacy and effects | Medicated cosmetics claiming therapeutic effects beyond the authorized range | Check the approved range, labeling, advertising, and sales materials. |
| General Goods | General products not classified as pharmaceuticals or similar regulated products under the PMD Act. | Treatment, prevention, improvement, or effects on bodily functions | General goods claiming to cure stiff shoulders or improve sleep disorders | Confirm whether pharmaceutical-like efficacy claims or medical device applicability issues arise. |
| Medical Devices / Health Equipment | Machinery or instruments whose medical device applicability depends on purpose and labeling. | Diagnosis, treatment, prevention, or improvement of bodily functions | Beauty devices claiming therapeutic effects, blood circulation improvement, or pain relief | Confirm medical device applicability, device class, approvals, certifications, and notifications. |
The issues vary depending on the product category, presence or absence of approvals or notifications, scope of labeling, and the overall context of the advertising, even with the same expressions.
Expressions That Often Cause Issues with Health Foods
In health foods and supplements, expressions that claim disease names, test values, or effects on bodily functions tend to cause issues.
For example, expressions such as "effective for diabetes," "cures high blood pressure," "prevents cancer," "boosts immunity to prevent infections," "lowers blood sugar," and "improves insomnia" require caution.
If overseas product advertisements include terms such as medical, therapeutic, anti-inflammatory, blood sugar control, immune booster, detox, and flush toxins, and these are directly translated and used on sales pages, they may cause issues under the PMD Act.
Ingredient confirmation, the Food Sanitation Act, the Food Labeling Act, and the Foods with Health Claims system for health foods are covered in the separate article "Health Foods and the PMD Act."
Expressions That Often Cause Issues with Cosmetics
The scope of efficacy claims that can be displayed for cosmetics is limited.
For example, claims such as "cures atopic dermatitis," "suppresses inflammation," "removes blemishes," "regenerates cells," "promotes hair growth," and "treats acne" may exceed the permissible range for cosmetics.
For cosmetics, not only the product label but also e-commerce pages, social media, brochures, video explanations, before-and-after images, and quoted customer reviews must be checked.
The definition of cosmetics, ingredient regulations, full ingredient disclosure, and advertising practices are covered in the separate article "Cosmetics."
Expressions That Often Cause Issues with Medical Devices and General Goods
Even health equipment, beauty devices, general goods, and general machinery can become problematic if advertising claims diagnosis, treatment, prevention of diseases, or effects on bodily functions as medical device-like efficacy claims.
For example, claims such as "cures pain," "improves blood flow," "breaks down fat," "has medical-level effects," "prevents disease," or "improves symptoms" require caution.
Even if sold overseas as beauty devices, wellness devices, or health equipment, advertising expressions used in Japan may raise questions about medical device applicability.
Issues regarding medical device applicability, device class, software as a medical device, and the Medical Device Marketing Authorization License are covered in the separate articles "Medical Devices" and "Medical Device Marketing Authorization License."
Application Requirements and Exclusions
| Category | Situations Where Pharmaceutical-like Efficacy Claims Become an Issue | Situations Often Excluded or Handled Separately | Practical Considerations |
|---|---|---|---|
| Food and Health Foods | When claims strongly suggest treatment, prevention, improvement of diseases, improvement of test results, or effects on bodily functions. | If claims are limited to nutritional supplementation, general health maintenance, or standard food labeling, they are handled under food regulations. | Even if import as food is permitted, advertising expressions may cause issues under the PMD Act. |
| Foods with Health Claims | When claims exceed the scope approved, notified, or permitted under standards, including disease names or treatment effects. | If claims remain within the range allowed by the notification, standard, or approval, they are handled under the Foods with Health Claims system. | Foods with Functional Claims, Nutrition Function Foods, and Foods for Specified Health Uses cannot freely claim efficacy beyond the permitted scope. |
| Cosmetics | When claims include atopic dermatitis, inflammation, hair growth, cell regeneration, treatment, or disease improvement. | Claims limited to cleanliness, beautification, enhancement of attractiveness, or maintaining healthy skin and hair fall under cosmetic regulations. | Import as cosmetics may be possible, but advertising exceeding the allowed cosmetic efficacy range can cause problems. |
| Quasi-Drugs | When claims go beyond approved efficacy and include treatment or disease improvement effects. | If claims are within the approved efficacy limits, they are handled under the quasi-drug system. | Even for medicated cosmetics, advertising exceeding the approved scope requires attention. |
| General Goods | When claims include alleviating stiff shoulders, improving insomnia, improving blood circulation, or preventing diseases. | When explanations are limited to household goods, sundries, or general relaxation products, they are handled as general goods. | Even for general goods, advertising expressions can raise issues of pharmaceutical-like efficacy claims or medical device applicability. |
| Medical Devices and Health Equipment | When claims refer to diagnosis, treatment, prevention, improvement of bodily functions, pain relief, or blood circulation improvement. | If claims are limited to general health management, exercise assistance, beauty, or relaxation, they are handled on a case-by-case basis. | For devices, confirmation is required not only for pharmaceutical-like efficacy claims but also for medical device applicability. |
| Personal Import | When personal import items are sold domestically with efficacy claims in advertising. | If limited to personal use, they are handled separately from commercial import sales. | Being able to import personally does not mean the product can be sold or advertised domestically. |
Main Checkpoints in Import Sales
| Verification Item | Main Content | Common Causes of Stoppage |
|---|---|---|
| Product Classification | Confirm whether the product falls under food, health food, cosmetics, quasi-drugs, medical devices, or general goods. | Assuming that the overseas product classification applies as-is in Japan. |
| Ingredients and Form | Confirm pharmaceutical ingredients, ingredients used exclusively as pharmaceuticals, usage methods, and dosage forms. | Judging based solely on the product name or country of sale without checking ingredient lists. |
| Labeling and Advertising | Check labels, instructions, e-commerce pages, social media posts, advertisements, videos, and testimonials. | Using overseas advertisements directly translated into Japanese. |
| Efficacy Claim Expressions | Check whether disease names, treatment, prevention, improvement, or bodily function effects are claimed. | Even if direct expressions are avoided, the overall advertisement may imply effects. |
| Scope under Applicable Regulation | Check the allowed claim scope under Foods with Health Claims, cosmetics, quasi-drugs, medical devices, and other categories. | Conducting advertising beyond notifications, approvals, or certifications. |
| Purpose of Sale | Confirm whether the product is for personal use or commercial import and sale. | Using personally imported products for domestic sales or distribution. |
Regulatory Application Flow
- Confirm into which category the product may fall: food, health food, cosmetics, quasi-drugs, medical devices, or general goods.
- Check from ingredients, form, usage, dosage, and sales purpose whether classification as a pharmaceutical is an issue.
- Obtain overseas labels, advertisements, product descriptions, and e-commerce pages.
- Check Japan-oriented labels, advertisements, landing pages, social media posts, video scripts, and testimonials.
- Confirm that disease names, symptom names, treatment, prevention, improvement, or effects on bodily functions are not claimed.
- Check for implications through testimonials, reviews, expert comments, research data, graphs, or images.
- Confirm that the claims do not exceed regulatory limits set for Foods with Health Claims, cosmetics, quasi-drugs, medical devices, or other categories.
- Confirm whether the import is for personal use or commercial import and sale.
- Check whether advertising agencies, sales agents, affiliates, or social media operators plan to alter expressions.
- If there is uncertainty, conduct pharmaceutical regulatory confirmation before import or sales launch.
- Maintain continuous management of advertising corrections, use of testimonials, and campaign expressions after sales launch.
Import Operational Workflow
| Stage | Main Points to Check | Common Causes of Delays |
|---|---|---|
| Before Procurement | Check ingredients, usage, product classification, overseas advertising, and sales expressions in Japan. | The product is sold as a general item overseas, leading to the assumption that it will not be problematic in Japan. |
| Before Import Arrangement | Organize whether the product falls under food, cosmetics, quasi-drugs, medical devices, or general goods. | Advertisement review is postponed until just before sales. |
| At Customs Declaration | Prepare the product name, usage, ingredients, sales purpose, and explanatory materials from the importer. | The invoice only states "supplement," "cosmetics," or "device" without detailed information. |
| Preparing Domestic Labeling | Check labels, instruction manuals, Japanese labeling, and efficacy claim expressions. | Foreign labels are directly translated, leaving disease names or treatment terms. |
| Creating Sales Pages | Review e-commerce pages, social media posts, landing pages, testimonials, reviews, and expert comments. | Although direct expressions are avoided, the overall content may imply pharmaceutical-like effects. |
| After Sales Start | Continuously check advertisement revisions, monitoring, quoted reviews, and campaign expressions. | Additional exaggerated expressions may be added by agents or advertising companies after sales begin. |
Common Challenging Cases in Import Operations
| Case | Common Issues | Documents to Check | Practical Points of Attention |
|---|---|---|---|
| Direct translation of overseas supplement advertisements | Expressions such as "blood sugar control," "anti-inflammatory," and "immune booster" could become pharmaceutical-like efficacy claims. | Overseas advertisements, Japanese landing page drafts, ingredient lists, sales page drafts | Revise expressions for Japan and confirm what is permitted as food. |
| Implying therapeutic effects with cosmetics | Expressions related to atopy, inflammation, hair growth, or cell regeneration may exceed the scope of cosmetics. | Advertising drafts, labels, full ingredient declarations, product descriptions | Confirm the range of efficacy claims accepted for cosmetics. |
| Displaying therapeutic effects for health devices | Claims such as pain improvement, blood flow improvement, treatment effects, or medical-grade effects may raise medical device applicability issues. | Product specifications, advertising drafts, intended use, instruction manuals | Determine whether the product can be treated as general goods or whether medical device applicability must be confirmed. |
| Using testimonials suggesting disease improvement | Even if not directly written by the seller, the overall advertisement may imply pharmaceutical-like efficacy claims. | Reviews, social media posts, landing pages, affiliate articles, review quoting policies | Careful control of expressions is necessary when using testimonials or reviews in advertising. |
| Domestic resale of personally imported products | Confusion arises between personal-use imports and commercial resale imports. | Purchase history, sales pages, quantities, delivery destinations, sales plans | For domestic sales, confirm ingredients, classification, labeling, and advertising separately. |
| Advertising agencies adding exaggerated claims | Post-sales landing pages, social media posts, videos, and campaign messages may pose pharmaceutical advertising risks. | Advertising operation documents, outsourcing contracts, social media post drafts, video scripts | Establish approval rules and change management for advertising content. |
| Using detoxification and expulsion claims | Claims about expelling toxins, cleansing the liver, or body purification may imply effects on bodily functions. | Advertising drafts, product descriptions, ingredient lists, landing page structures | Confirm whether expressions remain general beauty or health claims, or create a pharmaceutical-like impression. |
| Exceeding the declared range for Foods with Health Claims | Advertising for Foods with Functional Claims or Nutrition Function Foods may go beyond the permitted scope. | Declaration documents, approved labeling, advertising drafts, sales pages | Cross-check declarations, standards, and approval scope against advertising expressions. |
Differences Between Personal Import and Commercial Import
Issues related to pharmaceutical-like efficacy claims are addressed differently depending on whether the import is for personal use or for commercial sales.
Products imported for personal use within a certain scope and products imported for sale, resale, advertising, or distribution in Japan fall under different regulatory checks.
If health foods, cosmetics, medical devices, or general goods obtained through personal import are sold domestically, they must be treated as commercial import and distribution and checked accordingly.
Especially for items purchased through overseas e-commerce and resold domestically, checks are required for ingredients, classification, labeling, advertising, the Food Sanitation Act, the PMD Act, and the Act against Unjustifiable Premiums and Misleading Representations.
Points to Note Regarding Labeling and Advertising
Pharmaceutical-like efficacy claims are judged not only by the product label but also by the overall advertisement.
Even if direct expressions are avoided, if testimonials, photos, graphs, expert endorsements, citations of research results, or video content imply disease treatment or prevention effects, caution is necessary.
For example, even without explicitly stating "cure," the combination of photos of people suffering from illness, graphs showing test value improvements, doctor comments, and post-use testimonials could collectively imply pharmaceutical-like efficacy claims.
It is important to review labeling and advertising for Japan before sales begin.
Key Checks for Freight Forwarders and Customs Operations
Freight forwarders and customs personnel should verify not only the cargo name and HS code but also the purpose of the importer’s product sales.
Particularly with health foods, beauty-related products, testing supplies, health devices, and general goods, pharmaceutical advertising risks are more likely to arise.
Freight forwarders are not in a position to make final judgments regarding the presence of pharmaceutical-like efficacy claims.
However, for cargo intended for sale where the advertising expressions or product descriptions include disease names, treatment, prevention, or effects on bodily functions, it is necessary to prompt the importer for confirmation and share this information with customs brokers and relevant parties as early as possible.
If confirmation is requested, the freight forwarder should collect product catalogs, ingredient lists, usage explanations, draft sales pages, advertisement drafts, label drafts, and results of regulatory checks from the importer, and relay them to customs brokers and relevant parties.
Freight forwarders should avoid making definitive statements such as "It is food, so there is no problem," "It is general merchandise, so the PMD Act does not apply," or "This expression is fine."
Scope of Freight Forwarder Involvement
| Category | Supportable Actions | What Should Not Be Definitively Stated | Practical Response |
|---|---|---|---|
| Health Food / Supplement Imports | The forwarder can request the importer to submit ingredient lists, product descriptions, overseas advertisements, and draft Japanese sales pages. | It should not be definitively stated that there is no issue under the PMD Act just because it is food. | Prompt the importer to confirm regulatory and advertising compliance. |
| Cosmetics Imports | Support collecting labels, full ingredient declarations, advertising materials, and draft e-commerce pages. | Do not conclude that therapeutic expressions are permissible solely because the product is a cosmetic. | Connect the importer to regulatory checks on the scope of cosmetic efficacy claims. |
| General Goods / Health Equipment Imports | Encourage confirmation of usage, target customers, advertisements, specifications, and instructions for use. | Do not definitively state that because the product is general merchandise, it is not a medical device and the PMD Act does not apply. | Prompt the importer to verify whether the product may fall under medical devices. |
| If a direct translation of overseas advertising exists | Support organizing comparison materials between overseas advertising and Japanese advertising drafts. | Do not conclude that a literal translation is acceptable or that the expression is safe. | Prompt verification that the expression has been revised for the Japanese market. |
| If a customs inquiry is made | Collect ingredient lists, usage explanations, draft sales pages, and regulatory confirmation results from the importer. | The freight forwarder should not make the final judgment on importability or sellability. | Share information with customs brokers, importers, and regulatory affairs personnel. |
| If advertising agencies or sales agents are involved | Prompt verification of planned advertising changes and management systems for sales pages. | Do not conclude that confirming only the advertisements at the time of import is sufficient. | Have the importer confirm rules for managing advertising expressions after sales start. |
Required Documents
| Document | Content to Confirm | Purpose in Actual Logistics Practice |
|---|---|---|
| Product Catalog | Product overview, usage, sales targets, efficacy claim expressions | Used to confirm product classification and advertising risks. |
| Ingredient List / Specification Sheet | Pharmaceutical ingredients, raw materials, quantities, quality standards | Used to confirm classification as a pharmaceutical based on ingredients and form. |
| Explanation of Intended Use | Whether sold as food, cosmetics, general goods, medical devices, or another category. | Used for classification at customs clearance and sales stages. |
| Overseas Labels / Overseas Advertisements | Efficacy expressions, disease names, and bodily function representations used overseas. | Used to check risks related to direct translation for the Japanese market. |
| Draft Japanese Labels / Draft Sales Pages | Expressions actually displayed and advertised within Japan. | Used for advertising checks under the PMD Act. |
| Draft Social Media Posts / Video Scripts / Landing Page Structures | Overall advertisement impression, images, testimonials, headlines, and calls to action. | Used to verify implied pharmaceutical-like efficacy claims. |
| Testimonials / Policy on Quoted Reviews | Presence or absence of quotes indicating disease improvement, test value improvements, or treatment effects. | Used to check risks when advertising uses expressions from parties other than the seller. |
| Notification / Supporting Documents for Foods with Health Claims | Permitted scope of labeling under the relevant system. | Used to confirm that notifications, standards, or permissions are not exceeded. |
| Documents Indicating Scope of Approvals / Certifications / Notifications | Recognized efficacy claims and intended uses for quasi-drugs, medical devices, and similar regulated products. | Used to confirm consistency between advertising expressions and the approved or permitted scope. |
| Regulatory Confirmation Results | Classification and advertising confirmation results by the importer or specialist. | Used for customs inquiries, pre-sales checks, and internal management. |
Four-Column Decision Checklist
| Verification Stage | Counterparty for Confirmation | Items to Check | Response if Issues Are Found |
|---|---|---|---|
| Before Procurement | Importer, Overseas Manufacturer | Product classification, ingredients, form, overseas advertising, labeling for planned sales countries | If pharmaceutical-like expressions are present, review sales expressions intended for Japan. |
| Before Import Arrangement | Importer, Regulatory Affairs Personnel | Whether the product falls under food, cosmetics, quasi-drugs, medical devices, or general goods | If classification is unclear, conduct expert verification before shipment. |
| Before Customs Declaration | Importer, Customs Broker | Product name, usage, sales purpose, ingredient list, usage explanation, advertising materials | If materials are insufficient, supplement explanations about the product and sales purpose. |
| When Creating Japanese Labeling | Importer, Labeling Personnel | Check whether labels, instructions, or product descriptions contain disease names or treatment expressions. | Remove pharmaceutical-like expressions or revise them to legally permissible expressions. |
| When Creating Sales Pages | Importer, Advertising Personnel, Regulatory Affairs Personnel | E-commerce pages, landing pages, social media, videos, expert comments, graphs, images | Verify that the overall advertising does not create a pharmaceutical-like impression. |
| When Using Testimonials or Reviews | Importer, Advertising Agencies, Sales Agents | Check for reviews implying disease improvement, improved test values, or therapeutic effects. | Establish citation rules and avoid using problematic expressions in advertising. |
| Before Sales Launch | Importer, Regulatory Affairs and Legal Personnel | Whether advertising expressions remain within legally allowed limits. | If there are doubts, make corrections before starting sales. |
| After Sales Launch | Importer, Advertising Agencies, Sales Agents | Advertising updates, social media posts, campaigns, affiliate article expressions. | Continue managing expressions after sales launch and correct any excessive claims. |
| During Customs or Government Inquiries | Importer, Customs Broker, Regulatory Affairs Personnel | Product classification, usage explanation, advertising expressions, regulatory confirmation results. | Freight forwarders should refrain from definitive statements and organize importer confirmation documents for submission. |
Practical Scenario 1: Translating Overseas Supplement Advertising as-Is
There are cases where importers procure overseas supplements and plan to sell them via e-commerce in Japan.
The overseas product pages may contain expressions such as "blood sugar control," "anti-inflammatory," and "immune booster."
If importers translate these literally as "controls blood sugar," "suppresses inflammation," or "enhances immunity" and post them on Japanese sales pages, these could be problematic as pharmaceutical-like efficacy claims.
In such cases, importers need to review the product descriptions, advertising text, landing pages, and social media posts intended for Japan, and confirm the permissible range of expressions for food products.
Practical Scenario 2: Cosmetic Advertising Implying Therapeutic Effects
When importers sell overseas cosmetics in Japan, advertisements may use expressions such as "atopic dermatitis improved," "suppresses inflammation," "removes spots," and "regenerates cells."
Even if the product itself will be treated as a cosmetic, if advertising expressions exceed the permitted scope of cosmetic efficacy claims, issues under the PMD Act may arise.
Additionally, caution is required if before-and-after photos or testimonials imply therapeutic effects.
Importers need to confirm the range of acceptable expressions for cosmetics and the overall impression of the advertising targeted for Japan.
Practical Scenario 3: Claiming Physical Function Improvement with Health Devices
Importers may bring in overseas health or beauty devices and sell them in Japan.
Overseas product descriptions may include claims such as "improves pain," "improves blood circulation," "therapeutic effect," or "medical-level."
Using such claims as-is for the Japanese market could cause issues as medical device-like efficacy claims.
In such cases, it is necessary to clarify whether expressions will be limited to general merchandise or whether confirmation as a medical device is needed.
Practical Scenario 4: Testimonials and Reviews Implying Disease Improvement
Importers sometimes post user testimonials stating things like "stopped medication," "no longer visiting the hospital," or "blood sugar normalized," without directly claiming "cure" or "prevention."
Even if these are not claims by the seller, they could imply pharmaceutical-like efficacy claims when viewed as part of the overall advertising.
Attention is also needed when using reviews, rankings, comparison articles, affiliate articles, and social media posts.
Importers must check not only their own website but also sales pages created by sales agents and advertising companies.
Practical Scenario 5: Selling Personal Import Goods Domestically
There are cases where health foods or beauty products purchased overseas through e-commerce and obtained as personal imports are then sold domestically in Japan.
In cases of domestic sales of items obtained for personal use, import and sales for business purposes require confirmation of ingredients, classification, labeling, advertising, and compliance with the PMD Act, the Food Sanitation Act, and the Act against Unjustifiable Premiums and Misleading Representations.
Moreover, making pharmaceutical-like efficacy claims on sales pages could lead to issues involving unapproved or unlicensed pharmaceuticals.
Importers should not confuse the ability to obtain products through personal import with the ability to sell or advertise them domestically in Japan.
Impact When Customs or Sales Are Suspended
If pharmaceutical-like efficacy claims become an issue, delays in customs clearance, postponed sales launch, advertising corrections, label revisions, replacement of sales pages, suspension of product sales, and recall actions may occur.
Even if products clear customs as food or cosmetics, advertising expressions used at the sales stage may cause PMD Act issues.
Importers need to treat customs clearance and sales advertising as integrated steps, confirming them as a whole from before procurement through pre-sales launch.
Role Distribution Regarding Health Food, Cosmetics, and Medical Device Articles
"Health Foods and the PMD Act" is an article that organizes information on health foods and supplements regarding the Food Sanitation Act, the Food Labeling Act, the Foods with Health Claims system, ingredient verification, and the differences between personal import and commercial import.
"Cosmetics" is an article that organizes the definition of cosmetics, the difference from quasi-drugs, cosmetic standards, full ingredient labeling, and cosmetic advertising.
"Medical Devices" is an article that organizes the definition of medical devices, device class, medical device applicability, boundaries with home-use beauty devices, and software as a medical device.
In contrast, this article "Pharmaceutical-like Efficacy Claims" is a cross-sectional article that organizes judgment criteria used in labeling and advertising common to foods, cosmetics, general goods, health equipment, and related product categories.
Common Misunderstandings
| Common Misunderstanding | Actual Perspective | Practical Considerations |
|---|---|---|
| If it is food, the PMD Act does not apply | Even for foods, advertising that makes pharmaceutical-like efficacy claims could be problematic. | Check e-commerce pages, social media posts, landing pages, and testimonials as well. |
| It is safe as long as prohibited words are avoided | Judgment is based not only on words but also on the overall impression of advertising. | Also check images, graphs, reviews, and expert comments. |
| It is acceptable to directly translate overseas advertisements | Expressions permitted overseas may cause issues under the PMD Act in Japan. | Modify for Japanese audiences and conduct regulatory checks. |
| Reviews are not expressions of the seller | If reviews or testimonials are used as advertising, they could imply pharmaceutical-like efficacy claims. | Manage policies on citation, publication standards, and advertising agency operations. |
| If it is general goods, efficacy can be freely stated | Even general goods claiming treatment, prevention, or improvement could trigger issues under the PMD Act or medical device applicability. | Confirm intended use, advertising, and effects on the body. |
| Products that can be imported for personal use can be sold | Importing for personal use differs from domestic sales for business purposes. | Recheck ingredients, classification, labeling, and advertising when selling domestically. |
| There is never a problem if boosting immunity is only described | Depending on context, expressions implying infection or disease prevention could be problematic. | Check disease names, prevention claims, and combinations with testimonials. |
| Just leave it to the advertising agency | Even if expressions are created by advertising or sales agencies, the seller is responsible for advertising management. | Establish approval rules for advertising expressions and controls for changes. |
Practical Considerations
Pharmaceutical-like efficacy claims are critical issues that can cause problems not only during classification of imported cargo but also in labeling and advertising for domestic sales.
Even with health foods, cosmetics, or general goods, if treatment, prevention, improvement of diseases, or effects on body functions are claimed, confirmation under the PMD Act is necessary.
Importers need to avoid merely translating overseas advertisements and should verify compliance with Japan’s PMD Act, the Food Labeling Act, the Act against Unjustifiable Premiums and Misleading Representations, and the scope of labeling under each relevant system for the Japanese market.
While freight forwarders are not advertising regulators under the PMD Act, if pharmaceutical-like expressions are observed in imports for sales purposes, they should prompt importers to verify compliance and share information with customs brokers and stakeholders.
Summary
Pharmaceutical-like efficacy claims are labeling or advertising expressions that indicate treatment, prevention, or improvement of diseases, or effects on the body’s structure or functions.
Even health foods, cosmetics, general goods, and health devices may face issues under the PMD Act if their advertisements or labels imply pharmaceutical-like efficacy claims.
Judgment requires comprehensive review of disease names, treatment, prevention, improvement claims, effects on body functions, usage and dosage, expert comments, testimonials, images, and the overall impression of advertising.
Importers must confirm not only product classification at customs but also labeling, e-commerce pages, social media posts, advertisements, reviews, and sales materials during domestic sales.
Pharmaceutical-like efficacy claims represent a cross-cutting regulatory risk between health foods, cosmetics, general goods, and medical devices under the PMD Act. Pre-import ingredient verification and Japan-targeted advertising checks are the most important preventive measures.
