【Client Alert】Japanese Advertising Regulations for Drugs, Medical Devices, Quasi-drugs and Cosmetics -Key points for overseas companies selling through online platforms in Japan
FAQ / Click to Expand
- 1. Can we just translate our global advertising claims into Japanese using automatic translation tools provided by online platforms?
ー No, automatic translation tools require particular care and should be treated only as a drafting aid, not a compliance tool. Familiar global claims such as “anti-aging,” “repair,” or “whitening” may create drug-like or exaggerated advertising risks under Japanese law. A platform-generated translation may convert a broad English marketing phrase into a strictly regulated efficacy claim. You must redesign your claims in light of Japanese product classifications and permitted claim ranges. - 2. How does Japan's product classification differ from the US or EU, and why does it matter for advertising?
ー US or EU classifications do not necessarily map onto Japanese classifications. Notably, Japan has a unique “quasi-drug” category, which commonly includes medicated cosmetics, hair-growth products, and antiperspirants. Your available advertising claims are strictly limited by your product's specific classification. For general cosmetics, claims must remain within Japan's permitted 56 efficacy claims. For quasi-drugs, advertising must remain strictly within the approved indications of each specific product. - 3. Do Japanese advertising regulations only apply to the main product description text on our website?
ー No, Japanese review is not limited to express wording. Regulations apply to the entire online sales funnel, including product names, images, videos, user reviews, affiliate articles, and social media posts. The overall impression on ordinary consumers is also evaluated. Furthermore, influencer campaigns must be reviewed under Japan’s rules on stealth marketing (undisclosed advertising) to ensure Japanese consumers can clearly identify business-sponsored content. - 4. Can we use disclaimers like “results may vary” to safely use claims that might exceed the approved scope?
ー No, a disclaimer does not automatically cure a claim that exceeds the permitted or approved scope. You must revise the main claim itself rather than relying on disclaimer language. Similarly, using before/after photos or user testimonials may imply guaranteed efficacy or create misleading superiority claims, which cannot be fixed merely by adding a disclaimer. -
5. What are some examples of common global marketing claims that often need reworking for Japan?
ー Common global expressions often require claim-by-claim review. For example:➢ Whitening / Brightening: A general cosmetic should not suggest that it whitens the skin, removes spots, or reduces pigmentation.➢ Anti-aging / Regenerate / Repair: These may suggest functional improvement or repair of body tissue, potentially creating an unpermitted drug-like claim.➢ Clinically proven / Dermatologist tested: These may raise issues as a guarantee by medical professionals or as an unsubstantiated claim. - 6. If our product page passes the online platform's review, does that mean it is legally compliant?
ー Not necessarily. Legal compliance and platform review are overlapping but separate checks. Major Japanese platforms maintain their own policies, but non-compliant claims can lead to severe consequences under Japanese law, such as administrative action, criminal penalties, and administrative surcharges. At the platform level, violations may result in failed ad reviews, product delisting, and account restrictions.
1. Japan Requires Claim Redesign, Not Just Translation
Japan is an important healthcare and beauty market, and many overseas companies now enter it through cross-border e-commerce or Japan-based online marketplaces. However, Japan’s regulatory approach to advertising is not limited to product labels or formal promotional copy. Product names, product descriptions, images, videos, user reviews, affiliate articles and influencer posts may all be assessed as advertising if they suggest disease prevention or treatment, effects on body functions, or product efficacy, effects or performance.
This means that familiar global claims such as “anti-aging,” “repair,” “regenerate,” “clinically proven” or “whitening” may require substantial revision before use in Japan. A claim that is acceptable, or at least commonly used, in another jurisdiction may create a drug-like, medical device or exaggerated-advertising risk under Japanese law depending on the product classification and the relevant approval, notification or permitted claim range.
Automatic translation tools provided by online platforms require particular care. A platform-generated Japanese translation may convert a relatively broad English marketing phrase into a regulated efficacy claim, a drug-like claim or a claim exceeding the approved scope. Even where the wording was generated or suggested by the platform, the business that adopts it for its product page or advertising materials may be held responsible for the resulting display.
2. Executive Summary: Three Questions to Ask First
| Question | Why it matters |
|---|---|
| 1. What is the product under Japanese law? | US or EU classification does not necessarily map onto Japanese classification. Japan has a unique “quasi-drug” category, and available advertising claims may be limited by item-specific approvals. |
| 2. Does the copy, image or review make an efficacy or performance claim? | Japanese review is not limited to express wording. Images, videos, before/after presentations, testimonials, social media posts and the overall impression on ordinary consumers may be relevant. |
| 3. Can the platform page pass both legal and platform review? | Regulatory compliance and platform policy compliance are separate issues. Non-compliant or high-risk claims may lead to administrative action, surcharges, failed ad review, product delisting, account restrictions and reputational damage. |
3. Regulatory Framework and Comparison with the US and EU
Advertising for drugs, medical devices, quasi-drugs and cosmetics in Japan is regulated through a layered framework, including the Pharmaceuticals and Medical Devices Act (PMD Act), the Standards for Fair Advertising Practices for Drugs, etc., the Act against Unjustifiable Premiums and Misleading Representations, the Specified Commercial Transactions Act and the Health Promotion Act. Under the PMD Act, false or exaggerated advertising may be problematic whether the relevant claim is express or implied. Advertising for unapproved drugs or medical devices may itself be prohibited in certain circumstances.
| Topic | Japan | US | EU |
|---|---|---|---|
| Product categories | Drugs / medical devices / quasi-drugs / cosmetics. Quasi-drug is a Japan-specific category. | Drug / device / cosmetic, etc. No category identical to Japan’s quasi-drug. Depending on the product and claims, similar products may be regulated as drugs, cosmetics, medical devices, pesticides or other regulated products. | Medicinal product / medical device / cosmetic product, etc. No category identical to Japan’s quasi-drug. Depending on the product and claims, similar products may be regulated as medicinal products, cosmetics, medical devices, biocidal products or other regulated products. |
| Advertising claims | Strict review against approvals, notifications and permitted claim ranges. Express and implied claims both matter. | Claims are assessed under FDA/FTC frameworks, including drug claims and cosmetic claims. | EU regulations and Member State rules apply, including common criteria for cosmetic claims. |
| Consumer advertising | DTC advertising of prescription drugs is not permitted. Unapproved product advertising also requires caution. | DTC prescription drug advertising is permitted in certain areas, subject to FDA requirements. | Consumer advertising of prescription medicines is generally prohibited. |
| Endorsements / undisclosed advertising | Guidelines and designation under the Premiums and Representations Act should be considered. | FTC Endorsement Guides are central to disclosure practices. | Unfair Commercial Practices Directive and Member State guidance apply. |
4. Key Product Category Issues
| Category | Main point | Typical risk |
|---|---|---|
| Cosmetics | Cosmetic claims should generally remain within the scope of Japan's permitted cosmetic efficacy claims (commonly referred to as the “56 claims”). Drug-like efficacy claims should be avoided. | Direct use of claims such as “anti-aging,” “regenerate,” “repair” or “lifting” may be viewed as drug-like or exaggerated, depending on the context. |
| Quasi-drugs | Quasi-drug is a Japan-specific category. It commonly includes medicated cosmetics, hair-growth products, antiperspirants, medicated toothpaste and hair dyes. Advertising must remain within the approved indications of each product. | Claims such as “brightening” or “whitening” require careful review. Even for approved quasi-drugs, claim wording must track the approved indication and should not suggest broader skin-whitening or spot-removal effects. |
| Drugs and medical devices | A product approved overseas may still be unapproved in Japan. Advertising unapproved drugs or medical devices may be prohibited. Approved products also cannot be advertised beyond their approved efficacy, effects or performance. | Cross-border e-commerce and overseas-hosted pages may still raise Japanese law issues if they target Japanese consumers. |
5. Claims That Often Need Reworking for Japan
The following examples are not a statutory list of prohibited words. They are common global marketing expressions that often require claim-by-claim review when adapted for Japan.
| Claim example | Japan-facing risk | Practical response |
|---|---|---|
| Whitening / brightening | May be rendered into Japanese as “bihaku” or another expression linked to quasi-drug-approved claims. A general cosmetic should not suggest that it whitens the skin, removes spots or reduces pigmentation. | Avoid relying on platform auto-translation. Consider claim language limited to appearance, radiance or makeup effects where appropriate, and verify the product classification and approved indication. |
| Anti-aging / regenerate / repair | May suggest functional improvement, rejuvenation or repair of skin or body tissue, potentially creating a drug-like claim. | Reframe around permitted cosmetic effects such as moisture, texture or appearance, if supported and within the permitted scope. |
| Clinically proven / dermatologist tested | May raise issues as a guarantee by medical professionals or as a substantiation claim, depending on presentation and evidence. | Review evidence, context, disclaimers and the visual prominence of the claim. Evidence alone does not cure a non-permitted claim. |
| Before/after photos and user testimonials | May imply guaranteed efficacy, create misleading superiority claims or be treated as advertising testimonials. | Review images, captions, audio, subtitles, review solicitation practices and the overall consumer impression. |
| Results may vary | A disclaimer does not automatically cure a claim that exceeds the permitted or approved scope. | Revise the main claim itself rather than relying on disclaimer language. |
6. Online Platforms, Social Media and Automatic Translation
Product pages, landing pages, banners, videos, text embedded in images, social media posts, affiliate articles and reviews influenced by a seller may all be treated as advertising. Compliance review should therefore cover the entire online sales funnel, not just the main product description.
Influencer campaigns should also be reviewed under Japan’s rules on stealth marketing (undisclosed advertising). Overseas influencer agreement templates may not be sufficient if they do not ensure that Japanese consumers can clearly identify business-sponsored content.
Major Japanese platforms typically maintain their own listing and advertising policies based on the PMD Act, the Premiums and Representations Act and related rules. Legal compliance and platform review are overlapping but separate checks.
Platform automatic translation should be treated as a drafting aid, not as a compliance tool. It may not take into account Japanese product classification, approved indications, the 56 cosmetic claim framework or current platform review practices. Terms such as “repair,” “whitening” and “clinical” may be translated into Japanese language that creates a more aggressive regulated claim than the original English copy.
7. MAH/DMAH Structure and Advertising Review
For drugs, quasi-drugs, cosmetics and medical devices, overseas companies should assess whether a Japan-based marketing authorization holder or, for certain foreign-manufactured products, a designated marketing authorization holder is required under the PMD Act. The specific requirements differ by product category and regulatory pathway. For cosmetics, companies should also review manufacturing/marketing business licensing, product notifications, foreign manufacturer-related filings, post-import storage or labeling operations, and labeling responsibilities before importing and selling products in Japan.
8. Enforcement Risk and Launch Checklist
False or exaggerated advertising under the PMD Act may lead to administrative action, criminal penalties and administrative surcharges based on relevant sales. Issues under the Premiums and Representations Act, including stealth marketing, may also lead to orders, surcharges and platform-level consequences such as delisting or ad suspension.
| Initial action | Purpose |
|---|---|
| Confirm Japanese product classification | Identify approvals, notifications, permitted claims and sales structure. |
| Map global claims | Find wording that should be deleted, revised or replaced for Japan. |
| Review product pages, images, videos and social media together | Assess not only words but the overall impression on ordinary consumers. |
| Review influencer and affiliate arrangements | Set rules for disclosure, content control, review solicitation and evidence retention. |
| Check platform policies early | Reduce risk of failed platform review, launch delay, delisting or account restrictions. |
| Retain substantiation and review history | Prepare for regulator inquiries, platform inquiries and surcharge-related explanations. |
| Human-review platform auto-translation | Check generated Japanese wording before adoption from the perspective of classification, claims and platform policy. |
9. Conclusion
Japanese advertising regulation for healthcare and beauty products is not merely a translation issue. It is a practical risk area where product classification, approved indications, advertising status, consumer impression and platform policies overlap. Overseas advertising assets that work well in other markets may need to be redesigned before launch in Japan.
Our firm advises on Japan market entry, MAH/DMAH structures, advertising review, regulatory inquiries and communications with online platforms in both English and Japanese. Please contact the attorneys below if you would like to discuss a specific product or campaign.
Key Public References
- Japan: MHLW, Advertising Regulations for Drugs, etc.; MHLW, Standards for Fair Advertising Practices for Drugs, etc.
- Japan: MHLW, Scope of Cosmetic Efficacy Claims; MHLW materials on the PMD Act surcharge system; Consumer Affairs Agency materials on stealth marketing.
- US: FDA, Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?); FDA, Prescription Drug Advertising and Promotional Labeling; 21 CFR Part 202, Prescription Drug Advertising (eCFR current version).
- US: FTC/eCFR, 16 CFR Part 255, Guides Concerning Use of Endorsements and Testimonials in Advertising (eCFR current version).
- EU: Regulation (EC) No 1223/2009 on cosmetic products (EUR-Lex consolidated version; current version available as of 1 May 2026).
- EU: Commission Regulation (EU) No 655/2013 on common criteria for cosmetic claims.
- EU: Directive 2001/83/EC on medicinal products for human use (EUR-Lex consolidated version; current version available as of 1 January 2025).
- EU: Regulation (EU) 2017/745 on medical devices, including Article 7 on claims (EUR-Lex consolidated version dated 10 January 2025).
- EU: Directive 2005/29/EC on unfair commercial practices (EUR-Lex consolidated version dated 28 May 2022).
（Written by: Naoko Ishihara)
This newsletter is intended for general informational purposes only and does not constitute legal advice for any specific matter. Please consult counsel for advice on specific products, claims or campaigns.
Partner
Email: naoko.ishihara@tkilaw.com
Partner at TKI. Naoko Ishihara is an expert in intellectual property (IP) and regulatory law, with over 15 years of experience at major U.S. and Japanese global law firms.
- Practice Focus: IP licensing & distribution, technology transfer, strategic alliances, and regulatory compliance (including the PMD Act and the Premiums and Representations Act). She handles cross-border IP/commercial & regulatory matters, advising multinational corporations on advertising reviews, marketing practices, and disputes before Japanese courts, the JPO, and the JFTC across sectors like healthcare, cosmetics, medical devices, and software.
-In-house Expertise: Extensive experience in corporate legal functions and internal investigations for multinational corporations. Assisting global brands with safe Japan market entry.
- Admissions: Daini Tokyo Bar Association (2009), California State Bar (2017).
- Affiliations: Licensing Executives Society, Copyright Law Association in Japan, Japan Trademark Association, Japan Arbitration Association. She also serves as an Outside Statutory Auditor for Global Vascular Co., Ltd. and Pivot Inc.