【Client Alert】Entering Japan’s Online Health & Beauty Market: Advertising Compliance Risks for Platform Sellers
Entering Japan’s Online Health & Beauty Market: Advertising Compliance Risks for Platform Sellers
This page provides an English executive summary of the Japanese article “オンラインプラットフォームにおける 医薬品・医療機器・医薬部外品・化粧品の広告規制― 出店を検討する企業のための実務上の留意点 ― ”. The full article is available in Japanese.
Executive Summary/ Key Questions (FAQ)
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What are the key legal frameworks governing the online sale and advertising of pharmaceuticals, medical devices, quasi-drugs, and cosmetics?
― The primary regulations include the Pharmaceutical and Medical Device Act (PMD Act), Fair Advertising Standards for Pharmaceuticals and Related Products, the Act against Unjustifiable Premiums and Misleading Representations, the Act on Specified Commercial Transactions, and the Health Promotion Act. These laws and regulations are often applied cumulatively to a single advertisement. False or misleading advertising, as well as advertising of unapproved products, is strictly prohibited. - How do advertising restrictions differ by product category?
― Cosmetics are subject to strict limitations on the scope of efficacy claims that may be made, while quasi-drugs may only be described within the scope of their approved indications and effects. For pharmaceuticals and medical devices, advertising of unapproved products is prohibited, and claims that exceed the scope of approval are also not permitted. - What types of content may be considered “advertising” in an online shop?
― Not only the body text of a webpage, but also text within product images, videos, social media posts, landing pages linked externally, and other representations that may influence consumers’ purchasing decisions may broadly be deemed “advertising.” - How are customer reviews and influencer marketing regulated?
― If a company requests, arranges, or is involved in the publication or dissemination of such content, it will be regarded as advertising and may be subject to stealth marketing regulations. - Can disclaimers such as “This is an individual’s personal opinion” avoid legal risk?
― They may not. Because advertisements are assessed based on the overall impression of the representation, even if such disclaimers are included, the content may still be subject to regulation if images, catchphrases, or other elements evoke medicinal efficacy. - Is compliance with statutory laws and regulations sufficient when listing products on online platforms?
― No. It is also necessary to comply with the policies of each online platform, which may impose standards stricter than those under applicable laws and regulations. Violations may entail risks such as suspension of listings or account restrictions.
This English page is provided for informational purposes only. The Japanese version constitutes the authoritative text.
(Written by: Naoko Ishihara, Minoru Fukawa)

Partner
Email: naoko.ishihara@tkilaw.com
Partner at TKI. Naoko Ishihara is an expert in intellectual property (IP) and technology 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 IP components of M&A. She handles cross-border IP/commercial disputes before Japanese courts, the JPO, and the JFTC across sectors like software, automotive, semiconductors, and medical devices.
-In-house Expertise: Extensive experience in corporate legal functions and internal investigations for multinational corporations.
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.

Associate
Email: minoru.fukawa@tkilaw.com