Request a DemoIn Japan, PR activities and advertising/publicity activities related to cosmetics are regulated under Article 66 of the Pharmaceuticals and Medical Devices Act (hereinafter referred to as "the Act") focusing on exaggerated advertisements, and subordinate regulation supported by Guidelines for Cosmetic Advertisements (hereinafter referred to as "the Guidelines"). Since the surcharge system was introduced to the Act on August 1, 2021, enterprises will receive a fine equivalent to 4.5% sales of illegal products if they breach Article 66.
Part 1 Scope
Article 66 applies to cosmetic advertisements in/on newspapers, magazines, television, radio, websites, blogs, e-mail, telephones, mail, sales promotion tools, and other social networking services for general consumers. Besides, academic research reports are also subject to this regulation if the intention is for disclosure to general customers and are classified as advertisements.
Stipulation of Exaggerated Advertisement (Article 66)
No person must, explicitly or implicitly, advertise, describe, or circulate false or exaggerated statements regarding the name, manufacturing process, efficacy and effects or performance of pharmaceuticals, quasi-pharmaceutical products, cosmetics, medical devices, or regenerative medicine products.
It is to be construed as falling under the preceding paragraph to advertise, describe or circulate such statements as lead to the false impression that a physician or other person has certified the efficacy, effects or performance of pharmaceuticals, quasi-pharmaceutical products, cosmetics, medical devices or regenerative medicine products.
No person may use statements or diagrams suggesting criminal abortion, or any obscene statements or diagrams in connection with pharmaceuticals, quasi-pharmaceutical products, cosmetics, medical devices or regenerative medicine products.
Part 2 Cosmetics Advertising Supervision
In Japan, cosmetics advertisements are not subject to prior review before being posted. Enterprises need to self-check whether the ads are compliant before posting ads on their product or website. If the advertisement is posted on other media, such as magazines, TV, etc., the media needs to check whether the applicant's advertising content meets the requirements. In addition, some platforms also have their advertisement delivery standards.
The authority will take necessary measures if inappropriate expressions are found in the advertisement. According to the Act, any person who violates the advertising regulations of Article 66 shall be punished by imprisonment with work for not more than two years, or a fine of not more than 2,000,000 yen.
In addition, Japan introduced a surcharge system on August 1, 2021, stipulating that even if the violater is not arrested, he/she would be subject to administrative discretionary fines equivalent to 4.5% sales of the offending products.
Part 3 Relevant Laws and Regulations
Regulations | Applicable categories | Advertising Regulatory Contents |
Pharmaceuticals Quasi-drug products Cosmetics Medical devices Regenerative medicine products | False or exaggerated advertisement; | |
Regulation for Enforcement of Fair Competition Code Concerning the Labeling of Cosmetics | Cosmetic Quasi-drugs | Independent and reasonable choices of consumers; Fair competition among operators; |
Standards for Fair Advertising Practices Concerning Pharmaceuticals, etc. | Pharmaceuticals Quasi-drug products Cosmetics Medical devices Regenerative medicine products | False or exaggerated advertisement; (Product name, manufacturing, efficacy, safety, ingredients, and highest grade, etc.) |
Cosmetic Quasi-drugs | Requirements for cosmetics advertisment | |
All products | Inappropriate representations of goods and services in aspects of quality, content, price, etc. Illegal and malicious solicitation; | |
All products | Prohibited advertisement |
The promotion of cosmetics is mainly regulated by the Act, which ensures the quality, effectiveness, and safety of pharmaceuticals, quasi-drugs, cosmetics, medical devices, and regenerative medicine products, and makes restrictions on safety measures during manufacturing, sales, and post-marketing supervision. The subordinate regulation Guidelines further illustrate and explain how to make compliant cosmetic advertisements based on Standards for Fair Advertising Practices Concerning Pharmaceuticals, etc.
Part 4 Advertisement Requirements
4.1 Product name
In principle, for both Japanese domestic and imported products, enterprises can only use the approved product name after making a manufacturing and sales declaration to the Ministry of Health, Labour and Welfare (MHLW). . Actually, many merchants use abbreviations or nicknames of products in their advertising.
According to the Guidelines, abbreviations and nicknames for cosmetics may be used if there is no risk of misleading of the product's identity, based on the advertisement's context. However, the following situations need to be avoided.
| No. | Cosmetic | Quasi-drug |
1 | Use only Roman characters as names; | |
2 | Overuse of letters, numbers and symbols; | |
3 | Use a name that does not conform to the actual dosage form; | |
4 | Use a name has trademarks of the name; | |
5 | False, exaggerated or potentially misleading names; | |
6 | Use the name of a specific ingredient in a compounding ingredient; | |
7 | Use in conflict with the Regulation for Enforcement of Fair Competition Code Concerning the Labeling of Cosmetics; | Use only a generic name that makes it difficult to identify the specific product; |
8 | The same name as the existing pharmaceuticals and quasi-drugs; | Use any name that is clearly owned by other companies; |
9 | Names that are easily confused with pharmaceuticals or quasi-drugs (e.g. xx medicine, medicinal xx, acne xx, Kampo xx, etc). | Use specific efficacy/effects (e.g. anti-acne cream) |
10 | / | Use an unrecognized efficacy in name; |
11 | / | Emphasis on safety; |
12 | / | Defame other companies' products. |
4.2 Ingredient
4.2.1 False or exaggerated ingredient
Cosmetic ingredients must not be exaggerated or falsely advertised. For example, ingredients from animals shall not be claimed as plant ingredients. Besides, enterprises shall not imply their products have "noble ingredient blends" or "luxury prescriptions".
4.2.2 Ingredient quantity
It is not allowed to advertise expressions such as "several kinds of xxx " or "multiple kinds of xxx", e.g., a combination of several kinds of amino acids, which may easily cause misunderstandings by consumers. The Guidelines stipulates that the number of ingredients must be clearly stated, or the names of all ingredients shall be listed.
4.2.3 Acronyms
The use of acronyms to declare compound ingredients should be avoided. When compound ingredients are represented by abbreviations or letters, consumers may misunderstand them for a blend of good or new ingredients.
4.2.4 Specific ingredients
If an ingredient added to a product needs to be marked in a conspicuous way to attract consumers, its formulation purpose (56 permitted efficacy claims for cosmetics) must also be marked together, such as labeling "contains moisturizing ingredient Aloe Vera".
In the following cases, itshall not be marked as a specific ingredient:
(1) Ingredients containing the word "medicine";
(2) "Traditional Chinese medicine ingredient extract" has the image of medicinal herbs
(3) Antioxidant ingredients / skin improvement ingredients / skin beauty ingredients / beauty ingredients / aging care ingredients, etc., which may cause misunderstandings as to whether the ingredient is an active ingredient. However, as quasi-drugs do contain active ingredients, it is permissible to advertise approved functional ingredients in quasi-drugs.
4.2.5 Additive free
Simply using expressions such as "no additives" or "additive-free" is inaccurate because it is unclear what additive has not been added. This kind of expressions implies a guarantee of safety and may be a slander of other companies . Therefore, while promoting an additive-free product, it must clearly express what additive has not been added.
Notably, when an ingredient is included as a carryover ingredient (added to the product but disappears during product making), expressions such as "no additives" or "additive-free" cannot be used.
4.3 Efficacy
4.3.1 Cosmetics
4.3.1.1 56 permitted efficacy claims:
There are 56 cosmetic efficacy claims stipulated in the Scope of Efficacy Claims Allowed of Cosmetics that can be directly used in advertisements. Besides, some claims in the scope are in the form of combination, such as "reducing fine lines caused by dryness". These combined claims cannot be used alone in an ad, such as a single claim of "reducing fine lines".
It is noteworthy that the scope does not mean that enterprises must use the stated efficacy claims verbatim, as long as the meaning of the claims does not exceed the scope during publicity. Therefore, it is particularly important for enterprises to express the effect skillfully within the range so as to capture the attention of consumers.
4.3.1.2 Efficacy of physical effect
In addition to the 56 permitted efficacy claims, cosmetic advertisements can also promote the use feeling and physical effects of make-up without violating the facts.
Example:
Prevents makeup from falling off
Makes small wrinkles inconspicuous
Makes skin look supple
A refreshing use feeling (objective）
4.3.1.3 Highest-level expressions
Highest-level statements or similar statements about the efficacy and safety of cosmetic products are forbidden. For example, "Unparalleled/absolute safety", "Effect No. 1" or "the first in the world". However, statistical facts such as "Sales No. 1" that do not involve efficacy and safety can be used without giving consumers false perceptions of efficacy or safety.
4.3.2 Quasi-drugs
Aside from general cosmetics, cosmetics in quasi-drugs are so-called medicated cosmetics. In addition to cosmetic functions, it contains active ingredients against skin problems and requires approval from MHLW. According to the Guidelines, the efficacy that can be claimed in medicated cosmetics are as follows.
No. | Types | Efficacies/claims |
1 | Shampoo |
|
2 | Hair Conditioner |
|
3 | Toner |
|
4 | Cream, Lotion, Hand cream, Cosmetic oil |
|
5 | Shaving lotion |
|
6 | Sun Cream |
|
7 | Facial Mask |
|
8 | Medicinal Soap (including facial cleanser) | (including those formulated with antiphlogistic agent) Cleanse, sterilize, and disinfect skin. Prevents body odor, sweat odor and acne. Cleanse the skin and prevents acne, razor burn, and rough skin. |
*Depending on the mechanism of action, efficacy "suppressing the production of melanin and preventing spots and freckles" is also recognized. | ||
Besides, permanent wave, hair dye, and medicated oral-care products also belong to the quasi-drug category. In addition to the above-mentioned requirements, the efficacy claims of quasi-drugs must comply with one rule: the actual approved efficacy shall prevail.
4.4 Manufacturing
The advertised manufacturing method should be consistent with the actual manufacturing method and research performance, and avoid contradiction.
Highest level expression, such as "best technology", "most advanced manufacturing methods", etc., cannot be used to describe the methods and research of cosmetics. Besides, using words such as "created by the secret method of ..." or "a collection of pharmaceutical company technology" will misinterpret the product's advantages and imply that other companies' products are not good enough.
