March, 2008
Mr.Takeshi Yoshida , Pharmacist
Yoshida Administrative Scrivener's Office

Restrictions on Advertising and Labeling
under the Pharmaceutical Affairs Law in Japan

1.Classification of Restricted Products  2.Restrictions on Advertising  3.Import: Cosmetics  Health Foods 
1. Classification of Restricted Products Under the Pharmaceutical Affairs Law
Restricted products are classified under the Japanese Pharmaceutical Affairs Law into gpharmaceuticalsh, gquasi-drugsh, gcosmeticsh, and gmedical devicesh (hereinafter referred to as "pharmaceuticals etc.") The Pharmaceutical Affairs Law, Article 1, requires that quality, efficacy, and safety be secured by satisfaction of certain requirements under the Pharmaceutical Affairs Law and by imposition of certain restrictions as needed. That is, distribution of these restricted products requires that the requirements stipulated in the Pharmaceutical Affairs Law be satisfied and that authorization be acquired in accordance with the business involved (business permits and product approval).

The classes of restricted products are defined in Article 2 of the Pharmaceutical Affairs Law. It is important first of all to confirm which class a product handled falls under. gQuasi-drugsh and gcosmeticsh resemble each other in the point of being weaker in action, but gquasi-drugsh are covered by Article 2, Paragraph 2 of the Pharmaceutical Affairs Law, while gcosmeticsh are covered by Paragraph 3 by the way the products are marketed. 

There is no classification of gquasi-drugsh in the EU and United States. Japan's gquasi-drugsh include products corresponding to "cosmetics" in the EU and "cosmetic pharmaceuticals" and "cosmetics" in the United States.

[Ref.1] Labeling in Case of Different Objectives of Products
2. Restrictions on Advertising Under the Pharmaceutical Affairs Law and Penal Provisions
Under the Pharmaceutical Affairs Law, advertising is strictly restricted. Advertising is strictly restricted under the Pharmaceutical Affairs Law, specifically in gExaggerated Advertisementh (Article 66), gRestriction on Advertising of Drugs for Designated Diseasesh (Article 67) and gProhibition of Advertisement of Drugs, etc. before their Approvalh (Article 68). Furthermore, three requirements for advertising are presented in the September 29, 1998 Notification of the Director of the Supervision and Guidance Division of the Pharmaceutical Safety Bureau of the Ministry of Health and Welfare. If all of the following requirements are satisfied, it is judged that the matter involved corresponds to an advertisement.

1) Clear intention of drawing customers (fanning desire of customers to purchase) 
2) Clear indication of name of specific pharmaceutical or other product 
3) State enabling knowledge by general public 

The advertising restrictions cover not only businesses, but also individuals. Blogs and individual websites are also covered by the restrictions. This is based on the fact that the Pharmaceutical Affairs Law prohibits the spreading of rumors due to the fact that information, due to its meaning and weight, may have a direct effect on human life. 

There are penal provisions for violations of the advertising restrictions. A sentence of up to two years imprisonment or a fine of up to 2 million yen or both may be imposed. 

A look at past product recalls of quasi-drugs and cosmetics shows that most were due to the range of marketing and range of labeling being exceeded. Therefore, in applying the Pharmaceutical Affairs Law, it is necessary to sufficiently understand the legal grounds regarding advertising. 

[Ref.2] Points in Product Recall Procedures
3. Handling of Imports
3-1. Cosmetics

For points to watch when handling imports, the case of cosmetics will be explained. The next six items are the minimum necessary requirements. 

1) Confirmation of the laws corresponding to the Pharmaceutical Affairs Law of the country of origin. 
2) Understanding of thinking regarding contracts. 
3) Confirmation of approach at the time of customs clearance and related regulations. 
4) Fact of not being internationally prohibited: for products scheduled to be handled and for countries of
     origin in transactions
5) Approach for countries other than Japan, for example, authorization. 
6) Sufficient confirmation of ingredients. 
Unless obtaining this information, unforeseen situations that occur might not be able to be handled. Some of the information is available over the Internet, but it is also necessary to acquire it directly from the local authorities in charge. Even if checking and confirming compliance with the regulations of the country of origin before import, the Pharmaceutical Affairs Law applies after import. Therefore, when handling imports, it is necessary to investigate and confirm differences between product classifications between the overseas markets and Japan, then judge compliance with Japan's Pharmaceutical Affairs Law, related regulations and notifications.
Under the Pharmaceutical Affairs Law, parties that have acquired permits as so-called "manufacturer-sellers" are obliged to control and supervise distribution. "Manufacturer-sellers" have to establish systems to take responsibility for market. Further, "manufacturer-sellers" are required to run quality studies and field studies for guaranteeing quality and to work to secure the quality, efficacy, and safety stipulated in Article 1 of the Pharmaceutical Affairs Law.

[Ref.3] Distribution Channels under the Pharmaceutical Affairs Law (Enforced in April 1,2005)
[Ref.4] Three Roles of Manufacturer-Sellers

When newly importing cosmetics, the following procedures are necessary. 

1) Application for permit for manufacture and sale of cosmetics
2) Application for permit for manufacture of cosmetics (not required when consigned to other companies)
3) Contract for use of test and inspection facilities (when lacking own inspection facilities)
4) Notification of foreign manufacturer of cosmetics (application for each foreign manufacturer) Finished
     same day
5) Notification for manufacture and sale of cosmetics (application for each product): Finished same day
6) Import notification for cosmetics (application for each product): Finished same day
7) Customs clearance procedures
3-2. Health Foods

"Health foods" is a general, not legal expression. The related laws include the "Pharmaceutical Affairs Law", the "Premiums and Representations Act", the "Health Promotion Law", the "Food Sanitation Law" and the "JAS Law". Food is in principle covered by the "Food Sanitation Law", but comes under the "Pharmaceutical Affairs Law" and the "Act Against Unjustifiable Premiums and Misleading Representations" as "pharmaceuticals" depending on how their efficacy and effect are marketed (labeled) 

However, as an exception, efficacy and effect can be labeled for "special health food" defined under the "Health Promotion Law" (so-called "nutritional function food"). Labeling as gspecial health foodh is limited to the fields of action of regulation of intestinal functions, action against high blood pressure, action against diabetes, etc.

A gspecial health foodh mark is issued by the Ministry of Health, Welfare, and Labor. Submission of test data by designated test organizations is required. In general, acquisition of this mark reportedly requires several hundred million yen. Further, any changes in the test criteria requires the tests be redone and involve new costs.
There are the following cases where labeling of efficacy and effect as "food" is not allowed without obtaining authorization:
1) Expressions relating to nutritional supplementation, maintenance of health and beauty.
   The expression gnutritional supplementationh itself is not considered a pharmaceutical-like efficacy
   or effect. It is not possible to suggest improvement of physiological functions by supplementing
   deficient nutritional ingredients or by aiming at nutritional supplementation for specific locations.

   <Allowable labeling> "Nutritional supplementation for persons at  peak of their

   working years" and "nutritional     supplementation for growing years"
   <Prohibited labeling> "Nutritional supplementation when physical strength 
     drops during  sickness or after sickness" and "nutritional supplement for eyes"

2) Expressions intending treatment or prevention of diseases
   <Prohibited> "Effective against cancer", "slimming", "prevents adult-onset diseases",
   "cures constipation",    etc. 

3) Expressions intending general strengthening and promotion of functions of body
   <Prohibited labeling> "Eliminates fatigue", "restores vitality", "improves studying ability",
    "prevents colds",  "improves metabolism", "prevents ageing", "activates cells", etc.

4) Expressions implicitly indicating effectiveness in treating and preventing diseases
   Names, catch phrases, labeling and explanation of ingredients/manufacturing processes/sources
   /derivation, articles, conversations with physicians or scientists and citation of personal
   experiences etc.

5) Expressions suggesting effect against specific part of the body
   The "Criteria Relating to the Range of Pharmaceuticals" carries a list of ingredients used for
   pharmaceuticals. The ingredients of this list cannot be used for food. 

   Regarding shape, ampoules, sublingual tablets, liquids filled in sprayers to be sprayed into the mouth and
   absorbed from the mucous membrane are judged to be "pharmaceuticals". However, capsules, tablets,
   powders, granules and liquids are not judged to be "pharmaceuticals" if labeled as "food".

  Regarding designation of the dosage and administration, labeling of a "rule" for ingestion is possible,
   but definitive labeling is not allowed.

   <Allowable labeling>
   - Take three to six pills a day as a rule as a nutritional supplement. 
   <Prohibited labeling>
   - Five pills a day
   - Determine dosage and administration in accordance with symptoms

   - "Wrap in oblate and swallow" or other expressions similar to methods of ingestion distinctive to     
   - Expressions of upper limits of ingestion for avoiding overeating.
Finally, whether or not to allow labeling of efficacy and effects is judged by the authorities, so to deal with this, it may be said be necessary to build up precedents and increase public awareness. To determine whether advertisements or labeling would violate the "Pharmaceutical Affairs Law", it is recommended to inquire at the sections in charge in the local governments.