6th Report of Market Access Ombudsman Council (March 16, 2000)

2-(1) Relaxing regulation on dietary supplements

1. Complainant: US Embassy

2. Ministry concerned: Ministry of Health and Welfare

3. Background:

(1) There is a growing interest in health among the Japanese public, and so-called "dietary supplements," products to secondarily supply or supplement nutrients, are currently being sold. The United States or other countries have laws covering dietary supplements where the efficacy or preventive properties of the foods themselves are concerned, whereas Japan does not.

(2) In Japan, substances ingested orally are classified either as foods, pharmaceuticals or quasi-pharmaceuticals (referred to hereafter as "pharmaceuticals"). Whether a product is a pharmaceutical is determined comprehensively based on type of ingredients, format (formulation, package, wrapping, design), on labeling describing purpose of use, effects and efficacy, method of administration dosage and method of sales, instructions given when selling and so on, and decided according to whether people usually perceive that it is a product intended for the purposes described in the Pharmaceutical Affairs Law. Standards are determined by the "standards concerning the scope of pharmaceuticals," a notice issued by the head of the bureau. Accordingly, even though a product may be sold in other countries as a food, it may come under the pharmaceuticals classification in Japan, depending on its formulation, ingredients. Labeling concerning effects, efficacy and so on may also be regulated. In accordance with revisions made to the above standards, some products have begun to be handled not as pharmaceuticals but as foods, as follows: from March 1997, some vitamins; from March 1998, some herbs; from March 1999, some minerals.

(3) However, in order for dietary supplements from other countries to be imported as foods, all their ingredients, additives and so on must be permitted for use in foods in Japan. Accordingly, additives approved for use during the pharmaceuticals manufacturing process may not actually be allowed to be used in products classified as foods, since they are not designated as additives under the Food Sanitation Law. Additionally, vitamins and minerals, even if they are the principal ingredients in dietary supplements, may be regulated as food additives.

(4) In accordance with the "Decision, . on dietary supplement categories" made by the Office of Market Access in December 1998, the ministry concerned is currently studying the matter in two committees, the Study Group on Handling of So-called Dietary Supplements and the Study Group on Reviewing Standards on the Scope of Pharmaceuticals.

4. Complaint:

(1) Legislation of the Definition of Certain Foods as Dietary Supplements and their System

In order to do in Japan what is done for dietary supplements of the food category in the United States, the classification of dietary supplements and their system should be legislated. The system of dietary supplements consists of many factors including ingredients, shapes, directions for use, exclusion of the ingredients of dietary supplements from the definition of food additives and health benefit claims and should be legislated as follows.

1) The term 'dietary supplement' means a product intended to supplement the diet that contains one or more of the following dietary ingredients:
(a) a vitamin; (b) a mineral; (c) an herb or other botanical; (d) an amino acid and a protein; (e) a fatty acid and its glyceride; (f) dietary fiber and a carbohydrate; (g) a dietary substance for use by man to supplement the diet; (h) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (a), (b), (c), (d), (e), (f) or (g).
In addition dietary substances such as glutathione, coenzyme Q-10 and taurine should be excluded from the classification as substances to be solely used for drugs (1-a) in the regulation, concerning the range of drugs, of the Medical and Pharmaceutical Safety Bureau. They are constituents of foods and are used as an ingredient of dietary supplements in overseas markets.

2) Foods including dietary supplements should be able to take any form that is safe and convenient for consumers and appropriate for maintaining their quality.

3) Labeling and specifying directions for usage and dosage should not be restricted for dietary supplements.

4) The ingredients described in clause above which are used in or intended for use in dietary supplements should be excluded from the definition of food additives of the Food Sanitation Law in order to avoid the restriction of ingredients of dietary supplements for the reason that they are not listed in the positive list of food additives.

5) Making health benefit claims, which describe the role of a dietary ingredient intended to affect the structure or function in humans and characterize the documented mechanism by which a dietary ingredient acts to affect such structure or function, should be allowed for dietary supplements if they have scientific substantiation for such a role and a mechanism in order to enable consumers to make an appropriately informed choice for their own health. These health benefit claims should be excluded from the third definition of drugs of Pharmaceutical Affairs Law, which states that articles intended to affect the structure or any function of the body of man or other animals are drugs.

(2) Exclusion from the definition of food additives

A vitamin including its various chemical forms and compounds and a mineral compound in a vitamin or mineral dietary supplement should be regarded as food stuff and not a food additive because it is the main ingredient of such a dietary supplement. The definition of food additives of the Food Sanitation Law states that additives are the stuff used in the process of manufacturing foods or for the purpose of processing foods or preserving foods by addition or mixture to foods, soaking foods and other means.
Complex supplements, which contain multiple ingredients of vitamins, minerals and/or herbs, are popular in Europe and the United States. In such cases, other ingredients except for one, which is the main food stuff of a dietary supplement, could be interpreted as food additives, even if the above statement is affirmed. Therefore Clause 4) of Item 1 is necessary in order to exclude all the ingredients from food additives in such a case.

(3) Abolishment of the upper limits for daily intake

The upper limits for daily intake for vitamins B6, B12, K, biotin, pantothenic acid, folic acid and minerals including zinc, chromium, selenium, manganese, molybdenum, copper, fluorine and iodine should be abolished because MOHW has established the recommended dietary allowances for these nutriente recently.

5. Results of deliberation:

According to the ministry concerned, the necessary measures were taken during FY1999 to abolish maximum levels on daily intakes for substances for which a daily requirement is established. This action is commendable.
As a result of deregulation, some vitamins, herbs and minerals have successively been deemed not to be pharmaceuticals under the Pharmaceutical Affairs Law and it is possible to distribute them as foods from March 1, 1997, but according to the complainant, restrictions concerning food additives under the Food Sanitation Law actually apply, and as far as export of products is concerned, the situation remains unchanged. For its part, the ministry maintains that the complaint is from the perspective of the situation in the United States only, and that the Codex, established to study international specifications for foods, and many other countries, lack a system for dietary supplements like that described in the complaint, and that where some ingredients contained in dietary supplements which correspond to food additives are concerned, in many foreign countries other than the United States, only those listed on their positive lists may be used.
Given the decision made by the Office of Market Access, the ministry says that its Study Group on Handling of So-called Dietary Supplements ("the Study Group," hereafter) is currently studying dietary supplements like vitamins, minerals, herbs and so and that it will make public a final report by April 1, 2000.
The 2nd Experts Committee meeting of the OTO (held in December 1999) examined this matter and determined that the ministry's handling of the issue through its Study Group could be a serious issue if the complainant perceives that it goes against the Office of Market Access's decision. The Committee chairman issued an opinion that the ministry should respond in accordance with the intent of the Office of Market Access's decision.
Subsequently, the ministry issued an interim report whose main points were introducing a mandatory warning against excessive ingestion, based on scientific proof, of vitamin, mineral and herbal dietary supplements, and allowing labeling concerning the benefits of nutrients, in order to give consumers more choice. In accordance with the final report the ministry will make by April 1, 2000, specifications and standards for individual ingredients and labeling standards will be studied with a view to implementing the system and these are planned to be implemented successively. In addition, the Food Sanitation Investigation Council's joint subcommittee on food additives and toxicity will begin studying food additive regulation where so-called dietary supplements are concerned.

Based on the above, the following measures should be taken by the ministry concerning the dietary supplement category.

(1) In accordance with the Office of Market Access's decision, the ministry should decide how to handle the dietary supplement category and reach a conclusion on revisions of standards for the scope of pharmaceuticals, in order that products usually distributed and sold as dietary supplements in other countries may be handled as foods in Japan without being regulated as pharmaceuticals.

(2) Where food additives are concerned, the ministry should study and reach a conclusion during FY2000 concerning how to handle food additive regulation in the case of dietary supplements, so that products usually distributed and sold as dietary supplements in other countries may be handled appropriately in Japan.

(3) The ministry should report to the Market Access Ombudsman Council on the status of the dietary supplement category, at an early date during FY2000.

Government decision (March 21, 2000)

2-(1) Relaxing regulation on dietary supplements

Measures concerning the dietary supplement category will be taken as follows.

(1) In accordance with the Office of Market Access's decision, the ministry will decide how to handle the dietary supplement category and will reach a conclusion on revisions of standards for the scope of pharmaceuticals, in order that products usually distributed and sold as dietary supplements in other countries may be handled as foods in Japan without being regulated as pharmaceuticals.

(2) Where food additives are concerned, the ministry will study and reach a conclusion during FY2000 concerning how to handle food additive regulation in the case of dietary supplements, so that products usually distributed and sold as dietary supplements in other countries may be handled appropriately in Japan.

(3) The ministry will report to the Market Access Ombudsman Council on the status of the dietary supplement category, at an early date during FY2000.