3rd Report of the Market Access Ombudsman Council (March 18, 1996)

2-(1) Clarifying the Definition of "Dietary Supplements" and Deregulating Their Restrictions

1. Complainants: American Chamber of Commerce in Japan, Japan Foreign Trade Council, Tokyo Chamber of Commerce and Industry

2. Ministry concerned: Ministry of Health and Welfare

3. Background Information:

As people have become more interested in their health, they are getting more interested in food products that supplements nutrition in a secondary and supplementary manner, or the so called "dietary supplements." Many types of dietary supplements are on the market today; many of which are imported products.

Such countries as the United States, Denmark and Netherlands have established legal infrastructure for dietary supplements by taking into account their effectiveness and preventative effects.

In Japan, there is no legal definition of dietary supplements. What individuals consume orally are classified into food products or drugs. Whether a product is considered a drug or not is determined by examination of various factors such as the ingredients of the product, shape (e.g. dosage form, container, packaging, design, etc.), purpose, indications and dosage indicated on the product, sales method, and demonstration or presentation upon sale. That is, the judgment of the ministry concerned depends on whether the product would normally be recognized as a product whose purpose is governed by the Pharmaceutical Affairs Law. As a guideline for this judgment, "the Standards Defining Range of Drugs" is available. Therefore, even if a product is sold as a food product overseas, depending on the dosage form or ingredient, for example, the product may be considered a drug in Japan. In other words, for a dietary supplement product to be allowed into Japan as a food product, all the food product raw materials, food product additives, etc., must be permitted for use in food products in Japan. The dosage form should not resemble that of a drug and the indication of its effects is also subject to regulation. Since whether a product is considered a drug depends on the "recognition of an average person," the Ministry of Health and Welfare has revised its judgment criteria according to changes in the awareness of general consumers, diversification of dietary life style, and changes in how the product has been used for a drug.

If a product is considered a drug, under the Pharmaceutical Affairs Law, the product can not be manufactured or imported as a business unless the manufacturer or importer of the product obtains a license.

Furthermore, the ministry concerned is advancing a deliberation on the review of the classification of food product and drug, including the factors of safety and pharmacological effects. Under the Deregulation Action Plan (March 1995), the ministry concerned plans to make vitamins exempt from the drug regulations by the end of fiscal year 1996 and herb by the end of fiscal year 1997, and then consecutively other products as well.

4. Complaint:

A complaint was made that all products that are sold as food products overseas should be sold as food products in Japan, without being classified as drugs and therefore subject to the regulations of drugs.

(1) Recognition of dietary supplements

Dietary supplements, which are distributed all over the world, should be clearly defined in a law based on nutritional requirement (referred to as RDA (recommended daily allowance) abroad) in the interest of international harmonization. In this case, "the Standards Defining Range of Drugs" should be revised so as to remove food products considered dietary supplements from the range of drugs.

(2) Deregulation of labeling and establishment of a guideline

Taking account of the functions of the food and its physiological actions in the body, the ministry concerned should allow the functions of the product as a dietary supplement and methods of its effective use as well as precautions to be explained. In addition, the indication of other necessary information such as the eligible age group should be permitted. In this case, establishing "the appropriate labeling guideline" may need to be considered, in order to prevent indications of superfluous effects and incorrect use.

(3) Liberalization of shape (dosage form)

The ministry concerned should allow consumers to freely select the dosage form that is safe, easy to use, and necessary for the preservation of quality. Dosage form should not be used as a means to distinguish from drugs at the cost of convenience to consumers. In addition, at present, only Japan uses dosage form for this purpose.

(4) Deregulation of ingredients restriction

Even food product raw materials or ingredients that have been used extensively in Europe or the United States, or whose safety has been sufficiently verified, can be considered drugs. Those cannot be used as dietary supplements in Japan and their usage standards are extremely severe. Therefore, deregulation is necessary.

5. Results of Deliberation:

The ministry concerned should take the following actions in addition to the deregulation measures it has announced so far.

It is undesirable that products distributed and sold as food products abroad are classified as drugs. In addition, in order to conform to changes in consumer needs such as changes in dietary life style, it is necessary to take some measures for dietary supplements. As for the classification of drugs and food products, in the mid- to long-term, the ministry concerned should consider deregulating the restrictions on food product raw materials and ingredients and establishing a new category for dietary supplements.

As the current regulation on shape (dosage form) is too complex to understand, it should be abolished or substantially eased if appropriate indication as a food product (a dietary supplement) is established so that consumers can make correct choices without getting mixed up.

As for the restriction on labeling, priority should be given to consumers' interests. Because food products require appropriate labeling on ingesting method, dietary supplement claim, precautions, etc., the ministry concerned should relax the regulations on labeling, which enables consumers to appropriately select the product they require.

Furthermore, products distributed and sold abroad normally as food products should not be regulated as drugs, but be allowed into the market as food products in Japan. In addition to the measures under the Deregulation Action Plan (March 1995), the ministry concerned should ease as much as possible the current regulations on shape (dosage form) and labeling, for example, for vitamins in fiscal year 1996 and for herb in fiscal year 1997. The measures should be advanced consecutively to products other than vitamin and herb, beginning with minerals in fiscal year 1998.

Government decision (March 26, 1996)

2-(1) Clarifying the Definition of "Dietary Supplements" and Deregulating Their Restrictions

As for the classification of drugs and food products, in the mid- to long-term, deregulation of the restrictions on food product raw materials and ingredients and establishment of a new category for dietary supplements will be considered.

The regulation on shape (dosage form) will be abolished or substantially eased if appropriate indication as a food product (a dietary supplement) is established so that consumers can make correct choices without getting mixed up.

As for the restriction on labeling, relaxation will be made to allow labeling on ingesting method, dietary supplement claim, precautions, etc., which will enable consumers to appropriately select the product they require.

Products distributed and sold normally abroad as food products will not be regulated as drugs but be allowed into the market as food products. For this purpose, the current regulations on shape (dosage form) and labeling will be relaxed as much as possible for vitamins in fiscal year 1996 and for herb in fiscal year 1997; and the measures will be advanced consecutively to products other than vitamin and herb, beginning with minerals in fiscal year 1998.

Follow-up (May 12, 1997)

2-(1) Clarifying the Definition of "Dietary Supplements" and Deregulating Their Restrictions

In March 1997, the concerned ministry began a ministry-wide deliberation of classification methods for drugs and food products, in order to respond to the establishment of a new category of dietary supplements. Individual product categories will be handled as follows:

(1) Vitamins

Seven types of vitamins, including vitamin A and B1, which it is widely accepted in Japan are ingested from foods, will clearly be labeled as "food" for the time being, and products which do not claim any pharmaceutical effects will not be considered as drugs, regardless of shape (capsules, tablets, etc.) (Directive of March 1997 from the Director of the Pharmaceutical Affairs Bureau, Ministry of Health and Welfare).
Vitamin B6 and five other vitamins mentioned in the same directive will be handled similarly, as long as daily dosage falls below a certain amount. Regarding restrictions on labeling, products requiring labeling to describe timing and dosage, precautions, etc. which are needed to ensure consumer safety will not be banned uniformly but a decision will be made in each case, unless the product's effects and benefits can readily be imagined.

(2) Herbs and minerals

Regarding approval for changing the classification of some herbal ingredients from drugs to foods and allowing the distribution of some minerals in shapes similar to drugs (capsules, etc.) as foods, document research was begun in January 1997. After study by experts, the classification of herbs as foods will be implemented in FY1997 and of minerals in FY1998.