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| 5th Report of Market Access Ombudsman Council (March 17, 1998) |
1. Complainant: U.S. Chamber of Commerce in Japan, American Embassy in Japan
2. Ministry concerned: Ministry of Health and Welfare
3. Complaint:
Concerning the Cabinet decision to deregulate nutrition supplements based on the March 26, 1996 decision of the Office of Market Access and the program to promote deregulation that followed, status of progress has not been clarified and almost no progress has been made in actual liberalization. In keeping, it is important to make the status of progress in deregulation transparent and to implement deregulation promptly.
Two new problems have emerged, as follows.
(1) Considerations of the investigative committee on herbs, etc., and the ministries concerned have been extremely slow; it will likely take many years for deregulation to become a reality.
(2) For nutrition supplements, which have gone from being regarded as pharmaceuticals to being regarded as food, the strict regulation of them as food poses a serious barrier to imports.
Based on the above, the following improved measures should be considered.
(1) For dose-type nutrition supplements, because at present only 7 kinds of vitamins have been deregulated and conditional deregulation applies to the remainder, the liberalization of all dose-type nutrition supplements should be promoted.
(2) Investigation of benefits, etc., that have yet to be investigated should be done immediately.
(3) Because the ministries concerned are only beginning internal cross-investigations on this new category, "nutrition supplements," and investigation status lacks transparency, schedules should be clarified and actual measures to make progress transparent and adoption measures implemented immediately upon.
(4) Deregulation of the herbs, minerals, etc., that are commonly distributed and sold overseas as food should be advanced without delay so that they may be distributed and sold as food without being regulated as pharmaceuticals.
4. Corresponding Policy of the Ministries concerned:
In Japan, pharmaceuticals and foods are judged collectively based on ingredients, indications, dosage, claim, etc. As long as claim of benefits is effects are not advocated, the major vitamins are classified as food, even if capsules and other pharmaceutical-like dosages are used. For vitamins used exclusively as pharmaceuticals and that may be problematic in terms of side effects and other safety issues, content is restricted and handling is as described above.
Overseas, the status of regulations on the "dietary supplement " classification, indications and dosage all differ; Japan's situation is thus not unique. For example, in terms of dosage, over seven countries, including France and Switzerland, use one judgment standard for pharmaceuticals.
At present, the U.S., Europe, Japan and other countries are participating in the FAO/WHO joint food standards program (CODEX), and although guidelines on range, indications, etc., of nutrition supplements are under consideration, agreement has not been reached.
For U.S. nutrition supplements, in addition to the number of times the U.S. Food and Drug Administration has issued warnings concerning quality and safety, Japan, which has no experience in this area, also requires scientific investigation to permit related distribution in Japan.
(1) These problems are discussed below.
1) Because many of the herbs involved are unknown in Japan and related safety has not yet been confirmed, the investigative committee on herbs is scientifically investigating safety, and based on the investigation results, it is considering other primary factors (usage purpose, indications, claim, etc.), and attempting to resolve which kinds of herbs should be freed from the framework of pharmaceutical regulations. The range of herbs under investigation is those sold as food in the U.S. and Europe. Preferential positioning will be based on sales results (sales position) in the U.S., and investigations are being conducted from the necessary information that has been obtained.
Subjects for investigation include the 150 kinds of herbs for which there is demand in the U.S. market (from the September 9, 1997 MOSS follow-up meeting), and the necessary measures will be implemented within fiscal year 1997.
2) Concerning deregulation related to relevance as pharmaceuticals, an investigative committee (a research group on vitamins) has been established that is conducting investigations, and deregulation is being worked on. Having conducted investigations of each country's market, regulatory system, usage methods, indications, etc., and international trends based on the program to promote deregulation, the investigative committee is now investigating scientific safety. Deregulation is being undertaken using the examination results thus obtained as a reference.
Concerning the designation of new food additives, based on the policy indicated in March of 1996 in the WTO report and other procedures, the same as in various European countries, when there is an actual request from related businesses, deregulation will be implemented based on the deliberation of the Food Safety Council. At the February 1996 Expert Meeting of the Market Access Ombudsman Council of OTO, at which the subject of reviewing the standards on the range of pharmaceuticals was deliberated, parties related to one of the complainants in attendance, the U.S. Chamber of Commerce in Japan, stated something to the effect that a rational system has been established for the designation, etc., of food additives and that there is no need to change it.
(2) The following concerns the request for improvements. In future, as well, Japan will both be involved in the work of establishing guidelines on nutritional supplements at CODEX and will be advancing investigations in consideration of these international trends. When these international trends have been determined, Japan will not delay, and to ensure a system, on which international agreement has been reached, it will take the following measures.
1) Concerning the liberalization of form (including dosage-form, container, package and design), deregulation of vitamin dosage has already been undertaken, and minerals and herbs are also being investigated while giving consideration to clear, appropriate labeling as food that will allow consumers to make correct selections without confusion.
2) Restrictions on indications are being examined, giving consideration to labeling that will enable consumers to accurately select what they need by themselves in terms of appropriate ingestion and nutrition-supplementing effect, caution labels, etc.
3) In terms of measures for dealing with nutrition supplements as a new category, the period for such measures is currently being examined by the related departments within the ministries, and with international trends kept in view, reports and the like will be made on the results of these investigations, as necessary.
* Attention will be given to CODEX trends and overseas legal systems and market conditions will be investigated.
* Opinions will be exchanged on items with special characteristics, etc., that are regulated domestically under the Pharmaceutical Affairs Law, Food Sanitation Law, Nutrition Improvement Law and similar laws.
4) Concerning the handling of nutrition supplements normally handled as food overseas, deregulation of vitamins went into effect in March of 1997. In April of 1997, the investigative committee on herbs was established, and measures are to be implemented within the same fiscal year. In June of 1997, an investigative committee on minerals was established, and measures are slated for sometime within fiscal year 1998. We wish to have personnel representing the U.S. Chamber of Commerce in Japan and American Embassy staff in attendance at these investigative committees.