Worldwide Regulatory Review: Japan

After more than a year of work and countless committee meetings, Japan has still not established a regulatory system to govern its health foods industry. Meanwhile, the proposed new rules, if enacted at all, may be only skin deep, says industry observer Kaori Nakajima

Despite many committee meetings canvassing opinion from representatives of the industry, consumers, media, academia and policymakers, Japan still has no regulatory system governing health foods. Proposals and pre-proposals have been laid on the table, but nothing has come to fruition in the form of functioning regulations. It?s a confusing situation because many people, including the media, believe regulatory floodgates have finally opened for health foods, including dietary supplements, when this is not the case. Indeed, the opposite may be happening.

A joint committee of six members was created in April 2003 by the Japanese Ministry of Health, Labor and Welfare to develop a regulatory system for ?health foods,? a previously undefined regulatory arena. The committee was supposed to draft a proposal by December 2003. It has now met 12 times in little more than a year with no resolution in sight.

Certain matters have been clarified, however, such as just what constitutes health foods. Notes from one committee meeting stated: ??Health foods? will mean a wide variety of foods that are sold and used with the purpose of contributing to the maintenance and promotion of health. These foods include Foods with Health Claims (FOSHU and Foods with Nutrient Function Claims). The ?so-called health foods? are those health foods that are not Foods with Health Claims.?

This is interesting. Foods with Health Claims [Foods for Specified Health Uses (FOSHU) and Foods with Nutrient Function Claims] have been regulated by the Ministry of Health, Labor and Welfare since 2001. These kinds of foods are the only type that can carry some kind of a health claim in Japan. It would seem the committee has decided to put Foods with Health Claims under the big umbrella of ?health foods? and that ?health foods? have finally gained status in the regulatory arena.

This may lead the innocent observer to think a whole new raft of foods will be able to make health claims. This is not necessarily so. Only Foods with Health Claims are allowed by law to make health claims as it stands, and it would appear only those foods will be able to enhance the claims they may make. So, very little has changed.

Trying to position Foods with Health Claims was the easy part. Foods with Nutrient Function Claims (the name comes from Codex?s Nutrient Function Claims) are foods containing nutrients required for human wellness and vitality. However, under this definition, the case could be made that human wellness and vitality can be achieved via vitamins and minerals only. Foods with Specified Health Uses (FOSHU) are those with scientific support to maintain or improve specified health conditions. When it comes to positioning the ?so-called health foods? in this whole scheme, the committee is reluctant. Should they allow a third category of foods with some kind of scientific verified health claims system? Or should they expand upon the Foods with Health Claims framework to provide space for the ?so-called health foods? to be able to compile some kind of substantiation? A close look at the committee?s intentions reveals a tightening of claims options, even as they appear to be moving toward a more liberal system.

No escaping FOSHU
The committee has highlighted the following points of consideration:

Everything has to do with FOSHU. No door has been opened for the ?so-called health foods? at all. This is disconcerting, especially in regard to supplements such as herbs, carbohydrates, proteins, lipids, bee products and mushrooms ? all of which will have no scope for claims under the proposal. According to the proposal, there will be three levels of evidence: A, B and C. Level A means there is both medical and nutritional scientifically substantiated evidence. They will apply to Foods with Nutrient Function Claims and FOSHU. Level B evidence must meet existing FOSHU substantiation criteria. Level C evidence alludes to a food?s functionality, but its effectiveness is not substantiated and will apply to conditional FOSHU. These foods must carry a disclaimer, stating that while the food affects the structure/function of the body, the ?grounds of this claim are not necessarily well-established.? That said, both B- and C-level claims will require clinical trials on Japanese subjects.

Standardised FOSHU will be reserved mostly for pre- and probiotics, since their effects on the structure/function of the body have been evident for many years. This will speed FOSHU evaluation for look-alike FOSHU—hence less work for everyone, but less development of truly innovative foods. Disease risk-reduction claims provide valuable information to the consumer. Before taking the bold step of making claims, scientists must consider not only disease risk factors, but also have medical and nutritional substantiation for intake levels and individual physiology. The safety/effectiveness examinations that the FOSHU candidate products must go through is based on tough, almost drug-like criteria.

The proposal states the system should adopt more rational steps toward approval, by considering FOSHU more as foods, and not be required to demonstrate such a high level of safety and effectiveness. Thus the screening level of FOSHU will most certainly be reconsidered. Presently, it has two disease risk-reduction claims in mind: calcium and osteoporosis; and folic acid and neural tube defects. We do not know, however, if more are really going to be considered at all.

Wanted: a powerful government health zealot
It also says it should clarify the system, indicating reassessment of FOSHU products already on the market may be required. There are a lot of ?shoulds? in the proposal. The committee has left a lot of space for discussion.

There are other specifications related to the appropriateness of claims, safety guidelines, consumer education and diffusion of information to the public. The committee seems to know what is important and what ?should? be done. There is, however, no road map for how or when it must be done.

As it stands, the ?so-called health foods? that have waited more than a year to gain legitimacy are little closer to this goal. This proposal needs a zealous advocate, preferably a powerful parliament member to seize its cause and push it forward. Until that happens, the discussions are likely to go on ad infinitum with little hope of significant change.

Kaori Nakajima is chief of staff, scientific and regulatory affairs, for the Health Food Department at the Japan Health Food & Nutrition Food Association. Respond: [email protected].
All correspondence will be forwarded to the author.