Navigating Japan’s Regulatory Framework

By Evon Chan, Regulatory Affairs Adviser, EAS Strategic Advice (Asia Office) | November 1, 2012

Local authorities distinguish between several types of health food products.

Japan’s rapidly growing market for health food continues to be driven by increasing numbers of health conscious consumers. And when the market grows, inevitably there is focus on the regulatory framework in place to handle increased demand. It is unsurprising, therefore, that in September 2009 authorities created the Consumer Affairs Agency (CAA), which took over the Ministry of Health, Labour and Welfare’s (MHLW) responsibility for the implementation of laws relating to nutrition labeling and health claims approval in this emerging market.
In Japan, health food encompasses a fairly broad category of foods:
  • Foods with Nutrient Function Claims (FNFC)
  • Food for Specified Health Uses (FOSHU)
  • So-called “health foods”
Food with Nutrient Functional Claims (FNFC) refers to foods labeled with the functions of their nutritional ingredients. Seventeen nutrients (12 vitamins and five minerals) are permitted for use in FNFC products, with established minimum and maximum daily amounts to ensure sufficient nutrient intake and safety. More specifically, eight nutrients are not permitted for use in FNFC, including vitamin K and phosphorus. These nutrients are prohibited, as deficiency in these nutrients do not exist in Japan.
At present, only Foods for Specified Health Uses (FOSHU) require pre-marketing approval because FOSHU is a product-specific approval system. For all other health food products the onus is on manufacturers to ensure their products meet the requirements stated in a number of other laws, including the Food Sanitation Law, the Health Promotion Law, Pharmaceutical Affairs Law and the Act against unjustifiable premium and misleading presentation.
The CAA is responsible for the registration approval process of FOSHU products, and FOSHU is divided into four subcategories:
2. Qualified FOSHU
3. Standardized FOSHU
4. FOSHU with disease risk reduction claims
These four subcategories have varying levels of efficacy requirements based on the types of claims in each category. Qualified FOSHU, whereby the scientific evidence is not sufficient to be granted full FOSHU approval, requires a detailed review process with scientific evidence for each application. Standardized FOSHU—a short cut process for products for which safety of use has already been approved by the CAA—does not require the detailed review but must meet the standards and specifications laid out by the CAA when sufficient efficacy evidence has been accumulated in that particular subcategory. And reduction of disease risk FOSHU, the highest level of FOSHU, is permitted for products whose ingredients are clinically and nutritionally established to reduce a risk of certain disease. The four categories of FOSHU are summarized in the table below.
Table 1

Important to note though, is that the FOSHU approval system is actually voluntary. In other words, companies are given flexibility to market so-called “health food” without obtaining FOSHU approval on the condition that these products do not bear any health claims or claim physiological effects on the human body.
In order to protect the public from false and misleading label claims, the CAA has made several changes to encourage industry participation in the FOSHU approval system. Qualified and standardized FOSHU, for example, were introduced with reduced quantity and quality requirements of scientific evidence for lower level claims. 
In general, food products are not permitted to bear claims unless they are classified as Foods with Nutrient Function Claims (FNFC) or Foods for Specified Health Uses (FOSHU).
The Ministry of Health, Labour and Welfare (MHLW) has established standards and specifications for nutrient function claims. For example, the claim “Niacin is a nutrient that helps to maintain skin and mucosa healthy,” can be declared on product labels. The distinction between FNFC and FOSHU is that FOSHU are allowed to bear claims relating to their clinically proven function, whereas FNFCs are not necessarily clinically proven. For a product to be approved as FOSHU, it must be registered with the CAA. The conditions for approval are:
  • Improvement of dietary habits and contribution to health maintenance and enhancement can be expected by consuming the product
  • Availability of scientific evidence for the claimed health benefit
  • Clinical and nutritional intake level of the product and/or its functional component is established
  • The product and/or its functional component is safe for human consumption
  • The following items regarding functional component are defined: Physical, chemical and biological characterization and its methods; Methods of qualitative and quantitative analytical determination
  • The nutrient constituent of same type of the food is not significantly changed
  • The food is intended to be consumed on a daily basis and not on rare occasions
  • The product or its functional component is not included in the medical drug list
Examples of FOSHU claims are shown in the table below.
Table 2

When an application has been submitted, the CAA’s food labeling division typically reviews it. If the registration dossier is accepted, then it will be forwarded to the Consumer Commission and the Food Safety Commission for the efficacy and safety to be evaluated. The dossier will then be evaluated in detail by the Consumer Commission. Before final approval is given, the health claim of the product is submitted to the MHLW to ensure it is in compliance with the Pharmaceutical Affairs Law. Once the registration process is completed, the CAA will determine whether or not to grant approval for the product under the regulatory requirements for FOSHU.
The approval process for FOSHU takes at least six months from the day the CAA receives the submission (and three months for Standardized FOSHU).
As of May this year, the number of FOSHU-approved products had grown to 1,000 items.
The CAA is continuing to make progress toward more regulation for so-called “health foods,” by developing guidelines to tighten regulatory controls on false and misleading labeling. At the same time, the CAA is also collecting scientific evidence on targeted nutritional components for further discussion. This will certainly impact those products being marketed under the umbrella of so-called “health foods.”

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