New Food Labeling Policies Adopted in 2015

From the early years of introducing functional foods, values hinging on Mar­ket orders of worth have prevailed. While the link between food and health is not new in Japan, as exemplified by the idiom Ishoku Dogen; “a balanced diet leads to a healthy body”), the concept of functional foods did not gain widespread recognition until the early 1980s, when the world’s first func­tional food, a sports drink called “Pocari Sweat,” launched in Japan.

The Use of Health Foods in Japan 195 the market potential, food companies have actively promoted functional foods since then.^[721] As industry responded to a high demand for such foods as cal­cium-fortified foods, dietary fiber drinks, and fermented soy protein drinks, and so on, by 2004, the size of the Japanese market for FoSHU is said to have reached more than 1 trillion yen (10 billion US dollars)^[722] and then again dou­bled in the following 10 years.^[723] Occupying a middle ground between food and drugs, functional foods are seen by industry as offering endless marketing opportunities to health-conscious consumers in Japan and are a fast-growing, multi-billion-dollar industry. Indeed, functional foods maintained a significant presence in the Japanese market over the ten-year period beginning in 1997.

Though functional foods have gained a prominent position in the market, one needs to recall that the term “functional foods” is primarily a marketing term referring to varying types of foods, such as traditional foods with newly defined significance or newly formulated foods whose ingredients or formula­tion may be novel. The term “functional food” is commonly used in our daily life, and there is a scientific journal dedicated to the subject, but there remains a lack of consensus on a definition of the term.

Interestingly, for Japanese consumers, the Market order of worth plays a role in determining the desirability of foods.

It is true that we tend to be attracted to expensive health improvement foods because it seems that expensive ones have more effect than others. [If they are expensive], naturally we expect those will have more effects.

(comments by a participant in the public forum)

The 2015 Reform was an extension of this thinking. Drawing on assump­tions within the Market order of worth, people in policy circles and busi­nesses shared the sense that the food regulations that existed before 2015 were hindering businesses from being competitive in the market. Among the three categories of foods with health claims, namely FNFC, FoSHU, and

FFC, FoSHU occupied the largest market share, but people in business saw some signs that the market was no longer growing by 2009, particularly when trends were compared with the upward trend witnessed from late the 1990s to early 2000s^[725] (see Figure 12.2). Parallel to this was the announcement by Prime Minister Shinzo Abe that the government would reform health claims of foods for the purpose of enabling consumers to make informed decisions about foods that would help them to lead a healthy life.^[726] In line with the usual pattern of food policy decision-making processes, once such statement was made by the prime minister, there were cascading activities by councils and committees mandated to work on details about the content and workings of the rules. For instance, following up on what was stated by the prime minis­ter, the Regulation Reform Council (RRC) suggested that the then-current regulatory framework of FNFC and FoSHU was limiting the capabilities of Japanese companies that might otherwise be able to expand on their product lines and increase market share and was preventing some, especially small and medium-sized companies, from entering into the health food market.

A series of meetings was held by the committee, and in April 2015, the CAA announced to the public that the Japanese government would introduce the third category of health claim labeling for food. This category of voluntary labeling, FFC, allows companies to display a product’s specific health benefits on retail food packaging. Unlike the situation with FoSHU certification, no government approval is required for the labels of foods designated FFC. While the FoSHU label states that the product has been approved by the CAA, the label for FFC says the product’s function claims have not been individually reviewed by the agency.

The Use of Health Foods in Japan 197

Businesses have shown strong interest in the new system. From the per­spective of people in business, the reform that took place in 2015 is seen as a deregulation of functional foods, because the government’s requirements are much less rigorous than those for obtaining FoSHU certification; the result is more rapid introduction of products with smaller product-development costs.

Seen as a newly emergent business opportunity, the changes made in 2015 were also welcomed by people outside Japan. For example, a US government report candidly stated:

... this new FFC registration process is more affordable and faster than the registration process for Food for Specialized Health Uses (FoSHU). CAA also revised its regulations for Food with Nutrient Functional Claims (FNFC) to increase product eligibility, to expand the list of eligible nutri­ents, and to include fresh foods. These changes by the CAA should create new opportunities for U.S. exporters to the world’s third largest health food market.^[728]

Ideas hinging on Market justification have triggered various visible phenom­ena. Among many noticeable changes was a dramatic increase in the number of notifications regarding FFC, while the number of applications to be certi­fied for FoSHU has been declining.

The 2015 Reform highlights issues of the food policy decision-making pro­cess in Japan that pertain to competing public policy agendas such as responding to the public’s concerns while promoting the growth of industry. The way in which the government justified the 2015 Reform was to state that introduc­ing the new category of health claims to food would support the dual goals of growth in the Japanese economy and making a contribution to public health. Food labels that carry functional claims are framed as an appropriate mecha­nism for consumers to make informed choices and for businesses to be given an opportunity to enter the market or expand their market share. However, not everyone necessarily agreed with the statements that the government made. Critics with expertise in food safety as well as representatives of consumers groups have raised concerns about the varying ways in which the information on labels can be interpreted (similar to the case of other types of health foods) as well as the varying ways in which businesses within the food industry define an adequate level of evidence to claim foods as safe. Within the community of food safety experts, the standard for determining the safety of substances in food is using “the empirical evidence from prior history of safe use.” In the absence of a prior history of safe use, potential new functional ingredients must be evaluated for safety before introduction into the market. If that is the case, the safety evaluation of new functional ingredients should adhere to the same safety testing principles used for other substances and should replicate the intended use levels.^[730] The Committee which worked on the details of 2015 Reform chose not to specify years required for history of safe use and suggested that the required years would vary “case by case.” This stance has led companies to define safety in varying ways, resulting in a situation in which some companies interpret a scientific protocol in a precautionary manner, while others proceed to sell products that might not necessarily have sufficient evidence. In princi­ple, the safety evaluation of new functional ingredients should adhere to the same safety testing principles used for other substances and should replicate the intended use levels, but that has not always been the case, as indicated in the government report.^[731]

V.