Health Food Regulations in Japan

Health food regulation is primarily built on the Industrial order of worth; the dominant idea is that health food regulation functions properly as long as the system is built logically and rationally—for instance, using scientific data.

Figure 12.1 Classification of foods and drugs in Japan

Source: Translated by the author from the information available at www.caa.go.jp/policies/policy/ food_labeling/foods_with_function_claims/pdf/150810_2.pdf

Health food regulation in Japan is organized in terms of the regulatory cat­egories “Foods with Health Claims” (FHC), “So-Called ‘Health Foods’,” and “General Foods” (see Figure 12.1). FHC are defined as foods that alter physi­ological functions and have characteristics partway between those of a drug and those of a conventional food.^[703] FHC are divided further into three sub­categories defined by differences in purpose and function: “Foods with Nutri­ent Function Claims” (FNFC), “FoSHU” and “Foods with Functional Claims” (FFC). FNFC refers to foods that are labeled with the functions of nutritional ingredients (vitamins and minerals). FNFC do not require the government’s permission for health claims for specified nutrients. FoSHU carry a health claim that indicates a physiological effect on the human body, and manufac­turers are required to submit data from clinical trials of the product if FoSHU certification is sought. Foods categorized as FFC, a category newly introduced in 2015, also carry functional claims on the labels, but the FFC category does not require governmental approval or oversight; instead, manufacturers are responsible for determining the safety and functionality of their products by

The Use of Health Foods in Japan 189 substantiating them in published literature.^[704] Then there is the category of Non- FoSHU products (which are called “So-Called ‘Health Foods”) that may have the appearance of food, drinks, or tablets; these do not require permission from the Consumer Affairs Agency (CAA), the governmental organization charged with oversight of food standards and health claims.

Put differently, the regulatory framework recognizes four different types of foods, governed by different types of laws: FNFC do not require application, registration, or prior notification to the government as long as companies meet the standards set by Japan’s Consumer Affairs Agency; FoSHU involve safety evaluation and approval by the government; with regard to FFC, companies must notify and provide the CAA with scientific information on the safety and functionality of their products, but marketing is not subject to govern­ment permission. Meanwhile, foods that are categorized as “So-Called Health Foods” require no special oversight but cannot be accompanied by specific claims about health effects.

Given this patchwork of multiple regulatory categories under which health­promoting foods are designated, it may not be surprising that consumers are sometimes misdirected or misinterpret information about health claims. The types of health foods sold in the marketplace range from general foods to functional foods and from food-like dietary supplements to medicine-like supplements, and government authorities require widely varying amounts of scientific evidence and oversight to ensure the safety and efficacy of each of these foods. Indeed, the rise of health foods blurs the boundaries between food and drugs in the eyes of consumers. The result is that health foods are met with high expectations of drug-like health effects by some, but because they are understood by others to be foods, the possibility of health risks arising from misuse, overconsumption, or drug interactions is not widely recognized. Thus, the possibility that such foods might, similarly to drugs, have unforeseen side effects is not taken into consideration by consumers.^[705] These circumstances present a challenge to the governing authorities because consumers’ blanket understanding that “health food” that is sold in the market is safe and effective sets the stage for social confusion and in some cases leads to health problems.

Indeed, cases have been reported in which ingestion of certain types of health foods have led to health problems, generating side effects or allergic reactions, sometimes even resulting in death. For example, the National Con­sumer Affairs Center (NCAC) ofJapan, an independent administrative agency

for consumer advocacy, reports a substantial number of incidents that required medical attention.^[706] Further, the Japan Medical Association (JMA) acknowl­edges that the misuse and overuse of health foods constitutes a serious public health threat for Japanese society and has been carrying out projects to establish a system for medical doctors who are members of the JMA to share informa­tion regarding health problems related to health foods. It has also been trying to establish a systematic method for clinics to disseminate information to patients about the proper use of health foods.^[707] Although the number of cases may appear small in proportion to the Japanese population overall, the problem is serious and includes reported fatalities.

The present medical infrastructure is not set up to provide an effective response to these problems because thus far health problems arising from health foods—such as interactions between drugs and health foods—have not been addressed carefully by either patients or medical doctors. Patients rarely mention the use of health foods to medical doctors at the clinic, and medical doctors rarely ask patients about the use of health foods when prescribing drugs. Insuf­ficient clinical data have been collected on drug interactions with health foods,^[708] simply because the concept of such interactions was not recognized until very recently. Combined with the complex regulatory framework, the lack of clinical data underscores the point that consumers are not as protected as they think they are. Health claim labeling policies were meant to empower consumers make informed choices about what to eat, based on the assumption that consumers would read and be able to understand what is written on the labels and would then be able to figure out how to relate daily intake of those foods to their eve­ryday eating practices. In summary, regulations applying to functional foods rest on the assumptions of the Industrial order of worth, whereby informed consumers will use information provided by regulatory agencies to promote and protect their health. Other societal considerations, such as practical and economic needs or social relational and symbolic influences of the use of health foods are not a part of the logic that shapes the existing regulatory framework.^[709]

IV.