I. Introduction: Defining “Health Food” in Taiwan

Food and drugs have long been established categories, but they are not neces­sarily dichotomous. The development and marketing of health food redefines the boundary of food and drugs, leading to difficulty in regulation.

Since the passing of the 1999 Health Food Control Act,¹ wherein it is defined as “food with healthcare effects,” “Health Food” has been a formal legal term in Taiwan. Herein, I distinguish this term from health food in the everyday sense by capitalizing it. According to Article 2 of the Act, “health care effects” are only those that “have been scientifically proven to be capable of improving people’s health and decreasing the harms and risks of diseases.” Therefore, not every food with health claims is a Health Food by law. The law distinguishes Health Foods from drugs by noting that these health effects cannot involve “medical treatments aimed at treating or remedying human

1 The Act has been amended 5 times to date, and the latest amendment was in 2018.

DOI: 10.4324/9781003271918-17

Effective Health Foods, Ineffective Drugs 203 diseases.” Furthermore, Health Foods “shall be announced [as such] by the central competent authority.”^[737]

After its amendment in 2006, the Health Food review and approval process has had two tracks. Track 1 reviews cases individually based on scientific evi­dence of the food’s safety and healthcare effects, whereas Track 2 sets specific standards for individual ingredients or components. Currently, Track 1 approval for foods can be applied for under 13 categories of healthcare claims; a Health Food permit cannot be applied for any food with health claims outside the 13 categories. Many popular products are thus excluded from Health Food status application, such as those with claims of weight control or weight loss benefits, cosmetic functions, or relief of postmenopausal symptoms.^[738] Among the thou­sands of health foods on the Taiwanese market, only 366 and 67 have obtained Health Food permits through Track 1 and Track 2, respectively.^[739] To date, only two Track 2 ingredients have been announced by the Taiwan Food and Drug Administration (TFDA); the foods for which applications can be submitted through Track 2 are limited.^[740] Therefore, the law only regulates a minority of so-called health foods. Health Foods should not be regarded as products on the food-drug spectrum but rather as a new socially and legally constructed category that overlaps with both food and drugs but is accompanied by distinct regulations. Numerous researchers in Taiwan have made similar arguments to mine. Cheng and Chen used the term “health techno-food” to describe vari­ous modern health foods and stress the effects on the food industry of emerging genetic technology and the adoption of modern medical knowledge.

Most case studies centered on the technoscientific social network surround­ing Health Foods have limited their discussions to herbal products, includ­ing those developed using traditional Chinese medicine ingredients. In one study, An observed that the emergence of the Health Food category in Taiwan bridged the gap between food and drug regulations. The classification of a herbal product can changed from one category to the other if it is approved as a Health Food. For example, herbal products developed from traditional Chinese medicine-related knowledge or ingredients would initially be classi­fied as being part of a broad food category, for the regulation is loose for food production. Later, testing of such products under TFDA-approved experimen­tal protocols can provide scientific evidence of their health effects. Thus, the opportunity for their entry into the global pharmaceutical market may arise.^[742] However, herbal products do not always successfully transition from food to drug. Red yeast rice is an example of a Health Food that was demonstrated in trials to be effective but was not accepted by medical professionals and failed to be classified as a drug.^[743]

Separate from the issues of products derived from traditional herbal med­icines, the use of certain agents as drugs in Western medicine has sparked controversy surrounding Health Food regulation in Taiwan. Herein, I present a case study of glucosamine, an ingredient widely used in drugs and health foods worldwide to manage degenerating osteoarthritis. The TFDA has not yet established a standard protocol for the use of glucosamine in animal experi­ments to prove its health effects. Therefore, glucosamine products are not clas- sifted as Health Foods in Taiwan. According to the TFDA’s scientific review, glucosamine products can be classified as foods or drugs depending on the ingredients. This chapter describes how between-country or between-region differences in regulatory frameworks redefine the trajectory of objects, how industries or distributors shape the scientific discourse in coping with obscured food-drug boundaries, and how the Health Food Control Act failed to regu­late glucosamine in Taiwan. The coproduction of scientific knowledge from the classification and regulation of foods and drugs in and across countries and regions is highlighted.

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