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Abstract: Dietary supplements promote health and prevent disease in aging societies. Taking dietary supplements is a form of self-medication that can cut public medical expenses. To solve issues over quality, Good Manufacturing Practice (GMP) has been advocated as a standardized management system for manufacturing dietary supplements. In order to clarify the effect of a company's organizational capability on its adoption and implementation of quality control standards, we analysed the relationships between various company characteristics and the GMP of 90 Japanese manufacturing companies in the dietary supplement industry. The results suggested that, (i) the size of the company, (ii) whether it was a pharmaceutical manufacturer, and (iii) the variety of products it manufactured, were key factors that led to better GMP adoption in the dietary supplement market.
Keywords: dietary supplement; food; pharmaceutical; quality standardization; quality certification; industry convergence; organizational capability; GMP
1.Introduction
Background
The dietary supplement, the special functional food presented in the form of tablets or capsules, promotes health and disease prevention in aging societies as a form of selfmedication that can cut public medical expenses. The market for dietary supplements has expanded steadily, in accordance with expectations and increased food technology innovation (Bigliardi, 2013; Starr, 2015; Costa, 2017).
In this study, we defined a dietary supplement as 'a food shaped as a tablet, capsule, or powder that is different from regular food and contains functional physiological ingredients'.
The dietary supplement industry is open to a variety of small and medium-sized enterprises (SMEs) and start-up companies that make use of novel functional ingredients and/or local specialty foods, players in the pharmaceutical, food or other industries, and supportive companies such as OEM manufacturers. In Japan, more than 70% of final dietary supplement manufacturers outsource the manufacturing of their dietary supplements to OEM manufacturers.
Today in Japan, the size of the dietary supplement market has reached USD 8 billion, and an industrial ecosystem has developed based on the transdisciplinary environment. In 2015, the unique Food with Function Claims (FFC) system started in Japan, which provided more information about functional food products to consumers and helped small companies develop functional foods.
However, quality issues have emerged, such as inappropriate manufacturing process management and insufficient ingredient amounts (Pravst, 2011). Some cases were presumed to be due to inappropriate...