Functional Foods and Anti-aging: What Are Foods with Functional Claims

Originally, describing functionality such as effects and efficacy in foods was prohibited under the “Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices” (Pharmaceuticals and Medical Devices Act). The only exception was health foods approved by the Consumer Affairs Agency, which were traditionally limited to Foods for Specified Health Uses (FOSHU) and Foods with Nutrient Function Claims. However, the development costs for FOSHU are said to be several hundred million yen or more, and the review period can take several years, which has been heavily criticized. Therefore, Foods with Functional Claims, which allow companies to express functionality on the condition that evidence has been obtained in clinical trials, and which can be reported to the Consumer Affairs Agency under the responsibility of the company, were initiated in April 2015 to utilize research results conducted at universities and companies. By 2023, over 6000 cases have already been accepted, and the market size is estimated to be approaching 500 billion yen. The outline of Foods with Functional Claims is described in the “Guidelines for Notification of Foods with Functional Claims” posted on the Consumer Affairs Agency’s website (Fig. 106.1). Notifications are made online, and the content and clinical evidence are also described. The Consumer Affairs Agency checks the notification documents and, if there are no omissions or formal defects, issues a notification number and discloses the information on the Consumer Affairs Agency’s website, etc.