Japan has a long history of using foods with health benefits and Japanese people are well-known for their

longevity. In 1991, the Ministry of Health, Labor and Welfare introduced a functional food regulation

called “foods for specified health uses” (FOSHU) in Japan. After the introduction of the functional food

system, many clinically proven FOSHU products with health benefits have been developed and launched

in the market. As a result, the net sales of FOSHU products reached 6.2 billion dollars in 2007. Most of

the health claims relate to improving gastro-intestinal health using probiotics. Triglycerides, high blood

pressure, high LDL-cholesterol, and high blood glucose are mainly associated with the related health

claims. After 2007, the market for FOSHU products was almost saturated. However, a novel functional

regulatory systemcalled “Foods with Function Claims” was established in 2015 based on the Dietary

Supplement Health and Education Act system established in the USA. Major health claims in the new

regulation system are associated with fatigue, eyes, memory, stress, sleep, joints, blood flow, body temperature,

muscles, and Body Mass Index. After the introduction of the new system, the total sales for

functional foods including FOSHU products reached 8 billion dollars in 2018. The new functional regulatory

system is more flexible in terms of health claims, the protocol for clinical studies, and the required

results. Therefore, the market for new regulatory products is still growing. In the present paper, the

potential of both regulatory systems and some related issues will be discussed.