Food for Specified Health Use (FOSHU)

With ever increasing varieties of health food available these days, one great advantage of FOSHU is that we can promote their functionality by clearly answering the question about what kind of effects can be expected. Since we started the business, we have been committed to developing FOSHU products and acquiring appropriate approvals. Today, we are proud of having an extremely successful FOSHU development history in having obtained the largest number of approvals—outdistancing by far other companies nationwide.

FOSHU is a name given to foods that contain functional ingredients (functional components) effective in the maintenance and promotion of health (physical conditioning function) and display specific health use (functionality) such as “to help maintain intestinal condition” on the packaging. In the application process, business operators have to submit scientific data on efficacy, safety, quality and other evidence for their products, which should be approved only after a one- to five-year period of strict examination and evaluation by the relevant ministry.

It is not an easy task to develop FOSHU. Proofs of its safety and efficacy nearly as extensively as for pharmaceutical products are required; therefore, a number of experiments, including clinical trials have to be operated to obtain medical and nutritional evidence. Despite the fact that it requires a considerable amount of time to apply in addition to the burdens such as an immense amount of time and money, human resources, facility investment, there is no guarantee that FOSHU approval will be granted. Moreover, it is possible that the market will have changed significantly by the time the FOSHU approval is granted.
TOYO SHINYAKU supports the introduction of FOSHU to your company, providing the services that greatly reduce necessary development costs, development period, and even for the risks.

What is TOYO SHINYAKU’s CRO (Contract Research Organization)?

CRO (Contract Research Organization) is a clinical consignment organization. However, our CRO activities are not simply to take on consigned clinical tests, but also provide a complete support with the acquisition of FOSHU patents in mind. By harnessing our advantage as a ingredients developer and manufacturer, as well as our knowledge in regard to FOSHU patent acquisition as symbolized by our No. 1 nationwide patent acquisition, we build consistent systems to include related tasks from ingredients development to product design, test planning, testing, support for the acquisition of patents, manufacturing, all the way up to sales promotion support. We can flexibly help with your FOSHU development.

Surprisingly, many customers are troubled when it comes to FOSHU development, with questions like: ‘We have no idea how to go about developing FOSHU,’ ‘We did the same tests done by companies who have already acquired their FOSHU patents, but we are still unable to get ours,’ ‘We invested an enormous amount of development fund and human resources but we are unable to acquire FOSHU patent,’ among many others. The cause of their problems is because of the latency of the knowhow related to FOSHU development within their company data that usually does not get to see daylight. At TOYO SHINYAKU, we are here to help with your FOSHU development by putting our FOSHU development experience and results to full use. Even if your company possesses absolutely no knowledge about FOSHU, TOYO SHINYAKU is here to support you from the start.