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• FOSHU (Food for Specified Health Use) Business

No.1 in the total number of FOSHU approval
As people become more aware of "primary prevention of illness" due to the aging of society and the increase of medical costs, the FOSHU market has been expanding every year. Toyo Shinyaku has been focusing on obtaining the FOSHU approvals as part of our business, which is to contribute to the health through food. The current number of our FOSHU products tops the list with 208 products, creating an extensive product line.

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. At TOYO SHINYAKU, we have been focusing on achieving FOSHU development since our establishment and have accumulated great results. In 2005 we became Japan’s No. 1 manufacturer to have acquired the highest number of FOSHU patents. In 2010 we acquired over 200 patents among other achievements, making our FOSHU development system unmatched by any other.

In foods there is a primary functionality (nutrient) necessary for sustaining life and a secondary functionality (taste) for the enjoyment of eating. There is also a third functionality (physical condition adjustment) for health maintenance, such as adjusting the body’s rhythms, biological defense, prevention of illness, recovery from fatigue, and anti-ageing. FOSHU (Food for Specified Health Use) are foods carefully designed by focusing on the third functionality (physical condition adjustment) to help reduce health risks that come with unbalanced lifestyle, and are approved by Japan’s Consumer Affairs Agency for the use of the ‘Usage for health’ labeling that indicates what kind of health functionalities are effective.

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.

FOSHU development support to meet customers’ needs

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 raw materials 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 raw material development to product design, test planning, testing, support for the acquisition of patents, manufacturing, all the way up to sales 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.

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