Modifications to Foods with Functional Claims (FFC)
Food for Specified Health Uses (FOSHU) includes ingredients that may impact our bodies and are typically labeled to specify the expected effects that these ingredients may have upon consumption.
The government judges the efficacy and safety of all FOSHU foods and grants authorization accordingly.
In addition to this process, there is a separate system called Foods for Functional Claims (FFC).
Based on rules laid out by the government, this system requires the distributors themselves to report on the functionality and safety of their food products, backed by scientific evidence, to the director of the Consumer Affairs Agency (CAA) before selling their products.
FFC does not operate on the premise that the government will authorize products on a case-by-case basis.
If FFC finds that the scientific evidence for the claims submitted by the producers is unreasonable, in accordance with the Act against Unjustifiable Premiums and Misleading Representations, those claims can be issued as falsehoods or exaggerations.
On June 30, authorities enforcing the Act against Unjustifiable Premiums and Misleading Representations determined that there was no rational basis to support the functionality claims of two FFC products, “Kinari Takumi” and “Kinari Kyoku,” supplements by Sakura Forest Co.
The company made the following claims about their products: “DHAs and EPAs have properties that lower triglyceride levels,” “Monoglucosyl Hesperidin has properties that lower blood pressure,” and “Hydroxytyrosol derived from olives suppresses the oxidation of bad cholesterol.” However, authorities found that these claims had no rational basis.
In response, Sakura Forest Co. submitted a withdrawal request for the two products on the same day that authorities issued the order.
To prevent mistrust of FFC, we have issued instructions to all relevant business associations to conduct periodic re-examinations of the scientific evidence backing the functionality claims of all labeled products.
Furthermore, to enhance the quality of scientific evidence, authorities plan to revise the submission guidelines of FFC to align with those covered in the updated Prisma 2020 international guidelines rather than the outdated Prisma 2009.
Authorities have investigated and subsequently questioned products either containing the same ingredients or possessing the same scientific backing as the two recalled Sakura Forest Co. products, and have requested a response within two weeks.
There are approximately 90 products under investigation.
As soon as the investigation process is complete, an overview of the results will be released to the public.
