“Future Measures Regarding FFC Labeling System in response to the Case* Involving “Beni Koji” Supplements” (Japan)

By | July 3, 2024

On May 27, 2024, the Consumer Affairs Agency (CAA) released the “Report of Discussion on Foods with Functional Claims (FFC)(Japanese). Subsequently, on May 31, Future Measures Regarding FFC Labeling System in response to the Incident Involving Red Koji Supplements(Japanese). was published as the materials for the Ministerial Meeting on Measures Regarding Red Koji-Related Products(Japanese).

* A recent case involved a pharmaceutical company’s Beni-Koji (rice fermented with red yeast)-related products, which caused a series of health issues among users of its dietary supplement products.

<Overview of future measures regarding the FFC system>

  1. For all FFC, make it mandatory for business operators to collect and provide information on health hazards linked to their products(enables to implement the administrative measure based on the Food Labeling Standards and the Food Sanitation Act)
  2. Measures to enhance the reliability of the FFC system (Establishment of GMP (Good Manufacturing Practices) requirements, etc.)
  3. Digital transformation of information provision and strengthening consumer education
  4. Roles sharing between the national and local governments

The following are excerpts from the proposal in the report on Discussion on FFC.

Obligation to collect health hazards and provide information to government agencies

Since the current notification guidelines cover all FFC, including processed foods, fresh foods, not just supplements, it is appropriate to make it mandatory to collect and provide information on health hazards linked to all types of FFC without limiting the scope to only supplements.

Management of manufacture/quality

In response to this case, it is appropriate to make it a legal obligation to conduct manufacturing and quality control of FFC in supplement form in accordance with GMP stipulated by the regulations at the time of notification and during the sales period after notification to ensure quality in the manufacturing process management of FFC in the form of supplements and to enhance the reliability of FFC, (snip). Specifically for ingredients containing functional components, the manufacturers of products in the form of supplements (final products) must ensure to embrace the principles of equivalence and homogeneity of all the components of the ingredients (with the ones for which the evidence was notified) at the stage of their receipt in accordance with GMP, under the responsibility of the notifier (who is the person responsible for labeling).

How to convey information on FCC to consumers

-As an indication related to the requirement of “not for the purpose of diagnosis, treatment or prevention of disease”, labeling “not a drug” must be clearly stated on the same panel as indications of FFC claims.
-An indication of “FFC” and the notification number must be displayed in close proximity to each other to enhance identification.
-Improve the labeling method to one clearly indicating that safety and functionality of the food product was not assessed by the government.
And state clearly that information on the scientific basis of functionality and safety, can be confirmed on the CAA website unlike so-called ‘health foods’.

As a further issue to be considered, it is expected that the Foods for Specified Health Uses will be also made mandatory to provide information on health hazards and to establish GMP requirements. In the future, the Food Labeling Act and the Food Sanitation Act are expected to be revised, as well as the Guidelines for Notification of FFC. We recommend that business operators who handle not only Foods with Functional Claims but also labels related to health read them.

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