On December 27, 2024, the Ministry of Health, Labor and Welfare (MHLW) of Japan issued Circulars No. 419 and No. 420 of the Consumer Food and Drug Administration (CFDA), amending two regulations on food products in the tablet and capsule categories, with the aim of improving the regulatory measures for similar products after the incident of injury to Kobayashi Pharmaceuticals' health products containing monascus ingredients. Specifically respectively:

(1) Revision of the Guidelines for Production Management and Quality Control of Food Products in Tablets and Capsules, with the main content stipulating the testing and inspection methods for the quality and safety of microbial raw materials (including algae) added into food products in tablets and capsules, and adding new provisions on the production of specifications for food products containing microbial raw materials in tablets and capsules and the requirements for the display of product information;

(2) The amendments in point 1 are introduced into the Guidelines for Independent Inspection of Safety of Raw Materials and Product Formulation Design for Tablets and Capsules, which require the manufacturers and processors of such foods to implement the relevant requirements in the independent inspection. The above amendments are effective from the date of publication.

For more details, please refer to: https://www.mhlw.go.jp/content/11135200/001367553.pdf