Japan Moves to Strengthen Oversight of Functional Food Industry After Kobayashi Scandal

In response to the March 2024 health scare involving a supplement containing red yeast rice, and in an effort to increase transparency and accountability in the industry, MHLW has proposed measures to suspend even ban functional food businesses that fail to report adverse health incidents associated with their products.

On May 23, 2024, Japan's Consumer Affairs Agency (CAA) convened the "6th Meeting on Food with Function Claims" to address the food safety concerns raised by the Kobayashi Pharmaceutical red yeast rice incident. According to the official report released following the meeting, the Ministry of Health, Labour and Welfare (MHLW) has stated its intention to make the report of health damage a legal obligation for enterprises. Additionally, the report emphasizes the Good Manufacturing Practice (GMP) standards, as well as stricter labeling requirements to improve the identifiability of Food with Function Claims (FFC).

Points of the meeting summary:

1. The red yeast rice incident highlighted delays in reporting health damage to the government, prompting CAA to discuss the necessity of making such reporting a legal obligation.

Subject: not limited to supplements, but extended to all FFC.

Responsibility: FFC notifiers shall be mandated to report any information they receive directly from a physician or indirectly from customers, pharmacists or other healthcare professionals about a product suspected of having a causal relationship with health damage. This reporting obligation should apply regardless of the severity of the reported symptoms. The company should report immediately, rather than first evaluating the collected health damage information and deciding whether to report it.

Meanwhile, the MHLW proposed that this obligation shall also result in the possibility of invoking Food Sanitation Act, which means failure to comply with this mandatory reporting obligation could lead to the suspension or prohibition of business operations.

2. There is a need to make GMP-based manufacturing and quality control mandatory. Regarding raw materials, including imported ones, the manufacturers should adhere to GMP principles when procuring materials. This means ensuring the overall equivalence and homogeneity of the raw ingredients, regardless of their source.

3. Package labeling should be improved to clearly distinguish FFC from approved Food for Specified Health Uses (FOSHU), to inform consumers that FFC lacks official safety and efficacy evaluations, and highlight that functional food claims can be verified online by consumers.