Health ministry weighs mandatory reporting of supplement harm

2026-06-29

The Health, Labour and Welfare Ministry has begun considering making businesses report health damage caused by supplements. The measure would target manufacturers and others, with the aim of improving safety in the wake of the Kobayashi Pharmaceutical red yeast rice supplement problem that came to light in March 2024.

Looking at a system overhaul

The ministry will present its policy proposal to a specialist panel of the Pharmaceutical Affairs and Food Sanitation Council that will meet soon. It is also considering revising related ordinances under the Food Sanitation Act.

Consistency with the current system

Under the current system, businesses are required to report serious incidents or multiple health damage cases to public health centers for foods with health claims, known as Tokutei Hoken Yo Shokuhin, or Tokuho, for which the government reviews efficacy and safety. Similar reporting is also required for foods with functional claims, which may display functions at the company's responsibility if scientific evidence is submitted.

By contrast, supplements not classified as these products, as well as supplements that qualify as nutritional function foods and do not require an approval application, are treated the same as ordinary foods, and reporting of health damage has remained only an effort obligation.

The Consumer Affairs Agency on the 9th presented a plan to clearly define supplements as 'foods intended to supplement nutritional intake from the normal diet or assist the regulation of physiological functions'. Based on that definition, the Health, Labour and Welfare Ministry plans to impose on products that fall under supplements regulations at the same level as those for Tokuho and foods with functional claims.

The ministry is also considering introducing a system to verify whether businesses handling supplements have obtained or filed the operating permits required under the Food Sanitation Act. It plans to outline the direction as early as this summer.

Kobayashi Pharmaceutical's red yeast rice supplement was sold as a food with functional claims, but a harmful substance mixed into the manufacturing process led to a spate of reports of kidney disease and other illnesses. In response, the government has strengthened measures for Tokuho and foods with functional claims, and is discussing how supplements as a whole should be regulated.

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