Kobayashi knock-on effect: Japanese functional foods businesses legally bound to four new rules from Sep

By Tingmin Koe

- Last updated on GMT

Red yeast rice was thrusted into the spotlight following complaints of kidney diseases linked to Kobayashi Pharmaceutical's contaminated red yeast rice products. © Getty Images
Red yeast rice was thrusted into the spotlight following complaints of kidney diseases linked to Kobayashi Pharmaceutical's contaminated red yeast rice products. © Getty Images

Related tags Kobayashi Pharmaceutical FFC Red yeast rice Foods with Function Claims

Manufacturers of Foods with Function Claims (FFC) are legally bound to four newly added requirements from September 1 – the latest move in regulating Japan’s functional foods industry since Kobayashi Pharmaceutical’s red yeast rice scandal broke out.

First, manufacturers are required to inform Japan’s Consumer Affairs Agency (CAA) of new scientific findings related to the safety or effectiveness of their products.

If a particular functional claim is deemed to be inappropriate with the emergence of new scientific knowledge, commercially available products making such claims will not be allowed to continue doing so.   

Second, manufacturers would need to report cases of health hazards related to their products to CAA.

Third, factories involved in the processing of dietary supplements would need to produce their products based on "Good Manufacturing Practices (GMP)", so as to ensure safe and high-quality products.

It was previously reported that only FFCs in conventional supplement formats,​ such as tablets, capsules and powder, will need to follow GMP standards.

The government will be giving a two-year transition period, meaning GMP will be enforced from September 1, 2026.

Fourth, manufacturers are required to self-inspect whether they are following CAA’s measures and make an annual report on this.

The new rules would be introduced under the "Food Labelling Standards" that is currently undergoing review and pursuant to the “Food Labelling Act”. They were also drafted based on a expert committee formed in light of Kobayashi Pharmaceutical's red yeast rice scandal. 

From April 1, 2025, manufacturers are also required to submit notification documents for products containing novel ingredients to the CAA as early as 120 days before the planned selling date. Currently, companies could do so 60 days before the planned sale date.

In addition, the submission of product packaging samples, which was previously optional, will now be required at the time of notification to the CAA.

The regulator will then check and ensure if the wording on the label is appropriate.

Investigation

Kobayashi Pharmaceutical is investigating to see if there is a causal relationship between its products and as many as 84 death cases, according to local media reports. 

Kidney disease is the most common adverse effects linked to Kobayashi Pharmaceutical’s contaminated red yeast rice products, where puberulic acid was identified as one of the ingredients unexpectedly found in the products.

So far, five death cases have been reported with regard to the scandal.   

However, Kobayashi Pharmaceutical said on June 28 that one of the cases was “not related”, ​as after checking with the deceased’s family, it was discovered that the deceased had not taken the affected products.

Two cases were described as “cannot be said that there was no relation”, ​as both cases had taken the affected products.

However, the company said that for one of the cases, the death was caused by a combination of the affected products and other factors, while for the other case, the doctor had said that the intake of the product was not a direct cause of death.

For the last two cases, the company said it was unclear if they were related to the intake of its products, as one patient had died from an unrelated cause, and it had not managed to get doctor’s consent for an investigation of the case.  

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