Japan functional foods review: More than 110 health hazards on 18 FFC products reported
The health hazards mostly manifested in the form of diarrhoea and rashes, with some hospitalised and no deaths reported.
The findings were yielded after CAA sent out a notice to FFC businesses on the 28th of last month, requiring them to declare health hazards linked to their products.
Recent death cases linked to the consumption of Kobayashi Pharmaceutical’s red yeast FFC had prompted the inquiry into FFC businesses.
Five deaths and 231 cases of hospitalisation have been linked to Kobayashi Pharmaceutical’s products as of April 14, according to the Ministry of Health, Labour and Welfare. Also, puberulic acid – a natural compound made from blue mold – has been detected in its products.
Companies were given until April 12 to declare known cases of health hazards to the CAA.
As of April 11, the CAA had received responses for 5,551 products from 1,395 businesses, amounting to a response rate of 81.7 per cent. It is expecting responses from a total of 1,693 companies regarding 6,795 products that are notified as of March 22.
Of which, 117 health hazards involving 18 FFCs made by 11 businesses were reported. Some had manifested itself as diarrhoea and rashes, while more than one cases required hospitalisation.
The 18 products, however, were not revealed, as a causal relationship between the products and the adverse events is not yet established.
The agency is planning to conduct a detailed analysis on the 18 products with the help of medical experts and would make the results public.
It also said that prior to the declaration, none of the 117 health hazards had been made known to them. In response, the businesses involved claimed that this was because the cases were mostly mild in nature and there was no clear causal effect between the health hazards and their products.
In the case of Kobayashi Pharmaceutical, it was found that the company had taken about two months to report cases of kidney ailments and the suspected links to its products to the government.
FFC system to overhaul?
In addition, the CAA has been instructed by the government to devise a plan for the Foods with Function Claims system by the end of May.
The agency said last Thursday that it had formed a committee to review the system.
The committee is chaired by Professor Takehisa Nakagawa from Kobe University Graduate School of Law/ Faculty of Law and will involve representatives from The Japan Dietetic Association and National Institute of Health Sciences’ Division of Biomedical Food Research etc.
On the other hand, out of the 8,198 FFCs notified as of April 8, 18.5 per cent or 1,521 products have been withdrawn.
Most of the withdrawals were due to the discontinuation of sales, but the number of products that were withdrawn due to a lack of scientific evidence was not revealed.
