小林製薬の紅麹（べにこうじ）製品を巡る健康被害問題を受け、機能性表示食品制度

消費者庁「機能性表示食品を巡る検討会」が報告書をまとめました。この報告書では、機能性表示食品制度の今後の在り方について提言されています。以下は報告書の要点です：

健康被害情報の収集と行政機関への情報提供の義務: すべての機能性表示食品について、届出者が健康被害情報を行政機関に報告することを法的に義務づけることが提言されています。

製造管理と品質管理: サプリメントについては、医薬品と同様にGMP（製造管理および品質管理）基準に基づく製造と品質管理を法的義務とすることが提案されています。

この報告書は、機能性表示食品制度の運用改善に向けた重要な提言を含んでいます。

A Consumers Affairs Agency panel has proposed that reporting of health problems caused by "functional foods" should be mandatory and that quality control should be tightened for such products.

The panel discussed reforms in response to health problems caused by Kobayashi Pharmaceutical supplement products containing beni kо̄ji red fermented rice.

The panel of experts on Thursday called for the introduction of these legal rules governing functional foods — those that advertise health-enhancing ingredients but which haven't been reviewed by the government — replacing the current guidelines. It also backed the establishment of similar regulations for foods with specified health uses, or those for which the government has determined there's enough scientific evidence on their benefits and safety.

The proposals will be reflected in a plan that the agency will soon draft to revise the functional foods system.

The panel proposed that all health problems confirmed with a doctor's diagnosis be subject to the envisaged mandatory reporting rule, given that Kobayashi Pharmaceutical made public the health problems two months after it had learned of them. Those breaking the rule would be banned from claiming that their products are functional foods.

Meanwhile, the agency said Thursday that its emergency survey on functional foods found 82 instances of health problems in relation to 31 products based on health problem reports by doctors, out of which 75 cases were related to supplements.

The survey, carried out in response to the Kobayashi Pharmaceutical scandal, which is linked to at least five deaths in Japan, covered 6,795 products made by 1,693 companies registered as of March 22.

The agency initially announced in April that 147 instances of health problems concerning 35 products were reported, but revised the figures downward after excluding products that were not registered as functional foods and reports made by people other than medical professionals.

KEYWORDS

Kobayashi Pharmaceutical factory in Osaka was searched by Japanese health officials after reports of five deaths and 114 hospitalizations possibly linked to dietary supplements containing “Beni-Koji” red yeast rice.

The company has been recalling products with Beni-Koji in recent days after receiving reports of kidney ailments.