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Food Safety Alert: A Deep Look into Japan’s Kobayashi Pharma Supplement Pill Scandal

In the area of nutrition and health, beni koji, a traditional fermented food and medicinal ingredient, has gained significant popularity due to its rich composition of beneficial and health-promoting active ingredients. Kobayashi Pharmaceutical's recall of FFC products containing beni koji ingredient has greatly impacted the current health functional food Industry. Many enterprises have been asked to provide product safety information.

Recently, the renowned Japanese company, Kobayashi Pharmaceutical Company, Limited (hereinafter the "Kobayashi"), has been hit by a severe food safety crisis resulting in multiple reported fatalities, which is considered as a major safety accident since Japan's implementation of the "health functional food system". The product at the center of the controversy is a "Food with Function Claims (FFC)" containing beni koji ingredient. As of March 31, 5 people have died, and a total of 157 person-times have been hospitalized for treatment.

This incident causes a sharp decline in Kobayashi's stock and prompts urgent inspections by relevant authorities on the safety of approximately 7,000 notified FFC products available in the market.

Timeline of Actions and Incident Progression

Two months ago, Kobayashi received reports indicating that consumers might have suffered health damages after consuming their FFC products. However, the company failed to promptly notify the government.

On March 22, 2024, Kobayashi announced that a number of consumers had experienced health problems, including kidney diseases, after using their Red Yeast Pill containing beni koji. In response to these incidents, the company conducted ingredient analysis on the product and the beni koji used in it. The results revealed the presence of unexpected ingredients in some of the beni koji products. Subsequently, the company initiated an urgent recall of approximately 300,000 units of FFC products containing beni koji, citing potential risks to human health.

On March 24, 2024, Kobayashi disclosed that they had supplied beni koji to 52 enterprises involved in the production of beverages and food items. Subsequently, various food and alcoholic beverage manufacturers in Japan announced the recall of their products containing beni koji produced by Kobayashi.

On March 25, 2024, 33 individuals reported experiencing health abnormalities, including kidney diseases, after consuming FFC products containing beni koji manufactured by Kobayashi. Out of the affected individuals, 26 were hospitalized for further medical treatment.

On March 26, 2024, Japan's Ministry of Health, Labour, and Welfare (MHLW) announced the occurrence of a second fatality associated with the consumption of FFC products containing beni koji. The number of individuals admitted to hospitals rose to 106.

On March 29, 2024, Kobayashi received the fifth fatality suspected to be related to the use of beni koji supplement. MHLW announced the detection of ingredient called "puberulic acid (プベルル酸)," derived from penicillium, in the beni koji supplement.

About Beni koji

The main/major raw material of beni koji (紅麹 in Japanese) is a type of rice known as red yeast rice. It is formed by the growth of the red yeast mold on white rice as a parasitic organism. In mainland China and Taiwan, China, it has been traditionally valued for its health benefits, including promoting blood circulation and warming the internal organs. It is also used in meat processing, alcohol production, and as a seasoning, food preservative, and natural coloring agent.

紅麹とは.jpgFigure 1: Beni koji (Red Yeast) Products

However, this ingredient can also produce citrinin, a toxic metabolite believed to be associated with kidney diseases. As early as 2014, the Japanese Food Safety Commission issued warnings, citing reports from Europe that indicated cases of suspected liver damage in France that were potentially linked to the intake of supplements derived from beni koji. Consequently, the European Union advised individuals to consult a doctor before taking supplements containing beni koji and established a standard limit for citrinin content in supplements (Maximum level: 100 μg/kg).

In addition, China also has established requirements for the citrinin content in beni koji. According to the GB 2761-2011 Maximum Levels of Mycotoxins in Foods, it stipulates that the citrinin content in beni koji products must be less than 0.05 mg/kg.

kobayasi.pngFigure 2: Kobayashi Ingredient Analysis Showed that Citrinin Was Not Detected

Based on this, Kobayashi conducted an examination of the components in their beni koji. As mentioned in Kobayashi's previous reports, the company's beni koji product does not contain citrinin, but may contain an unknown and unexpected ingredient, as revealed in the analysis results.

Until March 29, 2024, MHLW announced that "puberulic acid" was the culprit behind deaths caused by beni koji supplements. Puberulic acid is a natural ingredient found as a metabolite of certain types of penicillium. Although it possesses antibacterial properties that inhibit bacterial growth, it is highly toxic. There have been reports of over 300 types of mold toxins worldwide. Food contamination caused by mold toxins, including carcinogenic aflatoxins found in crops such as corn and peanuts, is often a significant concern.

In response to this, industry experts have previously emphasized that even if the final examination reveals the presence of a widely recognized natural ingredient, the lack of strict control over raw materials and scientific risk assessment during the production process can still pose potential safety hazards. Therefore, it is crucial for enterprises to implement robust quality control measures and adhere to regulatory protocols to minimize any potential risks associated with their products.

Immediate and Long-term Consequences

  • Recall costs

Upon the announcement of the recall, the stock price of Kobayashi experienced a sharp decline, dropping by 16.51% in just three days.

The beni koji is not only used in Kobayashi's products but is also supplied to 52 other food production enterprises. Additionally, some affected products were sold through cross-border channels to mainland China, including Kobayashi's overseas flagship stores on Tmall, Pinduoduo and JD.com. According to incomplete statistics, as of the end of February this year, approximately 1.06 million bags of the implicated products had been sold through retail channel, excluding those provided to other food production enterprises.

wps拼图0.pngFigure 3: Enterprises Joined in the Voluntary Product Recall (Left) & Recall Notice to Kobayashi’s Consumers on Tmall, Pinduoduo and JD.com (Right)

According to Japanese media, the estimated total cost of the recall for Kobayashi and its 52 clients is around 1.8 billion yen. However, according to the MHLW, the ultimate number of affected enterprises is expected to be at least over 170, both domestic and international, including trading enterprises. In addition, considering the compensation for deaths and hospitalizations related to the consumption of the supplements, Kobayashi's financial burden is expected to increase significantly.

  • Emergency market inspection

Since 2015, Japan has implemented a new system known as the Health Functional Food System. Building upon the previous framework, this system has introduced a new category called Food with Function Claims (FFC). This category includes both processed and fresh food products, essentially covering almost all types of foods, with the exception of limited categories such as Food with Nutrient Function Claims (FNFC), Food for Specified Health Uses (FOSHU), and alcoholic beverages.

FFC.pngFigure 4: Health Functional Food System

FFC is subject to the notification system. Enterprises has the responsibility of ensuring the safety and efficacy of their products, without any requirement for government approval. Enterprises are required to submit various documents to the Consumer Affairs Agency (CAA), including scientific evidence, within 60 days prior to sales. Once the notification number is obtained, the product can be sold in the market.

notification-1.pngFigure 5: Food with Function Claims (FFC) Procedure for Notification

The recent incident involving Kobayashi marks the first time in Japan since the supervision for FFC that a manufacturer has announced a product recall due to health-related issues. Furthermore, under the Food Labeling Act and related regulations, enterprises are obligated to establish a system for collecting information regarding health hazards and are required to promptly report any health-related issues. However, in the case of Kobayashi, although Kobayashi became aware of serious health hazards in mid-January, the company only reported it to the relevant authorities shortly before their press conference on March 22.

As a result, on March 28, 2024, CAA issued an urgent notice stating that they would conduct emergency inspections on all 6,795 notified FFC products. Approximately 1,700 enterprises are required to respond whether they have received any information regarding serious health hazards by April 12th, 2024.

  • Consumer comments

Yutaka Arai, commissioner of CAA, expressed her concerns about the safety of FFC. During media interviews, many consumers also expressed surprise and disappointment regarding this issue.

interview-consumers-comments.pngFigure 6: Interview Consumers’ Comments on This Matter

  • Consumer A: "After selling these products for so many years, why the company didn't report such issues until now? People who have been taking them for a long term have already consumed a significant amount. This ingredient is used in many food products, including miso."

  • Consumer B: "I trust the name recognition and buy products based on the reputation of the company. However, it is still scary even though I check the ingredients before making a purchase."

Japan attaches great importance to credit. Due to this incident, Japanese consumer's impression of FFC's safety will be significantly reduced. We eagerly anticipate the CAA to promptly disclose the investigation results regarding all FFC available on the market. ChemLinked will actively monitor and provide updates on the latest developments concerning the notification system for FFC.

ChemLinked Suggestions

1. Japan is a society built on trust. The discovery of safety issues in FFC undoubtedly challenges the trust of consumers. Therefore, companies should establish more rigorous testing standards and processes to ensure the integrity and safety of filing information before their products enter into the market.

2. During the manufacturing process, companies need to strictly adhere to production standards and make every effort to avoid potential safety hazards.

3. In the event of incidents that could potentially harm consumer health, companies should act swiftly, establish proactive communication and interaction channels with consumers, and strengthen traceability and tracking. The safety of consumers' lives must be given top priority.

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