Japan Reels After Dietary Supplement Linked to Deaths

Japanese drugmaker Kobayashi Pharmaceutical Co. is embroiled in a nationwide recall of its red yeast ingredient, used in popular supplements, food, and beverages, after five confirmed deaths and hundreds of hospitalizations. The deaths have been linked to the well-known cholesterol reducing supplement, drawing attention to the company’s lack of governance and crisis management.

The recall is having widespread repercussions on some 225 different manufacturers that buy red yeast directly from Kobayashi Pharmaceutical. The company’s red yeast dye is also distributed to up to 33,000 companies, according to Teikoku Databank. Red yeast dye, which is a derivative of red yeast, is used in many processed foods such as yogurt, shrimp cup noodles, crab cakes, dried fish, and cat food.

Japan’s Ministry of Health, Labor, and Welfare announced that more than 236 people had been hospitalized as of April 17 with kidney failure and other serious side effects. A government hotline set up to respond to public concerns received some 8,000 calls about the recall. More than 1,000 people had visited their general practitioner citing poor health after consuming the supplements.

Kobayashi Pharmaceutical is a household name in Japan. It has come under fierce criticism from local media for not taking action in order to prevent harm. It took the company two months to respond after the first hospitalization was recorded in January. Kobayashi Pharmaceutical initiated a voluntary recall on March 22.

The drugmaker is yet to announce the possible cause and has also been tight lipped on the compounds they are investigating.

The Ministry of Health inspected two company factories in west Japan and reported finding traces of toxic puberulic acid that could have been produced by blue mold. They also identified other compounds that should not be in the product, without giving details.

The ministry said that, while it plans to speed up testing processes, “the limited availability of batch samples means more time is needed for careful analysis.” Experts say it could take several months to determine the relationship between puberulic acid and kidney disease.

Currently, health guidelines stipulate that once health complaints are reported, the causal relationship between the illness and product should be evaluated. If there are concerns the situation could spread, a company is expected to report the incident to the government. Kobayashi Pharmaceutical justified their early inaction by citing the lack of a clear cause and effect link to consuming the dietary supplement.

Now the company is facing a public relations crisis. It has been inundated with consumer enquiries. Sales of its supplement pills are down 8 percent from the previous year. Kobayashi Pharmaceutical also pulled television commercials and suspended hiring. It faces the mammoth task of rebuilding the company’s reputation as a household name and regaining trust with consumers, while also bracing for compensation claims and civil lawsuits.

Secondary manufacturers who use Kobayashi Pharmaceutical’s red yeast ingredients have not reported health incidents but have voluntarily recalled products and suspended the sales of miso, sake, and tofu paste, among other processed foods.

The food and beverage industries in South Korea and Taiwan are also on high alert. There has been a case of renal failure in Taiwan after consuming the now-recalled supplement. South Korea says it is shipping recalled products back to Kobayashi Pharmaceutical’s headquarters in Osaka.

Japan’s Consumer Affairs Agency has criticized Kobayashi Pharmaceutical’s lack of safety management and its response to health complaints. The Ministry of Health and the Osaka municipal government conducted interviews with senior members of the company about their management practices. The ministry says it is currently devising a strategy to investigate how the raw materials were contaminated with puberulic acid and other substances.

The scandal has prompted debate on regulatory reform relating to corporate responsibility, monitoring and transparency to prevent another outbreak. In the United States, guidelines require reporting any serious health damage linked to a product within 15 days of detection. Many say Japanese companies should also be required to report even one case of serious health damage recorded by a doctor.