The scandal over Kobayashi Pharmaceutical’s beni kōji (red yeast rice) supplements has put a spotlight on regulatory inadequacies that prevented Japan from swiftly addressing concerns related to foods with health-enhancing claims — despite recent moves to step up vigilance.
Experts say the beni kōji supplement scandal — now linked to five deaths and over 200 hospitalizations — should not be treated as a one-off incident. Instead, it should be seen as a cautionary tale about how such health food items could pose more risks than benefits.
The health ministry and the National Institute of Health Sciences are currently trying to identify the toxic substance in the beni kōji pills that caused the kidney and other health problems reported around the nation and abroad.
Fixating on causes has its own downfalls, however. Hirohito Sone, a doctor of internal medicine at Niigata University who also serves as the head of a health ministry committee in charge of evaluating health food products, said that the desire to find the cause may itself have delayed Kobayashi Pharmaceutical from reporting the health issue to the government.
The company “might have thought the best solution was to solve what the causative agent was on its own,” he explained. “But whatever it was, the spread of damage could have been prevented even if the agent was unknown.”
Health food vendors in Japan are required to notify the government when they become aware of health damage that has been linked to the consumption of certain health foods — including dietary supplements. But the system is limited in scope, with mandatory reporting only applying to products that contain at least one of four ingredients that have long been advertised as having slimming and anti-aging effects.
The four designated ingredients are Coleus forskohlii, celandine, Pueraria mirifica and black cohosh.
None of the four ingredients were contained in the beni kōji products sold by Kobayashi Pharmaceutical, so the health issues tied to the drugmaker’s products were not reported under this system.
The health ministry also operates a voluntary system where public health centers that receive customer complaints linked to health foods are asked to report them to the health ministry. But according to Sone, only 18 cases had been voluntarily reported to the health ministry’s database in the 18 months between June 2020 and the end of 2022.
“(The systems) were in place, but weren’t functioning,” said Sone. “Our committee had been working to improve the (latter) system for a while, but, unfortunately, the changes could not be made in time to prevent the (Kobayashi Pharmaceutical) incident.”
By making it easier for doctors and others to report suspicions of links between certain foods and health issues, and thereby improving the quality of information that gets collected, Sone’s committee plans to build a robust database that can be utilized to conduct inspections at an early stage on products with multiple reports.
Experts also say the Kobayashi Pharmaceutical scandal should be a wake-up call about the dangers of taking dietary supplements as alternatives to prescription medicine.
Chikako Uneyama, a pharmacologist and guest researcher at Ritsumeikan University, had raised the alarm about beni kōji supplements long before the scandal broke.
The Beni Koji Koresute Herupu (Red yeast rice cholesterol help) pills marketed by Kobayashi Pharmaceutical contained a total daily amount of 2 miligrams of Monacolin, the same ingredient that is in the anti-cholesterol drug lovastatin, for which the smallest daily dose is 2.5 mg.
“Consumers should be very cautious about products that contain the same ingredients as medicine. If they have health benefits, they could have side effects, too,” Uneyama said.
Sone also said that many people falsely believe health foods are not harmful, when, in fact, prescription medicine is more effective, inexpensive and safe.
“People are unaware of this and (they don't go to hospitals) even though their health checkups show that they have very high cholesterol and need to be treated properly, because they don't like hospitals, or they are too busy, or they don't want to wait,” he said.
Concerns about Kobayashi Pharmaceutical’s failure to obtain a GMP (Good Manufacturing Practice) certification for the plant where the tainted supplements were manufactured have been raised by health experts.
GMP refers to a set of measures intended to ensure that pharmaceutical and food products are manufactured and tested according to clearly defined guidelines and properly documented.
But Uneyama said certifications alone do not ensure safety, noting that the quality of the certifying agencies varies, and that it is really up to the manufacturers to adhere to protocol.
Preventing another large-scale health scandal from happening requires a change in mindset, Sone said.
“The problem is that everyone's attention has been focused only on the identification of the causative agent, as if it were a mystery novel or a riddle to be solved,” he said.
“Even if the causative agent is determined, it is not the end of the story — it’s necessary to take this opportunity to establish a system for prompt reporting, improve the database for such reports, and quickly take action based on evaluations by medical experts.”
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