In the past two weeks, Japan reported several deaths and over a hundred hospitalizations due to kidney diseases after taking red yeast rice supplements, known as “beni-koji” manufactured by Kobayashi Pharmaceutical, flaming concerns both at home and abroad about the safety of health supplements.
As of Friday, the Osaka-based drugmaker’s “beni-koji” product has been associated with five deaths and 114 hospitalizations, with nearly 700 others seeking medical treatment or planning to do so.
While the growing health scare suggested potential hazards in Japan’s functional food labeling system and technical defects in the manufacturing process of red yeast rice as an ingredient, experts also cautioned consumers not to panic over products containing the ingredient.
REGULATORY LOOPHOLES
Health supplements, commonly called “functional foods” in Japan, were previously categorized into Food for Specified Health Uses and Food with Nutrient Function Claims. In 2015, the Japanese Consumer Affairs Agency (CAA) started a new labeling system for food functional ingredients called Food with Function Claims.
Manufacturers of such foods only need to submit scientific evidence supporting their claimed functionality to the consumer watchdog for registration before marketing, without the need to get approval from Japanese government agencies.
The lenient regulatory mechanism may lead to negligence in safety inspections by various parties involved. In a recent article, the national news agency Kyodo said that Kobayashi Pharmaceutical’s growing scandal over its red yeast supplements has reignited debate over Japan’s “functional food” labels, which have been criticized for years over the lack of sufficient scientific proof of safety and efficacy.
Citing a gap of over two months between the earliest reports of health issues received by Kobayashi Pharmaceutical and its product recalls, Keizo Takemi, Japan’s minister of health, labor and welfare, told a press conference that it was “regrettable” that the company did not provide relevant information to the government during the period.
Following the reports, the CAA announced plans to conduct an emergency inspection of over 6,000 functional foods.
Hidetoshi Tashiro, chief economist at Japan’s Sigma Capital Ltd., told Xinhua that Kobayashi Pharmaceutical’s food safety crisis also revealed organizational problems within the company.
Tashiro said the drugmaker, as a typical Japanese family-owned enterprise, might prioritize family interests over customer interests in decision-making. Its failure to conduct immediate measures or report to authorities about health damage reports has exacerbated the crisis.
MANUFACTURING DEFECTS
Kobayashi Pharmaceutical announced on March 22 that some people who took the supplements had experienced symptoms that often show in kidney diseases.
After analyzing its red yeast rice supplements and the red yeast raw materials used, the company suspects an “unintended substance” derived from mold may have caused the problems but is unable to ascertain a specific cause.
The health ministry said this Friday that Kobayashi Pharmaceutical has confirmed the presence of “puberulic acid” in the products involved. Puberulic acid is a highly toxic chemical compound derived from blue mold.
According to Kyodo, the drugmaker believes that the compound may be the ingredient in question and will verify it through Japan’s National Institute of Health Sciences and other institutions.
Shentu Yinhong, an expert at the China Association of Traditional Chinese Medicine, said that after drugs and health supplements are put on sale, companies must conduct strict monitoring, which includes but is by no means limited to reporting adverse reactions.
“It is reported that the batch of products in question also used a variety of additives during the tableting process. Kobayashi Pharmaceutical has yet to clarify whether these additives will cause adverse reactions, at least until now,” said the expert.
PANIC UNNECESSARY
Despite the incident, experts say there is no need to worry about the safety of other products containing Monascus purpureus, a mold species used to produce the “beni-koji.”
Under normal circumstances, it is hard to imagine that Monascus would produce harmful substances, and there is no need to worry about the safety of normal Monascus, said Hideaki Taraki, an honorary professor at the University of Tokyo who has been engaged in food-safety-related work for many years.
Shentu also said that a Japanese company’s individual quality problem does not mean that the safety of other red yeast rice products is in question.
However, experts warned that health supplements, which are tablets or capsules made of concentrated functional ingredients, can not be used as medication. If they contain harmful ingredients, they may pose greater health risks as consumers tend to take a large amount of them for a long time.
Doctors and pharmacists can warn consumers of the side effects of drugs and explain how to use them, but medical experts still rely on consumers to make their own judgments when taking health supplements, which may lead to safety risks.
