Foods with Function Claims: Manufacturing Processes Must Be Checked Urgently

Safety is a major prerequisite for supplement products to meet their intended purpose of helping to maintain health. Manufacturers must inspect their production processes and thoroughly ensure quality control.

Following a series of cases in which people developed kidney problems after taking supplements made with benikoji red rice mold — foods with function claims manufactured by Kobayashi Pharmaceutical Co. — a government investigation has confirmed the presence in the supplements of three types of compounds that should not have been there.

One of these compounds, puberulic acid, is a substance derived from blue mold, and it has been confirmed to cause kidney problems. Blue mold was detected at the company’s Osaka factory where the supplements in question were manufactured. That has increased suspicion that foreign substances found their way into the mix during the manufacturing process, resulting in the health problems.

Supplements have high concentrations of certain substances. As they are taken on a daily basis, the risk of harm to health increases if there are quality problems caused by the inclusion of foreign substances and other factors.

The government has decided to overhaul the current system for food products with function claims. If health problems are reported, manufacturers will be required to report such cases promptly to administrative entities, even if a causal relationship between the products and the problems, as well as the severity of the symptoms, is not clear.

It is necessary for the government to provide clear examples of specific cases that would require the prompt reporting, among other details.

The government has also drawn up measures to improve the quality control system. Regarding supplements in the form of tablets and capsules, it reportedly intends to require manufacturers to produce them in line with Good Manufacturing Practice (GMP), which provides standards specifying measures for quality and hygiene control.

Under the current system, it has been up to companies to decide whether to conduct quality control based on GMP standards. Kobayashi Pharmaceutical’s Osaka plant was not compliant with the standards. Other companies that produce supplement products also should reexamine their manufacturing processes and fix them swiftly if any problems are found.

There are four categories of food products claiming health benefits: “foods with function claims;” “foods for specified health uses” for which the central government checks safety; “foods with nutrient function claims,” which contain a certain amount of specific nutritional substances; and “foods in general.”

As supplement products can be found in all of these categories, similar health hazards could occur even outside of the category of foods with function claims. On this occasion, it is hoped that consideration will be given to establishing rules that can guarantee the quality and safety of all supplement products in general.

According to a survey on the general public by the Consumer Affairs Agency, many respondents did not understand exactly what “foods with function claims” and “foods for specified health uses” are.

In some cases, some people with preexisting conditions took benikoji supplements without consulting doctors. It is crucial for the central government and manufacturers to inform the public of the proper use of such products.

(From The Yomiuri Shimbun, June 2, 2024)