3 April 2024

To: Ms Nanako Jimi, Minister of State for Consumer Affairs and Food Safety

Ms Yutaka Arai, Commissioner for Consumer Affairs

Consumers Union of Japan

Open letter of enquiry on red yeast rice food products

Kobayashi Pharmaceutical’s products made from red yeast rice, have caused health problems for many users, and we believe that this incident highlights the problems with functional foods and genetic manipulation (GMO). Is it GMO or not? We request a review of food administration based on the lessons learned from the red yeast rice malt incident, and request answers to the following questions. We would appreciate your answers in writing by 19 April 2024 . We will publish these questions and answers.

Notes.

1, Regarding the functional food labelling system

There is no end to the number of health problems caused by Japan’s so-called functional food labelling system, under which labelling is permitted by notification by business operators, even when there is no peer-reviewed scientific evidence of functionality and safety that has been published.

(1) Does your agency have an understanding of how the number of health problems caused by the consumption of health foods (including supplements) has changed since the functional food labelling system was launched?

(2) Your Agency seems to be asking businesses that sell functional foods to gather information on health damage, but does your Agency keep track of such information? If so, shouldn’t the information be made public in order to prevent accidents like this one?

(3) We believe that what consumers need to improve their health is a nutritionally balanced diet, and that health foods are not that necessary. Also, do you think that functional foods help consumers to improve their health? Please answer by providing evidence for this.

(4) We believe that functional foods that cause health damage should be abolished, but how do you sum up this system? Are you considering a fundamental review?

2, Safety confirmation and labelling related to genetic manipulation of food products

There is information that Kobayashi Pharmaceutical improved the productivity of red yeast rice by exposing it to strong ultraviolet light, but there is a possibility that the genes of the fungus were damaged by the ultraviolet light. The company is also seeking technology involving genome editing in the improvement of red yeast rice in 2020, and it is possible that it was created through genome editing.

It is reported that puberulic acid has been detected, but as blue mould and red yeast belong to the same family, it is not impossible that red yeast may have carried a similar gene that led to its production by mutation. We have long been concerned that genetic modification (GMO) can cause unexpected changes in genes, leading to the production of toxic substances. We therefore ask the following questions.

(1) Do you know what kind of manipulation or processing method was used to produce the strain of red yeast rice in question? If so, please disclose this information as soon as possible.

(2) Is genome editing of micro-organisms used as food ingredients subject to notification to the Ministry of Agriculture, Forestry and Fisheries and the Ministry of Health, Labour and Welfare? Is your Agency aware of the existence of genome editing in the relevant red yeast strains?

(3) Since genetic engineering cannot eliminate the possibility of producing harmful substances due to unintended genetic changes, we believe that safety confirmation (whole genome analysis and animal experiments) and labelling should be mandatory for all genetically engineered foods.