Interview | Consumer Affairs Agency Highlights the Significance of Health Food

Gaku Yoda: Regarding health foods, it should be noted that both the aspect of food sanitation standards and the aspect of food sanitation surveillance should be considered in the designation of foods containing designated ingredients, including information gathering. As a result, the CAA and the MHLW will jointly oversee the designation process. When it comes to designations, the Prime Minister and the Minister of the MHLW will jointly consult with the Food Sanitation Standards Deliberation Council, which will be newly established under the purview of the CAA.

The surveillance administration, such as the collection of health damage information, will continue to be under the jurisdiction of the MHLW. On the other hand, the CAA will centrally manage the food sanitation standards related to the "safety" of health foods in general, including functional health foods, as well as the labeling system for the "efficacy" of the functions of the health foods.

Gaku Yoda: Yes. I understand that there are concerns regarding the transfer of food sanitation standards administration to the CAA as an organization responsible for consumer administration. However, I believe we can have a positive outlook.

The CAA has been responsible for the comprehensive risk communication task assigned by the government. As new food technology such as genome-edited foods and cultured meat improves and food diversification rapidly progresses, it will be able to further engage in the integrated risk communication with consumers and food sanitation standards administration, which will be increasingly demanded in the future.

Food sanitation is an area with highly specialized expertise, so decision-making based on scientific evidence is essential. Moreover, it involves undertaking risk communication supported by scientific knowledge. From the risk management perspective, I also believe that it is necessary to deepen communication with enterprises. Among various themes to address, I consider health foods to be one of the fields that should be given great importance.

Gaku Yoda: Currently, there are no specific prospects or predetermined plans. However, while there is no legal definition for "health foods," there is a labeling system for "health functional foods." To ensure that consumers have a proper understanding of "health foods" and to meet their high expectations for nutrition and health benefits, it may be ideal to expand the scope of health functional foods and gradually reduce the scope of other so-called "health foods." This would increase the proportion of health functional foods within the overall category of health foods. It is unlikely that anyone would oppose such a direction.

Masanori Imagawa: When considering what is best for consumers, I believe that ensuring safety and effectively conveying information are crucial. Implementing a system that allows consumers to choose products that are both safe and supported by scientific evidence of efficacy would be beneficial. Health foods are the only products that can comply with such a system, while enterprises that cannot meet the requirements would need to operate their products as regular food products. The distinction between these categories requires careful discussion with the industry.

The government constantly considers "the sake of consumers." I believe enterprises should have the same mindset. There is no room for debate that consumers should be the top priority. Therefore, I would like to explore, in collaboration with the industry, the rules and criteria of such a system and work towards achieving them. Ultimately, this will lead to consumer benefits. While the CAA is not directly involved in promoting the industry, it could indirectly contribute to the development of the health food industry.

Masanori Imagawa: I am aware that there are voices calling for such measures. However, I believe that it also requires the readiness from the industry.

Assuming we have discussions under the new system to create truly reliable and good products for consumers, for example, for health foods in the form of supplements, mandatory Good Manufacturing Practices (GMP) and the reporting of health-related incidents may be necessary, similar to designated ingredient-containing foods.

However, is this the kind of system we truly desire? There will inevitably be aspects that need to be discarded or compromised.

Gaku Yoda: Another point to consider is the division of enforcement of the Food Sanitation Act between the MHLW and the CAA. The CAA operates as an external agency of the Cabinet Office, allowing for comprehensive coordination with other ministries and agencies. It also plays a central role in risk communication with consumers. In addition to the conventional negative risk communication associated with the concept "health foods = questionable," I personally believe that there is a possibility for communication that promotes the impression that health foods are beneficial to consumers.

To achieve this, it is necessary to establish a distinction between products that meet certain standards and those that do not. For products that do not meet the standards, it is important to raise awareness among consumers. It is expected that the CAA will be required to address such matters in the future.

Gaku Yoda: As a potential approach to expanding the scope of health functional foods, it is indeed possible to consider adopting a standardized criteria-based approach. For ingredients with substantial scientific evidence, specific health claims can be used on them. This approach may make it easier for small and medium-sized businesses that may lack a well-established research and development system to enter the health functional food market. However, it is important to note that no formal decisions have been made yet for this standardized criteria-based approach.

Masanori Imagawa: It is just one proposal among several possibilities. It raises questions about whether the introduction of standard criteria falls within the scope of Food with Function Claims (FFC) or whether the focus is on enhancing the standard criteria for Foods for Specified Health Uses (FOSHU). Alternatively, it could involve creating a new category that is not established on a standard-based, notification-based, or registration system. These fundamental aspects, along with others, are areas that will be investigated in the future.

Gaku Yoda: Arai Yutaka (新井 ゆたか), the Director-General of the CAA, has also mentioned the discussion on standard criteria during a press conference. However, there are no immediate plans to rush into system revisions. Given that the FFC system has been in effect for some time and considering the need for the overall improvement in the health food sector, it is important to reexamine the health claims and regulatory systems of other countries. The CAA proposes to conduct investigations into overseas health claim systems in the next fiscal year. Based on that, the CAA believe that engaging in thorough communication with the industry and consumers is necessary to determine the specific mechanisms.

Gaku Yoda: Since the implementation of the FOSHU system, the number of applications for FOSHU approval has been stagnated. However, I believe that each of the health functional food systems has its advantages. One of the advantages of FOSHU, which is based on the Health Promotion Act, is that it serves as a labeling system and is linked to health policies. Medical policy is an extension of health policy. Therefore, among health functional foods, FOSHU has the highest degree of administrative involvement. It is believed that the reevaluation of the system, including its operational aspects, is necessary to further enhance its unique qualities.

For example, in the case of the Standardized FOSHU, there is no need for consultation with the CAA, so expanding the scope of the standardized FOSHU may revitalize the system. Additionally, in terms of clarifying the positioning of health functional foods, there is potential for activating the industry by introducing disease risk reduction claims that are currently forbidden for other health functional foods.

Gaku Yoda: This did give me a chance to think about it. The system of notification-based FFC, where enterprises themselves provide the scientific evidence and make health claims based on their own responsibility, holds significant expectations from the perspective of promoting industries such as biotechnology. We believe it is a system that should continue to be utilized. However, since there is no administrative involvement in the examination of safety and efficacy, the scientific approach of using this system and the attitude of enterprises are called into question.

While it is a notification-based system, it is designed for enterprises that have established a certain level of research and development infrastructure. Of course, it does not mean that enterprises must independently conduct research and development under the system. Nevertheless, as they submit notifications and engage in sales, they are expected to have a sense of accountability towards consumers, including providing scientific evidence. Simply stating, "We have notified because the raw material manufacturer assured us that there is no issue," does not fulfill the enterprise's responsibility for providing an explanation in regards to the systematic review*. The notification-based system leaves a legal uncertainty that if the scientific evidence does not serve as reasonable proof for the claims made, the scientific evidence may be deemed an unfair representation under the Premiums and Representations Act. It is necessary to be aware of this before notification.

*Systematic review is a method that involves using databases where research papers are registered to systematically extract and review papers based on predetermined criteria. It provides a comprehensive confirmation of the functionality of the ingredients involved, allowing for a cost- and time-effective approach compared to clinical trials. This method can be used for submitting notifications for FFC while minimizing expenses and time.

Currently, the number of notifications has exceeded 6,000, excluding withdrawals, but I believe there are also enterprises that simply wish to make health claims without much consideration. In this case, there is also a concern about whether it is appropriate to solely rely on enterprises to prove the scientific evidence under their own responsibility. I believe that enterprises in the health food industry themselves share this concern.

Masanori Imagawa: In fact, over 100 systematic reviews have been submitted as part of the notifications. Enterprises are left with no choice but to differentiate themselves through advertising. However, this undermines the significance of having functional food labeling or health food products. If so, it might be worth considering the possibility of the government establishing clear guidelines for health claims and allowing advertising within those defined boundaries. This would reduce advertising competition and provide an opportunity to review the standard criteria from the perspective of advertising as well.

Gaku Yoda: From the perspective of consumers, the notification-based system seems to have ambiguous government involvement. The understanding of consumers regarding the difference between FOSHU and FFC has not been widely disseminated. Even if the CAA stated that the products have not been examined and approved by the government, consumers might still assume them as being approved because they have been notified to the CAA. If the notification-based system itself leads to consumer misunderstanding, it is difficult to ensure the healthy development of the system. Indeed, there seems to be a proliferation of marketing tactics using misleading representations, giving the impression that the government is also involved in practices beyond compliance. Due to these concerns, even if the notification-based system continues to exist in the future, there is reason to worry that consumers may not correctly understand its current form.