Business Opportunities Expanding with the Food Functional Claims System ① ~Background of the New System's Establishment and Future Outlook~ Part 1

On April 1st, Japan's new functional food labeling system came into effect. This major revision, the first in 44 years, raises questions: How will the Japanese market change? How will business opportunities expand? Members of Dentsu Inc. Healthcare Team interviewed experts.

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The new functional claims system could become a trump card for regional revitalization and holds the potential for Japan's food regulations to become a global standard . This is according to Professor Ryuichi Morishita of Osaka University Graduate School, who served as a member of the Cabinet Office's Regulatory Reform Council and was deeply involved in designing the system. We asked him about the significance of this major revision—the first in 44 years—beyond just functional claims, along with the background leading to its establishment and future prospects.

A Driving Force for "Self-Care and Self-Medication"

Kobayashi: Let's start with the background leading up to this new functional claims system.

Morishita: In 1971 (Showa 46), the Ministry of Health and Welfare (as it was then) issued a notification (the 46th Notification) aimed at regulating and cracking down on unapproved and unlicensed pharmaceuticals. Since then, functional claims on food products have been prohibited. Advertising also couldn't mention specific body parts or effects/efficacy, inevitably becoming image-based advertising. However, consumers were left unsure about what was actually good for them. The industry also had research results but couldn't communicate them, so they were asking if something couldn't be done.
Amidst this, the Abe administration established a government policy promoting "self-care and self-medication," meaning consumers take responsibility for maintaining their own health. The traditional approach to national healthcare spending involved paying after illness occurred. But proactively engaging in maintaining public health from the pre-disease stage is also a major role for the state. In other words, I believe allocating resources to preemptive healthcare (*) should be the core of proper healthcare policy. The background was a desire to advance this preemptive healthcare more proactively through promoting self-care and self-medication. The issue of functional claims had been a long-standing concern, so the movement for regulatory reform suddenly took concrete shape.

Japan's Lagging Food System

Kobayashi: What were the key points in the Regulatory Reform Council, where Professor Morishita also served as a committee member?

Morishita: First, conducting international benchmarking tests. The aim was to make Japan's regulatory reform the most advanced system by comparing it with those of various countries like the US, Europe, and China. Previously, the common approach was to find a middle ground between the US and Europe. This time, however, settling for the middle was deemed unacceptable. When we actually conducted the tests, Japan's regulatory approach was found to be the most outdated. The US relies on corporate responsibility, while the EU, China, and South Korea permit functional claims under government responsibility. ASEAN has already decided to introduce functional claims starting in 2015, leaving Japan as the only country left behind.

Furthermore, it's crucial to note that this regulatory reform isn't merely a relaxation. While it might appear as deregulation to those involved with Foods for Specified Health Uses (FOSHU), for companies handling supplements, it represents stricter regulation. Previously, there was no reporting obligation regarding safety or quality, nor was notification of sales required. Under the new system, while the benefit of being able to display functionality has emerged, requirements now include not only ensuring safety and quality but also disclosing evidence supporting the functional claims, such as collecting information on health hazards. In fact, the aspect of stricter regulation is quite strong. For consumers, this means increased reassurance. Moreover, the groundbreaking aspect is that approval is not granted by the government; notification suffices. Previously, Japan's system operated under the premise that the government assumed responsibility. This time, however, recognition is granted to private companies on a self-responsibility basis, provided conditions are met. This creates an entirely new, third route, distinct from the past.

This could also become a trump card for the sixth industrialization of agriculture and fisheries.

Kobayashi: Including agricultural and fishery products as targets for functional claims is also a major point.

Kobayashi: It's been 44 years since the 1971 "Notice 46" you mentioned earlier. It feels like a major mountain has finally started to move. The Ministry of Health, Labour and Welfare and the Consumer Affairs Agency took a cautious stance, while the Cabinet Office, Ministry of Agriculture, Forestry and Fisheries, and Ministry of Economy, Trade and Industry wanted to invigorate the market. I imagine there were many twists and turns before the discussions concluded. What were the major factors that led to the final agreement?

Morishita: In a word, it was the necessity of re-recognizing the demands of the times. The Ministry of Health, Labour and Welfare's original stance was arguably overly protective. They argued that allowing functional claims risked misleading people with illnesses into thinking the supplement could cure them, so it was better not to permit it. This was the debate they'd been having for a long time, including with the Consumer Affairs Agency. However, more consumers today are educating themselves, and information is abundant online. Yet, not everyone has equal access to that information. In other words, refusing to allow functional claims also creates inequality stemming from disparities in information literacy. Consequently, allowing such claims became a more viable option. These societal changes also served as a major driving force behind the reform.
The irony is that various supplements from overseas enter Japan, and these supplements display their functions. If they were in Japanese, it would violate the Pharmaceutical Affairs Law. Yet, the absurd argument emerges that the functional claims on overseas products are merely design elements. Such reasoning doesn't fly these days. That's how riddled with contradictions Japan's system had become.

※Preemptive medicine... This refers to medical approaches that predict disease onset before it occurs and intervene beforehand to prevent or delay the onset of illness. It is positioned as an evolution of preventive medicine, such as vaccinations.

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What is the Food Functional Claims System?

The Food Functional Claims System commenced in April. This system allows manufacturers to make claims about a food's functionality "under their own responsibility" by notifying the Consumer Affairs Agency, provided they have scientific data substantiating both safety and functionality. Functional claim foods are expected to appear on store shelves as early as June.

<Key Points of the New System>
1. Unlike Tokuho (Specific Health Use Foods), the government does not conduct safety or functionality reviews. The responsibility for the content and explanation of the scientific evidence, as well as ensuring no discrepancy between the scientific evidence and the labeling claims, lies with the manufacturer.
2.Notification to the Consumer Affairs Agency must be made at least 60 days prior to the sales date. Except for certain parts, all submitted materials will be disclosed on the Consumer Affairs Agency's website, allowing other businesses and consumers to verify the content.
3.All food products, including fresh foods, are covered. Therefore, participation is expected not only from food and beverage manufacturers but also from functional ingredient manufacturers, trading companies, farmers, and various other industries.

*Excludes beverages containing alcohol and foods that may lead to excessive intake of lipids or sodium.

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<Key Points of Functional Claims>
Claims can be made about the effects on maintaining or promoting health.
For example, claims can be made for specific body parts, such as "maintains eye health" or "supports quality sleep." However, expressions implying treatment or prevention of diseases, such as "for people with diabetes" or "for people with high blood pressure," or expressions exceeding the scope of health maintenance and promotion, such as "hair growth" or "skin whitening," are not permitted.

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