Nutraceuticals approval in Japan

In the last few decades, there is a growing appreciation for nutraceuticals and dietary supplements’ role in Japan to prevent health risks and improve health quality. The Japanese nutraceutical industry, such as dietary supplements and functional foods, grew at an average of 15 percent per year. In 2019, Japan’s health-related food market was the third-largest in the world, with an estimated value of $13.3 billion.

The rise in healthcare costs, coupled with the growing geriatric population, is considered the one prominent reason for the growth of the functional food industry in Japan.

The Council of Pharmaceutical Affairs and Food Hygiene under the MHLW scientifically evaluates the food products which come under the FOSHU (one of the categories of health products) for their effectiveness and safety.

Many clinically proven FOSHU products with health benefits were developed and launched into the market after implementing a functional food system. The total sales for functional foods, including FOSHU products, reached 8 billion dollars in 2018.

Top reasons to choose Japan market for your nutraceutical product

  • The positive market growth for nutraceuticals and dietary supplements.
  • Easy regulatory process.
  • Huge market size.
    • Increasing aging populations and an increase in intake of health supplements.
    • Gaining awareness of using health products for wellbeing.
    • The country’s fast pace and busy lifestyle make its consumers strongly rely on dietary supplements. 

Nutraceuticals/health foods navigation in Japan

The food or food ingredients that have defined physiological effects, Europe regulates as ‘nutraceuticals’ or ‘food supplements’ and Australia as ‘complementary medicines

In Japan, the terms “nutraceuticals” or “dietary food supplements are not very popular compared to most other countries and rather regulated as Foods with Health Claims (FHC).

Regulatory authority for Health Foods (Nutraceuticals) in Japan

The Japanese Ministry of Health, Labour, and Welfare (MHLW) is the regulatory authority for Foods with Health Claims (FHC).

The Consumer Affairs Agency (CAA) regulates the advertising and sale of food with health claims. Local health authorities oversee food manufacture.

Based on the functions and purpose, the Japan regulatory regulates and classifies the Health Foods as

  • FOSHU – Foods for Special Health Use.
  • FNFC – Foods with Nutrient Function Claims.
  • FOSDU – Foods for Special Dietary Use.

Foods for Special Health Use (FOSHU)

FOSHU refers to foods containing ingredients with functions for health, physiological functions, and biological activity on the body and officially approved to claim its physiological effects on the human body.

Based on the application requirements and review process, the FOSHU are classified as

  • Ordinary FOSHU,
  • Standard FOSHU,
  • Reduction of disease risk FOSHU, and
  • Qualified FOSHU.

Foods with Nutrient Function Claims (FNFC)

Foods with Nutrient Functional Claims (FNFC) refers to foods labeled with the functions of their nutritional ingredients. They are considered to be the “foods with function claims”.

Foods for Special Dietary Use (FOSDU)

Foods for Special Dietary Use (FOSDU) products can use medical and nutritional expressions to indicate that they are appropriate to promote growth or maintain or recover health among infants, children, the infirm, and pregnant women.

How to register your nutraceuticals in Japan?

Japan follows a unique regulatory process. Nutraceuticals are considered Health Foods, categorized, and each category follows a separate regulatory process.

It is crucial to ensure the following points to register nutraceuticals in Japan

  • Understand the regulations and various categories of nutraceutical products,
  • Review the product details to ascertain the category and regulations that apply for registration,
  • Apply with all required documents, respond to queries and receive the product registration, and then
  • Import the registered nutraceutical products into Japan.

The process to register nutraceutical/health foods in Japan

Review your product

Before initiating any registration process, one needs to review the product details to ascertain the category to which it belongs and the regulations applicable for registration.

It is better to undertake a detailed and thorough review of regulations for identifying the right category applicable to your product.


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Submit application with all required details, respond to queries, and receive the product registration

If you are sure of your product category for registration in Japan, and the applicable regulations for your product, gather all the necessary documents. However, it is likely to be driven by the category of the food it belongs to.

You may require the documents that determine the following aspects

  • Its effectiveness, based on scientific evidence, which includes clinical studies.
  • Its safety as assessed from historical consumption pattern data and additional safety studies conducted in humans, and 
  • Analytical determination of the functional component responsible for the beneficial physiological action.

Once you have collected all the necessary documentation, then you are ready for submission. The applicant shall submit the documents to the regulatory authority.

If all the documents are accepted and considered sufficient, then the application will be reviewed by the Pharmaceutical Affairs and Food Sanitation Council (PAFSC) and Food Safety Commission.

The Pharmaceutical Affairs and Food Sanitation Council (PAFSC) and Food Safety Commission check for completeness of the documentation, accepts, and reviews all the documents.

The MHLW issues the approval after obtaining the opinion from Pharmaceutical Affairs and Food Sanitation Council (PAFSC) and Food Safety Commission.

Review timeline

Based on the application category, the review timelines may vary.

Approval process flow for nutraceuticals in Japan

Nutraceutical approval in Japan

Import your nutraceutical products into Japan

After successful approval, the sponsor needs to import the approved products into Japan and for this, the sponsor needs to obtain the import license by submitting the necessary documents to the food sanitation inspection section of the MHLW quarantine stations.

Conclusion

Japan’s cost of living is generally high and has the highest life expectancy in the world.  Their consumption of nutraceuticals shows that older Japanese are willing to pay more for higher quality and nutritious foods. Along with this, the registration process has become faster and affordable than before. Japan’s supportive government and health-conscious consumers are promising factors for nutraceuticals market growth in the future.


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References

  1. https://www.nutraceuticalsworld.com/issues/2012-11/view_features/navigating-japans-regulatory-framework/
  2. https://www.sciencedirect.com/science/article/pii/S221345301930031X
  3. https://translate.google.com/translate?hl=en&sl=ja&u=https://www.caa.go.jp/policies/policy/food_labeling/health_promotion/pdf/health_promotion_180615_0005.pdf&prev=search&pto=aue
  4. https://issuu.com/peerasakchanchaiwittaya/docs/1._presentation1_status_of_function
  5. https://www.mhlw.go.jp/english/topics/foodsafety/fhc/03.html
  6. https://uk.practicallaw.thomsonreuters.com/8-618-1750?transitionType=Default&contextData=(sc.Default)&firstPage=true#co_anchor_a506030