In the last 15 years, the Japanese nutraceutical industry such as dietary supplements and functional foods grew at an average rate 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.

In the last few decades, there is a growing appreciation for nutraceuticals and dietary supplements’ role in Japanese people’s health in helping to induce prevention of health risks and improve health quality.

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

The food products which come under the FOSHU (one of the categories of health products) are scientifically evaluated in terms of their effectiveness and safety by the Council of Pharmaceutical Affairs and Food Hygiene under the MHLW. After the introduction of the functional food system, many clinically proven FOSHU products with health benefits have been developed and launched in the market. 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.
    • Increasing awareness of using health products for wellbeing.
    • The country’s fast pace and busy lifestyle makes its consumers strongly rely on dietary supplements, 

Regulatory for nutraceuticals in Japan

Food or food ingredients that have defined physiological effects are regulated as ‘nutraceuticals’ or ‘food supplements’ in Europe and ‘complementary medicines’ in Australia.

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

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

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, Health Foods in Japan are classified and regulated as

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

Foods for Special Health Use (FOSHU)

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

Further based on the based on the application requirements and review process by the regulatory authorities the FOSHU are further 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)

FOSDU products can use medical and nutritional expressions to indicate that they are appropriate for use in promoting growth or maintaining or recovering health among infants, children, the infirm, and pregnant women.

Regulatory process and labeling requirements vary for each category of product.

How to register your nutraceutical product in Japan?

Japan follows a unique regulatory process and the nutraceuticals are regulated as “Health Foods”. Health Foods are categorized further based on the purpose and their functions. Each category follows a separate regulatory process.

It becomes important that one ensures to

  • Understand the regulations and various categories of nutraceutical products,
  • Review the product details to ascertain the category it belongs to, and regulations applicable for its registration,
  • Submit application with all required details, respond to queries and receive the product registration, and then
  • Import the registered nutraceutical products into Japan.

Understand the regulatory and various categories of nutraceutical products

Before registering to market your nutraceutical product in Japan, it becomes important to understand –

  • How are Health Foods classified in Japan?
  • What are the nutraceuticals/dietary supplements/health foods that come under each category? 
  • What are the regulations that apply for each category for approval?
  • What are the documents and label requirements to register the nutraceutical product?
  • What are the timelines for approvals? And
  • What is the overall process that is applicable to register your specific product? 

Credevo experts have reviewed these details and tried to find answers to all such questions. Based on such review, a report with information on the complete process of registration of nutraceuticals in Japan has been prepared. This ‘Report on the Process of Nutraceuticals Registration in Japan‘, provided by Credevo, can be downloaded by clicking below details.

Provide the details in the form below to register your copy today?
Nutraceutical Products Registration in Japan
What would you get by downloading this report?
  1. Details on the regulations, requirements, and process to register nutraceutical products in Japan.
  2. Free assessment of your drug product by Credevo to check specific requirements applicable for its registration.
  3. A discount of upto $976 in service charges for registration, while availing services from Credevo.
You’ll be able to get help on the following questions related to Nutraceutical Drug Registration in Japan.
  1. How are nutraceuticals regulated in Japan?
  2. How are Health Foods classified in Japan?
  3. What are the nutraceuticals/dietary supplements/health foods that come under each category?
  4. What are the regulations that apply for each category for approval?
  5. What are the documents and label requirements to register the nutraceutical product?
  6. What are the timelines for approvals? and
  7. What is the overall process that is applicable to register your specific product?
$976

Review the product details to ascertain the category it belongs to, and regulations applicable for its registration

The regulatory process for registration of health products in Japan is a little complex as the products are categorized into different classes based on the functions and purposes. Understanding the category, which your nutraceutical product belongs to, is thus instrumental for the registration.

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


This review process can be made easier with Credevo expert reviewing your product details. If you have downloaded the above referred ‘Report on the Process of nutraceutical product registration in Japan’, just fill up the information below to receive a free assessment of your drug product details by Credevo experts to identify specific requirements applicable for its registration.
Provide the transaction ID received while downloading 'Report on the Process for Registration of Nutraceutical Product in Japan'
Provide your work email, which you used while downloading the report.

With this assessment, you can also choose to receive a cost proposal for the registration of your drug product. If you’d like to proceed with the registration, you can go ahead with the next step.


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

Once you are sure of your product category for registration in Japan, and the applicable regulations for your product, gather all the necessary documents. These documents may need to cover the following aspects, however, it’s 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 including 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 application needs to be submitted to the regulatory authority.

Once 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.

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

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

Nutraceutical approval process flow

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.


Do you have additional queries on nutraceutical product registration in Japan?
Send us a message below. Credevo has an excellent team of experts on the ground to assist with the nutraceuticals registration in Japan.
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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