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Nutraceutical Regulation in Japan

Over recent decades, the adoption of dietary supplements and nutraceuticals for mitigating health risks and improving well-being has surged in popularity within Japan. In the fiscal year 2021, the shipment value of health foods in the country reached an impressive 888 billion Japanese yen, showcasing a consistent upward trajectory compared to previous years. Japan is renowned for its robust regulatory framework governing nutraceuticals, which are commonly referred to as "foods for specified health uses" (FOSHU).

The Japan Nutrition and Supplements market is poised for substantial growth, with projections indicating that by 2030, it is anticipated that the Japan Nutrition and Supplements market will reach a value of $47.25 Bn from $23.71 Bn in 2022, growing at a CAGR of 9% during 2022-30. This impressive expansion is forecasted to occur at a robust Compound Annual Growth Rate (CAGR) of 9% during the period spanning 2022 to 2030. Several key factors underpin this growth trajectory, including evolving reimbursement scenarios, heightened consumer awareness, and the steady rise in disposable incomes.

Regulatory Compliance for Nutraceutical in Japan:

The regulation of nutraceuticals in Japan is overseen by the Japanese Ministry of Health, Labour and Welfare (MHLW). This regulatory body administers the Food with Health Claims (FHC) system, under which FOSHU products are categorized. The framework seeks to ensure that health claims made by these products are substantiated by robust scientific evidence.

Foods for Specified Health Uses (FOSHU):

FOSHU is a distinctive category of foods in Japan reserved for products with scientifically validated health benefits. These products are recognized for their capacity to contribute to the prevention or amelioration of specific health conditions when consumed as part of a balanced diet. FOSHU status is highly coveted and signifies a product's credibility and adherence to stringent regulatory requirements.

  • Japanese dietary supplements Registration process:

Registering a nutraceutical product in Japan involves a rigorous process to ensure safety, efficacy, and compliance with Japanese regulations.

  • Understand the Regulatory Framework:

Japan regulates nutraceuticals as "foods for specified health uses" (FOSHU). The regulations are administered by the Japanese Ministry of Health, Labour and Welfare (MHLW).

  • FOSHU Scientific Research and Development:

Conduct thorough scientific research and development to establish the health benefits and safety of your nutraceutical product. This often includes clinical trials and studies.

  • FOSHU registration Required Documents:

  1. Application Form: Start with the official application form provided by the MHLW.

  2. Scientific Research Data: This is the backbone of your application.

  3. Product Composition: Detailed information about the ingredients and their proportions in the product.

  4. Manufacturing Processes: A thorough description of the manufacturing processes.

  5. Safety Data: A comprehensive safety assessment of the product, including potential side effects and adverse reactions.

  6. Labeling and Packaging Information: A draft of the product label, including the health claims that will be made, usage instructions, and storage information.

  7. Declaration of Compliance: A declaration stating that the product complies with Japanese regulations and standards for FOSHU.

  8. Authorized Representative Information (if applicable): If the applicant is not based in Japan, information about the authorized representative in Japan who will act on behalf of the applicant in regulatory matters.

  • Nutraceutical Labeling Requirements Japan:

Labeling is a pivotal component of nutraceutical regulation in Japan. FOSHU products must bear the FOSHU mark prominently on their labels, signaling their approval status. Clear and scientifically substantiated health claims must also be featured on the label, informing consumers of the specific health benefits associated with the product.

  • Timeline for Nutraceutical approval and Fees associated:

The timeline for FOSHU registration typically takes approximately 12 to 24 months from the initial application to approval.

The fees for FOSHU applications and tests are only $1,600.

  • Compliance and Post-Market Surveillance of Nutraceutical in Japan:

After receiving FOSHU approval, ensure ongoing compliance with Japanese regulations. Be prepared to participate in post-market surveillance activities and provide updates on the safety and efficacy of your product as required by the MHLW.


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