Importing Health Foods and Dietary Supplements into Japan: A Detailed Guide

The rising health consciousness among Japanese consumers has significantly increased the demand for health foods and dietary supplements, offering a lucrative opportunity for foreign brands. However, the complex regulatory landscape in Japan requires careful navigation. This comprehensive guide aims to demystify the process of importing these products into Japan, with Gemini Group offering specialized support in registration, licensing, regulatory compliance, market entry, government relations, and public affairs.

Understanding the Japanese Market for Health Foods and Dietary Supplements

In Japan, health foods and dietary supplements don't have a distinct legal definition, which can complicate classification and regulatory processes. Products may be categorized as foods, quasi-drugs, or drugs, based on their ingredients, purpose, and presentation. Correctly classifying your product is essential for compliance and smooth customs processing.

The Import Process

Step 1: Classification and Import Application

Determining your product's classification is the first critical step. This classification affects which regulatory frameworks apply. Once you understand the classification of your product(s), you will need to formally notify MHLW prior to importing them into the market. This involves submitting an import application to the quarantine station at your product's entry port, ensuring compliance with Japanese laws.

Required Documentation:

• Notification form for importation of foods.

• Ingredient list by percentage.

• Production flowchart.

• Details of the manufacturing plant.

• Lab testing results from an MHLW-designated institute.

• Declaration of import.

• Invoice.

• Packing list.

• Bill of lading or airway bill.

Step 2: Compliant Product Labeling

Product labeling in Japan is regulated by the CAA and requires labels in Japanese, covering:

• Product name.

• Ingredients.

• Additives.

• Allergies.

• Content weight.

• Expiration date.

• Preservation method.

• Country of origin.

• Importer contact information.

• Nutrition facts.

For organic products, obtaining JAS certification is necessary for the "organic" label. Additionally, health benefit claims on labels are under strict regulation.

Labeling Health Benefits

The labeling of foods with health benefits in Japan is supervised by the CAA, positioning these products between food and pharmaceutical categories. It's advisable to consult with regulatory experts to determine if your supplement can make specific health claims.

Health Benefits Labels Types:

• Foods for Specified Health Uses (FOSHU): These are certified to have a positive impact on specific body functions, covering a wide range of products including dietary supplements and everyday items like tea and yogurt.

• Foods with Nutrient Function Claims (FNFC): This category includes ingredients like vitamins and minerals that supplement the diet, commonly seen in dietary supplements.

• Foods with Function Claims: Products in this category claim to impact overall health or specific body functions, based on scientific evidence. The responsibility for these claims lies with the business operators.

Step 3: Quarantine and Cargo Inspection

Upon arrival, products are inspected in a bonded area to verify compliance with Japanese food standards. Depending on the ingredients, prior consultation with the Animal Quarantine Service or Plant Protection Station might be required.

Step 4: Clearance and Distribution

After clearing customs and obtaining import approval, products can be distributed in Japan, marking your successful market entry.

Navigating Challenges and Ensuring Compliance

Understanding Japan's regulatory environment and market preferences is key to successful entry. Local partnerships and expert guidance can streamline the process and address potential challenges.

Partner with Gemini Group for Your Market Entry Needs

Gemini Group provides comprehensive support for businesses entering the Japanese health food and dietary supplement market. Our expertise in regulatory compliance, market entry strategies, and government relations ensures a smooth and successful market launch. Contact Gemini Group today to explore how we can facilitate your business goals in Japan.