“Importing and Selling Health Foods in Japan: Practical Regulatory Considerations [Part I]” : Life Sciences Team

Importing and Selling Health Foods in Japan: Practical Regulatory Considerations [Part I]
- Food-Drug Classification and Import Procedures • Safety Management Regulations

Introduction: Starting with a Single Scenario

In our previous issue (No. LFS_006), we introduced the fictitious launch of a foreign cosmetics brand in Japan as a case study to survey and explain the overall framework for classifying foods and cosmetics and the regulations governing advertising. This issue focuses on the import of food, particularly health foods (including Foods with Health Claims). It aims to examine the regulatory requirements that specifically apply when a foreign company imports health foods manufactured overseas into Japan for sale.

Because importing and selling health foods raises a wide range of issues, we have covered the topic in two parts. Part I addresses (1) whether a product may be imported as a "food" in the first place (i.e., whether it is classified as a food or drug); (2) import procedures under the Food Sanitation Act (notification to a quarantine station and customs clearance); and (3) safety management regulations specific to foods in supplement form. Part II will discuss (1) regulations governing advertising and package labeling; and (2) labeling systems for making function claims, including the Foods with Function Claims system. We have developed the following fictitious scenario to provide an overview of the issues that arise.

Please click here for the full article.

[Contents]

Introduction: Starting with a Single Scenario

1.    Threshold Question: Can the Product Be Imported as a "Food"? (Food-Drug Classification)

2.    Problem with Measure ①: Failure to Follow Import Procedures under the Food Sanitation Act

3.    Problem with Measure ④: Safety Management Regulations Specific to Foods in Supplement Form

Conclusion (Part I)

[Related Links]

Japanese: 「健康食品の輸入販売と法規制の実務対応【前編】－食薬区分・輸入手続・安全管理規制」：ライフサイエンスチーム

Korean: “건강식품의 수입·판매와 법규제 실무 대응【전편】－식품·의약품 구분 및 수입절차·안전관리 규제” (Korean version)

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