Japan Proposes Stricter Labeling Approval Rules for FOSHU

On February 27, 2025, Japan's Consumer Affairs Agency (CAA) released Proposal No. 235080082 to amend the labeling approval requirements for Foods for Specified Health Uses (FOSHU). The proposed revision includes:

Introduced new approval compliance requirements for FOSHU.
Strengthened Good Manufacturing Practice (GMP) requirements for tablet and capsule-type products made from natural extracts.
New permitted examples of disease risk reduction claims.
Mandatory observational studies as part of health claims approval.

The public comment period is open until March 28, 2025. Any comments can be submitted via the e-govm website.

Below are the details of the key proposed amendments (the text in red indicates changes to the previous lists):

Key Proposed Amendments

1. Stricter Quality and Manufacturing Standards

The proposal introduces new requirements for the production and quality control of FOSHU. Specifically, tablet , capsules, and similar products made from natural extracts must comply with GMP standards, which will be incorporated into approval and post-approval obligations.

Compliance obligations	Before	After
Labeling	The "labeling" refers to characters, figures, etc., displayed on the retail packaging of food products.	The "labeling" refers to characters, figures, etc., displayed on the retail packaging of food products. It also includes characters, figures, etc., that are visible through the packaging, as well as those on attached instructions or accompanying documents.
Approval	/	A proper production and quality control system must be established. For tablets and capsules made from natural extracts, compliance with the manufacturing and processing standards in Annex 6* is required. *Annex 6: Manufacturing and Processing Standards for Tablets and Capsules Made from Natural Extracts in FOSHU Products
Post-approval	/	1. Ensure hygiene management of manufacturing facilities and employees. 2. Maintain proper documentation of raw material specifications, including the origin of functional ingredients if necessary. 3. Verify compliance with food standards and ingredient specifications, including functional ingredients limits and safety-related ingredients. 4. Establish systems to prevent the shipment of non-compliant products and ensure proper handling during transportation and storage. 5. Conduct regular testing of functional ingredients even after approval. 6. Retain sufficient samples to verify any causal link between the approved food and reported health issues. 7. Properly store manufacturing and quality control records.

2. New Example and Clarifications for Disease Risk Reduction Claims

Japan classifies FOSHU into five types: Ordinary, Reduced Disease Risk, Standardized, Re-permitted, and Qualified FOSHU. FOSHU for disease risk reduction includes products with clinically and nutritionally supported ingredients that help reduce the risk of certain diseases (e.g., calcium for osteoporosis and folic acid for neural tube defects).

The proposal detailed the phrasing examples and scientific evidence requirements for disease risk reduction claims.

2.1 New Example

Application

Before

After

Disease risk reduction claims

For disease risk reduction claims, the labeling should indicate the presence of functional ingredients that help reduce disease risk and provide specific details on the risk reduction.

Example 1: This product is rich in [ingredients]. A healthy diet containing an appropriate amount of [ingredients] may help reduce the risk of [disease].

For disease risk reduction claims, the labeling should indicate the presence of functional ingredients that help reduce disease risk and provide specific details on the risk reduction.

Example 1: This product is rich in [ingredients]. A healthy diet containing an appropriate amount of [ingredients] may help reduce the risk of [disease].

Example 2: Regular exercise and a healthy diet rich in [ingredients] are suitable for individuals with [Risk Factor]. This [Risk Factor] is a risk factor for [disease]. *

*However, the strength of the evidence regarding the relationship between [ingredients] and [disease] requires individual evaluation.

In addition, the proposal specifically states that when filling out the FOSHU label application form for approval, the product must be classified into one of the following categories:

Tablets, capsules or similar products made from natural extracts.
Processed foods other than category (a).
Fresh foods.

For category (b), the applicant must state the reason why the product does not belong to category (a).

2.2 Clarifications for Scientific Evidence

Attached file	Before	After
Raw material	Documents on the quality standards of raw materials used in the applied food product, and test management system.	Documents on the quality standards of raw materials used in the applied food product, test management system, and specifications for raw materials containing functional ingredient. If verifying the origin of functional ingredient is critical for quality control, the documentation must include verification methods and frequency.
Manufacturing method	Documents on the manufacturing method of the applied food product and the quality control system to prevent the distribution of defective products.	Documents on the manufacturing method of the applied food product, the production and quality control system (for tablet, capsule, and similar products made from naturally extracted ingredients, this includes documents in accordance with the manufacturing or processing standards specified in Annex 6), and the quality control system to prevent the distribution of defective products.
Literature	/	Observational studies or scientifically equivalent evidence are mandatory. In such observational studies, in addition to the functional ingredient itself, documents demonstrating the relationship between the consumption of foods containing the functional ingredient and disease may also serve as supporting evidence. However, the relationship between the functional ingredient and the food containing it must be explained, including considerations of intake levels (e.g., "functional ingredient" = tea catechins, "food containing the functional ingredient" = green tea, etc.).

Notably, the existing regulation does not clearly specify the requirements for observational studies. However, once the draft regulation is implemented, the submission of observational study data will become mandatory. The revised guidelines clarify that observational studies must not only provide evidence on the functional ingredient itself but also demonstrate the relationship between the consumption of foods containing the functional ingredients and disease risk reduction.