Health Function Catalogue Allowed for Health Food Claims - Helps Maintain Bone and Joint Health (Alleviates Pain or Stiffness/Alleviates Cartilage Damage)

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Health Function Catalogue Allowed for Health Food Claims - Helps Maintain Bone and Joint Health (Alleviates Pain or Stiffness/Alleviates Cartilage Damage)

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Summary

This announcement releases the Directory of Health Functions Allowed to be Claimed for Health Food - Helps Maintain Bone and Joint Health (Alleviates Pain or Stiffness/Alleviates Cartilage Damage) and its supporting technical guidelines. It officially incorporates this new function claim into the health food function directory. The attached guidelines specify the principles and requirements for evaluating this function, covering its applicable scope, animal tests, human trials, test items, and criteria for result determination.

Obligations

This is a new regulation that officially adds a new health function claim for health food and provides the technical guidelines for its evaluation.

1. New Health Function Claim Added

A new health function claim, “helps maintain bone and joint health,” is added to the official directory. This primary claim must be accompanied by at least one of the following secondary claims in parentheses:

Helps maintain bone and joint health (alleviates pain or stiffness)
Helps maintain bone and joint health (alleviates cartilage damage)
Helps maintain bone and joint health (alleviates pain or stiffness, alleviates cartilage damage)

2. Technical Guidelines for Evaluation

The announcement includes detailed guidelines for the testing and evaluation of this new function, outlining requirements for both animal tests and human trials.

3. Animal Test Requirements

Applicability: Products containing new health food raw materials are required to undergo animal testing. An exemption may be applied for if the formula’s raw materials are widely used in registered or filed health foods and there is sufficient scientific evidence supporting the formula’s relevance to the claimed function. However, the function claim “alleviates cartilage damage” must be supported by animal tests.
Models: Recommended models include drug-induced joint function abnormality models and surgery-induced joint instability models.
Indicators: Key functional indicators include joint pain/mobility (e.g., dual-foot balance test), laboratory indicators (e.g., inflammatory factors like IL-6, IL-1β; MMP-13; hyaluronic acid content), and cartilage morphology/histopathology.

4. Human Trial Requirements

Subjects: Participants should be individuals experiencing one or more symptoms of joint discomfort or functional limitation (e.g., knee pain, stiffness).
Design: The study should be a randomized controlled trial (RCT), double-blind, with parallel or crossover grouping. A minimum of 50 subjects per group is required for analysis, with a total of at least 100 subjects at the end of the trial.
Indicators: Efficacy is evaluated using:

Clinical Signs: e.g., Patellar grind test.
Joint Mobility: e.g., Goniometer test.
Laboratory Tests: Bone metabolism biomarkers and inflammatory factors.
Scales: Standardized questionnaires such as WOMAC, KOOS, or JKOM scales are recommended.

5. Result Determination and Claim Substantiation

The guidelines specify the positive test results required to substantiate the secondary function claims:

To claim “alleviates pain or stiffness”: Requires positive results in the dual-foot balance test (if animal test is applicable), at least one laboratory indicator in animal tests, and positive results in both scale calculations and joint mobility indicators in human trials.
To claim “alleviates cartilage damage”: Requires positive results in at least one laboratory indicator and cartilage morphology in animal tests, as well as positive results in scale calculations, at least two laboratory indicators, and the Patellar grind test in human trials.