Taiwan FDA Announces Draft Revision to Gastrointestinal Function Improvement Assessment Methods for Health Foods

On October 1, 2025, Taiwan Food and Drug Administration released a draft for Efficacy Assessment Method of Health Food for Gastrointestinal Function Improvement, aiming to update the evaluation and testing criteria for health food products claiming gastrointestinal health function. The draft is open for public consultation for 60 days following its publication.

Key updates:

This draft consists of four main sections: legal basis, scope of application, requirements for evaluation tests and testing methods, and health-function claims. The key amendments from the previous version are as follows:

1. Removal of animal experimentation: The draft eliminates the option of animal experimentation, in line with international trend and animal welfare principles.

2. Detailed requirements for human trials: Human trials are now required to adopt randomized, blinded, parallel design or cross-over design (with at least a two-week washout for cross-over trials). In addition, the draft specifies detailed safety monitoring items, including blood counts (RBC count, WBC count, WBC differential count, etc.), biochemical parameters (AST, ALT, BUN, etc.), urinalysis, and electrocardiogram (ECG) at the beginning, mid-term, and end-point.

Notably, removing animal experimentation in the evaluation of health foods follows an international trend. Taiwan currently categorizes 14 types of health foods. Among them, six categories (anti-fatigue, dental health, blood pressure regulation, iron level regulation, bone health, and knee joint health) have already eliminated animal experimentation and adopted human trials instead. Once this draft is finalized, gastrointestinal function improvement will become the seventh health food category to remove animal experimentation from its evaluation method.