On July 21, 2022, the Ministry of Food and Drug Safety (MFDS) disclosed the Guideline of Function Evaluation for Health Functional Food (Hair Health Promotion)1, aiming to guide enterprises in developing new efficacy for health functional food.
As stipulated in the Heath Functional Food Act2, if a business entity intends to use a non-notified functional ingredient or claim a new efficacy, the entity shall apply for an MFDS recognition. However, not all applications can pass. This guideline aims to help enterprises smoothly pass the application for the new health efficacy of hair health. According to the competent authority, by releasing the guideline, they intend to motivate the health functional food industry, as well as help enterprises develop new functional foods.
The guideline mainly outlines the function claim, human application testing, and evaluation index.
1. Function Claim
Function claim for hair health promotion is "can help maintain a good condition of hair (모발의 건강 상태 유지에 도움을 줄 수 있음)”, which refers to “helpful in relieving physiological hair loss and increase the resilience and glossiness of hair” according to the official notification. However, the authority also emphasized that claims that mislead consumers into thinking the product can assist in anti-hair loss or has other treatment effects are prohibited.
2. Human Application Testing
The human application testing should be last for over 24 weeks, taking account of the hair growth cycle. The test subjects should be adults aged 18 to 60 with slight hair damage but without hair loss symptoms. The age, hair length, and hair damage decree of the test participants in the experimental and control groups shall be similar and without significant differences.
3. Evaluation Index
The results of human application testing shall be meaningful compared to the control group. The evaluation index includes the following biomarkers:
Non-clinical evaluation index | Promotion of nutrients (hair amino acids, such as cystine, methionine, etc.) supply to hair |
Antioxidant and anti-inflammatory effects | |
Cell proliferation | |
Controls of Hair Follicle Cycling | |
Clinical evaluation index | Change in hair resilience |
Change in hair glossiness | |
Change in hair diameter | |
Beneficiary satisfaction | |
Evaluation of clinical photography of hair | |
Change of hair amount per unit area |
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