Taiwan FDA banned animal test on the application of anti-fatigue function claim

Anti-fatigue health claims are one of the most popular functional claims in Taiwan. Taiwan animal test ban to increase cost and time for registering products. Currently Taiwan FDA has just announced the ban on animal test in health foods and beverages making anti-fatigue claims in April.

The media mentioned that health foods manufacturers wanting to make anti-fatigue claims in Taiwan can expect to spend a higher cost and a longer time for registering products, after the local authorities banned animal testing on such items and insisted on human trials.

There will be a two-year transition period. Manufacturers wishing to make anti-fatigue claim will need to present evidence from human clinical studies when the transition period ends. This is the first time the authorities are banning animal test for health foods.

There are 13 functional claims for Taiwan health food certification. Anti-fatigue is the first claim that bans animal studies. This [ban on animal studies] does not affect other health claims in Taiwan at this stage. Other health foods claims that can be applied in Taiwan include aging postpone, osteoporosis care, blood lipid regulation, blood sugar regulation, hypersensitive body modification, body lipid formation inhibition, anti-wearying, gastrointestinal function improvement, liver protection, teeth care, blood pressure regulation auxiliary, iron absorption promotion and immunity regulation.

Additional fees for companies manufacturing anti-fatigue health foods is expected due to the cost for conducting human clinical trials is about two times higher than that of animal studies. It, however, is still cheaper to have the reliable human clinical tests to be held in Taiwan than those held in Western countries.

Of course, human clinical studies are more complex since there are other variables to consider, such as diet, lifestyle habits. Companies will thus need to exercise more caution when designing human clinical trials to reduce the impact of the variables. In addition, companies will need to spend a longer time on scientific studies, since they will need to first complete safety assessment and determine the health foods dosage requirement before they could conduct efficacy studies. Previously, companies could conduct safety and efficacy assessment at the same time.

Animal rights organization praised the move, though and still urging the authorities to end animal testing for products making other health claims as well. This new regulation has brought quite impact to the industry, this is undoubtedly a move aligning with international trends, especially like EU.

Assistance with Taiwan FDA Regulations on Functional Foods