Taiwan Regulatory Overview

The Taiwan supplement market represents one of the best markets in Asia. It is estimated that almost 80 percent of the Taiwan population uses nutritional supplements.

The regulatory body responsible for approval of health food products and supplement ingredients is referred to as the Department of Health (DOH). Nutritional products are regulated as part of the "Taiwan Health Foods Control Act" (HFCA). Under these regulations products sold in tablets or capsules may be classified as food, health food or medicine.

Most dietary supplements will classify as health foods, defined as food with specific nutrient or health maintenance benefits. Health foods include food in tablets, capsules, powders or oral liquid forms. This classification is not therapeutic, products aimed at treating or remedying diseases. The DOH recognizes health food products as those offering health maintenance benefits (similar to structure function claims) where the product promotes overall health or reduces the risk of disease or illness. With approval from DOH, products under this distinction may promote these health maintenance benefits on labeling or in advertisements. The DOH has approved categories for health maintenance claims that include:
- regulation of blood lipids
- anti-aging
- anti-fatigue
- maintaining dental health
- alleviating osteoporosis
- protecting the liver
- regulating blood sugar levels
- immune support
- improving gastrointestinal function

Products regulated as health foods must comply with safety standards and the ingredients must be known to have a proven health benefit.

In order to attain an approval on a product in Taiwan, a manufacturer must submit an application to the DOH for review. Health foods sold into Taiwan must comply with Good Manufacturing Practices (GMP) of the country of origin. Additionally, the applicant must provide the authorities with the ingredients, specifications, functions and effects of the health food, together with a summary of the manufacturing process, inspection standards and methods as well as other relevant data. The product label and sample must also be provided. A registration fee that can vary from $60 to $800 must be paid and then the DOH will conduct an initial assessment of the application. If the requirements are met on the application, it will be forwarded to the Health Food Evaluation Committee (HFEC) within DOH for further review. The HFEC will determine if the product is safe for consumption and authorize whether its health maintenance effect is valid. If these requirements are met, then the DOH will approve the application.

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