By Nick Lung    Photo：CANVA

1. Inspection and registration is a prerequisite for import

All vitamin tablets or capsules to be imported into Taiwan must be inspected and registered by the responsible manufacturer in accordance with Article 21 of the Food Safety and Sanitation Management Act. Regardless of whether the product is a low-dose food or a high-dose health food or drug, it must not exceed this inspection mechanism, otherwise it will not be able to complete customs clearance, let alone be legally sold on the market. Before importing, the product formula, ingredient analysis, label design and other information must be submitted, and the TFDA can only issue a license after review and approval.

2. Dosage is the regulatory boundary, and there is a difference between food and medicine.

TFDA determines the nature of the product based on the "Recognition Benchmark Table":

If the daily dosage of the product falls within the range listed in the table (such as 150-1000 mg of vitamin C per day), it belongs to the "food category" and must be registered for food inspection.

If it exceeds this range, resulting in an excessive dosage, or claims to have disease treatment functions, it will be classified as a "drug" and must apply for drug inspection registration and obtain a drug license in accordance with the "Pharmaceutical Affairs Law", and must comply with strict regulations such as drug GMP.

3. Label content and packaging are also controlled.

TFDA not only reviews the dosage of ingredients, but also strictly checks the product packaging and labeling. The inspection and registration information must include a complete list of ingredients, content labeling, warnings (such as "excessive consumption is not beneficial"), and claims must not involve efficacy or misleading terms. In addition, if the product contains non-traditional food raw materials or additives, it is also necessary to apply for "Food Additive Inspection Registration" or "Non-traditional Food Raw Materials Application" and comply with GMP/HACCP and other hygiene control standards

4. Exemption for personal use does not mean relaxation of standards

Although people can mail or bring vitamin products into Taiwan by themselves, they enjoy a certain amount of exemption (up to 12 bottles per item, a total of 36 bottles), and even exempt from TFDA inspection and registration, as long as the total value does not exceed approximately USD1,000 and the weight does not exceed 6 kilograms. However, this only applies to "personal use" and is strictly prohibited from sale. Once imported and resold without following the inspection system, a fine of NT$30,000 to NT$3,000,000 will be imposed in accordance with Article 30 of the Food Safety Act, and it may be forcibly removed from the shelves or destroyed

If the specific formula and daily recommended intake of the vitamin product can be provided, it can help to determine whether it is a food or a drug, and provide the most suitable inspection path and document preparation suggestions.

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