Regulatory Recommendations for Taiwan FDA

At issue, the regulation of capsules and the basing of penalties on capital strength.

AmCham Taipei’s Retail Committee in February prepared two position papers containing recommendations to the Taiwan Food and Drug Administration (TFDA) regarding recent issues of concern to its member companies.

The first involves the current regulation requiring that all imported foods (including food supplements) in capsule or tablet form go through a registration process with the TFDA. The requirement for domestic products is much narrower, however, necessitating registration only of vitamins containing over 150% of the daily recommended dosage. Because of the time and cost involved in registering, the differing treatment puts imported products at a competitive disadvantage.

The rationale given by the TFDA for requiring the registration of imports is to lower the risk that medications or non-vitamin dietary supplements in capsule/tablet form might be mistaken as being a food item or candy. But the same reasoning should also apply to domestically manufactured products.

The Committee suggests removal of the double standard by treating imported foods in capsule/tablet form in the same way as their domestic counterparts – that is, only imported vitamins containing 150% of more of the daily recommended dosage should be subject to TFDA registration.

The second position paper deals with the proposed system of penalties for violations of the Law Governing Food Sanitation and Safety. Among several potential problems with the draft proposal, the Committee cites the intention to make the size of the fine a function of the capital strength of the infringer. “In that case,” the paper notes, “the degree of liability, culpability, and impact of a legal violation would be determined simply by the amount of capitalization, not the severity of the violation, the number of impacted consumers, or the amount of financial gain accrued through the violation.”

With no supporting evidence, the paper continues, the draft proposal “appears to imply that large food operators are more culpable.” In fact, it argues, “large-scale food importers, manufacturers, and distributors with a large capital base generally maintain higher standards of social responsibility, and can be expected to adopt strict measures and take quick action to minimize any health risk to consumers.”

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