Setting the Wrong Standard

The proposed approach to regulating meal replacement foods would create some serious problems.

Meal replacement formula foods and beverages are used most commonly by dieters looking to shed some weight. The product is intended to be only a partial replacement for conventional meals – not the sole contributor to one’s daily intake.

Since the purpose is to substitute for only one or two meals a day, partial meal replacement foods are not formulated to provide 100% of all essential nutrients needed in the diet. Used as directed, such products have been clinically demonstrated in many countries as a safe and effective strategy for losing weight and for weight management. This approach helps to ensure an adequate supply of essential nutrients while limiting caloric intake.

In Taiwan, Meal Replacement Formula Food (abbreviated as MR) has been classified under the Food Act as a “Special Nutrient Food.” Under the law, any food product with the claim of “Meal Replacement” must be registered with the Taiwan Food and Drug Administration (TFDA), and before being imported and sold in Taiwan must undergo human clinical trials to confirm their safety and efficacy, and then obtain TFDA pre-market approval.

TFDA is now preparing to establish a Taiwan Meal Replacement Standard. But to the dismay of multinational companies marketing MR products in Taiwan, the standard as currently drafted sets highly complicated regulatory requirements, seemingly based on the assumption that the formula food would be the consumer’s sole source of nutrients over a long period of use. For example, each serving would have to provide one-third of all the nutrients in the Taiwan Daily Reference Intake Table, as well as a large amount of dietary fiber (which is not found in any other MR standard in the world).

Under the proposed MR Standard, in addition, the formula itself would have to provide all the required nutrients, whereas in most countries it can be mixed with milk or other foods to meet the requirement.

Multinational companies cannot be expected to reformulate their products simply to fulfill the regulations of a relatively small market such as Taiwan’s. Consequently, implementation of the Taiwan MR Standard as drafted would inevitably mean that international meal replacement foods will be pushed out from the Taiwan marketplace.

Besides the inconvenience to consumers of losing access to known brands with well-established track records, the TFDA’s policy – by in effect discriminating against foreign products – arguably could also constitute a technical barrier to trade subject to dispute in the World Trade Organization. The draft standard also appears to be totally out of sync with the government’s recent efforts to burnish Taiwan’s qualifications for inclusion in the Trans-Pacific Partnership free-trade grouping by bringing domestic regulations into greater conformity with international standards and practices.

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