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Updated Labeling Requirements of Foods for Special Medical Purpose in Taiwan

Along with the amendment of “Regulations Governing the Management of the Review, Registration, and Issuance of Permit Documents for Food and Related Products", Taiwan FDA updated the labeling requirements of FSMP food.

As revealed by Taiwan FDA Notice [1] on Feb 6th, 2020, Taiwan released the Labeling Requirements of Foods for Special Medical Purpose (FSMP) to renew the classification and labeling requirement of FSMP food and repeal the former Labeling Requirements to FSMP Product under Special Nutritional Food.

General Labeling Requirement

Except for the labeling items required by prepackaged food, FSMP product labels shall also include the following items:

  1. Target user

  2. Storage method before and after unsealing the products

  3. Use principle and dosage

  4. Label the following sentence or similar in bold, “This product belongs to Foods for Special Medical Purpose, not suitable for ordinary people and shall be used under the guidance of doctors or nutritionists.” Besides, the font color shall be a different color and contrast with the background color.

  5. Label the following sentence or similar, “The consumption of this product does not help with recovery from disease."

  6. Label the following sentence or similar, “not for intravenous therapy."

  7. Tube feeding food shall label the osmotic pressure.

  8. Other precautions

Further Requirements

What’s more, further requirements are put forward as per different FSMP types. Currently, FSMP foods are divided into the following four types in Taiwan. Check the notice for detailed labeling requirements of each type.

  • Nutritionally complete food: may be used as the sole source of nutrients

  1. Nutritionally complete food with a balanced formula

  2. Nutritionally complete food with a customized formula

  • Nutrition supplement formula food: cannot be used as the sole source of nutrients

  1. Nutrition adjusted supplementary formula food

  2. Special modular formula food

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