Special medical foods refer to products that are catered for individuals suffering from a particular illness.
On Feb 6, the Taiwan FDA announced new changes to the special medical foods labelling rules.
The new rules were introduced as special medical foods were carved out as a new category under the registration and documentation of foods and related products.
The ministry thus decided to introduce a set of guidelines on the product labelling of special medical foods.
Firstly, all special medical foods should specify the group of consumers that the product caters to, storage method before and after opening the product packaging, directions for use, and dosage amount.
Of note is the need for the products to bear warning messages on the labelling so as to alert consumers on the right ways to use the product.
Examples of the warning messages include 1) this is a special medical formula food, it is unsuitable for general consumption, and consumption must be in accordance to the guidance of doctors or nutritionists, 2) greater consumption of the product will not help to improve the disease, and 3) this product is not for intravenous use.
Second, the products should use appropriate claims depending on the purpose of its use, i.e. for providing a balanced nutrition or for providing a large amount of a particular nutrient.
In products containing a greater / lesser / zero amount of a particular nutrient, the labelling should bear the terms “increase”, “decrease” and “removed” concerning that particular type of nutrient.
With products that do not contain essential fatty acids as an example, these products must include the claim “this product does not contain essential fatty acids.”
When the product is not used as the only nutrition source, the warning message “this product is unsuitable to be used as the only nutrition source” must made on the labelling in bold.
The new framework has been implemented with immediate effect.
However, for manufacturers which have received the approval to produce special medical foods before Feb 6, they will be granted a transition period until Jan 1 next year. Products made from that date will need to follow the above guidelines.
To ensure compliance, the FDA has introduced punitive measures to arrest enterprises which have erred.
In the event of untruthful claims and the failure to make the labelling claims in accordance to the rules stipulated, enterprises will be punished according to the food safety laws.
For example, they will need to reclaim the products within a certain period of time for correction and will be fined up to NTD$4m (US$133k).