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Inspection and Labeling Management for manufacturers of Antrodia cinnamomea food products in Taiwan 【Date:2018-11-14】 unit:區管理中心

Antrodia cinnamomea (AC), a unique, rare fungus species which is native to Taiwan, demonstrates significant and specific health benefits. With its edible parts including the fruiting body and mycelium, AC is used in the formulation of many dietary supplements such as powders, tablets, and capsules. However, several studies indicate high doses of AC may induce adverse effects on cells and may be toxic to human body. Therefore, safety issues of the AC food products must be addressed. Regarding these concerns, TFDA will work in conjunction with local health bureaus to initiate “The inspection project of manufacturers of Antrodia cinnamomea food products in 2019” (The inspection project in 2019), the goal of which is to ensure that the AC food products meet the safety requirements under the Act Governing Food Safety and Sanitation (the Act).

The aim of the inspection project in 2019 is also to investigate the manufacturing plants of the AC food products. The comprehensive checks of such AC firms include food production and process controls, the registration requirements of food businesses, the permit documents of AC materials, the labeling of food products, and the regulatory compliance of good hygiene practices (GHP) for foods by the food businesses. If manufacturers or products demonstrate violations of the Act, punishments shall be applied.

      TFDA strongly recommends that the food businesses shall implement self-management. Thus, in order to comply with the “Antrodia cinnamomea food production controls and labeling regulations”, the food businesses must prepare the permitted documents before attempting to market AC products. They must clearly label advisory warnings regarding the fruiting body and/or mycelium of AC and the cultivation methods to ensure the product safety as well.