Results released on Wednesday of the Food and Drug Administration’s (FDA) inspection of nutritional supplement products containing the fungus Antrodia cinnamomea showed that eight products did not gain FDA approval before being put on sale, while 51 products were mislabeled.
FDA Southern Center section chief Lu Yun-ju (呂昀儒) said A cinnamomea is a species of fungus endemic to Taiwan and is often used to produce dietary supplements, but studies have shown that consuming a high dosage of the fungus can be toxic and increase risk of degenerative changes in cells.
The Ministry of Health and Welfare announced regulations for food products containing the fungus on July 10, 2015, stipulating that producers must submit a detailed document revealing all ingredients, the manufacturing process, product specifications and a repeated-dose 90-day oral toxicity test result for the FDA’s approval before launching their products. The regulations took effect on July 11 last year.
Photo: Wu Liang-yi, Taipei Times
The FDA’s inspection of 63 food companies in 16 counties and cities from November last year to last month showed that eight products from two companies — three products from Chang Gung Biotechnology Co (長庚生技) and five products from a biotechnology company called Yoyaer (耶和華以勒生技) — did not submit corresponding documents.
The products are A cinnamomea essence extract, Formosa A cinnamomea capsules and A cinnamomea essence soft capsules produced by Chang Gung, as well as five types of capsule products by Yoyaer that were sold under the brand name FKS.
FDA Southern Center director Liu Fang-ming (劉芳銘) said that 3,535 boxes and 42,510 bottles of the eight problematic products have been removed from shelves, and the companies will face fines of between NT$60,000 and NT$200 million (US$1,951 and US$6.5 million) if they continue to sell the products.
In addition, the inspection found 51 types of products containing the fungus had mislabeling problems, such as listing the nutrition facts in the wrong format, incomplete labeling of ingredients or incomplete company information.
Liu said a few companies printed pictures of the whole fungus on the product package when it only contained the mycelium — or vegetative structure — of the fungus.
As such pictures could mislead consumers, they were asked to improve their labeling and packages, he added.
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