The nation’s Food and Drug Administration (FDA) yesterday reiterated that cleansing soap products categorized as cosmetics should not be advertised as “germ-killing” products.
The agency made the remarks in response to a recent proposed rule by the US FDA requiring manufacturers of antibacterial soaps to prove the products are more effective in preventing disease than plain soap and water.
The US FDA on Monday said it was taking a closer look at antibacterial soaps, citing new data suggesting that their long-term use might contribute to bacterial resistance to antibiotics and might have unanticipated hormonal effects, which are potential health risks that may outweigh the products’ benefits.
The US concern stems from the wide use of triclosan as a chemical ingredient in antibacterial soaps. Animal studies have shown that triclosan may alter the way hormones work in the body.
Taiwan’s FDA categorizes cleansing products as either “germ-killing, over-the-counter drugs” or “cleansing cosmetics” according to the products’ intended use.
The agency reiterated that health authorities had pronounced in March that cosmetic products should not be labeled as “germ-killing” or tout the ability to prevent, avoid or strengthen protection against infection lest consumers be misled into thinking that they have a therapeutic effect or are used by specialists to treat particular diseases.
Hand sanitizers or medicinal soaps that claim to kill germs should comply with the Pharmaceutical Affairs Act (藥事法) on safety, effectiveness and quality.
Meanwhile, antibacterial soaps for skin cleansing that are considered cosmetic products should comply with the Statute for Control of Cosmetic Hygiene (化妝品衛生管理條例), it said. Cleansing products that contain any of the 21 active ingredients for antiseptic use listed in the statute can be labeled “antibacterial,” it added.
Triclosan is among the 21 ingredients, it said, while adding that its use in cosmetic products is also allowed in the EU, Canada and the US at a limit of 0.3 percent.