FDA Banned the Use of 19 Antibacterial Substances in Soaps


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By the Decision of 2 September 2016, the U.S. Food and Drug Administration (FDA) banned the use of 19 antibacterial substances in soaps. The aforementioned category, in addition to conventional bar soaps, also includes liquid soaps, foam and gel-based hand cleaners, as well as body washes (applied with water). The main reason behind the decision of FDA is the lack of sufficient evidence that the antiseptic cosmetic formulations of this kind might be better in combating microorganisms than plain soaps are.

Moreover, FDA claim that the prolonged use of soaps containing certain active antibacterial substances may be harmful to consumer health. Triclosan may be an example of this, proven to have an adverse impact on the endocrine system in the course of animal testing procedures. Since triclosan is used in many products of everyday use (clothes, toys, furniture, etc.), there are concerns that it could also affect our health in a negative way. Moreover, such broad and frequent use of triclosan or other antiseptic substances may contribute to the antibiotic resistance in bacteria being generated.

The current ban is not applicable to benzalkonium chloride, benzethonium chloride and chloroxylenol, as manufacturers obliged themselves to provide confirmatory data demonstrating their effectiveness. Another exemption concerns widely available hand sanitizers and the agents of special use that are applicable in hospitals and nursing homes.

U.S. manufacturers have a year to conform to the new regulation. Some of them, in anticipation of the event, had already started removing the controversial substances out of their products even before FDA published the decision.

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