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US FDA Requires Safety and Effectiveness of Antibacterial Soap Products
US Food and Drug Administration (FDA) has proposed a rule to require manufacturers of antibacterial hand soaps and body washes to demonstrate the safety and effectiveness of their products for long-term use.
Antibacterial Soaps and Body Washes under Examination
The FDA staff explained that “there currently is no evidence that over-the-counter (OTC) antibacterial soap products are any more effective at preventing illness than washing with plain soap and water.” The agency expressed concerns based on recent scientific studies that have raised concerns regarding certain chemical ingredients, such as triclosan and triclocarban, and that the “risks associated with long-term, daily use of antibacterial soaps may outweigh the benefits.”
The proposed rule would require manufacturers to provide more substantial data to demonstrate the safety and effectiveness of antibacterial soaps. The proposed rule is open for public comment for 180 days. Concurrently, companies have one year to submit new data on the covered antimicrobial ingredients. The FDA expects to finalize the rule by 2016.
(1) 21 CFR Parts 310 and 333 Safety and Effectiveness of Consumer Antiseptics;
(2)FDA Taking Closer Look at 'Antibacterial' Soap (http://www.fda.gov/
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