US FDA Requires Safety and Effectiveness of Antibacterial Soap Products

FAIRFIELD, N.J. - Jan. 22, 2014 - PRLog -- Without such evidence, these products will have to be reformulated or relabeled to remain on the market. The proposed rule only applies to consumer use products and does not affect hand sanitizers, wipes or antibacterial products used in health care or food preparation facilities.

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.

References:

(1) 21 CFR Parts 310 and 333 Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use, Federal Register Vol. 78, No. 242 (http://www.gpo.gov/fdsys/pkg/FR-2013-12-17/pdf/2013-29814...)

(2)FDA Taking Closer Look at 'Antibacterial' Soap (http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm378393...)

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