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The American Cleaning Institute and the Personal Care Products Council issued the following statement in response to the U.S. Food and Drug Administration’s (FDA) proposed rule governing antibacterial soaps and washes:


These products are over-the-counter drugs (OTC) and as such, go through rigorous review by FDA, including review of data and information submitted by industry and health care providers in the U.S. and worldwide. The proposed rule is a next step towards FDA finalizing the safety and efficacy of this OTC product category.


“We are perplexed that the Agency would suggest there is no evidence that antibacterial soaps are beneficial as industry has long provided data and information about the safety and efficacy of these products. In fact, in 2008, at industry’s request, FDA held a public meeting to discuss the data and industry asked FDA if the Agency required any further information. Our industry’s Topical Antimicrobial Coalition has submitted to the FDA in-depth data showing that antibacterial soaps are more effective in killing germs when compared with non-antibacterial soap.”



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