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U.S. industry reaffirms the effectiveness of antibacterial soaps and washes

In response to the U.S. Food and Drug Administration’s (FDA) proposed rule governing antibacterial soaps and washes [1], the American Cleaning Institute (ACI) and the Personal Care Products Council (PCPC) have reaffirmed the effectiveness and safety of these products.

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 two trade organisations said. “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.

According to ACI and PCPC, in-depth data already submitted by the industry shows that antibacterial soaps are more effective in killing germs when compared with non-antibacterial soap. The two organisations also argue that “a review of two dozen relevant published studies analyzing the effectiveness of antibacterial soaps showed that hand washing with these products produces statistically greater reductions in bacteria on the skin than when using non-antibacterial soap.

ACI and PCPC also intend to file comments to FDA reaffirming that “the use of antibacterial wash products in the home environment does not contribute to antibiotic or antibacterial resistance.

Last December, the FDA has issued a proposal to require manufacturers of antibacterial hand soaps and body washes to demonstrate that “their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections.” Under the proposal, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabelled to remain on the market.

Footnotes

[1] “Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record; Proposed Rule”, Food and Drug Administration, Department of Health and Human Services, 21 CFR Parts 310 and 333

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