American Cleaning Institute and Personal Care Products Council Issues the Following Statement in Response to FDA’s Proposed Rule on Antibacterial Soaps and Washes
The American Cleaning Institute www.cleaninginstitute.org and the Personal Care Products Council www.personalcarecouncil.org 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. Today’s proposed rule is a next step towards FDA finalizing the safety and efficacy of this OTC product category.
“Over the past two decades, manufacturers of these products have provided significant data and information to the Agency about the safety and efficacy of this 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.
“Additionally, 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.
“We 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. The ingredients used in antibacterial soap and washes have been evaluated and regulated by agencies and scientific bodies around the world. In some instances, these products have been found to be critical in the reduction of infection and disease.
“We applaud FDA for moving this rulemaking forward, and industry will continue to operate in good faith to submit any new data that is available. Consumers should continue to have access to antibacterial products that are used safely and effectively every day, in homes, offices, schools, child care centers, food facilities, and other commercial settings.”