ACI responds to FDA's proposed rule
American Cleaning Institute and Personal Care Products Council
Release Statement in Response to FDA’s Proposed Rule on Antibacterial Soaps and Washes
WASHINGTON — The American Cleaning Institute (ACI) and the Personal Care Products Council have 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.”
More information on the safety and benefits of antibacterial soaps can be found at www.FightGermsNow.com.
The American Cleaning Institute® (ACI) is the Home of the U.S. Cleaning Products Industry® and represents the $30 billion U.S. cleaning products market. ACI members include the formulators of soaps, detergents, and general cleaning products used in household, commercial, industrial and institutional settings; companies that supply ingredients and finished packaging for these products; and chemical producers. ACI (www.cleaninginstitute.org) and its members are dedicated to improving health and the quality of life through sustainable cleaning products and practices.
Based in Washington, D.C., the Personal Care Products Council is the leading national trade association representing the global cosmetic and personal care products industry. Founded in 1894, the Council's more than 600 member companies manufacture, distribute, and supply the vast majority of finished personal care products marketed in the U.S.As the makers of a diverse range of products millions of consumers rely on every day, from sunscreens, toothpaste and shampoo to moisturizer, lipstick and fragrance, personal care products companies are global leaders committed to product safety, quality and innovation.