ACI and PCPC Form Coalition to Promote Antibacterial Use to the FDA

The Personal Care Products Council (PCPC) and the American Cleaning Institute (ACI), which have formed the Topical Antimicrobial Coalition, have submitted their comments to the U.S. Food and Drug Administration (FDA) regarding its proposed rule on OTC antiseptic products, which they find could eliminate access to antibacterial soaps and increase foodborne illness. The FDA published the proposed rule on Dec. 17, 2013, to amend the 1994 tentative final monograph on antiseptic hand washes. According to the proposed rule, it sought proof that the actives in antimicrobial handwashes benefited the consumer more than washing with soap that doesn't contain the actives.

The comments demonstrate to the FDA that consumer antibacterial soaps are safe, effective and promote public health. The FDA’s proposal could eliminate the public’s access to safe and effective antibacterial soaps, including kitchens in the home and at daycare facilities.

The comments noted, “Washing the hands with an antiseptic handwash can help reduce the risk of infection beyond that provided by washing with non-antibacterial soap and water.”

The coalition believes that the FDA have not considered the benefit of antibacterial soaps for consumer use in schools, airports, daycares and other facilities. In addition, it finds that antibacterial soaps benefit the public in general in places like public restrooms. Consumer antiseptic products reduce the level of bacteria on skin, which reduces the risk of infection and disease. The groups add that new cases of foodborne illnesses caused by bacteria such as E. coli, Salmonella, Shigella and Campylobacter could range between 250,000 and 7.5 million, based on projections by Donald Schaffner, PhD, professor at Rutgers University’s Food Science Department.This could result in US $38 billion in healthcare costs.

The coalition's comments also take issue with assertions in the proposed rule that challenge the safety of antibacterial ingredients. “No scientific studies currently exist to demonstrate a correlation between the active ingredients considered in the proposed rule and adverse health effects on consumers. As a result, there are no measurable benefits of the proposed rule.”

In their comments to FDA, the coalition asks the FDA to: support safety evaluation approaches that avoid or minimize animal testing; reconsider its unnecessary and unreasonable proposed testing requirements (including animal testing) for safety and effectiveness, which are unlike any other rulemakings for over-the-counter drugs such as antibacterial soaps; review available and extensive data that shows there is no correlation between antibacterial soap use and antibiotic resistance; recognize antiseptic handwashes that are used in the food industry as a distinct category that should be subject to its own monograph.

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