American Cleaning Institute criticizes FDA's guidance against antibacterial soap; ACI says manufacturers comply with safety, efficacy requirements through extensive research

The American Cleaning Institute expressed disappointment at the recent consumer guidance issued by the Food and Drug Administration (FDA) urging consumers to “skip” using antibacterial soap.

ACI and a group of member company manufacturers of antibacterial soaps and ingredients continue to comply with stringent safety and efficacy requirements set by FDA in the 2016 final rule for consumer antiseptic hand washes, through a multi-year, multi-million-dollar research effort, according to James Kim, PhD, ACI Senior Vice President of Science & Regulatory Affairs.

“The timing of this consumer update is mysterious, given that there haven’t been any new advisories or findings by FDA that would prompt such a random piece of advice,” said Dr. Kim.

“The agency’s public statements could sow consumer confusion about the amount of scientific data and research that manufacturers have submitted over the years on product safety and effectiveness.

“Millions of times every day, consumers use these products safely and effectively.

“While FDA’s final rule is requiring human clinical efficacy trials to demonstrate that antibacterial soaps reduce the incidence of infectious disease (demonstrating prevention), a lot of research such as in vitro efficacy assays and smaller clinical studies have already been completed and/or published.

“Antibacterial soaps are used in healthcare and institutional settings for a reason. FDA is ignoring the fact that much of today’s healthcare has moved out of hospital medical facilities and into alternative settings such as homecare, where there are indeed individuals who are immunocompromised and/or otherwise ill and may need beneficial over-the-counter antiseptic products.

“Manufacturers stand behind the product science, research and data submitted over several decades to FDA. We urge the agency to refrain from issuing further prejudicial statements as we continue to conduct and share research on these beneficial products.”

The American Cleaning Institute^® (ACI – www.cleaninginstitute.org) is the Home of the U.S. Cleaning Products Industry^® and represents the $60 billion U.S. cleaning product supply chain. ACI members include the manufacturers and 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 distributors. ACI serves the growth and innovation of the U.S. cleaning products industry by advancing the health and quality of life of people and protecting our planet. ACI achieves this through a continuous commitment to sound science and being a credible voice for the cleaning products industry.