Proposed rules by the U.S. Food and Drug Administration (FDA) could remove antibacterial soaps and body washes from store shelves – and might lead to 7.5 million new cases of foodborne illness and more than $38 billion in health care costs annually, according to two US trade associations.
In an effort to maintain consumer access to the benefits of antibacterial soaps, the American Cleaning Institute (ACI) and the Personal Care Products Council, along with input from leading independent scientists, filed extensive comments with FDA on its proposed rule. The comments demonstrate to the Agency 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.
Antibacterial soaps "are critical to public health because of the importance hand hygiene plays in the prevention of infection," wrote the groups in their joint June 16 comments to FDA. "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."
FDA appears to have not considered that the consumer category includes use of antibacterial soaps in public areas such as schools, airports, daycares, and other facilities. Consumer antiseptic products reduce the level of bacteria on skin, which reduces the risk of infection and disease.
Elimination of these products would put the general population at risk. For example, individuals using public restrooms would no longer have access to antiseptic hand soaps.
The Topical Antimicrobial Coalition, which comprises ACI and the Council, estimated the costs of the proposed rule – associated with preventable gastrointestinal illnesses – that would occur if antiseptic hand wash products were not available.
The number of new cases of foodborne illness caused by bacteria such as E. coli, Salmonella, Shigella, and Campylobacter could range between 250,000 and 7.5 million, based on projections by Dr. Donald Schaffner, Professor at Rutgers University’s Food Science Department.
The groups’ 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 measureable benefits of the proposed rule."<
In their comments to FDA, the American Cleaning Institute and the Personal Care Products Council also asked the agency 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.
The detailed comments can be found online at www.fightgermsnow.com.