In an effort to maintain consumer access to the benefits of antibacterial soaps, the American Cleaning Institute (ACI) and the Personal Care Products Council have filed extensive comments with the FDA on its proposed rule.
The comments accompanied by input from leading independent scientists claims to demonstrate that consumer antibacterial soaps are safe, effective, and promote public health.
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 filing.
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 measurable benefits of the proposed rule.”
The groups also requested that the agency:
- 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 soap
- Review available and extensive data that shows there is no correlation between antibacterial soap use and antibiotic resistance.
Details of the proposal
The new regulation requires that finished antibacterial soaps for consumer use are recognized as safe and effective according to GRAS/GRAE regulations, while also specifying that this rule does not apply to products for use in medical environments.
The move is the latest in a debate that has been raging in the U.S. for 35 years, with consumer bodies and scientific research being countered by industry bodies and further research to argue that the ingredients are both safe and effective.
If the proposal is accepted, manufacturers will have to provide data for any antibacterial claims and if this is not possible they will have to reformulate. The ruling will be finalized in 2016.