The proposal is based on recent scientific studies that have raised questions over the continued and prolonged use of such products, while also questioning whether or not they are more effective than washing with regular soap and water.
It also demands that all consumer wash active ingredients are supported by data “that demonstrate a clinical benefit from the use of these consumer antiseptic wash products compared to nonantibacterial soap and water”.
Proposal will only apply to consumer products
The new regulation also 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.
Specifically the proposal is relevant to consumer hand soap and body lotion products, but does will not regulate hand sanitizers, mouthwash and other antimicrobial products widely used in the medical industry.
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.
Industry bodies fight back against proposal
The American Cleaning Institute and the Personal Care Products Council responded to FDA’s proposal with an official statement that underlined both what they claim is the proven efficacy and safety of 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,” the statement read.
“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.”
180 days for industry to respond
The FDA proposal gives 180 days for the public to comment on any aspect of it, while also giving industry up to one year to respond with further supporting data on the efficacy and safety of these products.
The PCPC and American Cleaning Institute said they now want to file comments to the FDA to reaffirm the assertion that these antimicrobial products are safe for over-the-counter use with the necessary data and that they play an important role in helping to control potentially dangerous bacteria in household environments.
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.