Today, FDA announced the issuance of a 137 page Proposed Rule designed to investigate whether antibacterial hand soaps are any more safe or effective than washing with simple bar soap. FDA is taking this action to evaluate the safety and effectiveness of these products due to the continued concern about the potential development of bacterial resistance from the widespread use of these agents. The Proposed Rule does not cover does not cover hand sanitizers, wipes or antibacterial products used in the healthcare setting. Rather, it is targeted towards the multitude of bar and liquid soaps used by consumers in routine daily hand and body washes that are advertised as, and contain an antimicrobial agent.
The Agency notes that “[U]nder the proposal, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabeled to remain on the market.”
The FDA News Release goes on to say; “Millions of Americans use antibacterial hand soap and body wash products. Although consumers generally view these products as effective tools to help prevent the spread of germs, there is currently no evidence that they are any more effective at preventing illness than washing with plain soap and water. Further, some data suggest that long-term exposure to certain active ingredients used in antibacterial products—for example, triclosan (liquid soaps) and triclocarban (bar soaps)—could pose health risks, such as bacterial resistance or hormonal effects.”
Firms will not be required to remove their products at this time; however, if they fail to demonstrate safety and efficacy, they will be required to reformulate their products and or revise the labeling.
The Proposed Rule will allow for a 180-day comment period, with a concurrent one-year period for firms to generate and submit required data to the Agency for evaluation. The FDA News Release can be found here, and the Proposed Rule can be found here.
For years, we have heard scientists voice their concern relative to the widespread use of antimicrobial in the home and non-healthcare settings. The development of multiple strains of resistant microorganisms over the years has provided an incentive for the research into new and more effective antibiotics. The FDA in doing its due diligence had also expressed its concern regarding this issue, but it is reassuring to see that the Agency will be collecting data to put this issue to rest one way or the other. Remember, it is not only the big things in life that we need to worry about (like car accidents or shootings), the small things like superbugs present quite a significant (and potentially deadly) risk to the health of the nation.