FDA ruling on over-the-counter antibacterial soaps

 

On 6 September 2016, the FDA in the United States made a ruling on antibacterial soaps that has received attention in Australia. This document aims to clarify what was decided and why, and how this relates to the National Hand Hygiene Initiative in Australia.

What has the FDA decided?

This week the FDA has moved to end the sale of any many over-the-counter (OTC) antibacterial soaps in the United States. The ruling applies to products used for hand or body wash that contain any of 19 specified active antibacterial ingredients, including triclosan and triclocarbon. Manufacturers marketing these products in the United States will have one year to comply with this decision.

Why did the FDA make this decision?

In 2013, the FDA requested evidence to demonstrate the efficacy and safety of OTC antibacterial soaps. The FDA has subsequently concluded that available evidence does not support the ongoing marketing of these products. The FDA have explained that “there isn’t enough science to show that over-the counter (OTC) antibacterial soaps are better at preventing illness than washing with plain soap and water”, while also noting that “the wide use of these products over a long time has raised the question of potential negative effects on your health.” They note that such negative effects could include selection for drug-resistant bacteria.

Does this ruling include products used in health care?

No, this ruling applies to over-the-counter products and is therefore focussed on consumer use in the community. It does not affect antibacterial products used in health care settings.

Does this ruling include alcohol-based handrubs?

No, this ruling applies to soap-based products that are used with water.

Is this decision consistent with the National Hand Hygiene Initiative (NHHI) in Australia?

Yes, although it is important to remember that this ruling relates to over-the-counter consumer products used in the community in the US, rather than products used in Australian health care organisations. However, we nonetheless note that this ruling is consistent with the NHHI recommendations. Hand Hygiene Australia recommends using alcohol-based handrub for all clinical situations where hands are visibly clean. Washing with soap and water is recommended when hands are visibly dirty or contaminated, contaminated with body fluids, or if exposure to potential spore forming organisms is strongly suspected or proven.

Further resources:

FDA Final Rule

FDA News Release

FDA Consumer Update 

Media Release from ASID and ACIPC