FDA Bans 19 Antibacterial Chemicals Used in Hand and Body Soaps

The FDA has banned 19 antibacterial ingredients used in hand and body soaps, citing a lack of evidence demonstrating that these ingredients are safe and more effective than ordinary soap for preventing illness.

Companies Submitted Insufficient or no Data

The ban specifically targets consumer products and does not apply to soaps used in hospital settings and food services. This is part of a larger effort by the FDA to push consumers toward using ordinary soap and water for sanitization.

Manufacturers have one year to remove these ingredients from their products or must take their products off the market; products containing these ingredients can still be sold during this time frame. Soaps that claim antibacterial properties are likely to have one of the banned ingredients.

The FDA proposed the ban in 2013 which could have been mitigated if companies submitted sufficient data to prove that the ingredients are safe and effective. However, the FDA stated that insufficient or no data was submitted by companies to demonstrate that the ingredients are Generally Recognized as Safe and Effective. The FDA also cited studies demonstrating that antibacterial ingredients may pose a risk to human health.

Triclosan and Triclocarbon are among the banned ingredients. Since the ban was proposed, several companies have already started to phase out these ingredients from their products. Companies including Johnson & Johnson and P&G are currently reformulating certain products to exclude these chemicals.

The FDA is also considering regulatory action for three ingredients commonly found in cleaning products (benzalkonium chloride, benzothonium chloride, chloroxylenol), and manufacturers have an additional year to submit data proving the safety and effectiveness of these products.

Managing Chemical Restrictions

In order to determine if products need to be reformulated, companies must first identify if any banned ingredients are in their products. Combined with other chemicals lists restricted by regulations such as RoHS, REACH, and Prop 65, companies may spend more time managing multiple evolving chemical lists than they would like. Read our newly released whitepaper on REACH to learn about the various chemical lists companies need to pay attention to and what they are required to do.

A software solution allows companies to easily compare their products against chemical lists and determine if any product changes need to be made. Proactively managing chemical restrictions enables companies to heighten the positive reputation of their brand and protect their bottom line.