FDA proposed rule requires antibacterial soap manufacturers to prove safety, effectiveness

Manufacturers of antibacterial hand soap and body wash will be required to show that their products are more effective than plain soap and water in preventing illness and the spread of infection, under a FDA-proposed rule.

If companies do not provide additional data on the products’ safety and effectiveness, including data from clinical studies to demonstrate that these products are superior to non-antibacterial soaps in preventing human illness or reducing infection, the products would need to be reformulated or relabeled to stay on the market. This is part of a larger, ongoing review of antibacterial active ingredients by FDA to ensure these ingredients are proven to be safe and effective. This proposed rule does not affect hand sanitizers, wipes, or antibacterial products used in healthcare settings. 

“The new FDA requirement for manufacturers to clearly provide evidence to support that their products are more effective than using plain soap and water could help to minimize potential health risks due to extended use of these products, but could also foster an increased awareness of the importance of proper infection control,” said Formulary advisor Abimbola Farinde, PharmD, MS, who serves on the faculty at Columbia Southern University, Orange Beach, Ala.

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.

Almost all soaps labeled “antibacterial” or “antimicrobial” contain at least 1 of the antibacterial ingredients addressed in the proposed rule. The most common active ingredients in antibacterial soaps are triclosan and triclocarban. Some soaps labeled “deodorant” may also contain these ingredients.

Widespread consumer use of antibacterial products, the accumulated scientific information, and concerns raised by healthcare and consumer groups have prompted FDA to reevaluate what data are needed to classify the active ingredients in consumer antibacterial products as “generally recognized as safe and effective” or GRASE.  

Consumers should continue to be diligent about washing their hands. If soap and water are not available, an alcohol-based hand sanitizer that contains at least 60% alcohol should be used. More information on appropriate hand washing from the CDC may be found here.

 The proposed rule does not require the antibacterial soap products to be removed from the market at this time. When the proposed rule is finalized, as previously stated, either companies will have provided data to support an antibacterial claim, or if not, they will have to reformulate (remove antibacterial active ingredients) or relabel (remove the antibacterial claim from the product's labeling) these products in order to continue marketing. The proposed rule is available for public comment for 180 days, with a concurrent 1-year period for companies to submit new data and information, followed by a 60-day rebuttal comment period.

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