The ban, however, does not extend to antibacterial soaps used by hospitals or the food industry because more research on their safety and effectiveness is required, the FDA said.
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The ruling cuts out 19 specific active ingredients, including the most commonly used ingredients – triclosan and triclocarban. All manufacturers will have one year to comply with the rulemaking by removing products from the market or reformulating (removing antibacterial active ingredients) these products.
In terms of effectiveness, the manufacturers had to prove to the FDA that antibacterial soaps worked better than plain soap and water at preventing the spread of germs or reducing infections. “If the product makes antibacterial claims, chances are pretty good it contains one of these ingredients”, Theresa Michele, the FDA’s director of the Division of Nonprescription Drug Products, told reporters. The rule doesn’t apply to hand sanitizers or wipes, or antibacterial products used in health care settings.
The ACI also disputed the FDA’s statements about the efficacy of antibacterial soaps, saying they’re safe for consumers to use, and “critical to public health because of the importance hand hygiene plays in the prevention of infection”.
The FDA is requiring 19 chemicals be removed from antibacterial soaps because of a lack of evidence they are more effective than plain soap and water at eliminating germs, and a lack of evidence they do not pose other health risks for users. They include triclosan and triclocarban.
The agency told manufacturers almost three years ago that they must show their products are safe and effective. The chemical has been linked to hormonal disruption during testing on animals, the FDA said, yet there is no ultimate proof that it is harmful to humans. Critics of antibacterial soaps have always stated that there was no scientific proof that these products kill germs.
The regulations would only cover soaps and body washes used with water.
The FDA ban comes more than 40 years after Congress asked the agency to evaluate triclosan and dozens of other antiseptic ingredients.
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“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”.
