The Food and Drug Administration (FDA) issued a final rule on Friday stating that companies can no longer market consumer antibacterial soap products including certain active ingredients. The ruling said that manufacturers did not demonstrate that certain ingredients are safe for long-term daily use and more effective than plain soap and water in terms of preventing illness and the spread of infections.
According to the FDA, the rule applies to products containing one or more of 19 active ingredients, including triclosan and triclocarban. The rule does not include hand sanitizers, wipes or products used in health care settings; only products that users rinse with water after using.
“Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are better than plain soap and water,” Dr. Janet Woodcock, director of the FDA’s center for drug evaluation and research, said in a statement. “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long term.”
In 2013, the FDA issued a proposal that required the manufacturers of antibacterial hand and body wash products to prove that their products were more beneficial than plain soap and water long term. The FDA reported that manufacturers did not provide necessary data to establish safety and effectiveness for the 19 specific ingredients. The proposed rule in 2013 suggested that long-term exposure to ingredients, such as triclosan in liquid soaps and triclocarban in bar soaps, could pose dangerous health hazards, including bacterial resistance and hormonal effects.
The American Cleaning Institute (ACI) released a statement in response to the FDA’s findings:
Antibacterial soaps are critical to public health because of the importance hand hygiene plays in the prevention of infection. Washing the hands with antiseptic soap can help reduce the risk of infection beyond that provided by washing with non-antibacterial soap and water. The FDA already has in its hands data that shows the safety and effectiveness of antibacterial soaps. Manufacturers are continuing their work to provide even more science and research to fill data gaps identified by FDA. In the coming year, ACI and its member companies will submit additional safety and effectiveness data on the key ingredients in use in consumer antibacterial soaps today: benzalkonium chloride, benzethonium chloride and chloroxylenol. It is important to note that this FDA rule does not affect consumer hand sanitizers, antiseptic products used in health care settings and antiseptics used in food handler settings. Consumers can continue to use antibacterial soaps with confidence as they have for decades in millions of homes, offices, schools, day care centers and other commercial settings.
