September 6, 2016

FDA cracks down on antibacterial hand soaps

Daily Briefing

FDA on Friday released a final rule that prohibits the sale of over-the-counter soaps with certain antibacterial chemicals, citing a lack of evidence to support their safety and efficacy.

Background: FDA considers restrictions on antibacterial soaps

FDA in 2013 decided to re-examine antibacterial soaps after an accumulation of scientific data from animal studies showed such soaps potentially could have harmful effects in humans. For example, some animal studies have shown certain antibiotic chemicals disrupted the normal development of the animals' metabolisms and reproductive systems.

FDA later that year issued a proposed rule that would require antibacterial hand soap manufacturers to submit evidence proving their products' ingredients were safe for long-term, daily use and more effective than non-antibacterial soap at preventing the spread of bacterial infections.

Ban details

FDA last week said manufacturers were unable to demonstrate that 19 different chemicals found in the "vast majority" of antibacterial hand soaps are safe. The agency said, "For these ingredients, either no additional data were submitted, or the data and information that were submitted were not sufficient for [FDA] to find that these ingredients are generally recognized as safe and effective."

The ban applies only to over-the-counter hand washes and soaps that contain those chemicals. According to USA Today, Theresa Michele, director of FDA's division of nonprescription drug products, said the ban will affect about 2,100 products, or about 40 percent of soaps currently for sale. Companies have one year to reformulate affected products or take them out of circulation, and according to FDA, some companies already have begun doing so.

Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, said, "Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water." She added, "In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term."

The ban does not apply to:

  • Cleansers used in health care and food service settings; and
  • Hand sanitizers and wipes that are designed to be used without water and contain more than 50 percent alcohol.

Some hospitals had already started to remove cleansers from their hospitals because of their possible contribution to antibiotic resistance and other health issues. Kathy Gerwig, Kaiser Permanente's environmental-stewardship officer and VP of employee safety, told the Wall Street Journal in February that the health system had banned triclosan and was working to remove 13 additional chemicals from its facilities. "We want to use our purchasing power to send a message that it’s not OK to use ingredients that might be harmful to our health," she said.

FDA also said the ban does not apply to products containing the antibacterial chemicals benzalkonium chloride, benzethonium chloride, and chloroxylenol. According to USA Today, the agency gave manufacturers until February to produce evidence showing those chemicals are safe and effective. FDA said it would make a decision on products containing those ingredients within one year.

Do antibacterial soaps do more harm than good?

Ban met by mixed reactions

The American Cleaning Institute in a statement opposed the rule, saying, "Antibacterial soaps are critical to public health because of the importance hand hygiene plays in the prevention of infection." The group added, "Washing the hands with an antiseptic soap can help reduce the risk of infection beyond that provided by washing with non-antibacterial soap and water."

But other stakeholders applauded the rule.

Jane Houlihan, research director of Healthy Babies Bright Futures, called the ban "terrific" and "a long time coming." She said, "There's no reason to put potentially harmful chemicals in products people use every single day on their hands, faces, and bodies."

Ken Cook, co-founder and president of the Environmental Working Group, in a release said, "This decision by ... FDA is a huge victory on behalf of human health and the environment" (Basen, MedPage Today, 9/2; Tavernise, New York Times, 9/2; Devaney, The Hill, 9/2; Kodjak,  "Shots," NPR, 9/2; Ross Johnson, Modern Healthcare, 9/2; Grover, Reuters, 9/2; Weintraub, USA Today, 9/2; Landro, Wall Street Journal, 2/15).

Video: The state of hospital antibiotic stewardship programs

The majority of hospitals are starting to invest in antibiotic stewardship programs, but our recent survey shows there's still plenty of work to be done.

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