September 06, 2016
2 min read

FDA bans consumer antiseptic soaps with certain ingredients

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The FDA has issued a final rule banning the marketing of OTC, consumer antiseptic soaps containing certain active ingredients, after manufacturers failed to demonstrate that they are both safe for long-term daily use or more effective than plain soap and water at preventing illness and infection.

The rule applies to consumer antibacterial wash products that contain one or more of 19 active ingredients, including triclosan and triclocarban, the most commonly used ingredients in antiseptics. However, it does not affect consumer hand sanitizers or wipes, or antibacterial products used in health care settings.

“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,” Janet Woodcock, MD, director of the FDA Center for Drug Evaluation and Research, said in a press release. “In fact, some data suggest that antibacterial ingredients may do more harm than good over the long-term.”

Janet Woodcock
Janet Woodcock, MD

According to Stuart B. Levy, MD, director of the Tufts University Center for Adaptation Genetics and Drug Resistance, in Boston, physicians should advise their patients of the potential harm posed by the environmental presence of antibacterial products used in households, which claim there is an additional advantage to their use when none has been proven.

“Physicians, drug companies and manufacturers of antibacterial products need to show that consumers in the U.S. and elsewhere who continue to use antibacterial soaps — although there is no recognized advantage — reduce the overall efficacy of the soaps and may be building drug resistance in their environment,” Levy told Healio Family Medicine. “The FDA ruling accepts alcohol and soap and water as acceptable antibacterial compounds.”

In 2013, the FDA issued a proposed rule regarding consumer antiseptics after data suggested that long-term exposure to certain ingredients could pose health risks, including bacterial resistance or hormonal effects. Manufacturers were required to provide additional data on the safety and effectiveness on certain ingredients if they wished to continue marketing products in which they were used.

According to the FDA, with regard to 19 active ingredients, manufacturers either provided no additional data, or submitted information that was not sufficient to rule them as generally recognized as safe and effective. These 19 ingredients are:

  • Cloflucarban;
  • Fluorosalan;
  • Hexachlorophene;
  • Hexylresorcinol;
  • Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate);
  • Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol);
  • Nonylphenoxypoly (ethyleneoxy) ethanoliodine;
  • Poloxamer — iodine complex;
  • Povidone-iodine, 5% to 10%;
  • Undecoylium chloride iodine complex;
  • Methylbenzethonium chloride;
  • Phenol greater than 1.5%;
  • Phenol less than 1.5%;
  • Secondary amyltricresols;
  • Sodium oxychlorosene;
  • Tribromsalan;
  • Triclocarban;
  • Triclosan; and
  • Triple dye.

Manufacturers have 1 year to comply with the marketing ban.

The FDA, in response to industry comments, has deferred rulemaking on three additional ingredients for 1 year, to allow manufacturers to submit new data on their safety and effectiveness in antiseptic washes. The three ingredients are benzalkonium chloride, benzethonium chloride and chloroxylenol. Consumer antibacterial soaps containing these ingredients may continue to be marketed during this time.

Since 2013, manufacturers have already started phasing out the use of certain ingredients in antiseptics, including tricolsan and triclocarban, according to the FDA.

“Washing with plain soap and running water remains one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others,” read an FDA statement on the final rule. “If soap and water are not available and a consumer uses hand sanitizer instead, the [CDC] recommends that it be an alcohol-based hand sanitizer that contains at least 60% alcohol.”

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