FDA News

FDA rule banning 19 ingredients from antibacterial soaps takes effect

Janet Woodcock
Janet Woodcock

An FDA rule banning 19 ingredients from over-the-counter consumer antiseptic washes took effect this week.

The FDA issued the rule last year, saying there was no scientific evidence that the ingredients were safe for long-term daily use or better than soap and water at preventing illness or the spread of germs.

“In fact, some data suggest that antibacterial ingredients may do more harm than good over the long term,” Janet Woodcock, MD, director of the FDA Center for Drug Evaluation and Research, said when the rule was issued.

Health officials have raised concerns that the ingredients in the products may contribute to drug resistance in the environment.

The FDA gave manufacturers a full year to wind down production and distribution of consumer antiseptic washes that contained the 19 ingredients, which include triclosan and triclocarban, the most commonly used agents in antiseptics. The rule applies only to products intended to be used with water, such as antibacterial soaps, hand washes and other antibacterial body washes. It does not apply to hand sanitizers or wipes and does not affect products used in health care settings.

As of Sept. 6, any unapproved over-the-counter antibacterial wash products containing the 19 ingredients are subject to regulatory action, FDA spokeswoman Andrea Fischer told Infectious Disease News. But Fischer said the agency does not intend to object if retailers continued to sell products containing the banned ingredients that were on the market prior to the Sept. 6 deadline.

The FDA initially proposed the rule in 2013 after data suggested that long-term exposure to certain ingredients could pose health risks, including bacterial or hormonal effects. The final rule was issued last September after manufacturers either provided no additional data or submitted information that was insufficient to rule the ingredients safe and effective, the FDA said.

The 19 ingredients affected by the ban are:

  • cloflucarban;
  • fluorosalan;
  • hexachlorophene;
  • hexylresorcinol;
  • iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate);
  • iodine complex (phosphate ester of alkylaryloxy polyethylene glycol);
  • nonylphenoxypoly (ethyleneoxy) ethanol-iodine;
  • 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.

The FDA gave manufacturers 1 year to submit data on the safety and effectiveness of three other ingredients — benzalkonium chloride, benzethonium chloride and chloroxylenol — in antibacterial soaps. According to Fischer, the FDA is still collecting data on these ingredients. In the meantime, manufacturers are allowed to market consumer antibacterial washes containing them. – by Gerard Gallagher

Reference:

Federal Register. Safety and effectiveness of consumer antiseptics; topical antimicrobial drug products for over-the-counter human use. 2016. https://www.federalregister.gov/documents/2016/09/06/2016-21337/safety-and-effectiveness-of-consumer-antiseptics-topical-antimicrobial-drug-products-for. Accessed September 7, 2017.

Disclosure: Woodcock and Fischer work for the FDA.

Janet Woodcock
Janet Woodcock

An FDA rule banning 19 ingredients from over-the-counter consumer antiseptic washes took effect this week.

The FDA issued the rule last year, saying there was no scientific evidence that the ingredients were safe for long-term daily use or better than soap and water at preventing illness or the spread of germs.

“In fact, some data suggest that antibacterial ingredients may do more harm than good over the long term,” Janet Woodcock, MD, director of the FDA Center for Drug Evaluation and Research, said when the rule was issued.

Health officials have raised concerns that the ingredients in the products may contribute to drug resistance in the environment.

The FDA gave manufacturers a full year to wind down production and distribution of consumer antiseptic washes that contained the 19 ingredients, which include triclosan and triclocarban, the most commonly used agents in antiseptics. The rule applies only to products intended to be used with water, such as antibacterial soaps, hand washes and other antibacterial body washes. It does not apply to hand sanitizers or wipes and does not affect products used in health care settings.

As of Sept. 6, any unapproved over-the-counter antibacterial wash products containing the 19 ingredients are subject to regulatory action, FDA spokeswoman Andrea Fischer told Infectious Disease News. But Fischer said the agency does not intend to object if retailers continued to sell products containing the banned ingredients that were on the market prior to the Sept. 6 deadline.

The FDA initially proposed the rule in 2013 after data suggested that long-term exposure to certain ingredients could pose health risks, including bacterial or hormonal effects. The final rule was issued last September after manufacturers either provided no additional data or submitted information that was insufficient to rule the ingredients safe and effective, the FDA said.

The 19 ingredients affected by the ban are:

  • cloflucarban;
  • fluorosalan;
  • hexachlorophene;
  • hexylresorcinol;
  • iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate);
  • iodine complex (phosphate ester of alkylaryloxy polyethylene glycol);
  • nonylphenoxypoly (ethyleneoxy) ethanol-iodine;
  • 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.

The FDA gave manufacturers 1 year to submit data on the safety and effectiveness of three other ingredients — benzalkonium chloride, benzethonium chloride and chloroxylenol — in antibacterial soaps. According to Fischer, the FDA is still collecting data on these ingredients. In the meantime, manufacturers are allowed to market consumer antibacterial washes containing them. – by Gerard Gallagher

Reference:

Federal Register. Safety and effectiveness of consumer antiseptics; topical antimicrobial drug products for over-the-counter human use. 2016. https://www.federalregister.gov/documents/2016/09/06/2016-21337/safety-and-effectiveness-of-consumer-antiseptics-topical-antimicrobial-drug-products-for. Accessed September 7, 2017.

Disclosure: Woodcock and Fischer work for the FDA.