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What You Need To Know About the FDA’s Proposed Rule on Antibacterial Soap

Posted at October 1, 2014 | By : | Categories : Blog | 1 Comment

page-heading3As you may have already heard, big changes could be coming for the hand soap used in your facility’s restrooms and break rooms. Why?

In December of 2013, the U.S. Food and Drug Administration issued a proposed rule requiring antibacterial soap manufacturers to provide more evidence that these soaps are not only safe, but also more effective than plain soap. The FDA proposes that if soap manufacturers can’t show such effectiveness, their soap products would need to either be removed from the shelves, labeled differently, or reformulated.
While the proposed rule doesn’t apply to hand antibacterial soaps used in hospitals, it could still have a significant impact on many industries.

What Are the FDA’s Issues with Antibacterial Soap?

The FDA maintains that there’s currently no evidence that antibacterial soap is more effective than regular soap. Evaluations that test the effectiveness of antibacterial soaps usually don’t test their effects on infection rates. Therefore, the FDA’s proposed rule would require that evaluations demonstrate benefits over traditional soap.

Also, antibacterial soap contains triclosan (in liquid soaps) and triclocarban (in bar soaps) – chemicals associated with risks such as bacterial resistance to antibiotics. Bacterial resistance can negatively affect many medical treatments. Moreover, some studies have demonstrated that triclosan may change the activity of hormones in the human body.

According to Janet Woodcock of the FDA: “Antibacterial soaps and body washes are used widely and frequently by consumers in everyday home, work, school, and public settings, where the risk of infection is relatively low. Due to consumers’ extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk.”

Upcoming Triclosan Regulation
The U.S. Food and Drug Administration and the Environmental Protection Agency (EPA) are currently evaluating the effects of triclosan to help achieve consistent regulation. The EPA is concerned with triclosan as a pesticide, and the FDA is concerned with its use in soaps. Through collaboration, these agencies are more effectively testing triclosan and determining its affects on health.

Alternative to Using Antibacterial Soap?
If the day comes when triclosan and triclocarban wind up being removed from the market, many experts say not to worry. Washing with traditional soap and water has always been an effective means of avoiding the spreading of germs and illnesses. According to Centers for Disease Control and Prevention (CDC,) hand washing with regular soap and water is effective when done:


  • Before, during, and after preparing food
  • Before eating
  • Before and after caring for someone who is sick
  • Before and after treating a cut or wound
  • After using the restroom
  • After changing diapers or cleaning up a child who has used the toilet
  • After blowing your nose, coughing, or sneezing
  • After touching an animal, animal feed, or animal waste
  • After handling pet food or pet treats
  • After touching the garbage

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