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FDA Issues Final Rule on Antibacterial Soaps

FDA news release; 2016 Sep 2

Publish date:

The FDA has issued a final rule establishing that over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients can no longer be marketed. Under the final rule, companies will no longer be able to market antibacterial washes with these ingredients because manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Details of the final rule include:

• The final rule applies to consumer antiseptic wash products containing 1 or more of 19 active ingredients, including the most commonly used ingredients – triclosan and triclocarban.

• The rule does not affect antibacterial products used in health care settings.

• The FDA has deferred rulemaking for 1 year on 3 additional ingredients used in consumer wash products—benzalkonium chloride, benzethonium chloride, and chloroxylenol—to allow for the development and submission of new safety and effectiveness data for these ingredients.

Citation: The US Food and Drug Administration. FDA issues final rule of safety and effectiveness of antibacterial soaps. FDA Web site. September 2, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm517478.htm. Accessed September 4, 2016.

Commentary: This is an example of marketing getting far ahead of the science which supports such marketing. People are afraid of germs. But as this FDA announcement points out —there is no evidence that antimicrobials added to soap decrease infections compared to regular soap and water—and there actually may be harm to them by increasing antimicrobial resistance and potential hormonal effects of the additives. With the exception of 3 specific antimicrobial additives that are still under study, all products that use the other 19 active ingredients will need to change their formulas or be taken off the market within 1 year.1 This rule applies to consumer soap, but does not affect either consumer or health care use of hand sanitizer. —Neil Skolnik, MD

1. US Food and Drug Administration. Antibacterial soap? You can skip it—Use plain soap and water. Consumer updates. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm378393.htm. Accessed September 9, 2016.

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