FDA: Final Ruling on OTC Antibacterial Soaps

The Food and Drug Administration (FDA) issued a final rule regarding over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients.

The Food and Drug Administration (FDA) issued a final rule determining that over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients can no longer be marketed because manufacturers have not demonstrated that the ingredients were both safe for long-term daily use and more effective than plain soap and water for the prevention of illness and the spread of certain infections. 

The final rule as published in the Federal Register affects consumer antiseptic wash products (those intended for use with water and are rinsed off after) that contain one or more of the 19 specific active ingredients, including triclosan and triclocarban, the most commonly used ingredients. 

The FDA initially proposed a rule in 2013 following some data that suggested long-term exposure to certain active ingredients in antibacterial products (eg, triclosan [liquid soaps], triclocarban [bar soaps]) could lead to bacterial resistance or hormonal effects. Manufacturers were required to provide the agency with additional data on the safety and efficacy of certain ingredients used in OTC consumer antibacterial washes in order to continue marketing products with those ingredients. This included clinical study data showing superiority of these products over non-antibacterial washes in preventing human illness or reducing infection. 

Manufacturers of the antibacterial hand and body wash products did not provide the required data to establish safety and efficacy for the 19 active ingredients listed in the final rulemaking. There was either no additional data submitted or insufficient data was submitted to deem the ingredients as Generally Recognized as Safe and Effective. 

The FDA has deferred rulemaking for 1 year on three other ingredients found in consumer wash products: benzalkonium chloride, benzethonium chloride, and chloroxylenol (PCMX). As the FDA allows for the development and submission of new safety and efficacy data for these ingredients, manufacturers may still market consumer antibacterial washes containing these ingredients. 

If soap and water are not available for washing and a consumer uses hand sanitizer instead, the Centers for Disease Control and Prevention (CDC) recommends that it be an alcohol-based sanitizer containing ≥60% alcohol. Consumer hand sanitizers or wipes, or antibacterial products used in healthcare settings are not affected by this final rule. 

Manufacturers must comply with the final rulemaking and either remove products from the market or reformulate these products within 1 year.

For more information call (888) 463-6332 or visit FDA.gov.