On December 17, 2013, the US Food and Drug Administration (FDA) published a long-awaited Proposed Rule (PR), which requires manufacturers of antibacterial hand soaps and body washes to submit data and information to the agency proving their consumer-use antibacterial drug products are more effective than plain soap and water in preventing illness and the spread of infection. The PR amends FDA’s 1994 Tentative Final Monograph (TFM) for Over-the-Counter (OTC) Healthcare Antiseptic Drug Products and covers consumer antiseptic soaps and body washes that are intended to be washed off with water (OTC skin antiseptics and antimicrobial wipes not intended to be washed off, such as antimicrobial wipes and leave-on lotions/creams, will be addressed separately by FDA). As a result of the PR, thousands of topical antimicrobial drug products currently on the US market could eventually be reformulated or removed from the market depending on FDA’s final safety and efficacy determinations for this OTC drug category.     

In issuing the PR, FDA noted that while consumers generally view antibacterial hand soap and body wash products as effective tools to help prevent the spread of germs, the agency believes there is “currently no evidence that [antibacterial soaps and washes] are any more effective at preventing illness than washing with plain soap and water.” FDA further noted that “some data suggest that long-term exposure to certain active ingredients used in antibacterial products – for example, triclosan (liquid soaps) and triclocarban (bar soaps) – could pose health risks, such as bacterial resistance or hormonal effects." 

Under the PR, product manufacturers are requested to provide FDA with data addressing “long-term” and “repeat exposure” use parameters. FDA also wants manufacturers to provide the agency with clinical outcomes data showing evidence of effectiveness, such as a reduction in user infections compared with soap and water washing. Antimicrobial active ingredients for which no additional safety and efficacy data is provided to FDA will likely remain classified as Category III (additional safety/effectiveness data required) under the Agency’s final OTC Monograph for consumer antiseptic drug products. Only ingredients designated by FDA in a final Monograph as Category I (safe and effective) can be lawfully used to formulate an OTC drug.  OTC antimicrobial drugs currently being marketed in the US under FDA’s above noted 1994 TFM may remain on the market until one year after FDA publishes a final OTC Monograph for consumer antiseptic drug products.   

The PR provides a 180-day public comment period that runs until June 16, 2014. Further, new ingredient safety and effectiveness data must be submitted to FDA by December 16, 2014. Based on this timetable, FDA hopes to publish a final OTC Monograph for consumer antiseptics by September 2016.