On Monday, FDA announced a new proposed rule that would amend the 1994 TFM for OTC antiseptic drug products.  The change would require companies that sell antibacterial soaps and body washes that are labeled “antibacterial” or “antimicrobial” to prove through a “controlled clinical outcome study” that their products prevent the spread of illness better than ordinary non-bacterial cleansers without such labeling – evidence establishing the germ-killing properties of the antiseptic ingredients used in product formulations would not be sufficient to establish the effectiveness of these products. 

The FDA proposal responds in part to new scientific data that has emerged since the 1994 TFM was issued that suggests that there may be risks associated with long-term, daily use of antibacterial soaps that may outweigh their benefits.  For example, FDA cites data suggesting that the antiseptic ingredients,  triclosan (used in liquid soaps) and triclocarban (used in bar soaps), which can be absorbed through the skin, may contribute to bacterial resistance to antibiotics, and may have unanticipated hormonal effects.  In view of such potential risks, the FDA proposal is designed to require manufacturers to provide more robust scientific evidence to FDA to demonstrate the safety and effectiveness of antibacterial soaps.

The proposal would cover antibacterial soaps and body washes for consumer use, but would not affect such antiseptic products as hand sanitizers, sanitizing wipes, and antibacterial products used in healthcare settings or the food industry.

The new rule will be open for public comment until June 15, 2014 and then subject to a 60-day rebuttal period.  EPA also regulates antimicrobial chemicals as pesticides, and the two agencies are coordinating their regulatory activities in this area.