Antiseptic Soaps under Scrutiny

Regulation

FDA is assessing the benefits of antibacterial consumer products as well as risks to public health and the environment should these products foster bacterial resistance.

On Oct. 20–21, the agency hosted a meeting in Silver Spring, Md., to gather information on antiseptic soaps, lotions, body washes, and wipes. Prior to the meeting, the agency released a document raising concerns about these products. Although their benefits are obvious in a health care setting where infection risks are high, the benefit of consumer antiseptics is less clear, the document says.

Currently, household and health care antiseptics are not regulated separately. At the meeting, FDA considered whether they should be. Currently, FDA sets rules for antiseptics used on humans and animals, and EPA regulates disinfectants applied to inanimate surfaces.

About six different antiseptic ingredients–or biocides–are used in household products, but triclo-san is the most common. In the lab, repeated exposures to sublethal doses of triclosan reduced bacterial susceptibility, which may also occur in the real world, the FDA document says.

The agency also has concerns about triclosans environmental effects. Although alcohol or bleach-based biocides dissipate quickly, triclosan often survives the sewage treatment process and may harm algae, FDA says.

Some medical groups oppose the routine use of antiseptics. The Council on Scientific Affairs of the American Medical Association said in 2002 that if bacterial resistance is shown for a product, it should not be used until data demonstrate it has no effect on public health.

However, the Soap & Detergent Association and the Cosmetic Toiletry & Fragrance Association claim that there is simply no clinical real-world evidence of increased [bacterial] resistance resulting from the use of antiseptic products.

FDAs eventual decision could have large implications on a valuable, growing market. According to analysts at Datamonitor, about 1,500 new antibacterial consumer products have been introduced since 2000.