Decades Later, FDA Takes Action on Safety of Antibacterial Soaps

Commonly used antibacterial soaps are no better at killing germs than washing with plain soap and water, but may harm health and contribute to making bacteria resistant to antibiotics, the U.S. Food and Drug Administration announced Monday.

"New data suggest that the risks associated with long-term, daily use of antibacterial soaps may outweigh the benefits," Colleen Rogers, Ph.D., a lead microbiologist at FDA, said in a statement.

In its proposed rule issued Monday, the FDA states that makers of antibacterial soaps and body washes must now demonstrate the safety and effectiveness of those products, noting:

Several important scientific developments that affect the safety evaluation of these ingredients have occurred since FDA's 1994 evaluation of the safety of consumer antiseptic active ingredients under the OTC Drug Review. New data suggest that the systemic exposure to these active ingredients is higher than previously thought, and new information about the potential risks from systemic absorption and long-term exposure have become available. New safety information also suggests that widespread antiseptic use can have an impact on the development of bacterial resistance.

Environmental and public health watchdog groups have long sounded the alarm about triclosan, a common anti-bacterial agent.

In 2008, Environmental Working Group found that

Triclosan has been linked to cancer in lab animals, has been targeted for removal from some stores in Europe for its health and environmental risks, and the American Medical Association recommends against its use in the home. It is also linked to liver and inhalation toxicity, and low levels of triclosan may disrupt the thyroid hormone system. Thyroid hormones are essential to proper growth and development, particularly for brain growth in utero and during infancy.

Triclosan breaks down into very toxic chemicals, including a form of dioxin; methyl triclosan, which is acutely toxic to aquatic life; and chloroform, a carcinogen formed when triclosan mixes with tap water that has been treated with chlorine. Scientists surveyed 85 U.S. rivers and streams, and found traces of triclosan in more than half.

Other studies indicate that it contributes to antibiotic-resistant bacteria.

According to reporting by Bloomberg, "Chemicals like triclosan were never intended for mass consumer use."

The FDA first proposed removing triclosan from some products 35 years ago, the Natural Resources Defense Council points out, but no final action from the FDA meant its use continued and grew.

In 2010, the NRDC sued the agency to make it issue a final rule on triclosan. Monday's proposal comes as a result of a settlement from that lawsuit.

"This is a good first step toward getting unsafe triclosan off the market," said Mae Wu, an attorney in NRDC's health program. "FDA is finally taking concerns about triclosan seriously."

While the proposed rule covers soaps and body washes, it leaves out products that don't use water like antibacterial wipes and sanitizers. The group Safer Chemicals Healthy Families points out that triclosan is widespread, and may also appear in products like toothpaste, cutting boards, yoga mats, textiles and household cleaners.

_____________________