FDA panel finds no advantage in use of antibacterial soaps

WASHINGTON – Popular antibacterial soaps and washes offer no more protection than regular soap and water, a federal advisory panel said Thursday, telling companies to prove their products are better if they expect to continue making claims to the public.

The independent expert panel, which advises the Food and Drug Administration, said by an 11-1 vote that it saw no added benefits to antibacterials when compared with soapy handwashing.

Panelists also said soaps that use synthetic chemicals – as do many products which claim to eliminate 99 percent of germs they encounter – could contribute to the growth of bacteria resistant to antibiotics.

Those risks, coupled with a lack of demonstrated benefits compared with soap and water, raised the prospect of new limits on an industry that has grown astronomically in the past decade.

The experts did not vote to recommend that the FDA take any specific regulatory action against antibacterials, but did urge the agency to study the products’ risks versus benefits.

“There’s no evidence they are a good value,” said Dr. Alastair Wood, chairman of the Nonprescription Drugs Advisory Committee.

Panelist Dr. Mary E. Tinetti said unless antibacterials can show some added benefit, “I think we’re seeing a lot of sentiment against (antibacterials) being marketed to the consumer.”

Still, committee members said such products reduce infections as well as soap and water do. The experts also wondered whether antibacterials may provide added benefit to some people who are particularly at risk for certain illnesses.

The FDA is not bound by the decisions of its advisory panels, but often follows their advice. The agency has the authority to add warning labels to or restrict the marketing of such soaps and related items, but it has given no indication any such actions are imminent.

Representatives of the soap industry say antibacterials are safe and more effective than regular soap, although they provided little data to support that assertion. The industry contends that killing germs is better than washing them off.

FDA officials and panelists raised concerns about whether the antibacterials contribute to the growth of drug-resistant bacteria, and said the agency has not found any medical studies that definitively linked specific antibacterial products to reduced rates of infection.

Both kinds of soaps reduced infections in households, but neither one worked better than the other, experts told the panel.

Antibacterial products kill most of the bacteria they encounter. Regular soap helps separate bacteria from the skin so the bacteria wash down the drain or transfer to a towel.