FDA advisers say antibacterial soaps no better than regular soap and water

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," Dr. Alastair Wood, chairman of the Nonprescription Drugs Advisory Committee, said after the meeting.


Panelist Dr. Mary E. Tinetti said unless antibacterials can show some added benefit, "I think we’re seeing a lot of sentiment against [them] 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.


"The importance of controlling bacteria in the home is no different than the professional setting," said Elizabeth Anderson, associate general counsel for the Cosmetic, Toiletry and Fragrance Association. "We feel strongly that consumers must continue to have the choice to use these products."


Industry representatives said they would provide more data to the FDA showing the products are safe and effective.


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.


Dr. Stuart B. Levy, president of the Alliance for Prudent Use of Antibiotics, said laboratory studies have suggested the soaps sometimes leave behind bacteria that have a better ability to flush threatening substances – from antibacterial soap chemicals to antibiotics intended to cure infections.


"What we’re seeing is evolution in action," he said of the process.


He advocated restricting antibacterial products from consumer use, leaving them for hospitals and homes with very sick people, where he says they are needed most.


"Bacteria are not going to be destroyed," he said. "They’ve seen dinosaurs come and go. They will be happy to see us come and go. Any attempt to sterilize our home is fraught with failure."


Levy said overuse of antibiotics is the main cause of bacteria’s developing resistance to them.

He acknowledged that a yearlong study showed that homes using antibacterial soaps did not show an increase in resistant bacteria in significant numbers, but he argued the soaps will still contribute to resistance over a longer period.


Panelists also distinguished alcohol-based hand cleansers from antibacterial soaps and washes. The cleansers are particularly useful in situations where there is no soap and water.