Oct. 20, 2005 -- Popular antibacterial soaps and washes are no more effective at preventing illness than plain -- and less expensive -- soap and water, an FDA advisory panel warned. The experts said it may not be worth the risk of spawning resistant bacteria.
The panel's conclusion could eventually lead to stricter regulation of hundreds of antibacterial products, now often sold with the suggestion that they offer an advantage over traditional cleansers.
But FDA officials said any potential rule changes that force stricter labeling or place limits on advertising claims are more than a year away at least.
Antibacterial soaps and alcohol-based hand gels are widely used by hospitals and clinics where they have shown some benefit in cutting the risk of patient-to-patient infections. But the products are also widely sold to the general public despite evidence that hand washing with regular soap and water is just as effective.
Regular Soap vs. Antibacterial Cleansers
In an 11 to 1 vote, advisory panel members concluded that mass-marketed antiseptics have shown no evidence of preventing infections more effectively than hand washing with regular soap.
"There's no evidence they're a good value," Alistair Wood, MD, chairman of the FDA's Nonprescription Drugs Advisory Committee, tells WebMD. "There doesn't seem any good reason to buy them."
The committee made a unanimous exception for evaporating alcohol-based hand cleansers, which it said could be of use in places without ready access to soap and water. Those places could include daycare settings with no nearby wash basin or use by travelers who spend time away from convenient, clean water sources.
Soap Industry Responds
Representatives of soap and detergent companies say their products live up to their labels, which claim that they significantly reduce the presence of germs on the hands.
"We believe that the benefit of reducing harmful germs on the skin is apparent," says Brian T. Sansoni, vice president of communications for the Soap and Detergent Association, an industry group.
"We are concerned that consumers' access to these products might be limited in some way," he says.
Risk of Resistant Bacteria
The FDA asked for the panel's advice because of a concern that chemicals used in antibacterial soaps could accumulate in the environment and promote potentially dangerous resistant germs.
The committee heard some evidence that two common antimicrobial agents, triclosan and triclocarban, accumulate in groundwater and soil. These have become widely used in products ranging from soaps to plastics. That could make them a risk for contaminating drinking water and farmed food and giving rise to potentially dangerous resistant bacteria.
The risk of resistant bacteria is theoretical. But several experts cautioned that even the potential risk of resistance may not be worth continued mass marketing of soaps that have no proven benefit to consumers.
Drug-resistant bacteria are considered a major health threat by public health experts. Some strains, including S. aureus (staph), have alarmed experts with increased levels of resistance to multiple antibiotics.
Ruth M. Parker, MD, an associate professor of medicine at Emory University in Atlanta and a member of the panel, called the potential for more antibacterial resistance "absolutely terrifying."
"You'd better show me its benefit and demonstrate to me why it still needs to be on the market," she tells WebMD.
Changes on soap-aisle shelves are not imminent, however. The FDA is unlikely to pull any existing products from the market but could move to raise the bar on new products or restrict their labeling or advertising.
Such changes could take place "at the soonest, in a year," says Charles Ganley, director of the FDA's office of nonprescription drugs.