FDA goes after antibacterial soaps

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The Food and Drug Administration is going after soaps and washes that might actually pose health risks.

A draft rule unveiled by the agency on Monday would require antibacterial soap companies to prove for the first time that their products are more effective than regular soap and water.

Millions of consumers use antibacterial soaps and body washes, but there is no evidence that they are any more effective at killing germs than traditional soap, the FDA said. In fact, some ingredients used in antibacterial products could actually have effects on users’ hormone levels or increase the risk of drug-resistant bacteria, creating risks that might outweigh the benefits, according to studies involving animals.

“I suspect there are many consumers — I know many — who assume that by using and antibacterial soap products, they are protecting themselves from illness; they’re protecting their families; they’re protecting their classroom if they are a teacher. But we don’t have any evidence that that is really the case over simple soap and water,” said Sandra Kweder, the deputy director of the FDA’s new drugs office.

The draft regulation requires antibacterial soap manufacturers to prove that their products are safe for long-term use and more effective than regular soap. If companies can’t prove that, their soaps will need to be changed or relabeled.

“Antibacterial soaps and body washes are used widely and frequently by consumers in everyday home, work, school, and public settings, where the risk of infection is relatively low,” Janet Woodcock, the head of the agency’s drug evaluation center, said in a statement. “Due to consumers’ extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk.”

Manufacturers that can’t prove their products’ effectiveness won’t have to take them off the market immediately, though. The draft regulation is open for public comments for 180 days. Companies also have one year to submit information about their products to the FDA.

The agency wants to finalize the rule by September 2016, Kweder said.  

The FDA’s proposal only covers soaps and body washes used with water. It does not affect antibacterial hand sanitizers, wipes or other products used at hospitals and other healthcare settings.

— This post was updated at 11:15 a.m.