WASHINGTON — After more than 40 years of study, the U.S. government siad it found no evidence that common anti-bacterial soaps prevent the spread of germs, and regulators want the makers of Dawn, Dial and other household staples to prove their products do not pose health risks to consumers.
Scientists at the Food and Drug Administration announced Monday they are revisiting the safety of triclosan and other sanitizing agents found in soap in countless kitchens and bathrooms. Recent studies suggest triclosan and similar substances can interfere with hormone levels in lab animals and spur the growth of drug-resistant bacteria.
The government’s preliminary ruling lends new support to outside researchers who long argued the chemicals are, at best, ineffective and at worst, a threat to public health.
“The FDA is finally making a judgment call here and asking industry to show us that these products are better than soap and water, and the data don’t substantiate that,” said Stuart Levy of the Tufts University School of Medicine.
While the rule only applies to personal hygiene products, it has implications for a broader $1 billion industry that includes thousands of anti-bacterial products, including kitchen knives, toys, pacifiers and toothpaste. Over the last 20 years, companies added triclosan and other cleaners to thousands of household products, touting their germ-killing benefits.
Under a proposed rule released Monday, the agency will require manufacturers to prove that anti-bacterial soaps are safe and more effective than plain soap and water. Products that are not shown to be safe and effective by late 2016 would have to be reformulated, relabeled or removed from the market.
“I suspect there are a lot of consumers who assume that by using an anti-bacterial soap product, they are protecting themselves from illness, protecting their families,” said Sandra Kweder, deputy director in the FDA’s drug center. “But we don’t have any evidence that that is really the case over simple soap and water.”
A spokesman for the cleaning product industry said the FDA already has “a wealth of data” showing the benefits of anti-bacterial products.
Monday’s action affects virtually all soap products labeled anti-bacterial, including popular brands from CVS, Bath and Body Works, Ajax and many other companies.
The rule does not apply to hand sanitizers, most of which use alcohol rather than anti-bacterial chemicals.
An FDA analysis estimates it will cost companies $112.2 million to $368.8 million to comply with the new regulations, including reformulating some products and removing marketing claims from others.
The agency will accept data from companies and researchers for one year before beginning to finalize the rule.