USA

FDA Orders Antibacterial Ingredients Removed From Soaps

Manufacturers couldn't prove such products were more effective than regular soap and water

USA
REUTERS
Sep 03, 2016 at 11:17 AM ET

Germophobes around the country are likely experiencing a collective freak out over a new U.S. Food and Drug Administration regulation. The FDA announced Friday that manufacturers of antibacterial soaps will no longer be able to market these products because they have not demonstrated that certain active ingredients are safe for long-term use, and there is no proof that such soaps are more effective than normal soap and water.

The rule, according to the FDA, refers to antiseptic wash products that contain one or more 19 active ingredients, including triclosan and triclocarban. It does not refer to waterless hand sanitizers or wipes, or antibacterial products that are used in health care settings. “Consumers may think antibacterial washes are more effective at preventing the spread of germs but have no scientific evidence that they are any better than plain soap and water,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”

In 2013, the FDA proposed a rule that required makers of antibacterial soaps to provide the agency with data on both the safety and the effectiveness of certain ingredients, including data that showed these soaps were better than regular soaps at preventing illness and/or minimizing the risk of infection. The proposal came after some research indicated that long-term exposure to ingredients such as triclosan (found in liquid soaps) and triclocarban (found in bar soaps) could pose certain health risks, such as bacterial resistance or hormonal effects. Manufacturers either submitted insufficient data or were unable to provide any data proving antibacterial products were superior.

“In response to comments submitted by industry, the FDA has deferred rulemaking for one year on three additional ingredients used in consumer wash produts—benzalkonium chloride, benzethonium chloride and chloroxylenol—to allow for the development and submission of new safety and effectiveness data for these ingredients,” the FDA wrote in a statement. “Consumer antibacterial washes containing these specific ingredients may be marketed during this time while data are being collected.”

Manufacturers will have a year to comply with the rule either by taking their products off the market or by reformulating existing products to meet new safety standards. However, some soap makers already began phasing out their usage of certain ingredients after the 2013 proposal.

In the past, researchers expressed concern that antibacterial soaps could contribute to the rise of drug-resistant germs. Some scientists have said that this new FDA ban will help alleviate some of the resistance that certain bacteria have built up from our use of strong germicides, and therefore slow the creation of any possible super germs.