FDA Bans Antibacterial Ingredients From Soaps

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For decades, store shelves have featured hand soaps, body washes, dish soap and other products that proudly proclaimed (or is that claimed) that they were antibacterial and helped thwart germs. However, they will not have the same labels or contents in the future. The U.S. Food and Drug Administration (FDA) issued a ruling that bans the ingredients that made them “antibacterial” from the soaps.

The decision, announced Friday, had been years in the making as the federal agency requested that and waited for soap makers to demonstrate that the chemicals they were using in their products were safe for daily use. The FDA was concerned that so-called antibacterial washes had active ingredients that were, at best, ineffective and, at worst, unhealthy for users.

The ruling does not affect hand “sanitizers” or chemicals in wipes sold to consumers. It also has no affect on antibacterial products used in hospitals and doctors’ offices.

There is a list of 19 chemical ingredients that is now banned from use in over-the-counter antibacterial wash products. The list includes two commonly used chemicals: triclosan and triclocarban. Some companies have already started removing these ingredients from their product formulas, and redesigning their labels. The FDA is giving manufacturers of effected soap products one year to comply and either remove their products completely from stores or change the ingredients they use to make them.

Soap manufacturers have known the ruling was undoubtedly forthcoming. The FDA issued a proposed ruling in 2013 that called for the ban. That action was spurred by research data suggesting that long-term use of some antibacterial products could lead to bacterial resistance or changes in hormone levels. The soap makers were asked then to prove that their products contents are safe and that their usage is more effective than plain soap and water in preventing the spread of infections and illness.

Antibacterial hand and body wash makers did not provide the data requested to ascertain the safety and effectiveness of the 19 active ingredients indicated. There was information submitted, but the FDA did not feel the data was sufficient  to warrant that the 19 ingredients could be deemed “Generally Recognized as Safe and Effective.” The companies did submit more information on three other chemicals in the FDA request that are used in consumer products for washing. The FDA is researching those ingredients – benzalkonium chloride, benzethonium chloride and chloroxylenol – further and is allowing products that include them to be sold for the foreseeable future.

“Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water,” according to the director of the FDA’s Center for Drug Evaluation and Research, Dr. Janet Woodcock. She pointed out that there are indications “that antibacterial ingredients may do more harm than good over the long-term.”

Government officials emphasize that washing hands with plain soap and running water remains one of the most effective ways consumers can avoid getting sick or spreading their germs to others. If soap and water are not available, the U.S. Centers for Disease Control and Prevention (CDC) say to use an alcohol-based hand sanitizer instead, provided it contains a minimum of 60 percent alcohol. Do not assume that so-called antibacterial ingredients found in some soaps on shelves now (until the complete FDA ban takes place) are effective.

Written and Edited by Dyanne Weiss

U.S. Food & Drug Administration: FDA issues final rule on safety and effectiveness of antibacterial soaps
Scientific American:   U.S. Bans Common Chemicals in Antibacterial Soaps
U.S. Centers for Disease Control and Prevention: Handwashing: Clean Hands Save Lives

Photo courtesy CDC

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