Procter & Gamble Co. is among U.S. manufacturers affected by a new Food & Drug Administration rule that bans the marketing of antibacterial soaps that contain ingredients that might do more harm than good.
Cincinnati-based P&G (NYSE: PG) and other manufacturers have a year to reformulate their products or remove them from store shelves and stop related advertising.
The FDA said Friday the rule would affect about 2,100 products, or 40 percent of the soaps and body wash market.
The ban applies to consumer products containing one or more of 19 active ingredients. The two most commonly used are triclosan (in liquid soap) and triclocarban (in bar soap).
“Regarding triclocarban, we have one Safeguard bar of soap variant in the U.S. that we’ve already reformulated and will be replaced well ahead of the FDA deadline,” P&G spokeswoman Tressie Rose told me. “A lot of coverage has focused on triclosan, which P&G removed from our products a few years ago."
This rule doesn’t affect consumer hand sanitizers, wipes or antibacterial products used in health care settings, the FDA said.
“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,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”
The FDA first proposed the ban in 2013, noting that some studies suggested that long-term exposure to active ingredients could pose health risks such as bacterial resistance or hormonal effects.
“Companies will no longer be able to market antibacterial washes with these ingredients because manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections,” the FDA stated.
In response to request from manufacturers, the FDA deferred rulemaking for one year on three additional ingredients used in consumer wash products: benzalkonium chrolide, benzethonium chloride and cholroxylenol (PCMX). Consumer antibacterial washes containing those ingredients may be marketed while their safety and effectiveness are studied further.
If plain soap and water aren’t available and a consumer uses hand sanitizer instead, the U.S. Centers for Disease Control and Prevention recommends that it contain at least 60 percent alcohol.
Source :http://www.bizjournals.com/
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