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FDA Cracks Down on Antibacterial Soaps

FDA’s Center for Drug Evaluation and Research (CDER) director Janet Woodcock said that consumers may believe that antibacterial washes are more effective at preventing the spread of disease-causing germs, but there are actually no scientific evidence to back up the idea that these products are better than soap and water.

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The FDA says, they aren’t any more effective than regular soap and manufacturers have been unable to prove that they’re safe for long-term use.

Linkou Chang Gung Memorial Hospital nephrologist Yen Tzung-hai (顏宗海) said that “Triclosan an triclocarban can be considered antibiotics”.

This final rule applies to consumer antiseptic wash products containing one or more of 19 specific active ingredients, including the most commonly used ingredients – triclosan and triclocarban.

The Food and Drug Administration (FDA) yesterday said that it would not immediately ban the use of chemicals used in antibacterial soaps, despite a U.S. prohibition on 19 such substances, adding that it would discuss the issue with specialists. Seventeen other active ingredients were also banned.

The FDA’s ruling specifically targets triclosan and triclocarban because of studies that show that these agents can generate drug-resistant bacteria and interfere with hormone levels, according to the agency. Manufacturers will have one year to remove the ingredients from their products or to take them off the market.

Antibacterial soaps containing benzalkonium chloride, benzethonium chloride and chloroxylenol will remain on the market while manufacturers develop additional safety and effectiveness data for these ingredients, she said. At that time, the agency required manufacturers to provide additional data on the safety and effectiveness of the active ingredients in their antibacterial soaps, if they wanted to keep those products on the market. “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term”. Dr. Michael Doldan with WNY Immediate Care said, “I think the antibacterial soap label catches the eye of some people, and they think that must be better right?”

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If soap and water aren’t available, the CDC recommends that people use an alcohol-based hand sanitizer containing at least 60 percent alcohol.

FDA bans antiseptic chemicals from soaps, cites no evidence