FDA Antibacterial Soap Rule Suggests Concern Over Chemicals

Monday, 16 Dec 2013 05:45 PM

By Morgan Chilson

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The Food and Drug Administration questioned whether there’s any evidence antibacterial soaps prevent disease and expressed concern that they might be creating a public health risk in a proposed tougher regulations released Monday.

Critics of the soaps that are supposed to kill harmful bacteria have been saying for years that the chemicals don’t work and that they may be creating drug-resistant germs. The FDA’s proposed new rule indicates the agency shares some of those concerns that chemicals used in antibacterial soaps, like triclosan, are safe, AP said.

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The rule will require manufacturers to prove their soap products using antibacterial chemicals are safe, The Associated Press said, and also more effective than the old-fashioned approach of soap and water. Should companies not be able to do this, they may have to change their marketing or even remove the products from the market.

The FDA will be accepting comments on the proposal before it is finalized.

“Antibacterial soaps and body washes are used widely and frequently by consumers in everyday home, work, school, and public settings, where the risk of infection is relatively low,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER) in a press release. “Due to consumers’ extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk.”

Consumers have prodded the FDA to release results of their evaluation of triclosan and other ingredients like it, the AP said. Most of the studies on the product have been done on animals, but some scientists are concerned the chemicals disrupt hormones in people, creating infertility issues, early puberty, and developmental problems.

In 2010, the European Union banned triclosan from being used in anything that will come in touch with food, such as silverware or food containers.

The FDA considered removing triclosan from all products in 1978, but did not take final action.

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