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FDA Ruling Hits Soap Segment.

WASHINGTON -- The Food and Drug Administration this month banned the sale of soap containing triclosan and several other antibacterial agents, saying manufacturers had failed to show the chemicals were safe for daily use.

Manufacturers have a year to remove the 19 different outlawed chemicals from their products. Triclosan, used in liquid soaps, and triclocarban, an ingredient in bar soaps, are the most common of the banned agents, found in about 40% of soaps in the marketplace.

The FDA first pledged to look at triclosan in soap in 1974.

Triclosan is also found in the popular toothpaste brand Colgate Total and can remain there, the FDA said, after the manufacturer convinced the regulator that its benefits in fighting plaque and gingivitis outweigh the health risks.

In announcing its ban, on September 2, the FDA said it found no evidence that antibacterial soaps were any more effective in preventing infection than plain soap and water. Industry groups, including the American Cleaning Institute (ACI), had argued that washing with an antiseptic hand wash can help reduce the risk of infection beyond that provided by a non-antibacterial soap and water.

"The FDA already has in its hands data that shows the safety and effectiveness of antibacterial soaps," ACI said in a September 2 statement. "Manufacturers are continuing their work to provide even more science and research to fill data gaps identified by the FDA. In the coming year, ACI and its member companies will submit additional safety and effectiveness data on the key ingredients in use in consumer antibacterial soaps today: benzalkonium chloride, benzethonium cholride and chloroxylenol."

Those three ingredients can remain on the market for now, the FDA said this month, but the agency wants the industry to provide evidence that the chemicals are safe and shouldn't be banned.

Some consumer products makers, including Johnson & Johnson and Procter & Gamble, have already said they intend to phase out the antibacterial agents from their products.

Triclosan is one of eight chemicals that Walmart wants its suppliers to remove or restrict from various health and beauty, household and cleaning products. But Walmart said in July that it is not asking Colgate-Palmolive to remove triclosan from its toothpaste because it had not been deemed unsafe in that context by the FDA.

Colgate-Palmolive introduced triclosan in Colgate Total in 1997 and has promoted it as the "only toothpaste approved by the FDA to help fight plaque and gingivitis." Before approving the toothpaste, the FDA asked ColgatePalmolive to conduct toxicology studies, which demonstrated to the agency that triclosan was safe and effective in toothpaste.

No other toothpaste in the United States contains triclosan, though plenty of antibacterial soaps and cosmetics count it as an ingredient.

Research on how triclosan and other antibacterial chemicals affect the human organism is in its early stages. Scientists have studied triclosan's effects in mice and bullfrogs, and have raised questions about possible harmful human effects, especially in infants and young children.

The Centers for Disease Control and Prevention (CDC) tested more than 2,500 people in 2003 and found that nearly threefourths had triclosan in their urine.

Caption: Many soaps will have to be reformulated in the wake of an FDA ban
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Title Annotation:SPOTLIGHT
Publication:MMR
Date:Sep 19, 2016
Words:528
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