FDA Targeting Antibacterial Soaps

Agency is seeking tougher rules on antibacterial soaps, which it says may pose health risks.

December 17, 2013

WASHINGTON — Maintaining there is no evidence that antibacterial chemicals used in liquid soaps and washes prevent the spread of germs and that they may even pose health risks, the Food and Drug Administration (FDA) has announced that it is restudying the safety of the soaps and their ingredients, the Miami Herald reports.

Recent studies have shown the chemicals triclosan, which is found in antibacterial soaps and washes, can interfere with hormone levels and spur the growth of drug-resistant bacteria. Researchers have long warned that the chemicals are, at best, ineffective and at worst, a public health threat.

Under its proposed rule yesterday, the agency said it will require manufacturers to prove that their soaps and washes are safe and more effective than plain soap and water. Absent such proof, they must reformulate the product, relabel it or possibly remove it from the market. The agency will accept comments on its proposal before finalizing it in coming months.

"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," said Dr. Janet Woodcock, director of FDA's drug center.

Triclosan is found in an estimated 75% of antibacterial liquid soaps and body washes sold in the United States.

FDA’s preliminary rule applies only to personal hygiene products but has implications for the $1 billion industry that includes thousands of antibacterial products, including kitchen knives, toys, pacifiers and toothpaste.

Some scientists worry that triclosan can disrupt hormones in humans, raising the risk of infertility, early puberty and other developmental problems. Other experts are concerned that the chemical is contributing to a surge in drug-resistant germs that render antibiotics ineffective.

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