Final Rule for Antibacterial Soap Efficacy and Safety Released by Federal Regulators

Officials with the U.S. Food and Drug Administration (FDA) just released the agency’s final rule concerning over-the-counter (OTC) consumer antiseptic hand soap products that are made with specific active ingredients, including triclocarban and triclosan.

These soaps are no longer marketable and firms that make these products will not longer be permitted to market these products as ingredient safety and efficacy could not be proven better when compared to plain soap and water. Also, according to Patient Daily, no evidence exists that these OTC soap products impede the spread of illness and infections.

Some manufacturers have begun eliminating the 19 named ingredients in the FDA list from their products. The two most common are triclocarban and triclosan, according to Patient Daily. The FDA ruling does not apply to consumer hand wipes, sanitizers, or antibacterial products that health care professionals use.
“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,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said. “In fact, some data suggests antibacterial ingredients may do more harm than good over the long term.”

According to Parent Herald, the agency has given companies one year to remove the items on the FDA’s list from their products.

Meanwhile, The Guardian reports that the antibacterial soaps that contain the banned ingredients do more harm than good. And, although many companies claim that these antibacterial soaps are important in eliminating bacteria, basic washing with regular soap and water is considered sufficient to kill potential pathogens that lead to infections in humans. In fact, adding these antibiotic chemicals may cause bacteria to become resistant after prolonged use.

The Parent Herald also reported that, although there is no direct toxicity from triclosan, some studies reveal that overexposure may cause a hormonal imbalance in animals. Triclosan may also cause antibiotic-resistant bacteria to develop. As the bacteria strengthen, they become able to resist even the strongest of antibiotics.

Triclosan, one of the more common components used today in antibiotic soaps was actually first introduced as a cleaning solution for medical practitioners for use prior to surgery. Soap companies began adding the chemical to their hand soaps, touting them as being able to kill unwanted bacteria.

Triclosan use has now become popular in consumer products such as soap, toothpaste, baby pacifiers, and even fabrics. Triclosan use has become so ubiquitous that a nationwide survey involving 2,517 healthy individuals and conducted in 2003 revealed that the chemical was found in the urine sample in 75 percent of those tested. Triclosan was also discovered in the breast milk of women and in human plasma, according to Parent Herald.

This entry was posted in Health Concerns, Toxic Substances and tagged , , , , , , , . Bookmark the permalink.

© 2005-2018 Parker Waichman LLP ®. All Rights Reserved.