FDA Curtailment of Antibacterial Soap Could Save Lives, Ecosystems

The Food and Drug Administration is giving manufacturers of antibacterial soaps and body washes a year to prove their products are safe and more effective than regular soap at preventing infection. Those that fail to make the cut risk being reformulated, relabeled or removed.

According to Colleen Rogers, a lead microbiologist for the FDA, there is no evidence that the products are better at preventing illness than plain soap, and that new studies suggest "risks associated with long-term, daily use of antibacterial soaps may outweigh the benefits."

Of particular concern is triclosan, a common ingredient that has exhibited hormone disrupting effects in animal studies. Effects in rats range from shifts in thyroid hormone and testosterone concentrations in males to changes in uterine weight in females.

The FDA also cited research indicating that the soaps may contribute to bacterial resistance to antibiotics as a reason behind the proposed law. Bacteria-resistant infections are a growing concern among health officials who warn of a high-stakes arms race against ever-evolving strains of bacteria. A study issued by the Centers of Disease Control and Prevention earlier this year estimated that some 2 million people living in the United States contract antibiotic-resistant infections every year. Of this number, roughly 23,000 die.

Besides their toll on human life, such infections are incredibly expensive, adding $20 billion in excess direct health costs annually, the study noted.

Humans aren't the only ones affected, either. A study published in the journal Environmental Science and Technology back in July found that levels of triclosan lurking in US waterways are giving rise to resistant bacteria.

John Kelly is a professor and associate chairperson at Loyola University Chicago's Department of Biology and the co-author of the study published over the summer. Based on his and his colleagues' research, Kelly said he supports the proposed law, saying it should help decrease concentrations of antibacterials like triclosan in human-impacted ecosystems.

"But it will take time," he told Nature World News, citing other research suggesting triclosan takes more than 30 years to degrade.

Concern about the effects of compounds like triclosan aren't new for the FDA: In 2010, The Washington Post obtained a letter written by the health agency to a congressman admitting that recent studies called the health effects of triclosan into question.

When asked why the agency chose to take action now, FDA spokeswoman Andrea Fischer told Nature World News in an email: "We have evaluated the available literature, the recommendations from FDA's public meetings on antiseptics and the data and other information that were submitted as part of the agency's 1994 rulemaking on the effectiveness of consumer antiseptic wash active ingredients."

The proposed law does not apply to products used without water, including hand sanitizers and hand wipes, she added, saying they will be evaluated separately because they "are intended to be used in different circumstances."