Feds burst bubbles with antibacterial soap scrutiny

Under a newly proposed rule, the U.S. Food and Drug Administration will require makers of antibacterial hand soaps and body washes to demonstrate that their products are safe and more effective than regular soap in preventing infection and the spread of bacteria.

"Although consumers generally view these products as effective tools to help prevent the spread of germs, there is currently no evidence that they are any more effective at preventing illness than washing with plain soap and water," read an FDA statement issued Monday.

Companies that fail to demonstrate the safety and effectiveness of their products will have to reformulate them to back up the product claims or relabel them to keep them on store shelves.

The FDA said research has suggested that long-term exposure to antibacterial or antimicrobial chemicals such as triclosan in liquid soaps and triclocarban in bar soaps could have negative hormonal effects and allow bacteria to mutate into harder-to-control strains.

Animal studies have shown that triclosan may alter the way hormones work in the body, the FDA said. And while effects on animals don't always translate to similar effects on humans, the agency said more research needs to be done to better understand what effect, if any, the chemicals might have on the human body.

"People are using these products every day," said Mae Wu of the Natural Resources Defense Council, which questions the safety of the soaps. 

"Studies show that it might affect our hormones, important brain function and reproductive function, and we don't want to be exposed more than we have to," she told Al Jazeera.

The FDA's new guideline — which hasn't been finalized but is essentially effective immediately — applies just to antibacterial soaps that require water. Hand sanitizers and soaps used in places like hospitals are not affected.  

Some 2,000 soap products in the United States contain antimicrobial chemicals, and 93 percent of those in liquid form contain triclosan, the FDA said. Such products include Softsoap products from Colgate Palmolive, Cetaphil from Galderma Laboratories and Dial products from Henkel AG.

"Due to consumers' extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit ... to balance any potential risk," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

The FDA said the action is part of a larger ongoing review by the agency to ensure that antibacterial ingredients are safe and effective.

The announcement came five days after the FDA issued new voluntary guidelines to phase out the use of antibiotics as a growth enhancer in livestock, also in an effort to stem a surge in human resistance to antibiotics.

The livestock guidelines are "part of the (same) general equation of what are the benefits of using antimicrobials and how do they stack up against any risks?" said Sandra Kweder, deputy director of the Office of New Drugs at the FDA, in a conference call with journalists on Monday.

Almost all soaps labeled antibacterial or antimicrobial contain at least one of the antibacterial ingredients addressed in the FDA's proposed rule, most notably triclosan and triclocarban, and some deodorants may contain them, the agency said.

The proposed rule will be available for public comment for 180 days. Companies will be given one year to submit new data and information, followed by a 60-day rebuttal comment period.

Kweder said the proposed rule follows a longstanding public debate over antimicrobial products.

The FDA in 2005 suggested methods that companies could use to test their antimicrobial products and ensure safety and efficacy, she said. But she noted that the FDA never required companies to actually perform the tests or submit any such data to the agency.

"We want companies to test these products so consumers will know if there is any benefit," Kweder said, after poor response from the earlier voluntary testing schemes.

The American Cleaning Institute and the Personal Care Products Council take issue with the FDA's decision.

"We are perplexed that the agency would suggest there is no evidence that antibacterial soaps are beneficial as industry has long provided data and information about the safety and efficacy of these products," the industry groups said in a press release Monday.

"Consumers should continue to have access to antibacterial products that are used safely and effectively every day, in homes, offices, schools, child care centers, food facilities and other commercial settings."

In 2010 the European Union banned triclosan from products that come in contact with food. And in March the Canadian government deemed the chemical was toxic to the environment.

Still, the FDA is taking its time. Despite 40 years of investigation, the FDA says a final rule on antibacterial soaps for the U.S. won't be issued until 2016.  

Al Jazeera correspondent Kimberly Halkett contributed to this report. With Reuters.