The Food and Drug Administration issued a proposed rule requiring manufacturers to prove that their antibacterial cleaners are safe and more effective than plain soap and water.An estimated 75% of the anti-bacterial liquid soaps and body washes sold in the United States contain triclosan, a germ-killing ingredient. The only problem is, the Food and Drug Administration has no idea whether it actually works — and there's some evidence it may pose health risks.
To find out, the FDA on Monday issued a proposed rule requiring manufacturers to prove that their antibacterial cleaners are safe and more effective than plain soap and water. If companies can't show that their products are safe and effective, the soaps would have to be reformulated or relabeled to remain on the market.
"We want companies to actually test these products so that consumers that purchase them have a sense whether there really is any benefit at all over plain soap and water," said Sandra Kweder, deputy director of the office of new drugs at FDA's Center for Drug Evaluation and Research.
A joint statement from the American Cleaning Institute and the Personal Care Products Council said "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 efficiency of these products."
That's not FDA's take on it. "Consumers assume that by using antibacterial soap products they're protecting themselves and their families from illness — but we don't have any evidence that they're better than simple soap and water," Kweder said.
The advertising used for these products makes consumers think if they wash with them they won't get sick, said Kweder. "You'll see pictures of people sneezing and coughing and looking pretty ill."
But many of those images "look like people who have viral illnesses" such as the common cold, she said. Viruses are the most common cause of infections in the United States and antibacterial agents have no effect on them. Currently the only use for which triclosan has been shown to be effective is as an anti-gingivitis ingredient in toothpaste, said Kweder.
These products often sell for slightly more than regular soaps, so consumers are paying a premium for something which may be no better, or even worse, than plain soap and water.
"Simple hand washing with soap and water still remains one of the most effective ways to decrease the risk of spreading infections after preparing food, using the toilet, or after coughing or blowing your nose," said David Hill, director of global public health at Quinnipiac University's medical school in Hamden, Conn.
The federal ruling on triclosan and other antibacterial ingredients lends new support to longstanding warnings from scientists who say the chemicals can interfere with hormone levels.
"Given our emerging understanding of chemicals as hormone disruptors, this is a remarkable and positive step towards protecting children," said Leonardo Trasande, a professor of environmental medicine at New York University's Langone Medical Center.
Some evidence suggests that there may be an association between triclosan exposure and allergies. Because of that "there is little justification for widespread use of triclosan when soap and water or alcohol based hand sanitizers are available, said Trasande.
There are also concerns that the widespread use of antibacterial soaps may contribute to antibiotic resistance. "There are laboratory data showing that bacteria exposed to these products do change their resistance patterns," said Kweder. FDA wants to know more.
The agency's proposal comes more than 40 years after the agency was first tasked with evaluating triclosan and similar ingredients. Ultimately, the government agreed to publish its findings only after a legal battle with an environmental group, which accused the FDA of delaying action.
What the FDA decides to do and whether triclosan continues to be allowed in household cleaners could have broader implications for a $1 billion industry that includes hundreds of anti-bacterial products from toothpaste to toys.
The FDA has been working on this question since 2005, said Colleen Rogers, one of the agency's lead microbiologists.
The rules would not affect hand sanitizers, said Kweder. While soap and water work better than alcohol-based sanitizers "they're effective for use when water's not available."
The proposed rule gives companies until December 2014 to submit data and studies. The agency's goal is to finalize the rule "one way or the other" around September 2016, Kweder said.
Personally, I would stay away for any soap with chemicals.