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Antibacterial products get FDA safety challenge

Makers may be forced to alter ingredients

The government demanded that manufacturers prove germ-fighting chemicals were safe.Mandel Ngan/AFP/Getty Images

Popular antibacterial soaps and cleaning products could soon disappear from store shelves after the federal government demanded Monday that manufacturers prove that their germ-fighting chemicals were safe and more effective than plain soap and water.

The Food and Drug Administration published a proposed regulation to drop antibiotic-like substances found in soaps and cleaning liquid from a list of ingredients “generally recognized as safe.”

If the rules are made final by the FDA, it would probably force makers of personal hygiene products to demonstrate the safety of all bar soaps, liquid soaps, body washes, and dishwashing liquids labeled as “antibacterial” and “antimicrobial” or to remove or reformulate them by 2016.


Products promising antibacterial protection, sold under brand names including Dial and Lever, contain chemicals whose safety has been questioned for years, with research suggesting that they could interfere with hormones in the body and increase the resistance of bacteria to common antibiotic medications. Concern is focused on substances such as triclosan, found in liquid soaps, and triclocarban, found in bar soaps. “It’s an issue that’s been brewing since the mid-1990s,” said Dr. Stuart Levy, director of the Center for Adaptation Genetics & Drug Resistance at Tufts University School of Medicine. “We’ve been testifying against these products and waiting for the FDA to do something.”

His 1998 study published in the journal Nature found that triclosan destroyed bacteria similarly to antibiotics and led to the rise of mutant bacteria that could be more resistant to antibiotic drugs.

In a 2007 review of 27 triclosan soap studies, Levy and his colleagues also found that antibacterial soaps were no more effective than plain soap at preventing infectious-disease symptoms and reducing bacterial levels on hands.

Other researchers have found that antibacterial chemicals in soap interfere with hormonal systems in studies conducted in rats and mice. The chemicals decreased thyroid hormone levels and interfered with a cell’s ability to respond to sex hormones such as estrogen and testosterone, FDA deputy director Dr. Sandra Kweder said during a media briefing Monday.


Manufacturers will likely have to spend between $112 million and $369 million to reformulate products or relabel them, according to an FDA analysis.

The American Cleaning Institute and Personal Care Products Council, industry groups representing soap and hygiene product manufacturers, said in a joint statement that they intended to file comments to the FDA “reaffirming that the use of antibacterial wash products in the home environment does not contribute to antibiotic or antibacterial resistance.” The groups noted that they previously submitted “in-depth” data to the agency showing that antibacterial soaps vanquish more germs, including two dozen studies showing that these products led to greater reductions in bacteria on the skin than plain soap.

Almost all soaps labeled “antibacterial” or “antimicrobial” contain at least one of the ingredients that the FDA is proposing to ban. Household cleaning products with these labels likely also contain them. As many as 2,000 products could be affected, though some manufacturers have already started reformulating their products to remove triclosan and similar chemicals because of consumer concerns.

More than two-thirds of consumers say they look for liquid soaps making antibacterial claims, and more than one-third look for such labels when purchasing bar soaps, according to a survey this year conducted by Mintel, a global market research firm.

Most liquid hand sanitizers, such as Purell, and antibacterial wipes do not contain the worrisome ingredients and are not affected by the planned regulation, said the FDA. These “leave on” products contain alcohol instead to sanitize hands.


Industrial strength antibacterial products containing triclosan used in hospitals and food manufacturing facilities would not be affected by the new rule, nor are triclosan-containing toothpastes, such as Colgate Total, which are designed to fight gum infections. Toothpaste manufacturers submitted clinical trial data to the FDA establishing that their benefits outweigh any risks, Kweder said.

Such studies are lacking for antibacterial soaps and body washes. “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,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

Manufacturers will have about six months to submit comments on the planned regulation and up to a year after that to submit new research studies before the rule is finalized and implemented, likely in 2016. To keep these products on the market, companies will have to prove to the FDA that they work better than regular soap to prevent infections and pose no health risks when used regularly for many years.

The agency recommended using plain soap and water to wash hands instead of antibacterial soaps, which will remain on the market for now. If soap and water are not available, an alcohol-based hand sanitizer that contains at least 60 percent alcohol should be used.


“I applaud the FDA for taking a step to restrict the use of this harmful and ineffective chemical that continues to pollute our bodies,” Senator Edward Markey, Democrat of Massachusetts, said in a statement. “And I applaud companies that are already taking action to remove these dangerous chemicals and protect their consumers.”

Anthony Hay, a professor of microbiology at Cornell University, agreed that the “FDA has it right,” noting that triclosan and triclocarban from soaps have been found in sludge waste that’s consumed by worms — a food source for fish, dolphins, and birds. “It’s out there in the environment, and we don’t know what impact it’s having. There’s the real potential for harm and very minimal potential for benefit.”

Deborah Kotz can be reached at dkotz@globe.com. Follow her on Twitter @debkotz2.

Correction: An earlier version of this article incorrectly stated that Dove makes antibacterial soaps. They do not.