Antibacterial Hand Soaps Must Prove Germ-Killing Claims

Antibacterial hand washes would have to be proven safe and more healthy than plain soap to remain on store shelves under a U.S. proposal that could affect about half of the $900 million in liquid soaps sold each year.

Antibacterial soaps have gained “widespread consumer use” despite a lack of data showing added health benefits, the Food and Drug Administration said yesterday. The common ingredient, triclosan or triclocarban, also may be linked to hormone imbalances and antibiotic resistance, the FDA said, addressing 40 years of debate on overuse of the germ-killing chemicals.

New safety standards would affect as many as 2,000 soap products such as Henkel AG’s Dial, though many companies have already started phasing out triclosan, including Johnson & Johnson and Lysol-maker Reckitt Benckiser Group Plc. The rules also won’t apply to hand sanitizers such as Purell, and the FDA stopped short of addressing mouthwash, cosmetics and cleaners.

“It’s prudent for the FDA to take a step back and actually do a more thorough evaluation,” said Tracey Woodruff, director of the reproductive health and the environment program at the University of California in San Francisco. It’s “potentially misleading to consumers who aren’t that knowledgeable about this in terms of whether it’s really doing what it’s supposed to.”

Chemicals like triclosan were never intended for mass consumer use. The product began to be used as a surgical scrub in the 1970s, before slowly becoming prevalent as an ingredient in everyday household products, from soap to toothpaste to germ-resistant sponges.

Defining Safe

The FDA is giving the public six months to comment on the proposal and an additional 60-day rebuttal period, with the standards taking effect one year after the rule is made final. The agency may have to prepare itself for a fight with the American Cleaning Institute, which cited two dozen studies that it said have shown the benefits of using antibacterial soap.

“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,” the Washington-based lobbying group for the $30 billion U.S. cleaning-products industry said in a statement.

Kline & Co., a market researcher, estimates that about $900 million in liquid soaps were sold in U.S. retail in 2012, with about half labeled antibacterial. The FDA has never said whether triclosan, the main active ingredient, meets its standard for being “generally recognized as safe and effective.”

Market Effect

“It probably wouldn’t be an underlying big impact on the businesses if they’re forced to replace this,” said Ali Dibadj, a consumer-products analyst at Sanford C. Bernstein & Co. in New York. “The real question is, does this open up fear of using these products, period?”

J&J has said none of its baby-care products contain triclosan, and the New Brunswick, New Jersey-based company plans to eliminate the ingredient from adult items by 2015. Cincinnati-based Procter & Gamble Co., the world’s largest consumer-products maker, has said it will remove the substance by next year. Reckitt said in October it plans to remove the ingredient from all U.S. products by the end of 2014.

Henkel, based in Dusseldorf, Germany, said in an e-mailed statement it “will work with the FDA to ensure we are able to continue providing consumers with the safe, effective and high-quality products they demand.”

2016 Deadline

The FDA first floated a plan in the 1970s to limit the use of triclosan and acted yesterday largely because of a lawsuit by the Natural Resources Defense Council. The New York-based environmental advocacy group prodded the FDA to act specifically on triclosan, though after review, the agency proposed evaluating a wider array of chemicals.

“FDA continues to recognize that there are a lot of gaps about the safety and effectiveness of triclosan,” said Mae Wu, a lawyer with the health and environment division at the NRDC.

The court-ordered deadline for the final rule is 2016. If companies haven’t provided data to support germ-killing claims by then, they will either have to remove the antibacterial ingredients or eliminate the claims from the products’ labeling.

The proposal is positive for consumers if companies reformulate the soaps to remove the chemicals in question, Wu said. If they choose only to relabel the product as a regular soap, allowing them to keep triclosan in the hand washes, consumers won’t be protected, she said.

Antibiotic Resistance

The rule proposal dovetails with efforts to fight the rise of so-called superbugs and other types of antibiotic-resistant bacteria that the Centers for Disease Control and Prevention says are among the most serious threats to human health. The FDA last week set a schedule to phase out use of antibiotics to fatten cattle, hogs and chickens for human consumption following foodborne outbreaks of treatment-resistant pathogens.

Overuse of antibiotics, often the last line of defense against life-threatening germs spread commonly in hospitals, has complicated treatment for what were once easily cured diseases. More than 2 million people are sickened every year in the U.S. with antibiotic-resistant infections and at least 23,000 die, according to a CDC report in September.

About 2,000 soap products contain antibacterial ingredients the FDA is concerned about, and 93 percent of those use triclosan, regulators said on a conference call yesterday. Hand sanitizers aren’t affected by the proposal because they mostly contain ethyl alcohol, which the FDA recognizes as generally safe and effective.

EPA Oversight

“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,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

The FDA had made preliminary decisions in 1978 and 1994 that would have led to limits on triclosan use, though neither designation was made final. The NRDC sued in 2010 and won a consent decree last month that set deadlines for the FDA to make a decision about triclosan’s safety.

The Environmental Protection Agency also is reviewing triclosan, which the EPA regulates as a pesticide to slow or stop the growth of bacteria, fungi and mildew.

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