Deep breath, germophobes: The U.S. Food and Drug Administration is raising big questions about a commonly used additive to antibacterial soap. A trade association for the industry, however, says that triclosan is safe and effective.
The debate over the soap you use daily has gotten pretty messy lately.
This week, the U.S. Food and Drug Administration moved to curb the use of triclosan, a common antibacterial and antifungal ingredient in soaps. The agency is asking manufacturers that rely on the chemical to prove within the next year that their products are both safe and effective. In a statement, the FDA pointed to studies that show triclosan alters hormone regulation in animals and suggest the chemical could help make bacteria resistant to antibiotics.
But the American Cleaning Institute, a trade association representing the U.S. cleaning products industry, disputes that claim. ACI argues that the health concerns are overblown and that research (which it funded, a Chicago Tribune report notes) shows triclosan works effectively against specific infectious bacteria. The association says it has sent information on this subject to the FDA repeatedly over the past decade.
“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,” ACI said in a statement. “Our industry’s Topical Antimicrobial Coalition has submitted to the FDA in-depth data showing that antibacterial soaps are more effective in killing germs when compared with non-antibacterial soap.”
No evidence currently suggests triclosan is hazardous to humans, the FDA says, but its update to consumers notes that scientific studies conducted since it last looked at the ingredient “merit further review.”
A Long Debate
The triclosan debate traces back to 1978, when the FDA first proposed removing the agent from consumer products but never followed through. It later said it would publish a review of recent findings in 2011, but it missed that deadline and others. While a thorough study on the issue has yet to be completed, the FDA noted that a 1997 review involving Colgate Total toothpaste found the chemical effective in preventing gingivitis.
The Natural Resources Defense Council (NRDC) sued the FDA in 2010 to get it to issue a rule on the chemical’s use as an ingredient, and the agency agreed to take final action by 2016. It’s a move the environmental advocacy group welcomes.
“Triclosan is what we call a stupid use of a chemical,” NRDC senior scientist Dr. Sarah Janssen told the Chicago Tribune. “It doesn’t work, it’s not safe, and it is not being regulated.”
The FDA’s latest proposal asks manufacturers to provide evidence that products with triclosan are more effective at killing bacteria than regular soap and water. The proposal does not include hand sanitizers, wipes, or antibacterial products used in healthcare settings, but would affect more than 2,000 soap products, according to Bloomberg.
Companies that can’t provide such evidence would have to reformulate or relabel their products—or remove them from the market entirely. Soap manufacturers have until June 2014 to submit comments on the proposal; the FDA will then require that they provide evidence that the products are safe and effective by December. In the meantime, the FDA recommends that consumers not use antibacterial soaps.
ACI says that manufacturers will succeed in proving the products’ safety and effectiveness.
“These products are over-the-counter drugs (OTC) and, as such, go through rigorous review by FDA, including review of data and information submitted by industry and healthcare providers in the U.S. and worldwide,” the association said in a statement released on Monday. “Today’s proposed rule is a next step towards FDA finalizing the safety and efficacy of this OTC product category.”