FDA nixes 19 antibacterial handwash ingredients

The U.S. Food and Drug Administration (FDA) has ordered hand and body wash manufacturers to remove 19 ingredients from their over-the-counter antibacterial and antiseptic products, because “manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections,” according to the final rule released today.

Triclosan and triclocarban, two popular components of antimicrobial products, are on the FDA’s list, along with 17 other ingredients. Manufacturers will have one year from the date of the final rule to comply. Three additional ingredients—benzalkonium chloride, benzethonium chloride and chloroxylenol (PCMX)—are still being analyzed by the FDA.

“Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER) in an agency release. “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”

The agency issued its final rule after gathering three years of data on the effectiveness of the ingredients and potential harm or health risks.

In most cases, the best way to clean hands is a good scrubbing with plain soap and water. Otherwise, choose an alcohol-based hand sanitizer containing at least 60 percent alcohol, the FDA says.

Topics: Clinical , Infection control , Regulatory Compliance