Soaps and wash products containing certain antibacterial ingredients can no longer be sold, the U.S. Food and Drug Administration announced Friday.
In its ruling, the FDA said there was insufficient evidence to prove that soaps and washes with antibacterial ingredients, such as triclosan and triclocarban, were “more effective than plain soap and water in preventing illness.”
Overall, 19 antibacterial agents were called into question in the report.
Companies are also not allowed to market antibacterial claims about their wash products because they failed to demonstrate if the ingredients are “safe for long-term daily use,” the agency said in a statement. All antibacterial soaps must be removed from shelves by Sept. 6, 2017.
In 2013, the FDA proposed a rule whereby manufacturers had to prove their antibacterial soaps were safer and more effective than plain soap and water. After the proposal, several companies like Johnson & Johnson began phasing out these 19 antibacterial ingredients from their products.
Now, with the FDA’s ruling, the agency said to skip the antibacterial soaps altogether. The ban, however, does not extend to antibacterial soaps used by hospitals or the food industry because more research on their safety and effectiveness is required, the FDA said. Hand sanitizers and wipes are also immune from the ban. In June, the FDA proposed a separate investigation for these products.
Nor does the rule apply to three additional ingredients used in such products — benzalkonium chloride, benzethonium chloride and chloroxylenol. Companies have used these three products to replace triclosan in their products. The FDA has given manufacturers another year to provide safety and effectiveness data on these ingredients.
“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, director of the FDA’s Center for Drug Evaluation and Research in a statement. “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”
The FDA’s report also cautions that widespread antiseptic use could be harmful over time, allowing bacteria to become more resistant. The report also cited potential hormonal effects from triclosan, one of the ingredients flagged in the agency’s review.