The Food and Drug Administration (FDA) yesterday said that it would not immediately ban the use of chemicals used in antibacterial soaps, despite a U.S. prohibition on 19 such substances, adding that it would discuss the issue with specialists.
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Michele also noted that about 40% of the soaps on the commercial market contain one or more of the 19 banned ingredients.
Antibacterial hand and body wash manufacturers did not provide the necessary data to establish safety and effectiveness for the 19 active ingredients addressed in this final rulemaking, and manufacturers have already started phasing them out.
“Some data suggests that antibacterial ingredients may do more harm than good over the long-term”, said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
At the same time, manufacturers failed to show that their antibacterial products are any better than ordinary soap and water at preventing the spread of germs, the FDA said. All manufacturers will have one year to comply with the rulemaking by removing products from the market or reformulating (removing antibacterial active ingredients) these products. If soap and water are not available, the U.S. Centers for Disease Control and Prevention recommends that an alcohol-based hand sanitizer be used that contains at least 60 percent alcohol.
The FDA estimates that this ban will reduce Americans’ exposure to these active ingredients by 2.2 million pounds per year.
When shopping for handwash, many of us automatically reach for the antibacterial-pumped soaps but this may soon be a thing of the past.
The ban first was proposed by the FDA in 2013.
“The FDA will continue to collect data on the safety of the antibacterial agents and the regulations on them in other countries”, Hung said, adding that the agency would seek opinions from specialists and evaluate the issues before deciding whether the rules need changing.
Antibacterial soaps containing benzalkonium chloride, benzethonium chloride and chloroxylenol will remain on the market while manufacturers develop additional safety and effectiveness data for these ingredients, she said.
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When the FDA made its decision to ban the chemicals, the agency said they had received no studies from companies that showed the chemicals were safe and effective.
