While the U.S. Food and Drug Administration has benched over-the-counter consumer antiseptic hand wash products containing several potentially dangerous ingredients, hand sanitizer remains a trusted and reliable germ-killing option when soap and water are not readily available.
The FDA ruled in early September companies can no longer market antibacterial soaps and body washes containing 19 active ingredients including triclosan and triclocarban because manufacturers have failed to demonstrate that the ingredients are both safe for long-term daily use and are more effective than plain soap and water at preventing illness and the spread of certain infections.
Companies have a year to take these ingredients out of their products or remove them from the market.
Many manufacturers have already begun removing these ingredients from their products.
“There’s no data demonstrating that over-the-counter antibacterial soaps are better at preventing illness than washing with plain soap and water,” the FDA said in a press release.
The FDA’s long-term study of antibacterial products found no hard evidence they are a better germ neutralizer than the Centers For Disease Control’s No. 1 recommended method of killing germs and bacteria.
“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, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”
“The proposed rule does not require any consumer hand sanitizer products to be removed from the market at this time,” and that this rule “does not mean these products are unsafe or ineffective,” the FDA’s statement noted.
In 2013, the FDA mandated manufacturers provide the agency with additional data on the safety and effectiveness of certain ingredients used in over-the-counter consumer antibacterial washes if they wanted to continue marketing antibacterial products containing those ingredients. This included data from clinical studies demonstrating that these products were superior to non-antibacterial washes in preventing human illness or reducing infection.
The FDA determined antibacterial hand and body wash manufacturers did not provide the necessary data to establish safety and effectiveness for the 19 active ingredients.
Hand sanitizers’ effectiveness and safety as a germ killer remains unquestioned. The CDC continues to endorse alcohol-based hand sanitizers containing at least 60 percent alcohol as a proven germ stopper that if soap and water are not available.
Hand sanitizer manufacturers are working with the FDA to further demonstrate their reliability, safety and remarkable effectiveness at stopping germs.
Millions of Americans rely on the proven 99.9 percent germ-killing power of hand sanitizers daily when soap and water are not available.
“Today, consumers are using antiseptic rubs more frequently at home, work, school and in other public settings where the risk of infection is relatively low,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “These products provide a convenient alternative when hand washing with plain soap and water is unavailable, but it’s our responsibility to determine whether these products are safe and effective so that consumers can be confident when using them on themselves and their families multiple times a day. To do that, we must fill the gaps in scientific data on certain active ingredients.”
Numerous studies have validated the safety of hand sanitizers. Popular Science reports researchers have demonstrated continual use of alcohol hand sanitizers (30 times an hour over 12 hours) leads to no adverse skin or health conditions.
The FDA’s list of newly banned antiseptic chemicals includes:
- Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
- Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
- Nonylphenoxypoly (ethyleneoxy) ethanoliodine
- Poloxamer-iodine complex
- Povidone-iodine 5 to 10 percent
- Undecoylium chloride iodine complex
- Methylbenzethonium chloride
- Phenol (greater than 1.5 percent)
- Phenol (less than 1.5 percent) 16
- Secondary amyltricresols
- Sodium oxychlorosene
- Triple dye
“For these ingredients, either no additional data were submitted or the data and information that were submitted were not sufficient for the agency to find that these ingredients are Generally Recognized as Safe and Effective,” the FDA said.