The FDA is no longer allowing manufacturers to market OTC consumer antibacterial hand and body washes containing one or more of 19 active ingredients, including triclosan and triclocarban.

This is 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. Now, manufacturers will have one year to comply with the final rule by removing products from the market or reformulating them without the cited antibacterial active ingredients. Some manufacturers have already started removing these ingredients from their products, the FDA noted.

“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. “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”

The 19 active ingredients that are no longer Generally Recognized as Safe and Effective (GRAS/GRAE) for use as a consumer antiseptic wash are:
1.     Cloflucarban
2.     Fluorosalan
3.     Hexachlorophene
4.     Hexylresorcinol
5.     Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
6.     Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
7.     Nonylphenoxypoly (ethyleneoxy) ethanoliodine
8.     Poloxamer—iodine complex
9.     Povidone-iodine 5 to 10%
10.  Undecoylium chloride iodine complex
11.  Methylbenzethonium chloride
12.  Phenol (>1.5%)
13.  Phenol (<1.5%)
14.  Secondary amyltricresols
15.  Sodium oxychlorosene
16.  Tribromsalan
17.  Triclocarban
18.  Triclosan
19.  Triple dye

The FDA started requesting more safety and efficacy data on these active ingredients last year, but it originally proposed a rule back in 2013 after some data suggested that long-term exposure to certain active ingredients used in antibacterial products could pose health risks, such as bacterial resistance or hormonal effects. 

“Due to consumers’ extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk,” Dr. Woodcock stated at the time of the proposal.

Under the proposed rule, manufacturers were required to provide additional data from clinical studies demonstrating that their antibacterial products were superior to nonantibacterial washes in preventing human illness or reducing infection if they wanted to continue marketing them. For the 19 active ingredients addressed in the FDA’s final rule, either no additional data were submitted or the data and information that were submitted were not sufficient for the agency to determine that they are GRAS/GRAE.

In response to comments submitted by industry, the FDA has deferred rulemaking for one year on 3 additional ingredients used in consumer wash products—benzalkonium chloride, benzethonium chloride, and chloroxylenol—to allow for the development and submission of new safety and effectiveness data for these ingredients. Consumer antibacterial washes containing these specific ingredients may be marketed during this time while data are being collected.

Notably, the final rule does not apply to consumer hand sanitizers or wipes, or antibacterial products used in health care settings.

Washing with plain soap and running water remains one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others. If soap and water are not available and a consumer uses hand sanitizer instead, the CDC recommends that it be an alcohol-based product containing at least 60% alcohol.