FDA Rules: You Can’t Sell “Anti-Bacterial” Hand Soap With Triclosan Anymore

Image courtesy of Scott Akerman

After more than half a decade of various proposals, investigations, and dithering, the FDA today has announced that it’s changing the rules. 19 active ingredients in your hand soap — most notably including triclosan, until recently very common — are going to be heading off the market.

Starting next Tuesday, a whole bunch of stuff is losing its designation of Generally Recognized As Safe and Effective (sound familiar?) and can no longer be marketed to you for this purpose, the FDA announced today.

The rule specifically pertains to soap — products “intended for use with water, and rinsed off after use.” That means it doesn’t apply to hand sanitizers, wipes, or other products (like toothpaste). It also doesn’t apply to industrial-strength, commercial products used in health care settings.

“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 wheels on this one have been turning for many years, but not exactly quickly.

It’s been six years since the FDA’s 2010 determination that there was no actual evidence proving triclosan actually made your bathroom hand soap any more effective.

After that it was another three years before the FDA announced in 2013 that it was going to review triclosan and find out if it was at all safe or effective.

When the FDA first started actually looking into it back in 2013, the agency gave the manufacturers of antibacterial hand soaps one year to provide data on both the safety and effectiveness of the ingredients they were using. And for all 19 ingredients now nixed after today’s rule, the data just… wasn’t there. Either it wasn’t submitted at all or what did come in wasn’t sufficient to show that the ingredients were useful.

Meanwhile, evidence pointing the other way continued to mount. For example: while the FDA review was underway, one study found that triclosan — increasingly associated with risks to fetal development — was found in 100% of the pregnant women who participated in the study. Yes, literally all of them.

Manufacturers have, meanwhile, been moving much faster than the feds. Perhaps sensing the writing on the wall, many have long since taken action to cut triclosan from their products. A sampling of recent anti-triclosan moves includes:

The full list of active ingredients no longer considered safe and effective, and therefore no longer allowed in your soap, include:

  • Triclosan
  • Triclocarban
  • Fluorosalan
  • Hexachlorophene
  • Hexylresorcinol
  • Iodophors (Iodine-containing ingredients)
    • 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)
  • Secondary amyltricresols
  • Sodium oxychlorosene
  • Tribromsalan
  • Triple dye

The rule will become effective when it is officially published in the Federal Register after Labor Day weekend.