PUBLIC HEALTH
September 8, 2016

FDA Bans Antibacterial Soaps

There's a good reason the antibacterial soaps and body washes on drugstore shelves will have to be reformulated or removed within a year.

The FDA just dealt a major blow to antibacterial soaps, banning those that contain any of 19 different chemicals. This includes all soaps (and body washes) that contain triclosan or triclocarban. They can be sold for another year, but after that, they'll be gone.

Among the concerns that have been raised about these chemicals (mainly for triclosan and triclocarban) are that they persist in the environment; weaken muscle activity in animals; may act as endocrine disruptors; and may contribute to antibiotic resistance.

It's not just that they might possibly be dangerous, it's also that they don't kill any more bacteria than plain soaps do.

Congress first asked the FDA to investigate triclosan and dozens of other antiseptic ingredients over 40 years ago. Three years ago, the FDA essentially gave manufacturers an ultimatum — show that these products are safe and effective or stop selling them. The clock has now run out and these products must either be reformulated or discontinued.

The ban applies only to hand soaps and body washes, preparations that are washed off with water and that contain any of the 19 active ingredients (see list below). It does not apply to hand sanitizers or wipes or antibacterial products used in a health care setting such as a hospital. Nor does it apply to triclosan in toothpaste, where there is some evidence that it is effective against gum disease (gingivitis).

The director of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock, MD, explains the reasoning behind the ban: “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. In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”

The FDA's ruling then is not just about the possible danger to the public and the environment, it's about the fact that these chemicals don't kill any more bacteria than plain soaps do. Yes, they contain compounds that will kill additional bacteria in a laboratory setting. But this requires extended contact with the bacteria. Soaps, on the other hand, are made to be quickly washed off, where many then enter the waterways and become chlorinated waste.

The 19 chemicals the FDA has banned are: cloflucarban, 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) ethanol iodine 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, triclocarban, triclosan and triple dye.

Three other antibacterial ingredients — benzalkonium chloride, benzethonium chloride and chloroxylenol (PCMX) — were given a one-year reprieve, allowing manufacturer's to submit data showing that they are safe and effective. Manufacturers can continue to include them in soaps and body washes, for now.

It's not easy to remember the names of all these compounds. So if you're concerned about antibacterial soaps, you could just follow the FDA's advice and use plain soap and water, avoiding all products that call themselves antibacterial.

You can read the FDA's summary of the ban here. The full ruling appears in the Federal Register.

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