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FDA Violations

FDA Enacted a Rule Banning the Sale of Some Antibacterial Soaps

— September 13, 2016

On September 2, 2016, the Food and Drug Administration, FDA, enacted a final rule banning the sale of some antibacterial soaps. The ban includes liquid and bar soaps containing, among other active chemicals, the most commonly used triclosan and triclocarban. The manufacturers could not prove that the antibacterial soaps were any more effective than regular soap in preventing the spread of infection and illness. The FDA gave companies one year to either remove the ingredients from products or remove the products from the market.

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The rule was proposed in 2013 after the agency received information that long-term exposure to some chemicals in antibacterial products could cause health risks. Those risks included hormonal problems and bacterial resistance. Other products containing any of the 19 chemicals, including hand sanitizers that are not used with water and antibacterial products used in a health care setting, are not affected by the rule.

The manufacturers have been given more time, one year, to prove the safety and effectiveness of benzalkonium chloride, chloroxylenol and benezethonium. Proof must include additional research and science. Any soap products containing those ingredients are not affected by the rule for now.

Some manufacturers, including Johnson & Johnson, began phasing out the use of the 19 chemicals before the rule became final. It would appear that manufacturers already knew that soaps and washes containing one or more of the chemicals were no more beneficial than regular hand soap. In fact, many studies have been conducted over the years that indicate the chemicals are detrimental.

The Oxford Journals published an article in 2007 detailing the results of 27 studies that were found on the effectiveness of triclosan in soap products. The results were “soaps containing triclosan within the range of concentrations commonly used in the community setting (0.1%–0.45% wt/vol) were no more effective than plain soap at preventing infectious illness symptoms and reducing bacterial levels on the hands. Several laboratory studies demonstrated evidence of triclosan-adapted cross-resistance to antibiotics among different species of bacteria.”

This raises the question of whether human health and the environment were put at risk by those companies for one simple reason – money! That assumption is probably accurate given the frequency that we are seeing lawsuits and media coverage of the harm that many, many popular products, including medications, are causing or have caused.

According to the FDA, the most important aspect of preventing the spread of germs and avoiding illness is to wash using plain soap and water. When plain soap and water is not available, the Centers for Disease Control and Prevention, CDC, recommends using a hand sanitizer with ingredients of at least 60 percent alcohol. I, for one, will not purchase any antibacterial soap.

I would hope that when the one year period to phase the banned chemicals out of soap has expired, the companies will have to recall the products that remain on the shelves. In this way, those companies will have to eat any profits it hoped to gain by selling a product that is more harmful than beneficial.


Food and Drug Administration

Oxford Journals

Centers for Disease Control and Prevention

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