Manufacturers did not demonstrate safety and effectiveness of ingredients

Hands Washing Using Soap and Water / Antibacterial Soaps Containing Certain Ingredients No Longer Allowed on the Market
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September 02, 2016

The Food and Drug Administration (FDA) has issued a rule stating that over-the-counter antibacterial soaps containing certain ingredients are no longer allowed on the market.

Companies can no longer market the products because their manufacturers did not show that these ingredients are safe for daily use over a long-term period or more effective than simple soap and water. Some manufacturers have already begun to take these ingredients out.

The rule applies to soaps that contain one or more of 19 particular active ingredients, such as triclosan and triclocarban. The soaps are intended to be used with water and are rinsed off after being used. The rule does not apply to hand "sanitizers" or wipes, nor to antibacterial products that are used in healthcare.

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

The FDA first proposed such a rule in 2013 after reviewing data suggesting that health risks—such as bacterial resistance and effects on hormones—may result from long-term exposure to certain ingredients present in antibacterial products. Under this rule, product manufacturers had to give the agency more data about the safety and efficacy of those ingredients if they wished to market products containing them. This data was to include information gleaned from clinical studies showing that the products worked better to either prevent illness or lessen infection than non-antibacterial soaps.

However, the manufacturers did not provide the data needed to establish the efficacy and safety of the ingredients in question. As a response to industry comments, the FDA has postponed issuing a rule on three additional ingredients—benzalkonium chloride, benzethonium chloride, and cholroxylenol—for one year in order for the manufacturers to develop and submit new data regarding their safety and effectiveness. Companies are allowed to market products containing these ingredients during this time.

Washing using regular soap and running water is still one of the most important practices that consumers can do to avoid illness and the spreading of germs. If soap and water are unavailable and hand sanitizer is used instead, it is recommended that the sanitizer be alcohol based and contain at least 60 percent alcohol.

Manufacturers began phasing out the affected ingredients in 2013 after the FDA issued its proposed rule. They now have one year to comply with the final rule by finishing the removal of the ingredients.