FDA bans certain OTC antimicrobial hand, body wash

The FDA today issued a final rule banning certain over-the-counter antibacterial hand and body wash products due to a lack of evidence showing they are safe for long-term daily use or more effective than soap and water in preventing illness and the spread of certain infections.

The final ruling from the federal watchdog applies to products containing 1 or more of 19 specific active ingredients, including the most commonly used ingredients triclosan and triclocarban. The ruling does not affect alcohol-based hand sanitizers or antibacterial 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. In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term,” FDA Center for Drug Evaluation and Research director Dr. Janet Woodcock said in a prepared release.

The ruling dates back to a proposed rule in 2013, with the FDA suggesting that long-term exposure to certain active ingredients in the products could pose health risks, such as bacterial resistance or hormonal effects. Manufacturers were required, under the ruling, to submit additional data on the safety and effectiveness of the ingredients.

The FDA said that “antibacterial hand and body wash manufacturers did not provide the necessary data to establish safety and effectiveness for the 19 active ingredients addressed in this final rulemaking,” and that some manufacturers have already started removing the ingredients from their products.

The agency deferred its rule for an extra year on 3 additional ingredients – benzalkonium chloride, benzethonium chloride and chloroxylenol – to allow for additional safety and effectiveness data to be submitted, and said that the products “may be marketed during this time while data are being collected.”

The FDA said that manufacturers will have 1 year to remove the products from the market or reformulate the products by removing the antibacterial ingredients.

In June, the FDA submitted a proposed rule requesting additional data on active ingredients in topical consumer antiseptic rubs, including hand sanitizers, which are marketed over the counter.

The ruling came based on new scientific information and “input of outside scientific and medical experts on an independent advisory committee” with the agency seeking data on ethanol or ethyl alcohol, isopropyl alcohol and benzalkonium chloride.

The agency said it is “particularly interested in gathering additional data on the long-term safety of daily, repeated exposure to these ingredients by consumers, and on the use of these products by certain populations, including pregnant women and children, for which topical absorption of the active ingredients may be important.”

“Emerging science also suggests that for some antiseptic active ingredients, systemic exposure (full body exposure as shown by detection of antiseptic ingredients in the blood or urine) is higher than previously thought, and that more information is needed about the effects of repeated daily human exposure to some antiseptic active ingredients,” the FDA wrote in its proposed ruling in June.

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