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Sept. 2 — Hand and body washing products containing triclosan, triclocarban and 17 other antibacterial chemicals can no longer be sold over the counter after the FDA determined they may be harmful and ineffective.
The final rule establishing the ban on these chemicals means the likely end to their use in hundreds of consumer products. Theresa Michele, head of the Food and Drug Administration’s nonprescription drug evaluation division, said the cleaning industry did not or could not produce data showing that the benefits of these chemicals outweigh their potential health risks.
“Millions of Americans use antibacterial products every day,” Michele said in a Sep. 2 press conference, “but these products may not provide any benefits beyond soap and water.”
The runoff of these chemicals into water supplies has been a major concern for environmental activists because of their potential effects on the endocrine systems of aquatic animals. However, Michele said the FDA did not consider the environmental effects of the chemicals when making its decision, but instead looked only at their efficacy and their ability to affect human health.
Manufacturers will have a year from Sept. 6, when the final regulation will be published in the Federal Register, to phase these chemicals out of their products. Michele said roughly 40 percent of the more than 2,000 personal cleaning products on the market contain at least one of the 19 chemicals affected by the new regulation, which was first proposed in 2013. She said companies could reintroduce them into the marketplace only if they undergo the FDA’s screening for prescription drugs.
Not included in the 19 chemicals affected by this regulation are three other antibacterial agents: benzalkonium chloride, benzethonium chloride and chloroxylenol. Michelle said the FDA is giving the personal cleaning product industry more time to submit safety and efficacy data on these chemicals before it takes action on them.
The American Cleaning Institute, which represents companies that make products containing these chemicals, said in a statement that its members will work to provide FDA with the data it needs. But it also said the FDA already has data on the other 19 antibacterial chemicals that shows they are safe and effective.
The FDA’s actions only apply to consumer-grade washing products. The 19 chemicals are still permitted for use in alcohol-based hand sanitizers, which are used without water, and in antibacterial products that are used in health care settings.
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