FDA halts sales of ‘antibacterial’ soaps, washes
By Natalie Grover
The U.S. Food and Drug Administration said on Friday it is banning some over-the-counter antibacterial hand and body wash products, saying they are no more effective than soap and water and could cause long-term harm.
The ruling does not affect alcohol-based hand sanitizers such as Purell or antibacterial products used in hospitals and clinics.
The agency said it is banning products that contain any one of 19 ingredients that have not been proven safe. The move affects 2,100 products, or roughly 40 percent of the over-the-counter soap market, Dr. Theresa Michele, director of the FDA’s division of nonprescription drug products, told reporters on a conference call.
Johnson & Johnson, Procter & Gamble Co and Colgate-Palmolive Co have said they have either reformulated or are reformulating their products to get rid of the most common of the 19 ingredients, including triclosan and triclocarban.
Thomas DiPiazza, a spokesman for Colgate-Palmolive, said none of the company’s products in the continental U.S. are affected.
“A small quantity of our bar soap in Puerto Rico, where FDA rules also apply, is being reformulated,” he said.
Tressi Rose, a spokeswoman for Procter & Gamble, said it will replace “a few” remaining products well in advance of the FDA’s deadline for removing or reformulating the products a year from now.
The American Cleaning Institute, which represents cleaning products companies, including Dial Corp, a unit of Germany’s Henkel, Ecolab Inc and Steris Corp; insists the products are effective.
“Washing the hands with an antiseptic soap can help reduce the risk of infection beyond that provided by washing with non-antibacterial soap and water,” ACI spokesman Brian Sansoni said.
The FDA proposed banning the ingredients in 2013 unless companies could prove scientifically that they were safe and effective. The FDA it was not satisfied with the data
The FDA deferred by a year its ruling on three additional ingredients used in consumer wash products – benzalkonium chloride, benzethonium chloride and chloroxylenol (PCMX) – to allow for the development and submission of new safety and effectiveness data for these ingredients.
Consumer antibacterial washes containing these specific ingredients may be sold during this time, the FDA said.
Manufacturers are conducting research to fill data gaps identified by the FDA, Sansoni said.