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 The move affects 2,100 products, or roughly 40 percent of the
over-the-counter antibacterial soap market, Dr. Theresa Michele,
director of the FDA's division of nonprescription drug products,
told reporters on a conference call.
The ruling does not affect alcohol-based hand sanitizers 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.
Johnson & Johnson, Procter & Gamble Co and Colgate-Palmolive Co have
said they have either reformulated or are reformulating their
products to delete the most common of the 19 ingredients, including
triclosan and triclocarban.
FDA spokeswoman Andrea Fischer and Brian Sansoni, of the American
Cleaning Institute, which represents multiple cleaning products
companies, were unable to identify the products most affected by
Friday's ruling.
The FDA had proposed banning the ingredients in 2013 unless
companies could prove they were safe and effective, but was
unsatisfied with the data. The ACI, whose members include Dial
Corp., a unit of Germany's Henkel, insists the products are
effective.
"Clearly this is an industry that needed a good, swift kick in the
triclosan. It took far too long," said Ken Cook, the president of
the Environmental Working Group, a non-profit environmental research
organization.
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Thomas DiPiazza, a spokesman for Colgate-Palmolive, said none of the
company's products in the continental United States are affected,
although a "small quantity of our bar soap in Puerto Rico, where FDA
rules also apply, is being reformulated."
Procter & Gamble spokeswoman Tressi Rose said it will replace "a
few" products well in advance of the FDA's deadline for removing or
reformulating the products a year from now.
The regulator also deferred by a year a ruling on three additional
ingredients used in consumer wash products – benzalkonium chloride,
benzethonium chloride and chloroxylenol (PCMX) – to allow for the
submission of new safety and effectiveness data for those
ingredients.
Consumer antibacterial washes containing those 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.
(Reporting by Natalie Grover and Ankur Banerjee in Bengaluru;
Additional reporting by Toni Clarke in Washington; Editing by
Jonathan Oatis and Dan Grebler)
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