FDA draws line on antibacterial soaps
Agency gives makers using triclosan and other ingredients one year to change
WASHINGTON, PA. (WPVI) -- The Food & Drug Administration has issued new rules on over-the-counter anti-bacterial soaps and hand sanitizers.
The agency says products with triclosan and 23 other active ingredients must be re-formulated in the next year, taken off the market, or the makers must file new drug applications.
That would would be lengthy and expensive process, requiring manufacturers to prove their products are safe and effective.
Scientists have long questioned the safety and effectiveness of triclosan, and other active ingredients.
A University of Michigan study said triclosan was only partially effective, especially at slowing the growth of gram-negative bacteria.
Six of the commonly used ingredients - ethanol, propanol, benzalkonium chloride, povidone-iodine, benzethonium chloride, and chloroxylenol - got a temporary pass, while safety studies on them continue.
However, the FDA plans to review them again in a year.
