FDA issues proposed rule for healthcare cleaning products

The Food and Drug Administration (FDA) has issued a new rule requiring manufacturers of over-the-counter antiseptic products used in healthcare settings to provide further documentation of their safety and effectiveness. Under the rule, manufacturers must submit new studies covering issues such as possible hormonal side effects. Any product that could not prove its safety and effectiveness in the next three years would be subject to removal from the market. "We're not asking for any of these products to come off the market at this time, we're just asking for additional data," Theresa Michele, a director in the FDA's drug center, told the Associated Press. Proposed rule (.pdf)