WASHINGTON (April 30, 2015) – Prompted by a Natural Resources Defense Council lawsuit, the U.S. Food and Drug Administration today moved to evaluate the safety and effectiveness of medical antibacterial products, including hand washes and sanitizers, proposing a rule calling on manufacturers to submit additional safety- and efficacy-related data about such products. Those products not proven to be safe and effective by 2018 would have to be reformulated or removed from the market.
The following is a statement from Mae Wu, an attorney in NRDC’s health program:
“We are pleased that the FDA is moving to determine whether the antibacterial products widely used in healthcare settings are safe and effective for patients, doctors, nurses, and all healthcare workers. This is a long-overdue and important step toward removing potentially harmful chemicals from the marketplace.
“While today’s proposal only covers products in the healthcare setting, FDA’s next step is to continue its work and complete the process to ensure that antibacterial products and hand cleansers used in any setting are safe and effective or are no longer used.”