Duh ~~ just look at Clinton's hands --- it does NOT work!!
FDA Seeks Proof of Safety, Effectiveness of Hand-Sanitizing Products
DOW JONES & COMPANY, INC. 8:58 AM ET 6/29/2016
WASHINGTON -- The Food and Drug Administration is proposing a requirement that makers of antibacterial hand- sanitizing products submit data on safety and effectiveness if they want to stay on the market.
The federal agency had previously issued such rules on antibacterial soaps used with water and on sanitizers used in hospitals. This time, the FDA is focusing on gels, rubs, towelettes and other such over-the-counter products used to kill bacteria when soap and water aren't available. Not included are baby wipes, because they are generally not billed as killing bacteria, the agency said.
The FDA, which will allow the industry to comment over the next 180 days, issued the proposed rule Wednesday. It said it didn't have any special concerns over ingredients, but that it wanted to be sure it was apprised of the latest science, given the fact that such antibacterial products are in such wide use now.
Concurrently with the comment period, makers of such products will have a year to submit evidence that their products are safe when absorbed into the bloodstream, and that they actually do reduce the bacterial count.
The FDA said it was particularly interested in accumulating evidence concerning the safety of long-term, repeated exposure, especially in pregnant women and children.
"The idea of the rule is to fill in data gaps, particularly with safety, " said Janet Woodcock, director of the FDA Center for Drug Evaluation and Research. "We don't know how much they're absorbed into the body in maximum use." Dr. Woodcock noted that such products used to be primarily at events such as lobster dinners, but are today omnipresent in sites such as elevator lobbies.
About 90% of the products in question include ethyl alcohol, with the remainder generally featuring isopropyl alcohol or benzalkonium chloride. Makers of products will need to provide safety data for all three, but evidence on bacterial reduction only for the latter two.
Richard Sedlak, executive vice president for technical and international affairs at the American Cleaning Institute, said, "Hand sanitizers are a critical part of healthy hand hygiene routines for millions of consumers every single day. In fact, the Centers for Disease Control and Prevention recommend using alcohol-based hand sanitizers if soap and water are unavailable."
The FDA's action follows litigation filed in New York in 2010 by the Natural Resources Defense Council, which wanted the agency to speed up its regulations over the products. A November 2013 consent decree had set out the timetable by which the FDA was to act.
Write to Thomas M. Burton at tom.burton@wsj.com
(END) Dow Jones Newswires
06-29-160858ET
Copyright (c) 2016 Dow Jones & Company, Inc.
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