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FDA seeking information on hand sanitizers to ‘fill in the gaps’

Digital Journal readers may remember that last May, we reported the Food and Drug Administration (FDA) was requesting additional safety and effectiveness data for active ingredients in a broad range of products used in the healthcare setting.

This year, the FDA is focusing on topical consumer antiseptic rubs, including hand sanitizers marketed over-the-counter (OTC). In the agency’s statement, published on Wednesday, the FDA said more data is needed to help the agency ensure that regular use of these products does not present unknown safety and efficacy concerns.


The FDA also stressed it was not indicating the products are not safe to use or do not work, just as it said last year when requesting additional data on health-care related sanitizers. This time, the agency points out that in a few studies, there was a vague indication that some of the ingredients might be absorbed through the skin, according to NBC News.

Knowing if some of the ingredients, including ethanol or ethyl alcohol, isopropyl alcohol, and benzalkonium chloride can be absorbed through the skin, as well as their concentrations is doubly important, especially if they are being used by pregnant women and small children, says the FDA. “Since 2009, 90 percent of hand sanitizers used ethyl alcohol as their active ingredient,” the FDA said.

“Today, consumers are using antiseptic rubs more frequently at home, work, school and in other public settings where the risk of infection is relatively low,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

Dr. Woodcock points out that it is the agency’s responsibility to ensure the products being used multiple times a day on small children and others are safe and effective. “To do that, we must fill the gaps in scientific data on certain active ingredients,” she adds.

With the rise in the number of antibiotic-resistant pathogens, the FDA says the new data it is requesting could suggest the hand sanitizers may be playing a role in bacterial resistance. As of this time, nothing is being pulled off the market.

As everyone should already know, the best way to clean hands is by washing them with soap and water. The soap helps the water to wash away germs.

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We are deeply saddened to announce the passing of our dear friend Karen Graham, who served as Editor-at-Large at Digital Journal. She was 78 years old. Karen's view of what is happening in our world was colored by her love of history and how the past influences events taking place today. Her belief in humankind's part in the care of the planet and our environment has led her to focus on the need for action in dealing with climate change. It was said by Geoffrey C. Ward, "Journalism is merely history's first draft." Everyone who writes about what is happening today is indeed, writing a small part of our history.

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