Consumer hand sanitizers are popular, and they became more popular when brands started advertising they used the same chemicals hospitals use. FDA allowed it starting in 1994 (1994 Health Care Antiseptic TFM (June 17, 1994, 59 FR 31402)), the same year they gave supplements exemption from real FDA oversight.
But there is such a thing as overuse, and a generation of parents did just that with compounds like triclosan, believing their child needed it to stay healthy. And it caused numerous problems, not to mention helping very little that soap and water would not have resolved. If soap and water are not available, the CDC generally recommends using an alcohol-based hand sanitizer that contains at least 60 percent alcohol.
As part of the June 30, 2016 proposed rule on consumer antiseptic rubs, the FDA requested additional scientific data to support the safety and effectiveness of active ingredients used in OTC consumer antiseptic rubs, and now the ruling has been made final.,
Twenty eight products are to be used no more in over-the-counter products. Three other active ingredients—benzalkonium chloride, ethyl alcohol, and isopropyl alcohol—are still under review to make a determination regarding whether these active ingredients are generally recognized as safe and effective for use in OTC consumer antiseptic rub products.
This won't have much marketplace impact. Most manufacturers had stopped using there compounds already and FDA estimates less than 3% of the marketplace will be affected since most OTC consumer antiseptic rubs use ethyl alcohol as the active ingredient.
“Our action today aims to help provide consumers with confidence that the over-the-counter hand sanitizers they’re using are safe and effective when they don’t have access to water to wash with soap,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “In today’s final regulation we finalized the FDA’s previous determination that 28 active ingredients, including triclosan and benzethonium chloride, are not eligible for evaluation under the FDA’s OTC Drug Review for use in consumer antiseptic rubs. We’ve also reaffirmed our need for more data on three other active ingredients, including ethyl alcohol, which is the most commonly used ingredient in hand sanitizers, to help the agency ensure that these products are safe and effective for regular use by consumers. We believe industry has made good progress toward providing data and we will continue to provide updates to the public about the progress of collecting this data.”
The FDA previously issued final rules on consumer antiseptic washes (Sept. 2016) and health care antiseptics (Dec. 2017).
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