The rule issued on Thursday "confirmed our need for additional data on three other active ingredients, including ethyl alcohol, which is the most commonly used ingredient in disinfectants to help the agency ensure the safety and efficacy of these products on a regular basis by consumers. "- Dr Janet Woodcock, Director of the Center for Assessment and Evaluation of Medicines, said in a statement.
" We believe that industry has made significant progress in providing data, and m we will continue to provide the public with an update on the progress of the collection of this data. "
The final rule concerning dozens of other ingredients will affect less than 3% of the market, since the most common disinfectants for hands use ethanol, according to the FDA.
We have refined the preliminary definition of the FDA that 28 active ingredients, including triclosan and benzethonium chloride, can not be evaluated according to the FDA's OTC drug for use in antiseptic costs, "Woodcock said.
"However, our current activities are aimed at helping consumers confidently that the disinfectants they use are safe and effective if they do not have access to soap water."
"On behalf of our members who produce hand disinfectants and their ingredients, the American Cleansing Institute hopes to provide additional data to ensure full and complete FDA up to the latest information on ethanol and benzalkonium chloride used in these useful ACI products. the agency's decision to allow enough time to complete new research to obtain the data that the agency requires, this regulatory process is moving forward, "the statement states
Used by millions of Americans daily and often repeatedly, over the counter sanitary measures designed to reduce bacteria when hand washing
During the investigation, the FDA wanted to know more about the three ingredients in these products: ethanol (or ethyl). alcohol), isopropyl alcohol and benzalkonium chloride
Ethyl alcohol is a primary alcohol and isopropyl alcohol of secondary alcohol; although they are related, they have different chemical properties and absorption.
"Currently, the three active ingredients – benzalkonium chloride, ethyl alcohol and isopropyl alcohol – are delayed from further development of rules, which allows for research and submission of additional data on the safety and efficacy needed to determine whether these active ingredients as a whole recognized as safe and effective for use, says a FDA message
The status of these ingredients will be considered either after the completion of the research or at another time, the agency reports.