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RFA: FDA Sanitizer Guidance Brings Clarity But Won’t Resolve Shortage

June 2, 2020

Coronavirus, Regulatory


The U.S. Food and Drug Administration Monday night issued revised guidance on the production of ethanol for hand sanitizer.  The following is a statement from Renewable Fuels Association President and CEO Geoff Cooper:


“While we appreciate that FDA responded to RFA’s request for more clarity and specific interim impurity limits, we do not believe the new guidance will help alleviate the hand sanitizer shortage in any meaningful way. We welcome the specificity in the new guidance, but the new interim limits for certain impurities are overly restrictive and create a roadblock for producers who could otherwise supply huge volumes of safe, clean, high-quality ethyl alcohol to hand sanitizer manufacturers. For example, FDA’s new limits for certain impurities are eight times more restrictive than what is typically found in a glass of red wine and twenty times more restrictive than what has been allowed in hand sanitizer by other countries, including Canada, during the COVID-19 pandemic.


“Meanwhile, as hospitals, first responders, nursing homes, restaurants, retail stores, churches, and other public and private spaces seek out new sources of hand sanitizer to address the shortage, the U.S. continues to significantly ramp up imports of hand sanitizer from China and other countries. It is unfortunate that we are importing this product from China, when abundant supplies of high-purity American-made ethanol could be used instead. Still, we will continue to work with the FDA to ensure ethanol producers can do their part to combat COVID-19 and provide larger quantities of ethyl alcohol for hand sanitizer.”


Ken Colombini