RFA CEO Calls FDA’s Clarity On Sanitizer Guidance “Overly Restrictive”

Source: By Iowa Agribusiness Radio Network • Posted: Thursday, June 4, 2020

RFA President and CEO Geoff Cooper released a printed statement Tuesday in response to the U.S. Food and Drug Administration’s Monday night announcement on revised hand sanitizer production guidance. Cooper says, “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.”

Iowa Senator Charles Grassley discussed the issue with Ag reporters on Monday. Grassley says the FDA released temporary guidance on March 27th regarding ethanol used for hand sanitizer production during the COVID-19 pandemic.

“We found out that ethanol plants were willing when they are shut down to convert to hand sanitizers,” Grassley said, “at least the alcohol base part of that. There was an ‘okay’ given in late March, and then the FDA withdrew approval. A lot of these producers don’t know where they stand.”

As a result of the ongoing uncertainty, Grassley says he and fellow Iowa Senator Joni Ernst sent a letter to the FDA requesting clarification on its temporary policy for the manufacture of alcohol-based hand sanitizer products during the COVID-19 pandemic. Grassley’s comments Monday came prior to the FDA’s updated guidance Monday evening.

“We were informed that the FDA has taken additional action to help ensure there is widespread access to hand sanitizers during the COVID-19 public health emergency,” Grassley said. “I won’t be able to tell you if that ruling is going to satisfy me and Ernst, and all of the ethanol people that contacted us. However, we at least have word that FDA realizes it made a mistake when they withdrew that support for ethanol being used in hand sanitizers.”

The FDA says it is working with industry to ensure that harmful levels of impurities are not present if ethanol is used in sanitizer products. FDA’s latest announcement states they are “specifying interim levels of certain impurities that they have determined can be tolerated for a relatively short period of time, given the emphasis on hand hygiene during the COVID-19 public health emergency and to avoid exacerbating access issues for alcohol-based hand sanitizer.”