FDA updates guidelines to allow select impurities in hand sanitizers

by Alexandra Kelley | Jun. 02, 2020

coronavirus COVID-19 community spread hand sanitizer new regulations FDA carcinogens impurities food and drug administrations ethanol companies

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The FDA implemented new regulatory measures to evaluate certain impurities in hand sanitizers manufactured by ethanol companies.
These less rigid guidelines aim at preventing a hand sanitizer shortage during the coronavirus pandemic.

The Food and Drug Administration (FDA) will temporarily allow a certain amount of impurities in alcohol-based sanitizers to keep them accessible during the coronavirus pandemic, the agency announced Monday.

The new regulations will monitor and provide further clarity on impurity limits for ethanol companies that recently switched to producing hand sanitizer during the outbreak. This is a reverse course for the FDA, which tightened restrictions in April, according to Reuters. The move also aims to keep supply and access of sanitizers on par with demand.

In a press release, the FDA says that it is working with producers to ensure that carcinogens are not present if ethanol is used to create hand sanitizer for consumers.

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The regulating body notes that in the typical fermentation and distillation process used to manufacture hand sanitizer, comparable impurities would not be present. For ethanol producers who have turned to producing sanitizer to help curb a shortage of sanitizer in the U.S., however, contamination may arise from the usage of select equipment, chemicals and containers.

“Based on careful review and consideration of available data, we are specifying interim levels of certain impurities that we 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,” the statement read.

Reuters reports that the FDA guidelines will allow at most 2 parts per million of the carcinogen benzene and 50 ppm, or parts per notation, of carcinogen acetaldehyde.