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U.S. temporarily to allow certain impurities in hand sanitizer
Source: Reuters
HEALTH NEWS JUNE 2, 2020 / 11:09 AM / UPDATED 5 HOURS AGO
U.S. temporarily to allow certain impurities in hand sanitizer
Stephanie Kelly
2 MIN READ
NEW YORK (Reuters) - The Trump administration said this week it will temporarily allow some impurities in alcohol-based hand sanitizer to ensure access to the product during the coronavirus pandemic, reversing course after having tightened restrictions in April.
The move will provide clarity on impurity limits for a slew of fuel ethanol companies that had switched to producing hand sanitizer during the outbreak, after regulators discovered some of the impurities, including cancer-causing acetaldehyde, several weeks ago.
“We are specifying interim levels of certain impurities that we have determined can be tolerated for a relatively short period of time,” the Food and Drug Administration said on its website.
“We believe that our temporary guidances sets the proper level of flexibility at the current time to help protect Americans during this public health emergency.”
The FDA guidance allows up to 2 parts per million of benzene and 50 ppm of acetaldehyde, according to the website.
-snip-
U.S. temporarily to allow certain impurities in hand sanitizer
Stephanie Kelly
2 MIN READ
NEW YORK (Reuters) - The Trump administration said this week it will temporarily allow some impurities in alcohol-based hand sanitizer to ensure access to the product during the coronavirus pandemic, reversing course after having tightened restrictions in April.
The move will provide clarity on impurity limits for a slew of fuel ethanol companies that had switched to producing hand sanitizer during the outbreak, after regulators discovered some of the impurities, including cancer-causing acetaldehyde, several weeks ago.
“We are specifying interim levels of certain impurities that we have determined can be tolerated for a relatively short period of time,” the Food and Drug Administration said on its website.
“We believe that our temporary guidances sets the proper level of flexibility at the current time to help protect Americans during this public health emergency.”
The FDA guidance allows up to 2 parts per million of benzene and 50 ppm of acetaldehyde, according to the website.
-snip-
Read more: https://www.reuters.com/article/us-health-coronavirus-ethanol-sanitizer/u-s-temporarily-to-allow-certain-impurities-in-hand-sanitizer-idUSKBN23924J
______________________________________________________________________
Source: U.S. Food & Drug Administration
Coronavirus (COVID-19) Update: FDA Takes Action to Protect Public Health; Increase Supply of Alcohol-Based Hand Sanitizer
For Immediate Release:
June 01, 2020
Statement From:
Commissioner of Food and Drugs - Food and Drug Administration
Stephen M. Hahn M.D.
Today, the FDA has taken additional action to help ensure widespread access to hand sanitizers during the COVID-19 public health emergency. Consumer and health care personnel safety is a top priority for FDA, and an important part of FDA’s mission is to protect the public from harm, including as we seek to increase supply of hand sanitizer. To that end, we have updated our guidances to provide additional clarification on the manufacturing and compounding of certain alcohol-based hand sanitizer products to help ensure that harmful levels of impurities are not present in ethanol used in hand sanitizer.
-snip-
We previously updated these temporary guidances in April to reflect data submitted by fuel ethanol manufacturers producing ethanol via fermentation and distillation, indicating that at least some of their fuel ethanol products have harmful chemicals, including gasoline and benzene, which are known human carcinogens (cancer-causing agents). These impurities would not be expected from a typical fermentation and distillation process but may be present in the manufacturing environment of fuel or technical-grade ethanol, due to the use of certain chemicals, equipment or containers.
The FDA is working with industry to ensure that harmful levels of impurities are not present if ethanol is used in these products. 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.
-snip-
For Immediate Release:
June 01, 2020
Statement From:
Commissioner of Food and Drugs - Food and Drug Administration
Stephen M. Hahn M.D.
Today, the FDA has taken additional action to help ensure widespread access to hand sanitizers during the COVID-19 public health emergency. Consumer and health care personnel safety is a top priority for FDA, and an important part of FDA’s mission is to protect the public from harm, including as we seek to increase supply of hand sanitizer. To that end, we have updated our guidances to provide additional clarification on the manufacturing and compounding of certain alcohol-based hand sanitizer products to help ensure that harmful levels of impurities are not present in ethanol used in hand sanitizer.
-snip-
We previously updated these temporary guidances in April to reflect data submitted by fuel ethanol manufacturers producing ethanol via fermentation and distillation, indicating that at least some of their fuel ethanol products have harmful chemicals, including gasoline and benzene, which are known human carcinogens (cancer-causing agents). These impurities would not be expected from a typical fermentation and distillation process but may be present in the manufacturing environment of fuel or technical-grade ethanol, due to the use of certain chemicals, equipment or containers.
The FDA is working with industry to ensure that harmful levels of impurities are not present if ethanol is used in these products. 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.
-snip-
Read more: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-protect-public-health-increase-supply-alcohol-based
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