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FDA Temporarily Lowers Hand Sanitizer Purity Requirements

June 3, 2020
The agency said they would allow more impurities in alcohol-based hand sanitizer.

In a statement from the Food and Drug Administration, the federal government announced it would relax regulations on impurities in alcohol-based hand sanitizer. The move, announced today by FDA Commissioner Stephen M. Hahn, M.D., is intended to “help ensure widespread access to hand sanitizers during the COVID-19 public health emergency.”

According to the FDA, the agency previously updated its restrictions in April in response to requests from fuel ethanol manufacturers, who had pivoted their supply chains to produce hand sanitizer instead of fuel.

The FDA’s statement said that data produced by those manufacturers showed their fuel ethanol products contained gasoline and benzene, which it said were known carcinogens. The updated guidance allows hand sanitizer to include up to 2 parts per million of benzene.

The coronavirus pandemic has stretched supply chains around the world to the breaking point by playing havoc with the economies and industrial sectors of entire countries. Now, even as the United States has reopened most of its factories, sharp demand for products required to maintain stricter cleanliness standards has put suppliers under strain. The Institute of Supply Managers listed hand sanitizer and a variety of PPE as supplies in notably short supply during May.

The FDA recommends use of hand sanitizer containing at least 60% alcohol as a substitute for washing with ordinary soap and water, and hand sanitizer stations for workers to regularly clean their hands at have become a common feature of reopened factories invested in keeping workers healthy.

While many manufacturers of durable goods have repurposed supply chains to producing face shields, masks, gloves, gowns, and similar products, alcohol-based hand sanitizer has proven a popular COVID-19 relief product for chemical companies and brewers to manufacture at scale. Dow Chemical Co., Ineos, and small distilleries all around the world have turned their stocks of chemical alcohol and chemistry equipment into supply lines for the cleaning agent.

About the Author

EHS Today Staff

EHS Today's editorial staff includes:

Dave Blanchard, Editor-in-Chief: During his career Dave has led the editorial management of many of Endeavor Business Media's best-known brands, including IndustryWeekEHS Today, Material Handling & LogisticsLogistics Today, Supply Chain Technology News, and Business Finance. In addition, he serves as senior content director of the annual Safety Leadership Conference. With over 30 years of B2B media experience, Dave literally wrote the book on supply chain management, Supply Chain Management Best Practices (John Wiley & Sons, 2021), which has been translated into several languages and is currently in its third edition. He is a frequent speaker and moderator at major trade shows and conferences, and has won numerous awards for writing and editing. He is a voting member of the jury of the Logistics Hall of Fame, and is a graduate of Northern Illinois University.

Adrienne Selko, Senior Editor: In addition to her roles with EHS Today and the Safety Leadership Conference, Adrienne is also a senior editor at IndustryWeek and has written about many topics, with her current focus on workforce development strategies. She is also a senior editor at Material Handling & Logistics. Previously she was in corporate communications at a medical manufacturing company as well as a large regional bank. She is the author of Do I Have to Wear Garlic Around My Neck?, which made the Cleveland Plain Dealer's best sellers list.

Nicole Stempak, Managing Editor:  Nicole Stempak is managing editor of EHS Today and conference content manager of the Safety Leadership Conference.

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